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BEERSE, Belgien--(BUSINESS WIRE)--Janssen-Cilag International NV meldete heute die Veröffentlichung von Daten, die ein radiologisch nachgewiesenes progressionsfreies Überleben (rPFS) von 16,5 Monaten (95% CI, 13,5–20,0) und eine Behandlungsdauer von 11,6 Monaten (95% CI, 10,2–12,8) bei mit ZYTIGA® (Abirateronacetat) plus Prednison (AAP) behandelten Männern unter Alltagsbedingungen, außerhalb von klinischen Studien, zeigen. In der Studie wurden Männer beurteilt, die wegen metastasiertem, kastrationsresistentem Prostatakrebs (mCRPC) mit keinen oder nur leichten Symptomen im Anschluss an eine Androgendeprivationstherapie (ADT) behandelt wurden.1 Diese wertvollen Erkenntnisse zeigten sich trotz der Alltagsbedingungen der Studienpopulation, darunter Patienten mit schlechter Prognose oder schwer zu behandelnde Patienten, die in der Regel von klinischen Studien ausgeschlossen sind. Diese Daten sind Teil eines umfassenden Portfolios im Bereich Real-World Evidence (RWE), das Janssen auf dem diesjährigen American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) in Orlando, Florida, vorgestellt hatte. „Die Evidenzforschung unter Alltagsbedingungen ist in der patientenbezogenen klinischen Praxis zentral, da sie den Ärzten hilft, besser auf die Bedürfnisse der Patienten einzugehen. Sie ergänzt Daten, die aus klinischen Studien gewonnen wurden, um zu einem besseren Verständnis der Behandlungsergebnisse, des Krankheitsmanagements und des Einflusses auf die Lebensqualität bei breiten Patientenpopulationen, darunter solche mit Komorbiditäten, beizutragen“, sagte Dr. Martin Bögemann, Urologie, Universitätsklinikum Münster, Münster, Deutschland. „Es ist hilfreich festzustellen, dass neue Daten zu Behandlungsergebnissen bei Patienten unter Alltagsbedingungen diejenigen bestätigen, die im Umfeld klinischer Studien gewonnen wurden. Diese neuen Erkenntnisse ergänzen den wachsenden Bestand an Nachweisen unter Alltagsbedingungen, der in Europa zur Verfügung steht und der uns mehr und mehr hilft, die besten Therapien zu wählen, um die Behandlungsergebnisse für die Patienten zu transformieren.“ Patienten der Zulassungsstudie COU–AA–302 erzielten eine mediane Behandlungsdauer von 13,8 Monaten (IQR, 8,3–27,4) und ein medianes rPFS von 16,5 Monaten (95% CI, 13,8–16,8).1,2,3,4 Die Ergebnisse waren in beiden Settings ähnlich, obwohl fast 10 % der Patienten in der RWE-Studie viszerale Metastasen (Metastasen an inneren Organen, das heißt der Leber und/oder Lungen) und/oder einen Performance-Status der Eastern Cooperative Oncology Group (ECOG) von 2 bis 3 (nicht arbeitsfähig, Selbstversorgung jedoch ganz oder teilweise möglich) hatten.1 Diese Patienten wurden nicht in die COU-AA-302-Studie einbezogen.4 Dr. Ivo Winiger-Candolfi, Oncology Therapeutic Area Lead, Janssen Europe, Middle East and Africa (EMEA), sagte: „Evidenz unter Alltagsbedingungen ist äußerst wertvoll, da sie Erkenntnisse bietet, die klinische Studien ergänzen und bedeutende Einblicke in die Leistung und den Einsatz eines Arzneimittels in realen medizinischen Settings gibt, was schließlich in die bestmögliche Behandlung der Patienten umgesetzt wird. Dies wird insbesondere bei Prostatakrebs deutlich, da dies die häufigste Krebserkrankung bei Männern ist, die zudem eine vielfältige Patientenpopulation mit unterschiedlichem Behandlungsbedarf aufweist. Janssen unterstützt weiterhin die Evidenzforschung unter Alltagsbedingungen, um dabei zu helfen, die Behandlungsergebnisse der Patienten zu transformieren, damit Krebs in der Zukunft besser beherrschbar sein wird.” Prostatakrebs ist die am häufigsten diagnostizierte Krebsart bei Männern, mit über 400.000 neu diagnostizierten Fällen jährlich in Europa.6 Die neuesten Prostatakrebs-Zahlen belegen, dass gegenwärtig drei Millionen Männer in Europa von dieser Erkrankung betroffen sind.7 Die Boegemann-et-al.-Studie ist eine retrospektive Untersuchung der Akten (Chart Review) von 224 Patienten mit mCRPC mit keinen oder nur leichten Symptomen nach einer Androgendeprivationstherapie, die mit ZYTIGA (Abirateronacetat) plus Prednison (AAP) in 18 Zentren in Belgien, Deutschland und Großbritannien behandelt wurden.1 Das Prostatakrebsregister wurde 2013 als langfristige Initiative von Janssen ins Leben gerufen, um die optimale Behandlung von mCRPC in der Routinepraxis zu ermitteln. Das Register wurde in Zusammenarbeit mit Fachärzten auf dem Gebiet des mCRPC konzipiert. Die beobachteten Patienten werden in diversen Umgebungen in der Onkologie und Urologie behandelt, woraus sich ein Bild der routinemäßigen klinischen Praxis ergeben soll. 8 1 Boegemann et al. Real-World Treatment with Abiraterone Acetate in Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer Patients. Poster präsentiert auf dem American Society of Clinical Oncology Genitourinary Symposium 2017, 16. bis 18. Februar, Orlando, Florida, USA. Posterpräsentation. ASCO GU Abstract #239. Zuletzt abgerufen im Februar 2017. 2 Rathkopf et al. Updated Interim Efficacy Analysis and Long-term Safety of Abiraterone Acetate in Metastatic Castration-resistant Prostate Cancer Patients Without Prior Chemotherapy (COU-AA-302). EUROPEAN UROLOGY 2014; 66: 815-825. Zuletzt abgerufen im Februar 2017. 3 Ryan CJ, Smith MR, de Bono JS, et al. Abiraterone in Metastatic Prostate Cancer without Previous Chemotherapy. N Engl J Med. 2013 Jan; 368(2): 138 - 48. 4 Ryan C.J et al. Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study. The Lancet Oncology. 2015; 16, 2: p152-160. Verfügbar unter: http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(14)71205-7/abstract. Zuletzt abgerufen im Februar 2017. 5 Chowdhury S et al. The Prostate Cancer Registry: Real-World outcomes in first-line treatment of metastatic castration-resistant prostate cancer (mCRPC). Poster präsentiert auf dem American Society of Clinical Oncology Genitourinary Symposium 2017, 16. bis 18. Februar, Orlando, Florida. Posterpräsentation. ASCO GU abstract #212. Zuletzt abgerufen im Februar 2017. 6 Ferlay J et al. Cancer incidence and mortality patterns in Europe: Estimates for 40 countries in 2012. European Journal of Cancer. 2013; 49: p1374–1403. Zuletzt abgerufen im Februar 2017. 8 Chowdhury S et al. The Prostate Cancer Registry: First Results from an International, Prospective, Observational Study of Men with Metastatic Castration- Resistant Prostate Cancer (mCRPC). Poster präsentiert auf dem Europäischen Krebskongress 2015, 25. bis 29. September, Wien, Österreich. Posterpräsentation. ECC abstract #2548. Verfügbar unter: https://www.europeancancercongress.org/Scientific-Programme/Abstract-search?abstractid=21001. Zuletzt abgerufen im Februar 2017. 10 Hoy, SM. et al. Abiraterone Acetate: A review of its use in patients with metastatic castration-resistant prostate cancer drugs. Drugs 2013; 73:2077-2091. Zuletzt abgerufen im Februar 2017. 11 Ritch, CR. Cookson, MS. Advances in the management of castration resistant prostate cancer. BMJ. 2016 Oct 17;355:i4405. Doi: 10.1136/bmj.i4405. Zuletzt abgerufen im Februar 2017. 12 Ye,D. A phase 3, double-blind, randomized placebo-controlled efficacy and safety study of abiraterone acetate in chemotherapy-naïve patients with mCRPC in China, Malaysia, Thailand and Russia. Asian Journal of Urology. 2017.Doi.org/10.1016/j.ajur.2017.01.002. Zuletzt abgerufen im Februar 2017


BOUDRY, Switzerland--(BUSINESS WIRE)--Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that the European Commission (EC) has approved REVLIMID® (lenalidomide) as monotherapy for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation (ASCT). REVLIMID® is the first and only licensed maintenance treatment available to these patients. The REVLIMID® Marketing Authorisation has been updated to include this new indication, which expands on the existing multiple myeloma indications as combination therapy for the treatment of those not eligible for transplant who are newly diagnosed, or have received at least one prior therapy. Multiple myeloma is an incurable and life-threatening blood cancer that is characterised by tumour proliferation and suppression of the immune system.1 It is a rare but deadly disease: around 39,000 people are diagnosed with multiple myeloma in Europe, and around 24,000 people die from the disease each year.2 The median age at diagnosis in Europe is between 65 and 70 years.3 In Europe, patients who are fit and in good clinical condition are typically considered eligible for ASCT.4 For patients who are newly diagnosed with multiple myeloma and eligible for ASCT, key treatment goals are to delay disease progression and ultimately achieve long-term control over multiple myeloma.5 These patients typically receive induction therapy and high-dose chemotherapy with melphalan followed by ASCT. This treatment approach has been an established standard of care for over 20 years.6 Considering that over half of those patients who relapse do so within 2 to 3 years of ASCT,7,8 the approval of a maintenance therapy for use after ASCT that may delay disease progression represents a major advance for these patients. “ After ASCT, most patients will still see their disease recur or progress. We now have an opportunity to enhance immune function and delay disease progression by controlling residual malignant cells and slowing tumour growth. REVLIMID® has been shown to increase progression-free survival after ASCT in clinical trials. Having a licensed therapy for use in this very important setting means we now have the opportunity to delay disease progression by sustaining the response,” says Professor Michel Attal, Executive Director of the Institut Universitaire du Cancer Toulouse Oncopole and Institut Claudius Regaud, France. The EC decision to approve REVLIMID® as monotherapy for multiple myeloma in the post-ASCT setting was based on the results of two cooperative group-led studies, CALGB 1001049 and IFM 2005-02.10 In both studies, the primary efficacy endpoint in the study was progression-free survival (PFS) from transplant to the date of disease progression or death, whichever occurred first. REVLIMID® monotherapy as maintenance treatment post-ASCT significantly reduced the risk of disease progression or death in patients with multiple myeloma, leading to the studies being unblinded based on passing their pre-specified boundary for superiority at interim analysis. The updated PFS, using a cut-off of 1 February 2016 continues to show a PFS advantage: Individual studies were not powered for an overall survival (OS) endpoint. Using a cut-off of 1 February 2016, a descriptive analysis showed that the median overall survival in the CALGB 100104 was 111.0 months (95% CI, 101.8, not estimable) for patients who received REVLIMID versus 84.2 (95% CI 71.0, 102.7) in the placebo arm (HR=0.61; 95% CI 0.46, 0.81; p<0.001). In the IFM 2005-02 study, median overall survival was 105.9 months (95% CI, 88.8, not estimable) for patients who received REVLIMID versus 88.1 (95% CI 80.7, 108.4) in the placebo arm (HR=0.90; 95% CI 0.72, 1.13; p=0.355, not significant). In both of these phase III studies, the safety profile was in line with other clinical data in newly diagnosed non-stem cell transplant and a post-approval safety study in relapsed/refractory multiple myeloma. The most commonly reported adverse events in these two studies were haematological, and included neutropenia and thrombocytopenia. The most commonly reported non-haematological adverse events were infections. An increased incidence rate of haematological second primary malignancies (SPMs) was also observed in the REVLIMID® group compared with the placebo group in both studies. However, the EC decision confirms that the benefit-risk ratio for REVLIMID® is positive in this expanded indication. Tuomo Pätsi, President of Celgene European and International Operations, said, “ We are glad to provide a treatment option for these patients with multiple myeloma, who have previously had no licensed medicine available to them for maintenance treatment following ASCT. This latest approval underlines the important role of REVLIMID® in the treatment of multiple myeloma, extending its use across the disease spectrum, and demonstrating our commitment to multiple myeloma patients. We continue to invest in research and development as we strive to turn multiple myeloma – and other currently incurable diseases – into manageable conditions.” The EC decision for the use of REVLIMID® as monotherapy for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone ASCT follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) in January 2017. Celgene announced on 22 February 2017 that the U.S. Food and Drug Administration (FDA) has expanded the existing indication for REVLIMID® to include use for patients with multiple myeloma as maintenance therapy following autologous hematopoietic stem cell transplant in the U.S. CALGB 100104 was a phase III, randomised, controlled, double-blind, multi-centre study conducted in 47 centres in the United States. A total of 460 patients newly diagnosed with multiple myeloma – aged between 18 and 70 years – who achieved at least stable disease or better 100 days after undergoing autologous stem cell transplant, were randomised to receive either REVLIMID® maintenance (10 mg/day for 3 months, then 15 mg/day) or placebo, until disease progression, intolerable side effects or death. IFM 2005-02 was a phase III, controlled, double-blind, multi-centre study conducted in 77 centres across 3 countries in Europe. A total of 614 patients newly diagnosed with multiple myeloma, who were younger than 65 years without signs of disease progression within 6 months of undergoing autologous stem cell transplant, were then randomised to receive a 2-month consolidation regimen of REVLIMID® monotherapy, 25 mg per day on 21/28 days, followed by either REVLIMID® maintenance (10 mg/day for 3 months, then 15 mg/day) or placebo, until disease progression, intolerable side effects or death. REVLIMID® as combination therapy is approved in Europe, in the United States, in Japan and in around 25 other countries for the treatment of adult patients with previously untreated multiple myeloma (MM) who are not eligible for transplant. REVLIMID® is also approved in combination with dexamethasone for the treatment of patients with MM who have received at least one prior therapy in nearly 70 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand. REVLIMID® is also approved in the United States, Canada, Switzerland, Australia, New Zealand and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities and in Europe for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. In addition, REVLIMID® is approved in Europe and in the United States for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. In Switzerland, REVLIMID is indicated for the treatment of patients with relapsed or refractory MCL after prior therapy that included bortezomib and chemotherapy/rituximab. REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials. REVLIMID® (lenalidomide) is contraindicated in patients with known hypersensitivity to the active substance or to any of the excipients in the formulation. REVLIMID® (lenalidomide) is contraindicated during pregnancy, and also in women of childbearing potential unless all of the conditions of the Pregnancy Prevention Programme are met. Pregnancy: the conditions of the Pregnancy Prevention Programme must be fulfilled for all patients unless there is reliable evidence that the patient does not have childbearing potential. Cardiovascular disorders: patients with known risk factors for myocardial infarction or thromboembolism should be closely monitored. Neutropenia and thrombocytopenia: complete blood cell counts should be performed every week for the first 8 weeks of treatment and monthly thereafter to monitor for cytopenias. A dose reduction may be required. Infection with or without neutropenia: all patients should be advised to seek medical attention promptly at the first sign of infection. Renal impairment: monitoring of renal function is advised in patients with renal impairment. Thyroid disorders: optimal control of co-morbid conditions influencing thyroid function is recommended before start of treatment. Baseline and ongoing monitoring of thyroid function is recommended. Tumour lysis syndrome: patients with high tumour burden prior to treatment should be monitored closely and appropriate precautions taken. Allergic reactions: patients who had previous allergic reactions while treated with thalidomide should be monitored closely. Severe skin reactions: REVLIMID® (lenalidomide) must be discontinued for exfoliative or bullous rash, or if SJS or TEN is suspected, and should not be resumed following discontinuation for these reactions. Interruption or discontinuation of lenalidomide should be considered for other forms of skin reaction depending on severity. Patients with a history of severe rash associated with thalidomide treatment should not receive lenalidomide. Lactose intolerance: patients with rare hereditary problems of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Second primary malignancies (SPM): the risk of occurrence of hematologic SPM must be taken into account before initiating treatment with REVLIMID® (lenalidomide) either in combination with melphalan or immediately following high-dose melphalan and autologous stem cell transplant (ASCT). Physicians should carefully evaluate patients before and during treatment using standard cancer screening for occurrence of SPM and institute treatment as indicated. Hepatic disorders: dose adjustments should be made in patients with renal impairment. Monitoring of liver function is recommended, particularly when there is a history of or concurrent viral liver infection or when REVLIMID® (lenalidomide) is combined with medicinal products known to be associated with liver dysfunction. Newly diagnosed multiple myeloma patients: patients should be carefully assessed for their ability to tolerate REVLIMID® (lenalidomide) in combination, with consideration to age, ISS stage III, ECOG PS≤2 or CLcr<60 mL/min. Summary of the safety profile in multiple myeloma Newly diagnosed multiple myeloma: patients who have undergone ASCT treated with REVLIMID® (lenalidomide) maintenance: Newly diagnosed multiple myeloma: patients who are not eligible for transplant treated with REVLIMID® (lenalidomide) in combination with low dose dexamethasone: Newly diagnosed multiple myeloma: patients who are not eligible for ASCT treated with REVLIMID® (lenalidomide) in combination with melphalan and prednisone: Patients with multiple myeloma who have received at least one prior therapy: Paediatric population: REVLIMID® (lenalidomide) should not be used in children and adolescents from birth to less than 18 years. Older people with newly diagnosed multiple myeloma: for patients older than 75 years of age treated with REVLIMID® (lenalidomide) in combination with dexamethasone, the starting dose of dexamethasone is 20 mg/day on Days 1, 8, 15 and 22 of each 28-day treatment cycle. No dose adjustment is proposed for patients older than 75 years who are treated with REVLIMID® (lenalidomide) in combination with melphalan and prednisone. Older people with multiple myeloma who have received at least one prior therapy: care should be taken in dose selection and it would be prudent to monitor renal function. Patients with renal impairment: care should be taken in dose selection and monitoring of renal function is advised. No dose adjustments are required for patients with mild renal impairment and multiple myeloma. Dose adjustments are recommended at the start of therapy and throughout treatment for patients with moderate or severe impaired renal function or end stage renal disease. Patients with hepatic impairment: REVLIMID® (lenalidomide) has not formally been studied in patients with impaired hepatic function and there are no specific dose recommendations. Please refer to the Summary of Product Characteristics for full European prescribing information. Celgene International Sàrl, located in Boudry, Switzerland, is a wholly-owned subsidiary and International Headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, FaceBook and YouTube. This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. Celgene undertakes no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond Celgene’s control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in Celgene’s Annual Report on Form 10-K and other reports filed with the Securities and Exchange Commission. All registered trademarks are owned by Celgene Corporation. 9 McCarthy PL, et al. N Engl J Med. 2012;366(19):1770-1781. CALGB is the cooperative group Cancer and Leukemia Group B (now known as Alliance). 10 Attal M, et al. N Engl J Med. 2012;366(19):1782-1791. IFM is the cooperative group Intergroupe Francophone du Myélome.


NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) today announced that a Biologics License Application (BLA) for inotuzumab ozogamicin has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA). Inotuzumab ozogamicin is being evaluated for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Inotuzumab ozogamicin received Breakthrough Therapy designation from the FDA in October 2015 for ALL. Priority Review status accelerates FDA review time from 10 months to a goal of six months from the day of acceptance of filing, and is given to drugs that may offer major advances in treatment or may provide a treatment for which no adequate therapy exists. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in August 2017. “ALL that has recurred after, or is refractory to, first-line therapy is a rapidly progressing and deadly disease,” said Mace Rothenberg, MD, chief development officer, Oncology, Pfizer Global Product Development. “Based on the positive results of the INO-VATE 1022 Phase 3 trial, we believe inotuzumab ozogamicin, if approved, represents a new treatment option for adult patients with relapsed or refractory B-cell precursor ALL.” In addition, a Marketing Authorization Application (MAA) for inotuzumab ozogamicin in the same patient population is currently under review by the European Medicines Agency (EMA). The submissions are based on results from the Phase 3 INO-VATE 1022 trial, which enrolled 326 adult patients with relapsed or refractory B-cell ALL and compared inotuzumab ozogamicin to standard of care chemotherapy. The INO-VATE 1022 study had two independent primary endpoints, complete response with or without hematologic remission (CR/CRi) and overall survival (OS). Results from the trial were published in The New England Journal of Medicine in June 2016. Acute lymphoblastic leukemia (ALL) is an aggressive type of leukemia with a poor prognosis in adults.1 The current foundational treatment is intensive, long-term chemotherapy.2 In 2017, it is estimated that 5,970 cases of ALL will be diagnosed in the United States, with about 2 in 5 cases occurring in adults.3 Approximately 20 to 40 percent of newly diagnosed adults with ALL are cured with current treatment regimens.4 For patients with relapsed or refractory adult ALL, the five-year overall survival rate is less than 10 percent.5 Inotuzumab ozogamicin is an investigational antibody-drug conjugate (ADC) comprised of a monoclonal antibody (mAb) targeting CD22, a cell surface antigen expressed on approximately 90 percent of B-cell malignancies, linked to a cytotoxic agent.6 When inotuzumab ozogamicin binds to the CD22 antigen on B-cells, it is internalized into the cell, where the cytotoxic agent calicheamicin is released to destroy the cell.7 The most common adverse events (AEs) observed in clinical trials for inotuzumab ozogamicin were cytopenias, including febrile neutropenia. Common nonhematologic treatment-emergent AEs with inotuzumab ozogamicin included nausea, headache and pyrexia. Additionally, veno-occlusive liver disease (VOD) was observed more frequently in patients treated with inotuzumab ozogamicin, especially those who went on to receive hematopoietic stem cell transplantation. Inotuzumab ozogamicin originates from a collaboration between Pfizer and Celltech, now UCB. Pfizer has sole responsibility for all manufacturing and clinical development activities for this molecule. Pfizer Oncology is committed to pursuing innovative treatments that have a meaningful impact on those living with cancer. As a leader in oncology speeding cures and accessible breakthrough medicines to patients, Pfizer Oncology is helping to redefine life with cancer. Our strong pipeline of biologics, small molecules and immunotherapies, one of the most robust in the industry, is studied with precise focus on identifying and translating the best scientific breakthroughs into clinical application for patients across a wide range of cancers. By working collaboratively with academic institutions, individual researchers, cooperative research groups, governments and licensing partners, Pfizer Oncology strives to cure or control cancer with its breakthrough medicines. Because Pfizer Oncology knows that success in oncology is not measured solely by the medicines you manufacture, but rather by the meaningful partnerships you make to have a more positive impact on people’s lives. Pfizer Inc.: Working together for a healthier world® At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of healthcare products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer healthcare products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. For more information, please visit us at www.pfizer.com. In addition, to learn more, follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube, and like us on Facebook at Facebook.com/Pfizer. DISCLOSURE NOTICE: The information contained in this release is as of February 21, 2017. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about inotuzumab ozogamicin, an investigational oncology therapy, including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical trial commencement and completion dates and regulatory submission dates, as well as the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; whether and when applications for inotuzumab ozogamicin may be filed in any other jurisdictions; whether and when the BLA, MAA and any other such applications for inotuzumab ozogamicin may be approved by the FDA, the EMA or other regulatory authorities, respectively, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of inotuzumab ozogamicin; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. 1 National Cancer Institute: Adult Acute Lymphoblastic Leukemia Treatment (PDQ®) – General Information About Adult Acute Lymphoblastic Leukemia (ALL). Available at: http://www.cancer.gov/cancertopics/pdq/treatment/adultALL/HealthProfessional/page1. Accessed March 21, 2016. 2 American Cancer Society: Typical treatment of acute lymphocytic leukemia. Available at: http://www.cancer.org/cancer/leukemia-acutelymphocyticallinadults/detailedguide/leukemia-acute-lymphocytic-treating-typical-treatment. Accessed March 21, 2016. 3 American Cancer Society: What are the key statistics about acute lymphocytic leukemia? Available at:http://www.cancer.org/cancer/leukemia-acutelymphocyticallinadults/detailedguide/leukemia-acute-lymphocytic-key-statistics . Accessed January 26, 2017. 4 Manal Basyouni A. et al. Prognostic significance of survivin and tumor necrosis factor-alpha in adult acute lymphoblastic leukemia. doi:10.1016/j.clinbiochem.2011.08.1147. 5 Fielding A. et al. Outcome of 609 adults after relapse of acute lymphoblastic leukemia (ALL); an MRC UKALL12/ECOG 2993 study. Blood. 2006; 944-950. 6 Leonard J et al. Epratuzumab, a Humanized Anti-CD22 Antibody, in Aggressive Non-Hodgkin’s Lymphoma: a Phase I/II Clinical Trial Results. Clinical Cancer Research. 2004; 10: 5327-5334. 7 DiJoseph JF. Antitumor Efficacy of a Combination of CMC-544 (Inotuzumab Ozogamicin), a CD22-Targeted Cytotoxic Immunoconjugate of Calicheamicin, and Rituximab against Non-Hodgkin’s B-Cell Lymphoma. Clin Cancer Res. 2006; 12: 242-250.


News Article | February 15, 2017
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London: Tuesday, February 14, 2017: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) and AstraZeneca PLC ("AstraZeneca") will present data from the ongoing Phase II clinical trial of savolitinib in patients with papillary renal cell carcinoma ("PRCC") at the 2017 Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncology ("ASCO-GU"), to be held in Orlando, Florida from February 16 to 18, 2017. Savolitinib, a highly selective inhibitor of c-Met receptor tyrosine kinase, has shown early clinical benefit in multiple Phase I and II studies in a number of cancers. It was developed as a potent and highly selective oral inhibitor specifically designed to address issues observed in the clinic with first-generation c-Met inhibitors, including renal toxicity. PRCC, the second most common histologic subtype of renal cell carcinoma ("RCC"), is associated with alterations in the c-Met gene (e.g. mutations, amplifications, and/or chromosomal changes). Therapies that are currently available for RCC patients have demonstrated only modest benefit in PRCC and there are no therapies specifically approved for the treatment of c-Met-driven PRCC. National Comprehensive Cancer Network guidelines recommend enrolling patients in clinical trials for first-line systemic therapy. "There is a clear unmet medical need in PRCC," said Toni Choueiri, Director of the Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute. "The dataset from this Phase II study is compelling, with a very clear efficacy signal in MET-driven patients and an encouraging long duration of response, while remaining very well tolerated." He added, "These results support the initiation of the pivotal Phase III trial in a selected population of MET-driven PRCC. This innovative patient selection approach would be the first ever molecularly selected trial in renal cell carcinoma." "We are delighted to report this highly encouraging progression-free survival data in Met-driven papillary renal cell carcinoma, a disease with no approved treatment options," said Christian Hogg, Chief Executive Officer of Chi-Med. "With development of the companion diagnostic assay to screen Met-driven disease now also complete we are preparing for the initiation of our global Phase III study, the first global registration trial for savolitinib." The current Phase II trial is the largest prospective clinical study ever conducted in PRCC patients. It is a global single arm study of savolitinib in 109 patients with locally advanced or metastatic PRCC and was initiated in May 2014. It is being conducted in 22 clinical centers in the US, Canada, UK, and Spain, and completed enrollment in October 2015. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02127710. The most recent results of the study will be presented in detail as follows: Once presented, the presentation will be available at www.chi-med.com/news. Further information about ASCO-GU is available at gucasym.org. Chi-Med and AstraZeneca are currently initiating a global pivotal Phase III trial, the first pivotal study ever conducted in c-Met-driven PRCC and the first molecularly selected trial in RCC. Over the course of 2017, Chi-Med and AstraZeneca are also conducting a comprehensive molecular epidemiology study of approximately 300 PRCC patient samples to further understand the correlations between c-Met alterations and patient outcomes, including any predictive biomarkers. ABSTRACT A single-arm biomarker-based phase II trial of savolitinib in patients with advanced papillary renal cell cancer (PRCC) 1Dana-Farber Cancer Institute, Boston, US 2Fox Chase Cancer Center, Philadelphia, US 3Sarah Cannon Research Institute, London, UK 4MD Anderson Cancer Centre, Houston, US 5Tom Baker Cancer Center, Calgary, Canada 6Barts Cancer Institute, London, UK 7AstraZeneca, Waltham, US, 8AstraZeneca, Cambridge, UK 9Institute Gustave Roussy, Paris, France 10City of Hope, Duarte, US Background: Savolitinib (HMPL-504/Volitinib, AZD6094) is a potent, selective mesenchymal epithelial transition ("MET") inhibitor (IC of 4 nM). MET and its ligand, hepatocyte growth factor ("HGF"), are known to play an important role in the molecular events underlying oncogenesis in PRCC, a disease without a clear standard of care and marked by alterations of chromosome 7 (containing both MET and HGF genes) in a majority of patients as well as gene amplification or MET kinase domain mutations (Albiges et al 2014, Linehan et al, 2015). Methods: This study evaluates savolitinib in PRCC patients dosed at 600 mg daily until disease progression. Objective Response Rate ("ORR") is the primary endpoint. Progression-Free Survival ("PFS") & Duration of Response are secondary endpoints. Patient Reported Outcome ("PRO") and Health-Related Quality of Life ("HRQoL") questionnaires are exploratory endpoints. Eligibility includes naïve and previously treated metastatic PRCC, ECOG PS 0 or 1. Archival tumor was used to centrally confirm PRCC pathology post hoc and to determine MET status using Next Generation Sequencing (Foundation Medicine Inc, US). Results: As of 27 June 2016, 109 patients were dosed. Best response was PR n=8, SD n=43, PD n=48 & 10 patients were not evaluable for response. 44 patients are MET-driven (MET/HGF gene copy number gain or kinase domain mutations), 46 patients were MET-negative, 19 patients are status unknown. MET-driven pts included Papillary Type I & II histologies. All 8 responders were in the MET-driven group, 18% ORR in this subset. Median PFS in the MET-driven group was 6.2 months (95% CI: 4.1-7.0) vs. 1.4 months (95% CI: 1.4-2.7) in the MET-negative group (p=0.002). Overall 10/109 patients had adverse events ("AEs") leading to discontinuation. 23/109 patients had ≥ Grade 3 toxicity related to savolitinib. The most common AEs (all grades) includes: nausea (39%), fatigue (27%), edema (18%) and abnormal liver function tests (LFTs) (17%). One death from hepatic encephalopathy was considered related to savolitinib. PRO & HRQoL data was not statistically analyzed, descriptive data support main efficacy findings. Conclusions: In the largest biomarker-profiled trial dedicated to PRCC, savolitinib was generally well tolerated with anti-tumor activity in MET-driven patients. These findings warrant further clinical investigation of savolitinib in MET-driven PRCC. About the Unmet Medical Need in c-Met-Driven PRCC Patients Worldwide, about 366,000 new patients are diagnosed with kidney cancer annually, and the total market for kidney cancer treatments is expected to reach US$4.5 billion in 2020, according to Frost & Sullivan. RCC accounts for approximately 80-85% of kidney cancer and has several histological sub-types with different genetic and biochemical characteristics. Among these histologic variants of RCC, clear cell RCC ("ccRCC") is the most common, accounting for 75-80% of RCC. PRCC is the most common of the non-clear cell renal carcinomas accounting for 10-15% of RCC. The proportion of PRCC patients whose tumors are c-Met-driven has historically been estimated at 40-70%. In the largest study to date, presented at the annual meeting of the American Association for Cancer Research 2014, analysis of 220 frozen tumor samples catalogued in the French RCC Network indicated that 55-60% of PRCC patients showed gains in Chromosome 7 (i.e. c-Met amplification). The biology and molecular characteristics of PRCC are different from those of ccRCC. This results in significantly worse prognosis and treatment outcomes for patients with PRCC when compared to patients with ccRCC. Highlighting the unmet need is the fact that, although there are several drugs approved for use in RCC (the latest being approved in April 2016), these approvals were generally on the basis of studies conducted with a preponderance of ccRCC patients. The need for different agents and more specific data tailored to the PRCC disease setting has been identified as a critical gap in the care of these patients. About Chi-Med Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare-related consumer products. Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China. Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com. About AstraZeneca in Oncology AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients' lives and the Company's future. With at least six new medicines to be launched between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca's six Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in hematology. By harnessing the power of four scientific platforms - Immuno-Oncology, the genetic drivers of cancer and resistance, DNA Damage Response and Antibody Drug Conjugates - and by championing the development of personalized combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death. About AstraZeneca AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect Chi-Med's current expectations regarding future events, including its expectations for the clinical development of savolitinib, plans to initiate clinical studies for savolitinib in PRCC, its expectations as to whether such studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates, timing and availability of subjects meeting a study's inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of drug candidate savolitinib to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions, to gain commercial acceptance after obtaining regulatory approval, the potential market of savolitinib for a targeted indication and the sufficiency of funding. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see Chi-Med's filings with the US Securities and Exchange Commission and on AIM. Chi-Med undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.


LONDON--(BUSINESS WIRE)--Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) and AstraZeneca PLC (“AstraZeneca”) will present data from the ongoing Phase II clinical trial of savolitinib in patients with papillary renal cell carcinoma (“PRCC”) at the 2017 Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncology (“ASCO-GU”), to be held in Orlando, Florida from February 16 to 18, 2017. Savolitinib, a highly selective inhibitor of c-Met receptor tyrosine kinase, has shown early clinical benefit in multiple Phase I and II studies in a number of cancers. It was developed as a potent and highly selective oral inhibitor specifically designed to address issues observed in the clinic with first-generation c-Met inhibitors, including renal toxicity. PRCC, the second most common histologic subtype of renal cell carcinoma (“RCC”), is associated with alterations in the c-Met gene (e.g. mutations, amplifications, and/or chromosomal changes). Therapies that are currently available for RCC patients have demonstrated only modest benefit in PRCC and there are no therapies specifically approved for the treatment of c-Met-driven PRCC. National Comprehensive Cancer Network guidelines recommend enrolling patients in clinical trials for first-line systemic therapy. “There is a clear unmet medical need in PRCC,” said Toni Choueiri, Director of the Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute. “The dataset from this Phase II study is compelling, with a very clear efficacy signal in MET-driven patients and an encouraging long duration of response, while remaining very well tolerated.” He added, “These results support the initiation of the pivotal Phase III trial in a selected population of MET-driven PRCC. This innovative patient selection approach would be the first ever molecularly selected trial in renal cell carcinoma.” “We are delighted to report this highly encouraging progression-free survival data in Met-driven papillary renal cell carcinoma, a disease with no approved treatment options,” said Christian Hogg, Chief Executive Officer of Chi-Med. “With development of the companion diagnostic assay to screen Met-driven disease now also complete we are preparing for the initiation of our global Phase III study, the first global registration trial for savolitinib.” The current Phase II trial is the largest prospective clinical study ever conducted in PRCC patients. It is a global single arm study of savolitinib in 109 patients with locally advanced or metastatic PRCC and was initiated in May 2014. It is being conducted in 22 clinical centers in the US, Canada, UK, and Spain, and completed enrollment in October 2015. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02127710. The most recent results of the study will be presented in detail as follows: Once presented, the presentation will be available at www.chi-med.com/news. Further information about ASCO-GU is available at gucasym.org. Chi-Med and AstraZeneca are currently initiating a global pivotal Phase III trial, the first pivotal study ever conducted in c-Met-driven PRCC and the first molecularly selected trial in RCC. Over the course of 2017, Chi-Med and AstraZeneca are also conducting a comprehensive molecular epidemiology study of approximately 300 PRCC patient samples to further understand the correlations between c-Met alterations and patient outcomes, including any predictive biomarkers. A single-arm biomarker-based phase II trial of savolitinib in patients with advanced papillary renal cell cancer (PRCC) 1Dana-Farber Cancer Institute, Boston, US 2Fox Chase Cancer Center, Philadelphia, US 3Sarah Cannon Research Institute, London, UK 4MD Anderson Cancer Centre, Houston, US 5Tom Baker Cancer Center, Calgary, Canada 6Barts Cancer Institute, London, UK 7AstraZeneca, Waltham, US, 8AstraZeneca, Cambridge, UK 9Institute Gustave Roussy, Paris, France 10City of Hope, Duarte, US Background: Savolitinib (HMPL-504/Volitinib, AZD6094) is a potent, selective mesenchymal epithelial transition (“MET”) inhibitor (IC of 4 nM). MET and its ligand, hepatocyte growth factor (“HGF”), are known to play an important role in the molecular events underlying oncogenesis in PRCC, a disease without a clear standard of care and marked by alterations of chromosome 7 (containing both MET and HGF genes) in a majority of patients as well as gene amplification or MET kinase domain mutations (Albiges et al 2014, Linehan et al, 2015). Methods: This study evaluates savolitinib in PRCC patients dosed at 600 mg daily until disease progression. Objective Response Rate (“ORR”) is the primary endpoint. Progression-Free Survival (“PFS”) & Duration of Response are secondary endpoints. Patient Reported Outcome (“PRO”) and Health-Related Quality of Life (“HRQoL”) questionnaires are exploratory endpoints. Eligibility includes naïve and previously treated metastatic PRCC, ECOG PS 0 or 1. Archival tumor was used to centrally confirm PRCC pathology post hoc and to determine MET status using Next Generation Sequencing (Foundation Medicine Inc, US). Results: As of 27 June 2016, 109 patients were dosed. Best response was PR n=8, SD n=43, PD n=48 & 10 patients were not evaluable for response. 44 patients are MET-driven (MET/HGF gene copy number gain or kinase domain mutations), 46 patients were MET-negative, 19 patients are status unknown. MET-driven pts included Papillary Type I & II histologies. All 8 responders were in the MET-driven group, 18% ORR in this subset. Median PFS in the MET-driven group was 6.2 months (95% CI: 4.1–7.0) vs. 1.4 months (95% CI: 1.4–2.7) in the MET-negative group (p=0.002). Overall 10/109 patients had adverse events (“AEs”) leading to discontinuation. 23/109 patients had ≥ Grade 3 toxicity related to savolitinib. The most common AEs (all grades) includes: nausea (39%), fatigue (27%), edema (18%) and abnormal liver function tests (LFTs) (17%). One death from hepatic encephalopathy was considered related to savolitinib. PRO & HRQoL data was not statistically analyzed, descriptive data support main efficacy findings. Conclusions: In the largest biomarker-profiled trial dedicated to PRCC, savolitinib was generally well tolerated with anti-tumor activity in MET-driven patients. These findings warrant further clinical investigation of savolitinib in MET-driven PRCC. About the Unmet Medical Need in c-Met-Driven PRCC Patients Worldwide, about 366,000 new patients are diagnosed with kidney cancer annually, and the total market for kidney cancer treatments is expected to reach US$4.5 billion in 2020, according to Frost & Sullivan. RCC accounts for approximately 80-85% of kidney cancer and has several histological sub-types with different genetic and biochemical characteristics. Among these histologic variants of RCC, clear cell RCC (“ccRCC”) is the most common, accounting for 75-80% of RCC. PRCC is the most common of the non-clear cell renal carcinomas accounting for 10-15% of RCC. The proportion of PRCC patients whose tumors are c-Met-driven has historically been estimated at 40-70%. In the largest study to date, presented at the annual meeting of the American Association for Cancer Research 2014, analysis of 220 frozen tumor samples catalogued in the French RCC Network indicated that 55-60% of PRCC patients showed gains in Chromosome 7 (i.e. c-Met amplification). The biology and molecular characteristics of PRCC are different from those of ccRCC. This results in significantly worse prognosis and treatment outcomes for patients with PRCC when compared to patients with ccRCC. Highlighting the unmet need is the fact that, although there are several drugs approved for use in RCC (the latest being approved in April 2016), these approvals were generally on the basis of studies conducted with a preponderance of ccRCC patients. The need for different agents and more specific data tailored to the PRCC disease setting has been identified as a critical gap in the care of these patients. Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare-related consumer products. Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China. Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com. AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s six Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in hematology. By harnessing the power of four scientific platforms – Immuno-Oncology, the genetic drivers of cancer and resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalized combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death. AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas – Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca. This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect Chi-Med’s current expectations regarding future events, including its expectations for the clinical development of savolitinib, plans to initiate clinical studies for savolitinib in PRCC, its expectations as to whether such studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of drug candidate savolitinib to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions, to gain commercial acceptance after obtaining regulatory approval, the potential market of savolitinib for a targeted indication and the sufficiency of funding. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see Chi-Med’s filings with the US Securities and Exchange Commission and on AIM. Chi-Med undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.


BOSTON--(BUSINESS WIRE)--MetaStat, Inc. (OTCQB:MTST), a pre-commercial biotechnology company, today announced results from two clinical studies of its MetaSite Breast™ test reported at the 39th San Antonio Breast Cancer Symposium (SABCS) demonstrating that the MetaSite Score was significantly associated with increased risk of distant metastasis in Hormone Receptor (HR-positive), HER2-negative Early Stage Breast Cancer (ESBC). Data include results from the Kaiser Permanente Cohort Case-Control Study and the ECOG2197 Clinical Trail Cohort Study led by the ECOG-ACRIN Cancer Research Group. “We are pleased to present positive results from two prospectively designed, retrospective studies of MetaSite Breast™ confirming the clinical validity of the association between MetaSite Score and distant cancer metastasis,” said Douglas A. Hamilton, MetaStat’s President and Chief Executive Officer. “Data generated from these studies demonstrate that our MetaSite Breast™ test offers the potential to more accurately guide treatment decisions when added to the most widely utilized gene expression assay, Oncotype DX.” “These results further support the importance of incorporating intact tissue-based analyses when generating prognostic risk models. The ability to visualize and quantify biological attributes in tissue sections will continue to advance the field of precision medicine,” added Michael J. Donovan, PhD, MD, MetaStat’s acting Chief Medical Officer. Results from the Kaiser Permanente Cohort Study conducted by MetaStat, demonstrated MetaSite Score was a statically significant predictor of distant metastasis and a binary cutpoint was able to discriminate high and low risk patient groups when adjusted for clinical factors. Dr. Joseph Sparano, principal investigator for MetaStat’s ECOG2197 Cohort Study, presented data demonstrating the MetaSite Breast™ test is prognostic for distant metastatic recurrence within 5 years and provides complementary prognostic and potentially clinically actionable information to the low/mid-range Recurrence Score from Genomic Health’s (NASDAQ:GHDX) Oncotype DX, breast cancer test. Independent verification and clinical validation of MetaStat’s fully automated and analytically validated tissue-based MetaSite Breast™ test for risk of cancer metastasis in HR-positive HER2-negative ESBC. The Kaiser Permanente Cohort Prognostic Study is a case-control nested cohort of 3,760 patients diagnosed with ESBC from the Kaiser Permanente Northwest Health Care System in which 464 tumor samples were tested using the MetaSite Breast™ assay. MetaSite Score was a statistically significant predictor of distant metastasis (p=0.039) in patients with HR-positive HER2-negative disease. Using predefined cutpoints based on tertiles for the control group in the overall study population (n=282), MetaSite Score was significantly associated with distant metastasis for the high (MS>41) versus low (MS<13) score tertiles (OR=2.94; 9%CI=1.62-5.41, p=0.0005) and the intermediate (MS=13-41) versus low score tertiles (OR=2.24; 95%CI=1.23-4.13, p=0.009). A binary cut-point for the high risk group (MS>14) was significant with a 2-fold higher risk (OR=2.1, 95%CI=1.06-3.96) of distant metastasis versus the low risk group and adjusted for clinical covariates (p=0.036). A second study of the MetaSite Breast™ test in a uniformly treated clinical trial cohort confirmed the clinical validity of the association between MetaSite Score and distant recurrence in patients with HR-positive HER2-negative ESBC. The ECOG2197 Cohort Prognostic Study is a prospectively designed retrospective study (n=600) in an independent cohort (E2197; NCT00003519) of ESBC patients treated with surgery, 4 cycles of adjuvant chemotherapy (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 (AC) or docetaxel 60 mg/m2 (AT)) and endocrine therapy. Results from this study revealed a significant positive association between continuous MetaSite Score and distant recurrence-free interval (DRFI) p=0.001 and recurrence-free interval (RFI) p=0.00006 in HR-positive HER2-negative disease in years 0-5 and by MetaSite Score tertiles for DRFI (p=0.04) and RFI (p=0.01). Proportional hazards models including clinical covariates (N0 vs. N1; T1 vs. T2; high vs. int. vs. low grade) also revealed significant positive associations for continuous MetaSite Score with RFI (p=0.04), and borderline association with DRFI (p=0.08). MetaSite Breast™ provides useful prognostic information beyond the Genomic Health’s Oncotype DX Recurrence Score. Patients with high and intermediate MetaSite Score (MS>6) and low Recurrence Score (RS<18) results had 5 to 10-fold greater risk of distant recurrence compared to low MetaSite Scores (MS<6). Patients with high MetaSite Score (MS>17) and low Recurrence Score (RS<18) results had 9.7-fold greater risk (HR=9.7, 95%CI 1.8-54.1) of distant metastasis compared to patients with low MetaSite Score (MS<6) results. Patients with intermediate MetaSite Score (MS=6-17) and low Recurrence Score (RS<18) results had approximately 4.7-fold greater risk (HR=4.7, 95%CI=0.9-24.2) of distant metastasis compared to patients with low MetaSite Score (MS<6) results. The MetaSite Breast™ test is intended for use in patients with early stage (stage 1-3), invasive breast cancer who have node-negative or node positive, Hormone Receptor (HR)-positive, HER2-negative disease. Clinical studies have demonstrated the MetaSite score (MS) is significantly associated with increased risk of cancer metastasis. MetaSite Breast™ is an analytically validated, fully automated digital pathology/image analysis assay that identifies Mena expressing tumor cells in direct contact with CD68+ perivascular macrophages and CD31+ endothelial cells (“MetaSites”). MetaSites have been shown to be the portal of entry for cancer cells into the blood stream contributing to the development of cancer metastasis. The MetaSite Breast™ assay is performed on standard formalin-fixed paraffin-embedded (FFPE) tissue, analytically validated under CLIA and clinically available through MetaStat’s CLIA-certified commercial laboratory located in Boston, MA. MetaStat, Inc. (MTST) is a pre-commercial biotechnology company focused on the development and commercialization of diagnostic tests that are prognostic for the risk of cancer metastasis, companion diagnostics to predict drug response, and anti-metastatic drugs. Our driver-based platform technology is based on the pivotal role of the Mena protein and its isoforms, a common pathway for the development of metastatic disease and drug resistance in epithelial-based solid tumors. This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including those set forth in the company's Form 10-K filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the company undertakes no obligation to update such statements.


BEERSE, Belgium--(BUSINESS WIRE)--Janssen-Cilag International NV today announced the publication of data revealing radiographic progression-free survival (rPFS) of 16.5 months (95% CI, 13.5–20.0) and treatment duration of 11.6 months (95% CI, 10.2–12.8) in men treated with ZYTIGA® (abiraterone acetate) plus prednisone (AAP), in the real-world, outside the clinical trial setting. The study assessed men being treated for asymptomatic and mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC), following androgen deprivation therapy (ADT).1 These valuable insights were shown despite the real-world study population including those who had a poor prognosis or were difficult-to-treat patients, usually excluded from clinical trials. These data are part of a comprehensive real-world evidence (RWE) portfolio being presented by Janssen at this year’s American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) in Orlando, Florida. “Real-world evidence research is key in patient-focused clinical practice, as it helps physicians to better address patient needs. It complements data obtained from clinical trials to provide greater understanding of treatment outcomes, disease management and impact on quality of life in broad patient populations, including those with comorbidities,” said Dr Martin Boegemann, Department of Urology, Muenster University Medical Center, Muenster, Germany. ”It is helpful to see new data for treatment outcomes in real world patients confirm those seen in a clinical trial setting. These new findings add to the growing bank of real-world evidence available across Europe, which is becoming more and more important in helping us choose the best treatments to transform patient outcomes.” Patients in the pivotal COU–AA–302 trial reached a median duration of treatment of 13.8 months (IQR, 8.3–27.4) and a median rPFS of 16.5 months (95% CI, 13.8–16.8).1,2,3,4 Results were similar across both settings, despite almost 10% of patients in the RWE study having visceral metastases (metastases to internal organs i.e. the liver and/or lungs) and/or an Eastern Cooperative Oncology Group (ECOG) performance status of 2-3 (those unable to carry out work, but still capable or partially capable of self-care).1 These patients were not included in the COU-AA-302 study.4 Further to this, additional findings from The Prostate Cancer Registry, Europe’s first and largest prospective RWE study in mCRPC are being presented at ASCO GU.5 The Prostate Cancer Registry was initiated in 2013, as a long-term commitment by Janssen to address optimal treatment of mCRPC in routine practice in the real world. It has enrolled over 3,000 mCRPC patients in 199 centres across 16 European countries.5 Dr Ivo Winiger-Candolfi, Oncology Therapeutic Area Lead, Janssen Europe, the Middle East and Africa (EMEA) said: “Real-world evidence is extremely valuable in offering findings that complement clinical trials and provide significant insights into the performance and the use of a drug in real-world medical settings which will ultimately translate into how to best treat patients. This is particularly evident in prostate cancer, as it is the most common cancer in men and has a diverse patient population with varying treatment needs. Janssen is continuing to support real-world evidence research to help transform patient outcomes, with the aim of making cancer a more manageable condition in the future.” Prostate cancer is the most commonly diagnosed cancer in men, with over 400,000 new cases diagnosed in Europe each year.6 Latest prostate cancer figures show that there are currently three million men living with the disease in Europe.7 About the Boegemann et al. study The Boegemann et al. study is a retrospective chart review of 224 asymptomatic and mildly symptomatic post-ADT mCRPC patients treated with ZYTIGA (abiraterone acetate) plus prednisone (AAP) from 18 centres across Belgium, Germany and the UK.1 The real-world study included patients with visceral metastases (metastases to internal organs i.e. the liver and/or lungs) (9.8%) and those with an Eastern Cooperative Oncology Group (ECOG) performance status of 2-3 (those unable to carry out work, but still capable or partially capable of self-care) (9.4%) (patients usually excluded from the clinical trial setting).1 The Prostate Cancer Registry was initiated in 2013 as a long-term commitment by Janssen to address optimal treatment of mCRPC in routine practice. The Registry was designed in consultation with specialists in mCRPC and examines patients being managed in a range of oncology and urology settings, with the aim of reflecting routine clinical practice. 8 Patients are enrolled upon initiating a treatment for mCRPC or a period of surveillance, defined as not currently receiving an active treatment for castration resistance. The Registry is prospectively collecting data on a pan-European scale on patient demography and status, treatment sequencing and effectiveness, ongoing disease management, quality of life, medical resource utilisation and outcomes.8 The first analysis was presented at the 2015 European Cancer Congress (ECC) in Vienna, Austria and further data will be published regularly over the coming years.8 The latest Prostate Cancer Registry animation can be viewed here. ZYTIGA is the only approved therapy in mCRPC that inhibits production of androgens (which fuel prostate cancer growth) at all three sources that are important in prostate cancer - the testes, adrenals and the tumour itself.9,10,11 ZYTIGA has been approved in more than 90 countries and to date, has been prescribed to more than 269,500 men worldwide.12,13 In 2011, ZYTIGA in combination with prednisone/prednisolone was approved by the European Commission (EC) for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen. In December 2012, the EC granted an extension of the indication for ZYTIGA permitting its use, in combination with prednisone or prednisolone, for the treatment of mCRPC, in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.9 The most common adverse events seen with abiraterone acetate include urinary tract infection, hypokalaemia, hypertension, peripheral oedema and diarrhoea. For a full list of side effects and for further information on dosage and administration, contraindications and other precautions when using ZYTIGA, please refer to the summary of product characteristics, which is available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002321/WC500112858.pdf At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com/emea. Follow us on http://www.twitter.com/janssenEMEA for our latest news. Cilag GmbH International; Janssen Biotech, Inc.; and Janssen-Cilag International NV are part of the Janssen Pharmaceutical Companies of Johnson & Johnson. 1 Boegemann et al. Real-World Treatment with Abiraterone Acetate in Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer Patients. Poster presented at the American Society of Clinical Oncology Genitourinary Symposium 2017, February 16-18, Orlando, Florida, USA. Poster presentation. ASCO GU abstract #239. Last accessed February 2017. 2 Rathkopf et al. Updated Interim Efficacy Analysis and Long-term Safety of Abiraterone Acetate in Metastatic Castration-resistant Prostate Cancer Patients Without Prior Chemotherapy (COU-AA-302). EUROPEAN UROLOGY 2014; 66: 815-825. Last accessed February 2017. 3 Ryan CJ, Smith MR, de Bono JS, et al. Abiraterone in Metastatic Prostate Cancer without Previous Chemotherapy. N Engl J Med. 2013 Jan; 368(2): 138 - 48. 4 Ryan C.J et al. Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study. The Lancet Oncology. 2015; 16, 2: p152-160. Available at: http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(14)71205-7/abstract. Last accessed February 2017. 5 Chowdhury S et al. The Prostate Cancer Registry: Real-World outcomes in first-line treatment of metastatic castration-resistant prostate cancer (mCRPC). Poster presented at the American Society of Clinical Oncology Genitourinary Symposium 2017, February 16-18, Orlando, Florida. Poster presentation. ASCO GU abstract #212. Last accessed February 2017. 6 Ferlay J et al. Cancer incidence and mortality patterns in Europe: Estimates for 40 countries in 2012. European Journal of Cancer. 2013; 49: p1374–1403. Last accessed February 2017. 7 European Commission. CORDIS Express: Prevention, diagnosis and treatment of prostate cancer. Available at: http://cordis.europa.eu/news/rcn/122705_en.html. Last accessed February 2017. 8 Chowdhury S et al. The Prostate Cancer Registry: First Results from an International, Prospective, Observational Study of Men with Metastatic Castration- Resistant Prostate Cancer (mCRPC). Poster presented at the European Cancer Congress 2015, September 25-29, Vienna, Austria. Poster Presentation. ECC abstract #2548. Available at: https://www.europeancancercongress.org/Scientific-Programme/Abstract-search?abstractid=21001. Last accessed February 2017. 9 ZYTIGA® summary of product characteristics (February 2017). Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002321/WC500112858.pdf. Last accessed February 2017. 10 Hoy, SM. et al. Abiraterone Acetate: A review of its use in patients with metastatic castration-resistant prostate cancer drugs. Drugs 2013; 73:2077-2091. Last accessed February 2017. 11 Ritch, CR. Cookson, MS. Advances in the management of castration resistant prostate cancer. BMJ. 2016 Oct 17;355:i4405. Doi: 10.1136/bmj.i4405. Last accessed February 2017 12 Ye,D. A phase 3, double-blind, randomized placebo-controlled efficacy and safety study of abiraterone acetate in chemotherapy-naïve patients with mCRPC in China, Malaysia, Thailand and Russia. Asian Journal of Urology. 2017.Doi.org/10.1016/j.ajur.2017.01.002. Last accessed February 2017 13 Zytiga asset portal. Available at: https://janssenassetexchange.com/Zytiga/Home.aspx. Last accessed February 2017


News Article | December 22, 2016
Site: www.eurekalert.org

Portland, Oregon, Dec. 21, 2016 - The addition of bortezomib to a standard two-drug regimen for multiple myeloma patients significantly lengthened the time before their cancer returned, and significantly lengthened their lives, according to clinical trial results in The Lancet. Investigators from SWOG, the international cancer clinical trials network funded by the National Cancer Institute (NCI), compared the effectiveness of two drug regimens in newly diagnosed patients undergoing their first round of treatment for multiple myeloma, a type of bone marrow cancer. One regimen used in the study was lenalidomide with dexamethasone, a standard first-line treatment. The other drug regimen also included bortezomib, a second-line drug typically given to myeloma patients whose cancer progresses after initial therapy. SWOG researchers found that the addition of bortezomib made a significant difference for myeloma patients, giving them about another year of remission and another year of life. Patients receiving bortezomib, along with lenalidomide and dexamethasone, in their first six months of treatment had a median remission time of 43 months compared to a median remission of 30 months for patients who received lenalidomide and dexamethasone alone. Researchers also found that patients who received bortezomib lived a median of 75 months, or about six years, after their initial treatment. Patients who received the standard two-drug treatment lived a median of 64 months, or about five years, after initial treatment. "There's a lot of excitement about these research findings and this treatment option, which helps myeloma patients stay healthier longer and gives them more time to spend with people they love," said SWOG study principal investigator Brian G.M. Durie, M.D., a physician at Cedars-Sinai Outpatient Cancer Center in Los Angeles and chairman of the board at the International Myeloma Foundation. "Because the research was so solid, and the findings so strong, we're looking at a potential new standard of care." Results of the SWOG study, S0777, first gained attention in December 2015 at the 57th Annual Meeting of the American Society of Hematology (ASH) held in Orlando, Florida. Myeloma is the second most common blood cancer in the world. According to NCI statistics, in 2016 an estimated 30,330 new cases of myeloma will be diagnosed and 12,650 people will die of the disease in the U.S. In recent years, new drugs have brought new hope, and life expectancy for people diagnosed with multiple myeloma is slowly rising. SWOG researchers enrolled 471 eligible and consented adult patients in S0777 between February 2008 and February 2012 at 139 institutions throughout the National Cancer Trials Network (NCTN), the nation's oldest and largest publicly funded cancer research network. The NCTN includes SWOG, the Alliance for Clinical Trials in Oncology, ECOG-ACRIN Cancer Research Group, and NRG Oncology, which all enrolled patients to S0777, as well as the Children's Oncology Group, which focuses on pediatric cancers. S0777 patients ranged in age from 28 to 87, had active myeloma, and had not had a stem-cell transplant or any prior treatment for their disease. Patients were randomized into two groups. One group received the standard two-drug treatment for six cycles over six months. That includes lenalidomide, an immunomodulating therapy marketed as Revlimid by Celegene Corporation. The other group received a three-drug combination that included bortezomib, a proteasome inhibitor marketed as Velcade by Millennium Pharmaceuticals. These patients received the triple combination therapy for eight cycles over six months. Despite the increased remission and longevity, the three-drug combination did have a drawback: Patients who received bortezomib were much more likely to experience sensory neuropathy, or tingling, pain, numbness or weakness in their hands and feet. The NCI provided primary grant funding for S0777 and was the sponsor of the study. Millennium Pharmaceuticals, Inc., The Takeda Oncology Company, and Celgene Corporation provided the study drugs under their respective Cooperative Research and Development Agreements with the NCI. A national team of SWOG researchers led S0777. Along with Durie, they include: Antje Hoering, Ph.D, of Cancer Research And Biostatistics; S. Vincent Rajkumar, M.D., of Mayo Clinic; Muneer H. Abidi, M.D., of Spectrum Health and Michigan State University; Joshua Epstein, DS.c, of University of Arkansas for Medical Sciences; Stephen P. Kahanic, M.D., of Souixland Regional Cancer Center; Mohan C. Thakuri, M.D., of Southeast Clinical Oncology Research Consortium NCORP; Frederic J. Reu, M.D., of Cleveland Clinic; Christopher M. Reynolds, M.D., of Michigan Cancer Research Consortium NCORP; Rachael Sexton, M.S., of Cancer Research And Biostatistics; Robert Z. Orlowski, M.D., Ph.D, of MD Anderson Cancer Center; Bart Barlogie, M.D., Ph.D, of University of Arkansas for Medical Sciences; and Angela Dispenzieri, M.D., of Mayo Clinic. SWOG is a global network of researchers that design and conduct cancer clinical trials, and, as part of the Nation Cancer Institute's National Clinical Trials Network, is a major part of the cancer research infrastructure in the U.S. and the world. The group's goal is to change medical practice so it improves the lives of people with cancer. Founded in 1956, SWOG's 1,300 trials have led to the approval of 14 cancer drugs, changed the standard of cancer care more than 100 times, and saved more than 2 million years of human life. Learn more at swog.org.


Os dados interinos do ABOUND.70+ em 128 pacientes idosos (≥ 70 anos) que receberam tratamento de primeira linha com ABRAXANE/carboplatina para NSCLC avançado, revelaram que 91 (73%) pacientes apresentaram neuropatia periférica (NP) de grau ≥2 ou mielossupressão de grau ≥3 [parâmetro de avaliação primário]. No momento da análise, a média de sobrevida geral era de 14,6 meses e a média de sobrevida livre de progressão era de 6,2 meses, consideradas nos dois braços de tratamento [parâmetros de avaliação secundários]. Os doentes foram randomizados para receber o tratamento de primeira linha com ABRAXANE/carboplatina com frequência semanal e contínuo ou com frequência semanal a cada três semanas com intervalo de uma semana. i Considerando o total de pacientes, 80% descontinuaram o tratamento e a maioria fez isso devido a eventos adversos (24%) ou à progressão da doença (34%). A neuropatia periférica de grau ≥2 foi relatada em 34% dos pacientes e neutropenia, anemia e trombocitopenia de grau ≥3 foram observadas em 52%, 21% e 21% dos pacientes, respectivamente. i Os dados interinos do ABOUND.sqm em 284 pacientes, que receberam tratamento de indução de primeira linha com ABRAXANE/carboplatina para NSCLC escamoso em estágio III B/IV, indicaram que o perfil de segurança foi consistente com o que foi relatado anteriormente para o subconjunto de escamosos no ensaio clínico pivot de fase III.ii,iii Durante a fase de indução, todos os pacientes receberam quatro ciclos de 21 dias de terapia padrão com ABRAXANE/carboplatina.ii Considerando o total de pacientes, 119 (42%) descontinuaram o tratamento durante a fase de indução. A maioria dos pacientes descontinuou o tratamento devido à progressão da doença (34%) ou eventos adversos (24%). Os eventos adversos emergentes relacionados ao tratamento (TEAEs) de grau 3/4 mais comuns foram hematológicos e incluíram anemia (26%), neutropenia (43%) e trombocitopenia (15%).ii "Esses dados iniciais do programa de ensaios clínicos ABOUND são muito encorajadores, já que são consistentes com os resultados relacionados a esses subgrupos de pacientes com câncer de pulmão de não pequenas células, vistos no ensaio pivot de fase III do ABRAXANE", disse Michael Pehl, presidente de Hematologia e Oncologia da Celgene. "Esses dados, associados aos estudos em andamento do ABRAXANE combinado com novos agentes e imunoterapias, proporcionam uma compreensão mais profunda de como tratar desafiadoras populações de pacientes e nos ajudarão a continuar a desenvolver futuras opções de tratamento." Com a rápida evolução do cenário de tratamento de câncer de pulmão, a Celgene permanece empenhada em continuar a explorar novas combinações que beneficiarão aqueles que vivem com câncer de pulmão, incluindo pacientes que podem não se beneficiar de imunoterapia e terapia direcionada. O ABRAXANE está sendo avaliado ativamente como uma terapia de base para esses pacientes. Os resultados interinos do estudo de fase I do agente imunoterápico nivolumabe associado a ABRAXANE/carboplatina em 22 pacientes com NSCLC em estágio III B/IV também serão apresentados no WCLC. Os pacientes receberam quatro ciclos de terapia padrão com ABRAXANE/carboplatina em combinação com nivolumabe, seguidos por monoterapia com nivolumabe iniciada no ciclo 5. Os parâmetros de avaliação primários foram o número de pacientes com a toxidade limitante da dose e o percentual de pacientes com TEAEs de grau 3/4 ou descontinuação do tratamento devido a um TEAE. Os dados interinos sugerem que combinar ABRAXANE/carboplatina com o nivolumabe pode ter atividade antitumoral promissora em pacientes com NSCLC avançado sem nenhum evento adverso (EAs) inesperado.vi Também haverá uma apresentação oral no WCLC com foco nas novas descobertas dos registros do estudo de fase III para o ABRAXANE (Abstract 4460), que relatam o impacto da profundidade da resposta na sobrevida em pacientes com NSCLC avançado, tratados com a quimioterapia de primeira linha. Análises do mundo real de veteranos americanos com NSCLC também serão apresentadas no WCLC avaliando a prevalência de NSCLC escamoso em veteranos vs. na população geral (Abstract 4737) e a prevalência de doença autoimune em veteranos com NSCLC (Abstract 4745). Outros pesquisadores, que iniciaram os estudos apresentados no WCLC, também avaliaram o ABRAXANE como terapia de primeira linha (Posters P2.03a-028 e P2.06-018), segunda linha (Posters P2.03a-040, P2.03a-054 e P2.03a-056) ou terceira linha (Poster P2.06-015) para pacientes com NSCLC avançado, e também como adjuvante (Poster P2.03a-070) e neoadjuvante (Poster P2.04-034) e em pacientes com uma mutação EGFR virgens de quimioterapia (Poster P3.02b-061). Este é um estudo de fase I, aberto, multicêntrico sobre a segurança de regimes de quimioterapia com base no ABRAXANE administrado antes e/ou em combinação com nivolumabe em câncer pancreático, NSCLC e câncer da mama metastático. Este é um estudo de seis braços que avalia dois braços de tratamento por tipo de tumor/indicação. Este comunicado de imprensa contém declarações prospectivas, que são declarações gerais e não fatos históricos. As declarações prospectivas podem ser identificadas pelas palavras “espera”, “prevê”, “acredita”, “pretende”, “estima”, “planeja”, “irá”, “perspectiva” e outras expressões semelhantes. Essas declarações são baseadas nos planos atuais da gerência, em estimativas, premissas e projeções, e referem-se apenas às datas em que foram feitas. A Celgene Corporation não assume nenhuma obrigação de atualizar qualquer declaração prospectiva com base em novas informações ou eventos futuros, exceto se exigido por lei. As declarações prospectivas envolvem os riscos e incertezas inerentes, a maioria das quais de difícil previsão e que geralmente encontram-se fora do nosso controle. Os resultados reais podem ser materialmente diferentes dos implícitos pelas declarações de previsão futura em decorrência do impacto de uma série de fatores, muitos dos quais são discutidos em maiores detalhes no Formulário 10-K do Relatório Anual da Celgene Corporation e outros relatórios arquivados com a Comissão de Valores Mobiliários. i Langer C, et al. Safety and Efficacy Results from ABOUND.70+: nab-Paclitaxel + Carboplatin in Elderly Patients with Advanced NSCLC. Resumo 4630. Apresentado na Conferência Mundial de Câncer de Pulmão 2016 (WCLC), de 4 a 7 de dezembro de 2016. ii McCleod M, et al. Interim Results from ABOUND.sqm: Safety of nab-Paclitaxel + Carboplatin Induction Therapy in Squamous Non-Small Cell Lung Cancer. Resumo 4391. Apresentado na Conferência Mundial de Câncer de Pulmão 2016 (WCLC), de 4 a 7 de dezembro de 2016. iii Socinsky M, et al. Safety and efficacy of weekly nab®-paclitaxel in combination with carboplatin as first-line therapy in elderly patients with advanced non-small-cell lung cancer. Annals of Oncology. 24: 314–321, 2013. iv Weiss J, et al. ABOUND.70+: Interim Quality of Life Results of nab-Paclitaxel + Carboplatin Treatment of Elderly Patients with NSCLC. Resumo 4286. Apresentado na Conferência Mundial de Câncer de Pulmão 2016 (WCLC), de 4 a 7 de dezembro de 2016. v Thomas M, et al. nab-Paclitaxel + Carboplatin Induction Therapy in Squamous Non-Small Cell Lung Cancer: Interim Quality of Life Results from ABOUND.sqm. Resumo 4343. Apresentado na Conferência Mundial de Câncer de Pulmão 2016 (WCLC), de 4 a 7 de dezembro de 2016. vi Goldman J, et al. Interim Results from the Phase I Study of Nivolumab + nab-Paclitaxel + Carboplatin in Non-Small Cell Lung Cancer. Resumo 4127. Apresentado na Conferência Mundial de Câncer de Pulmão 2016 (WCLC), de 4 a 7 de dezembro de 2016. vii ClinicalTrials.gov. Safety and Efficacy Study of Nab®Paclitaxel With CC486 or Nab®Paclitaxel With Durvalumab, and Nab®Paclitaxel Monotherapy as Second/Thirdline Treatment for Advanced Nonsmall Cell Lung Cancer (abound2L+). Disponível em https://www.clinicaltrials.gov/ct2/show/NCT02250326?term=ABOUNd&rank=3. Último acesso em 30 de novembro de 2016. viii ClinicalTrials.gov. Safety and Efficacy Study of Abraxane in Combination With Carboplatin to Treat Advanced NSCL Cancer in the Elderly (ABOUND 70+). Disponível em https://www.clinicaltrials.gov/ct2/show/NCT02151149?term=ABOUNd&rank=2. Último acesso em 30 de novembro de 2016. ix ClinicalTrials.gov. Phase II Safety and Tolerability Trial With NabPaclitaxel Plus Carboplatin Followed by NabPaclitaxel for First Line Treatment of NSCLC Subjects With ECOG PS 2 (AboundPS2). Disponível em https://www.clinicaltrials.gov/ct2/show/NCT02289456?term=ABOUNd&rank=4. Último acesso em 30 de novembro de 2016. x ClinicalTrials.gov. Safety and Efficacy Study of Abraxane as Maintenance Treatment After Abraxane Plus Carboplatin in 1st Line Stage IIIB / IV Squamous Cell Non-small Cell Lung Cancer (aboundsqm). Disponível em https://www.clinicaltrials.gov/ct2/show/NCT02027428?term=ABOUNd&rank=6. Último acesso em 30 de novembro de 2016. O texto no idioma original deste anúncio é a versão oficial autorizada. As traduções são fornecidas apenas como uma facilidade e devem se referir ao texto no idioma original, que é a única versão do texto que tem efeito legal.


News Article | December 13, 2016
Site: www.businesswire.com

i Langer C, et al. Safety and Efficacy Results from ABOUND.70+: nab-Paclitaxel + Carboplatin in Elderly Patients with Advanced NSCLC. Abstract 4630. Presented at the 2016 World Conference of Lung Cancer (WCLC), December 4-7, 2016. ii McCleod M, et al. Interim Results from ABOUND.sqm: Safety of nab-Paclitaxel + Carboplatin Induction Therapy in Squamous Non-Small Cell Lung Cancer. Abstract 4391. Presented at the 2016 World Conference of Lung Cancer (WCLC), December 4-7, 2016. iii Socinsky M, et al. Safety and efficacy of weekly nab®-paclitaxel in combination with carboplatin as first-line therapy in elderly patients with advanced non-small-cell lung cancer. Annals of Oncology. 24: 314–321, 2013. iv Weiss J, et al. ABOUND.70+: Interim Quality of Life Results of nab-Paclitaxel + Carboplatin Treatment of Elderly Patients with NSCLC. Abstract 4286. Presented at the 2016 World Conference of Lung Cancer (WCLC), December 4-7, 2016. v Thomas M, et al. nab-Paclitaxel + Carboplatin Induction Therapy in Squamous Non-Small Cell Lung Cancer: Interim Quality of Life Results from ABOUND.sqm. Abstract 4343. Presented at the 2016 World Conference of Lung Cancer (WCLC), December 4-7, 2016. vi Goldman J, et al. Interim Results from the Phase I Study of Nivolumab + nab-Paclitaxel + Carboplatin in Non-Small Cell Lung Cancer. Abstract 4127. Presented at the 2016 World Conference of Lung Cancer (WCLC), December 4-7, 2016. vii ClinicalTrials.gov. Safety and Efficacy Study of Nab®Paclitaxel With CC486 or Nab®Paclitaxel With Durvalumab, and Nab®Paclitaxel Monotherapy as Second/Thirdline Treatment for Advanced Nonsmall Cell Lung Cancer (abound2L+). Available at https://www.clinicaltrials.gov/ct2/show/NCT02250326?term=ABOUNd&rank=3. Accessed November 30, 2016. viii ClinicalTrials.gov. Safety and Efficacy Study of Abraxane in Combination With Carboplatin to Treat Advanced NSCL Cancer in the Elderly (ABOUND 70+). Available at https://www.clinicaltrials.gov/ct2/show/NCT02151149?term=ABOUNd&rank=2. Accessed November 30, 2016. ix ClinicalTrials.gov. Phase II Safety and Tolerability Trial With NabPaclitaxel Plus Carboplatin Followed by NabPaclitaxel for First Line Treatment of NSCLC Subjects With ECOG PS 2 (AboundPS2). Available at https://www.clinicaltrials.gov/ct2/show/NCT02289456?term=ABOUNd&rank=4. Accessed November 30, 2016. x ClinicalTrials.gov. Safety and Efficacy Study of Abraxane as Maintenance Treatment After Abraxane Plus Carboplatin in 1st Line Stage IIIB / IV Squamous Cell Non-small Cell Lung Cancer (aboundsqm). Available at https://www.clinicaltrials.gov/ct2/show/NCT02027428?term=ABOUNd&rank=6. Accessed November 30, 2016.

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