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SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX:RO, ROG; OTCQX:RHHBY), today announced that the Phase III IMvigor211 study that evaluated TECENTRIQ® (atezolizumab) in people with locally advanced or metastatic urothelial cancer (mUC) whose disease progressed during or after treatment with a platinum-based chemotherapy (previously treated) did not meet its primary endpoint of overall survival (OS) compared to chemotherapy. The safety profile observed in IMvigor211 was consistent with what has been previously observed for TECENTRIQ. “While these results are not what we had expected, we believe that TECENTRIQ will continue to play an important role in the treatment of people with advanced bladder cancer,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We are committed to helping people with advanced bladder cancer and will discuss these data with health authorities.” The results observed in people treated with TECENTRIQ in IMvigor211 were generally consistent with those observed in a similar group of people in the Phase II IMvigor210 study. The IMvigor211 data will be further examined in an effort to better understand these results, including the initial observation that the chemotherapy arm results were better than study design assumptions. Full data from IMvigor211 will be presented later this year. TECENTRIQ was granted accelerated approval by the U.S. Food and Drug Administration (FDA) based on tumor response rate and duration of response in IMvigor210 for the treatment of people with locally advanced or mUC who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). IMvigor211 was a randomized pivotal study designed to support full approval globally and to serve as the confirmatory study to convert the accelerated approval to full approval in the U.S. The FDA recently granted accelerated approval to TECENTRIQ as an initial treatment for people with locally advanced or mUC who are not eligible for cisplatin chemotherapy. A Phase III confirmatory study, IMvigor130, is currently ongoing in this population. Genentech has an extensive clinical trial development program for TECENTRIQ, with more than 30 trials ongoing, 17 of which are ongoing or planned Phase III studies across several kinds of lung, kidney, skin, breast, colorectal, prostate, ovarian, bladder and blood cancers. This includes trials evaluating TECENTRIQ both alone and in combination with other medicines. IMvigor211 is the first randomized Phase III study of TECENTRIQ compared to chemotherapy in people with advanced bladder cancer who were previously treated with a platinum-based chemotherapy. The study evaluated the efficacy and safety of TECENTRIQ compared to chemotherapy (vinflunine, paclitaxel or docetaxel) administered every three weeks in 931 people with previously treated mUC who progressed during or following a platinum-based regimen. Eligible patients had an Eastern Cooperative Oncology Group performance status of 0-1, an evaluable tumor sample for centralized PD-L1 testing and had received at least one prior therapeutic regimen for mUC or who had developed mUC within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). The primary efficacy endpoint, overall survival, was to be tested in a successive fashion in study populations defined by PD-L1 expression. The first population tested was people with the highest levels of PD-L1 expression (IC2/3), followed by those with any level of PD-L1 expression (IC1/2/3), followed by the overall study population (Intention-to-Treat; ITT). Statistical significance needed to be achieved in the IC2/3 population in order to evaluate the IC1/2/3 population for statistical significance, and similarly achieved in the IC1/2/3 population in order to evaluate the overall study population for statistical significance. IMvigor210 is an open-label, multicenter, two cohort Phase II study that evaluated the safety and efficacy of TECENTRIQ in people with locally advanced or mUC, regardless of PD-L1 expression. People in a cohort of the study whose disease had progressed during or following previous treatment with a platinum-based chemotherapy regimen, or had disease progression within 12 months of treatment with a platinum-based or adjuvant chemotherapy regimen (n=310) received a 1200-mg intravenous dose of TECENTRIQ on day one of 21-day cycles until unacceptable toxicity or either radiographic or clinical progression. The primary endpoint of the study was objective response rate (ORR) as assessed by an independent review facility (IRF) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Secondary endpoints included duration of response. According to the American Cancer Society (ACS), it is estimated that more than 79,000 Americans will be diagnosed in 2017 with bladder cancer, which is the most common type of urothelial cancer. Less common forms include cancers of the urethra, ureters and renal pelvis. About 11 percent of new diagnoses of bladder cancer are made when the disease is in advanced stages. There is a dramatic difference in survival rates between early and advanced bladder cancer. Approximately 96 percent of people will live five or more years when diagnosed with the earliest stage of the disease, compared to 39 percent when diagnosed in advanced stages (stage III-IV) of the disease. Men are three to four times more likely to get bladder cancer during their lifetime than women. TECENTRIQ is a monoclonal antibody designed to bind with a protein called PD-L1. TECENTRIQ is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, TECENTRIQ may enable the activation of T cells. TECENTRIQ may also affect normal cells. TECENTRIQ is a prescription medicine used to treat: The approval of TECENTRIQ in these patients is based on a study that measured response rate and duration of response. There is an ongoing study to confirm clinical benefit. If your tumor has an abnormal EGFR or ALK gene, you should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working. It is not known if TECENTRIQ is safe and effective in children. TECENTRIQ can cause the immune system to attack normal organs and tissues in many areas of the body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death. Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider may treat a patient with corticosteroid or hormone replacement medicines. A healthcare provider may delay or completely stop treatment with TECENTRIQ if a patient has severe side effects. Patients should call or see their healthcare provider right away if they get any symptoms of the following problems or these symptoms get worse. TECENTRIQ can cause serious side effects, including: Before receiving TECENTRIQ, patients should tell their healthcare provider about all of their medical conditions, including if they: Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. The most common side effects of TECENTRIQ in people with urothelial carcinoma include: The most common side effects of TECENTRIQ in people with non-small cell lung cancer include: TECENTRIQ may cause fertility problems in females, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility. These are not all the possible side effects of TECENTRIQ. Ask your healthcare provider or pharmacist for more information. Report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. Report side effects to Genentech at 1-888-835-2555. Please visit http://www.Tecentriq.com for the TECENTRIQ full Prescribing Information for additional Important Safety Information. For more than 30 years, Genentech has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever to bring personalized cancer immunotherapy (PCI) to people with cancer. The goal of PCI is to provide each person with a treatment tailored to harness his or her own immune system to fight cancer. Genentech is studying more than 20 investigational medicines, 11 of which are in clinical trials. In every study we are evaluating biomarkers to identify which people may be appropriate candidates for our medicines. For more information visit http://www.gene.com/cancer-immunotherapy. Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.


Enrollment of second stage of melanoma cohort in Phase 2 ENCORE 601 trial proceeding ahead of schedule; expected to be completed in the third quarter Company to host conference call today at 4:30 p.m. ET WALTHAM, Mass., May 08, 2017 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing entinostat and SNDX-6352 in multiple cancer indications, today reported its financial results for the first quarter ended March 31, 2017. In addition, the Company provided a clinical and business update. As of March 31, 2017, Syndax had $92.8 million in cash, cash equivalents and short-term investments. During the first quarter, the Company continued to advance its ENCORE immuno-oncology clinical programs. The Company reported that enrollment in the second stage of the melanoma cohort in ENCORE 601 is proceeding ahead of schedule, with completion of enrollment expected by the end of the third quarter of 2017. Results for the melanoma cohort from the first stage of ENCORE 601 will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June. The Company also recently announced the expansion of ENCORE 601, a Phase 2 clinical collaboration with a subsidiary of Merck, known as MSD outside the United States and Canada, to include a cohort of patients with microsatellite stable colorectal cancer who have not previously been treated with an anti-PD-1 (programmed death receptor-1) therapy. These cancers represent about 85% of all colon cancers and have shown minimal response to anti-PD-1 therapy. The expansion was based in part on clinical responses observed in the PD-1 refractory melanoma cohort of ENCORE 601. Enrollment is expected to begin mid-2017. “Our pipeline of innovative therapeutic candidates for cancer continues to make meaningful progress, and the recent melanoma results, as well as the expansion of ENCORE 601 into colorectal cancer, highlight the potential application of entinostat to a broad range of cancers. We believe the substantial unmet medical need in melanoma patients who have failed treatment with a PD-1 antagonist represents a fast to market opportunity for an effective and well tolerated therapy, and we look forward to presenting updated results from the melanoma cohort of ENCORE 601 at ASCO. In addition, we have secured a Type B meeting with the FDA in late June to discuss the development path for entinostat in melanoma,” said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. “Later this quarter, we anticipate determining whether either of the non-small cell lung cancer cohorts have met the prespecified criteria to advance to the second stage of the trial.” "Based on updates from the Eastern Cooperative Oncology Group regarding enrollment in the ongoing E2112 Phase 3 registration trial, completion of enrollment and progression free survival analysis are anticipated in the first half of 2018. This trial of entinostat plus exemestane in advanced HR+, HER2- breast cancer is being conducted with ECOG-ACRIN and the National Cancer Institute under a Special Protocol Assessment with the FDA,” said Michael L. Meyers, M.D., Ph.D., Chief Medical Officer of Syndax. Syndax Expects to Participate in the Following Upcoming Investor Conferences As of March 31, 2017, Syndax had cash, cash equivalents and short-term investments of $92.8 million and 18,244,917 shares issued and outstanding. First quarter 2017 research and development expenses increased to $9.6 million from $4.8 million for the comparable period in the prior year. The increase was primarily due to increased clinical trial activities of $3.4 million, employee compensation expense of $0.8 million, legal and consultant expenses of $0.5 million and facility costs of $0.1 million. General and administrative expenses totaled $3.9 million during the first quarter of 2017 compared with $4.3 million in the comparable period in the prior year. The decrease in general and administrative expenses was primarily due to a decrease in employee compensation of $0.7 million partially offset by increases in consulting expenses and other costs related to being a public company of $0.3 million. The decrease in employee compensation of $0.7 million was primarily due to decreases in non-cash stock-based compensation of $0.9 million and bonus expense of $0.2 million, partially offset by an increased salary expense of $0.3 million due to increased headcount. For the three months ended March 31, 2017, Syndax reported a net loss attributable to common stockholders of $13.0 million, or $0.71 per share, compared to $12.9 million, or $2.85 per share, for the comparable prior year period. Today the Company provided operating expense guidance for the second quarter and full year 2017. For the second quarter and full year 2017, research and development expenses are expected to be $11.0 – $13.0 million and $52.0 - $57.0 million, respectively, and total operating expenses are expected to be $15.0 – $17.0 million and $68.0 - $73.0, respectively. In connection with the earnings release, Syndax's management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Monday, May 8, 2017. The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company's website at www.syndax.com. Alternatively, the conference call may be accessed through the following: For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors section of the Company's website, www.syndax.com. Syndax is a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Our lead product candidate, entinostat, which was granted Breakthrough Therapy designation by the FDA following positive results from our Phase 2b clinical trial, ENCORE 301, is currently being evaluated in a Phase 3 clinical trial for advanced hormone receptor positive, human epidermal growth factor receptor 2 negative breast cancer. Given its potential ability to block the function of immune suppressive cells in the tumor microenvironment, entinostat is also being evaluated in combination with approved PD-1 antagonists. Ongoing Phase 1b/2 clinical trials combine entinostat with KEYTRUDA® from Merck & Co., Inc. for non-small cell lung cancer and melanoma; with TECENTRIQ® from Genentech, Inc. for TNBC; and with BAVENCIOTM from Pfizer Inc. and Merck KGaA, Darmstadt, Germany, for ovarian cancer. Our second product candidate, SNDX-6352, is a monoclonal antibody that blocks the CSF-1 receptor and may also block the function of immune suppressive cells in the tumor microenvironment. SNDX-6352 is being evaluated in a single ascending dose Phase 1 clinical trial and is expected to be developed to treat a variety of cancers. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend," "believe" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Syndax's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the progress, timing, clinical development and scope of clinical trials and the reporting of clinical data for Syndax's product candidates, and the potential use of our product candidates to treat various cancer indications. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Syndax's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. Other factors that may cause Syndax's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Syndax's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein. Except as required by law, Syndax assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.


Enrollment of second stage of melanoma cohort in Phase 2 ENCORE 601 trial proceeding ahead of schedule; expected to be completed in the third quarter Company to host conference call today at 4:30 p.m. ET WALTHAM, Mass., May 08, 2017 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing entinostat and SNDX-6352 in multiple cancer indications, today reported its financial results for the first quarter ended March 31, 2017. In addition, the Company provided a clinical and business update. As of March 31, 2017, Syndax had $92.8 million in cash, cash equivalents and short-term investments. During the first quarter, the Company continued to advance its ENCORE immuno-oncology clinical programs. The Company reported that enrollment in the second stage of the melanoma cohort in ENCORE 601 is proceeding ahead of schedule, with completion of enrollment expected by the end of the third quarter of 2017. Results for the melanoma cohort from the first stage of ENCORE 601 will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June. The Company also recently announced the expansion of ENCORE 601, a Phase 2 clinical collaboration with a subsidiary of Merck, known as MSD outside the United States and Canada, to include a cohort of patients with microsatellite stable colorectal cancer who have not previously been treated with an anti-PD-1 (programmed death receptor-1) therapy. These cancers represent about 85% of all colon cancers and have shown minimal response to anti-PD-1 therapy. The expansion was based in part on clinical responses observed in the PD-1 refractory melanoma cohort of ENCORE 601. Enrollment is expected to begin mid-2017. “Our pipeline of innovative therapeutic candidates for cancer continues to make meaningful progress, and the recent melanoma results, as well as the expansion of ENCORE 601 into colorectal cancer, highlight the potential application of entinostat to a broad range of cancers. We believe the substantial unmet medical need in melanoma patients who have failed treatment with a PD-1 antagonist represents a fast to market opportunity for an effective and well tolerated therapy, and we look forward to presenting updated results from the melanoma cohort of ENCORE 601 at ASCO. In addition, we have secured a Type B meeting with the FDA in late June to discuss the development path for entinostat in melanoma,” said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. “Later this quarter, we anticipate determining whether either of the non-small cell lung cancer cohorts have met the prespecified criteria to advance to the second stage of the trial.” "Based on updates from the Eastern Cooperative Oncology Group regarding enrollment in the ongoing E2112 Phase 3 registration trial, completion of enrollment and progression free survival analysis are anticipated in the first half of 2018. This trial of entinostat plus exemestane in advanced HR+, HER2- breast cancer is being conducted with ECOG-ACRIN and the National Cancer Institute under a Special Protocol Assessment with the FDA,” said Michael L. Meyers, M.D., Ph.D., Chief Medical Officer of Syndax. Syndax Expects to Participate in the Following Upcoming Investor Conferences As of March 31, 2017, Syndax had cash, cash equivalents and short-term investments of $92.8 million and 18,244,917 shares issued and outstanding. First quarter 2017 research and development expenses increased to $9.6 million from $4.8 million for the comparable period in the prior year. The increase was primarily due to increased clinical trial activities of $3.4 million, employee compensation expense of $0.8 million, legal and consultant expenses of $0.5 million and facility costs of $0.1 million. General and administrative expenses totaled $3.9 million during the first quarter of 2017 compared with $4.3 million in the comparable period in the prior year. The decrease in general and administrative expenses was primarily due to a decrease in employee compensation of $0.7 million partially offset by increases in consulting expenses and other costs related to being a public company of $0.3 million. The decrease in employee compensation of $0.7 million was primarily due to decreases in non-cash stock-based compensation of $0.9 million and bonus expense of $0.2 million, partially offset by an increased salary expense of $0.3 million due to increased headcount. For the three months ended March 31, 2017, Syndax reported a net loss attributable to common stockholders of $13.0 million, or $0.71 per share, compared to $12.9 million, or $2.85 per share, for the comparable prior year period. Today the Company provided operating expense guidance for the second quarter and full year 2017. For the second quarter and full year 2017, research and development expenses are expected to be $11.0 – $13.0 million and $52.0 - $57.0 million, respectively, and total operating expenses are expected to be $15.0 – $17.0 million and $68.0 - $73.0, respectively. In connection with the earnings release, Syndax's management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Monday, May 8, 2017. The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company's website at www.syndax.com. Alternatively, the conference call may be accessed through the following: For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors section of the Company's website, www.syndax.com. Syndax is a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Our lead product candidate, entinostat, which was granted Breakthrough Therapy designation by the FDA following positive results from our Phase 2b clinical trial, ENCORE 301, is currently being evaluated in a Phase 3 clinical trial for advanced hormone receptor positive, human epidermal growth factor receptor 2 negative breast cancer. Given its potential ability to block the function of immune suppressive cells in the tumor microenvironment, entinostat is also being evaluated in combination with approved PD-1 antagonists. Ongoing Phase 1b/2 clinical trials combine entinostat with KEYTRUDA® from Merck & Co., Inc. for non-small cell lung cancer and melanoma; with TECENTRIQ® from Genentech, Inc. for TNBC; and with BAVENCIOTM from Pfizer Inc. and Merck KGaA, Darmstadt, Germany, for ovarian cancer. Our second product candidate, SNDX-6352, is a monoclonal antibody that blocks the CSF-1 receptor and may also block the function of immune suppressive cells in the tumor microenvironment. SNDX-6352 is being evaluated in a single ascending dose Phase 1 clinical trial and is expected to be developed to treat a variety of cancers. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend," "believe" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Syndax's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the progress, timing, clinical development and scope of clinical trials and the reporting of clinical data for Syndax's product candidates, and the potential use of our product candidates to treat various cancer indications. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Syndax's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. Other factors that may cause Syndax's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Syndax's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein. Except as required by law, Syndax assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.


Enrollment of second stage of melanoma cohort in Phase 2 ENCORE 601 trial proceeding ahead of schedule; expected to be completed in the third quarter Company to host conference call today at 4:30 p.m. ET WALTHAM, Mass., May 08, 2017 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing entinostat and SNDX-6352 in multiple cancer indications, today reported its financial results for the first quarter ended March 31, 2017. In addition, the Company provided a clinical and business update. As of March 31, 2017, Syndax had $92.8 million in cash, cash equivalents and short-term investments. During the first quarter, the Company continued to advance its ENCORE immuno-oncology clinical programs. The Company reported that enrollment in the second stage of the melanoma cohort in ENCORE 601 is proceeding ahead of schedule, with completion of enrollment expected by the end of the third quarter of 2017. Results for the melanoma cohort from the first stage of ENCORE 601 will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June. The Company also recently announced the expansion of ENCORE 601, a Phase 2 clinical collaboration with a subsidiary of Merck, known as MSD outside the United States and Canada, to include a cohort of patients with microsatellite stable colorectal cancer who have not previously been treated with an anti-PD-1 (programmed death receptor-1) therapy. These cancers represent about 85% of all colon cancers and have shown minimal response to anti-PD-1 therapy. The expansion was based in part on clinical responses observed in the PD-1 refractory melanoma cohort of ENCORE 601. Enrollment is expected to begin mid-2017. “Our pipeline of innovative therapeutic candidates for cancer continues to make meaningful progress, and the recent melanoma results, as well as the expansion of ENCORE 601 into colorectal cancer, highlight the potential application of entinostat to a broad range of cancers. We believe the substantial unmet medical need in melanoma patients who have failed treatment with a PD-1 antagonist represents a fast to market opportunity for an effective and well tolerated therapy, and we look forward to presenting updated results from the melanoma cohort of ENCORE 601 at ASCO. In addition, we have secured a Type B meeting with the FDA in late June to discuss the development path for entinostat in melanoma,” said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. “Later this quarter, we anticipate determining whether either of the non-small cell lung cancer cohorts have met the prespecified criteria to advance to the second stage of the trial.” "Based on updates from the Eastern Cooperative Oncology Group regarding enrollment in the ongoing E2112 Phase 3 registration trial, completion of enrollment and progression free survival analysis are anticipated in the first half of 2018. This trial of entinostat plus exemestane in advanced HR+, HER2- breast cancer is being conducted with ECOG-ACRIN and the National Cancer Institute under a Special Protocol Assessment with the FDA,” said Michael L. Meyers, M.D., Ph.D., Chief Medical Officer of Syndax. Syndax Expects to Participate in the Following Upcoming Investor Conferences As of March 31, 2017, Syndax had cash, cash equivalents and short-term investments of $92.8 million and 18,244,917 shares issued and outstanding. First quarter 2017 research and development expenses increased to $9.6 million from $4.8 million for the comparable period in the prior year. The increase was primarily due to increased clinical trial activities of $3.4 million, employee compensation expense of $0.8 million, legal and consultant expenses of $0.5 million and facility costs of $0.1 million. General and administrative expenses totaled $3.9 million during the first quarter of 2017 compared with $4.3 million in the comparable period in the prior year. The decrease in general and administrative expenses was primarily due to a decrease in employee compensation of $0.7 million partially offset by increases in consulting expenses and other costs related to being a public company of $0.3 million. The decrease in employee compensation of $0.7 million was primarily due to decreases in non-cash stock-based compensation of $0.9 million and bonus expense of $0.2 million, partially offset by an increased salary expense of $0.3 million due to increased headcount. For the three months ended March 31, 2017, Syndax reported a net loss attributable to common stockholders of $13.0 million, or $0.71 per share, compared to $12.9 million, or $2.85 per share, for the comparable prior year period. Today the Company provided operating expense guidance for the second quarter and full year 2017. For the second quarter and full year 2017, research and development expenses are expected to be $11.0 – $13.0 million and $52.0 - $57.0 million, respectively, and total operating expenses are expected to be $15.0 – $17.0 million and $68.0 - $73.0, respectively. In connection with the earnings release, Syndax's management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Monday, May 8, 2017. The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company's website at www.syndax.com. Alternatively, the conference call may be accessed through the following: For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors section of the Company's website, www.syndax.com. Syndax is a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Our lead product candidate, entinostat, which was granted Breakthrough Therapy designation by the FDA following positive results from our Phase 2b clinical trial, ENCORE 301, is currently being evaluated in a Phase 3 clinical trial for advanced hormone receptor positive, human epidermal growth factor receptor 2 negative breast cancer. Given its potential ability to block the function of immune suppressive cells in the tumor microenvironment, entinostat is also being evaluated in combination with approved PD-1 antagonists. Ongoing Phase 1b/2 clinical trials combine entinostat with KEYTRUDA® from Merck & Co., Inc. for non-small cell lung cancer and melanoma; with TECENTRIQ® from Genentech, Inc. for TNBC; and with BAVENCIOTM from Pfizer Inc. and Merck KGaA, Darmstadt, Germany, for ovarian cancer. Our second product candidate, SNDX-6352, is a monoclonal antibody that blocks the CSF-1 receptor and may also block the function of immune suppressive cells in the tumor microenvironment. SNDX-6352 is being evaluated in a single ascending dose Phase 1 clinical trial and is expected to be developed to treat a variety of cancers. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend," "believe" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Syndax's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the progress, timing, clinical development and scope of clinical trials and the reporting of clinical data for Syndax's product candidates, and the potential use of our product candidates to treat various cancer indications. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Syndax's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. Other factors that may cause Syndax's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Syndax's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein. Except as required by law, Syndax assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.


Enrollment of second stage of melanoma cohort in Phase 2 ENCORE 601 trial proceeding ahead of schedule; expected to be completed in the third quarter Company to host conference call today at 4:30 p.m. ET WALTHAM, Mass., May 08, 2017 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing entinostat and SNDX-6352 in multiple cancer indications, today reported its financial results for the first quarter ended March 31, 2017. In addition, the Company provided a clinical and business update. As of March 31, 2017, Syndax had $92.8 million in cash, cash equivalents and short-term investments. During the first quarter, the Company continued to advance its ENCORE immuno-oncology clinical programs. The Company reported that enrollment in the second stage of the melanoma cohort in ENCORE 601 is proceeding ahead of schedule, with completion of enrollment expected by the end of the third quarter of 2017. Results for the melanoma cohort from the first stage of ENCORE 601 will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June. The Company also recently announced the expansion of ENCORE 601, a Phase 2 clinical collaboration with a subsidiary of Merck, known as MSD outside the United States and Canada, to include a cohort of patients with microsatellite stable colorectal cancer who have not previously been treated with an anti-PD-1 (programmed death receptor-1) therapy. These cancers represent about 85% of all colon cancers and have shown minimal response to anti-PD-1 therapy. The expansion was based in part on clinical responses observed in the PD-1 refractory melanoma cohort of ENCORE 601. Enrollment is expected to begin mid-2017. “Our pipeline of innovative therapeutic candidates for cancer continues to make meaningful progress, and the recent melanoma results, as well as the expansion of ENCORE 601 into colorectal cancer, highlight the potential application of entinostat to a broad range of cancers. We believe the substantial unmet medical need in melanoma patients who have failed treatment with a PD-1 antagonist represents a fast to market opportunity for an effective and well tolerated therapy, and we look forward to presenting updated results from the melanoma cohort of ENCORE 601 at ASCO. In addition, we have secured a Type B meeting with the FDA in late June to discuss the development path for entinostat in melanoma,” said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. “Later this quarter, we anticipate determining whether either of the non-small cell lung cancer cohorts have met the prespecified criteria to advance to the second stage of the trial.” "Based on updates from the Eastern Cooperative Oncology Group regarding enrollment in the ongoing E2112 Phase 3 registration trial, completion of enrollment and progression free survival analysis are anticipated in the first half of 2018. This trial of entinostat plus exemestane in advanced HR+, HER2- breast cancer is being conducted with ECOG-ACRIN and the National Cancer Institute under a Special Protocol Assessment with the FDA,” said Michael L. Meyers, M.D., Ph.D., Chief Medical Officer of Syndax. Syndax Expects to Participate in the Following Upcoming Investor Conferences As of March 31, 2017, Syndax had cash, cash equivalents and short-term investments of $92.8 million and 18,244,917 shares issued and outstanding. First quarter 2017 research and development expenses increased to $9.6 million from $4.8 million for the comparable period in the prior year. The increase was primarily due to increased clinical trial activities of $3.4 million, employee compensation expense of $0.8 million, legal and consultant expenses of $0.5 million and facility costs of $0.1 million. General and administrative expenses totaled $3.9 million during the first quarter of 2017 compared with $4.3 million in the comparable period in the prior year. The decrease in general and administrative expenses was primarily due to a decrease in employee compensation of $0.7 million partially offset by increases in consulting expenses and other costs related to being a public company of $0.3 million. The decrease in employee compensation of $0.7 million was primarily due to decreases in non-cash stock-based compensation of $0.9 million and bonus expense of $0.2 million, partially offset by an increased salary expense of $0.3 million due to increased headcount. For the three months ended March 31, 2017, Syndax reported a net loss attributable to common stockholders of $13.0 million, or $0.71 per share, compared to $12.9 million, or $2.85 per share, for the comparable prior year period. Today the Company provided operating expense guidance for the second quarter and full year 2017. For the second quarter and full year 2017, research and development expenses are expected to be $11.0 – $13.0 million and $52.0 - $57.0 million, respectively, and total operating expenses are expected to be $15.0 – $17.0 million and $68.0 - $73.0, respectively. In connection with the earnings release, Syndax's management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Monday, May 8, 2017. The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company's website at www.syndax.com. Alternatively, the conference call may be accessed through the following: For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors section of the Company's website, www.syndax.com. Syndax is a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Our lead product candidate, entinostat, which was granted Breakthrough Therapy designation by the FDA following positive results from our Phase 2b clinical trial, ENCORE 301, is currently being evaluated in a Phase 3 clinical trial for advanced hormone receptor positive, human epidermal growth factor receptor 2 negative breast cancer. Given its potential ability to block the function of immune suppressive cells in the tumor microenvironment, entinostat is also being evaluated in combination with approved PD-1 antagonists. Ongoing Phase 1b/2 clinical trials combine entinostat with KEYTRUDA® from Merck & Co., Inc. for non-small cell lung cancer and melanoma; with TECENTRIQ® from Genentech, Inc. for TNBC; and with BAVENCIOTM from Pfizer Inc. and Merck KGaA, Darmstadt, Germany, for ovarian cancer. Our second product candidate, SNDX-6352, is a monoclonal antibody that blocks the CSF-1 receptor and may also block the function of immune suppressive cells in the tumor microenvironment. SNDX-6352 is being evaluated in a single ascending dose Phase 1 clinical trial and is expected to be developed to treat a variety of cancers. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend," "believe" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Syndax's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the progress, timing, clinical development and scope of clinical trials and the reporting of clinical data for Syndax's product candidates, and the potential use of our product candidates to treat various cancer indications. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Syndax's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. Other factors that may cause Syndax's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Syndax's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein. Except as required by law, Syndax assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.


News Article | December 16, 2016
Site: www.eurekalert.org

LUGANO-SINGAPORE, 17 December, 2016 - The first data on rare sarcomas in Asian patients is presented in three studies today at the ESMO Asia 2016 Congress in Singapore. Just half of patients with advanced angiosarcoma received chemotherapy even though it improved overall survival. CIC-rearranged sarcomas are shown to have a much worse prognosis than BCOR-rearranged sarcomas and clinical features are identified to aid accurate diagnoses. Angiosarcoma is the focus of two studies conducted by the newly formed Asian Sarcoma Consortium (ASC).1,2 This heterogeneous cancer has two distinct subtypes: elderly patients with scalp/cutaneous disease and a younger cohort with visceral disease typically in the liver, vascular systems, and breast. Treatment is challenging since the disease tends to be infiltrative, making surgery with clear margins difficult, while radiation is a poor option for tumours on the scalp and face. Chemotherapy has demonstrated activity in angiosarcoma but long term remission is rare. Both studies retrospectively included patients attending eight sites in six countries during 1990 to 2016. The first study outlines the epidemiology, real world treatment and clinical outcomes of angiosarcoma in Asia. The median age of the 423 patients was 67 years, about 60% had cutaneous angiosarcoma (they were more likely to be older, male, and have localised disease), while 40% had visceral angiosarcoma. In the localised setting, only about 60% of patients underwent surgery, but this was significantly lower in the cutaneous (55%) than visceral (75%) cohort. In those who underwent surgery, negative margins were only achieved in approximately 70% of cases. Close to half of patients who underwent surgery relapsed. Median relapse free survival was just 12.3 months with no statistical difference between the cutaneous (12.9 months) versus visceral (9.5 months) groups. Patients were more likely to relapse if they were more than 65 years old or had positive surgical margins. In the advanced setting, only about half of patients received chemotherapy. Median overall survival was 9.5 months with no significant difference between cutaneous (11.5 months) and visceral (8.3 months) groups. ECOG (Eastern Cooperative Oncology Group) performance status was an independent predictor of survival. However, after adjusting for ECOG performance status, overall survival was significantly better in patients who received chemotherapy than those who did not. "This is one of the largest studies in angiosarcoma and we found that overall prognosis was poor," said lead author Professor Richard Quek, deputy head and senior consultant, National Cancer Centre Singapore. "In patients with localised disease, negative surgical margin was prognostic for relapse free survival yet it was only achieved in 70% of patients. Neoadjuvant (pre-operative) treatment, be it chemotherapy or radiation, might enhance resectability of these tumours and thereby improve survival outcomes." Quek continued: "In patients with advanced disease we demonstrated that after adjusting for ECOG performance status, chemotherapy was associated with improved overall survival. But only half of our patients actually received chemotherapy, hence it would be important to understand the reasons behind this low treatment rate. Could these be physician-related factors? And if so, is more sarcoma-related continuing medical education needed to enhance care for our patients?" The second angiosarcoma study outlined the clinical characteristics and treatment of 277 patients with advanced metastatic or unresectable disease. The median age was 64 years. The predictors of better prognosis were younger age, female sex, and cutaneous (rather than visceral) disease. Use of chemotherapy gradually increased over the 20-year period, with a preference for paclitaxel and liposomal doxorubicin over other treatments. Progression-free survival in patients receiving at least one line of chemotherapy was 3.8 months. Overall survival was 8.3 months but was significantly higher in patients who received at least one line of palliative chemotherapy (11.5 months) than those who did not (4.4 months). "It's the first time we have data on expected survival for Asian patients with advanced metastatic or unresectable angiosarcoma," said lead author Dr Tom Chen, attending physician, National Taiwan University Hospital, Taipei, Taiwan. "This data will help us to develop clinical trials and new treatments for Asian angiosarcoma patients." The third study focused on Ewing sarcoma-like small round cell sarcomas.3 Ewing sarcoma is molecularly characterised by a EWSR1 gene alteration or FUS rearrangement. Small round cell sarcomas without these molecular characteristics are designated "Ewing sarcoma-like" disease. Recent molecular genetic studies have identified CIC-rearranged sarcoma (CIC-DUX4, CIC-DUX4L, CIC-FOXO4) and BCOR-rearranged sarcoma (BCOR-CCNB3, BCOR-MAML3, ZC3H7B-BCOR) among these Ewing sarcoma-like small round cell sarcomas. The study presented today describes the clinical characteristics and treatment outcomes of these two sarcomas. The study included 17 patients with CIC sarcoma, of whom 12 were male. Median age was 22 years, all cases were soft tissue tumours, and 59% of patients had local pain. The seven BCOR sarcoma patients were all male. Median age was 14 years and cases included bone and soft tissue tumours. The five-year overall survival rate was 28.2% for CIC sarcoma and 100% for BCOR sarcoma. Metastases were present in 71% of CIC patients at the initial visit and none of the BCOR patients. Only 29% of CIC patients responded to chemotherapy compared to 75% of BCOR patients. "CIC-rearranged sarcomas have a much worse prognosis than BCOR-rearranged sarcomas," said lead author Dr Makoto Endo, attending physician, National Cancer Centre, Tokyo, Japan. "CIC and BCOR sarcomas were previously classified as the same tumour. Our research will help us to make a precise diagnosis and should improve the management of these patients." Commenting on the studies, Professor Thomas Brodowicz, programme director, Bone and Soft Tissue-Sarcoma Unit, Medical University Vienna, Austria, said: "The two studies on angiosarcoma show that immediate progression-free survival and overall survival are low, which reflects the aggressiveness of this disease. It would be useful to have a more detailed breakdown of the patients - for example, the treatment and outcomes of primary angiosarcoma versus secondary, which forms at the site of radiation treatment for a previous cancer. It would also be helpful to know whether paclitaxel is more effective when taken every three weeks or weekly, which has an antiangiogenic effect that could be beneficial in angiosarcoma." He continued: "The study by Dr Endo provides practice-changing information. It shows that Ewing sarcoma-like small round cell sarcomas can be further categorised by their specific mutations, which have a strong prognostic impact. This should help us to tailor treatment."


News Article | December 19, 2016
Site: www.eurekalert.org

Bottom Line: Among women with breast cancer who received a type of chemotherapy called an anthracycline, those who had a certain genetic biomarker had a significantly increased risk for having anthracycline-induced congestive heart failure. Journal in Which the Study was Published: Clinical Cancer Research, a journal of the American Association for Cancer Research. Author: Bryan P. Schneider, MD, associate professor of medicine at the Indiana University Melvin and Bren Simon Cancer Center in Indianapolis. Background: Schneider explained that the decision to undergo chemotherapy for breast cancer is not always clear cut because each patient has a different risk of relapse and different tolerance to potential adverse effects of treatment. As a result, the more information a patient and his or her oncologist have about the potential risks and benefits of treatment the better prepared they are to make good treatment decisions, he noted. "Anthracyclines such as doxorubicin, which are widely used chemotherapeutic agents, cause congestive heart failure in about 1 to 2 percent of patients," continued Schneider. "Knowing which patients are at increased risk for this life-threatening effect of anthracycline chemotherapy is important to help oncologists counsel patients about their personal risks and benefits of such treatment." How the Study Was Conducted and Results: Schneider and colleagues analyzed genome-wide association data from 3,431 women with breast cancer who received doxorubicin as part of treatment received through enrollment in the phase III Eastern Cooperative Oncology Group (ECOG) 5103 clinical trial and for whom heart assessment data were available. Among these patients, 68 (2 percent) had cardiologist-adjudicated congestive heart failure. Because the majority of those who had cardiologist-adjudicated congestive heart failure (51) were European-American, the researchers limited the genetic association analysis to European-Americans. They identified several SNPs associated with risk of anthracycline-induced congestive heart failure. After looking at the chromosomal location of the SNPs, the researchers chose two of the top SNPs for validation in independent data sets. One of the two SNPs, rs28714259 was associated with risk of anthracycline-induced congestive heart failure among 2,415 women with breast cancer who received doxorubicin as part of treatment received through enrollment in the phase III ECOG 1199 clinical trial. It was also associated with low ventricular ejection fraction, which is a sign of heart damage, among 828 women with breast cancer who received doxorubicin as part of treatment through enrollment in the phase III BEATRICE clinical trial. Author Comment: "We found that the A allele of the single nucleotide polymorphism (SNP) rs28714259 was associated with increased risk of anthracycline-induced congestive heart failure among women with breast cancer," said Schneider. "Adding information gained from testing for this SNP to currently used clinical information could help oncologists provide a more precise prediction of the risks and benefits of anthracycline chemotherapy for patients with breast cancer. We are currently further testing this finding in patients receiving anthracyclines at the Indiana University Melvin and Bren Simon Cancer Center to better understand its contribution to heart failure risk in the face of other known risk factors and comorbidities." Limitations: According to Schneider, the study has two main limitations. First, not all of the clinical trials used the same method for assessing heart damage with corresponding long-term data. Second, the number of patients who had heart damage was relatively low because it is a rare adverse event. "As a result, additional studies in other patient groups and in the real-world setting of the clinic, as we are doing, are needed to confirm the association," Schneider said. Funding & Disclosures: The study was conducted by the ECOG-ACRIN Cancer Research Group [ACRIN (American College of Radiology Imaging Network)] and supported by funds from the Public Health Service, Susan G. Komen for the Cure, the Conquer Cancer Foundation, the Breast Cancer Research Foundation, the National Cancer Institute, the National Institutes of Health, and the Department of Health and Human Services. Schneider declares no conflicts of interest. To interview Bryan P. Schneider, contact Julia Gunther at julia.gunther@aacr.org or 215-446-6896. About the American Association for Cancer Research Founded in 1907, the American Association for Cancer Research (AACR) is the world's first and largest professional organization dedicated to advancing cancer research and its mission to prevent and cure cancer. AACR membership includes more than 37,000 laboratory, translational, and clinical researchers; population scientists; other health care professionals; and patient advocates residing in 108 countries. The AACR marshals the full spectrum of expertise of the cancer community to accelerate progress in the prevention, biology, diagnosis, and treatment of cancer by annually convening more than 30 conferences and educational workshops, the largest of which is the AACR Annual Meeting with nearly 19,500 attendees. In addition, the AACR publishes eight prestigious, peer-reviewed scientific journals and a magazine for cancer survivors, patients, and their caregivers. The AACR funds meritorious research directly as well as in cooperation with numerous cancer organizations. As the Scientific Partner of Stand Up To Cancer, the AACR provides expert peer review, grants administration, and scientific oversight of team science and individual investigator grants in cancer research that have the potential for near-term patient benefit. The AACR actively communicates with legislators and other policymakers about the value of cancer research and related biomedical science in saving lives from cancer. For more information about the AACR, visit http://www. .


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


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


Gupta V.,Princess Margaret Hospital | Richards S.,University of Oxford | Rowe J.,Eastern Cooperative Oncology Group
Blood | Year: 2013

Hematopoietic cell transplantation (HCT) and prolonged chemotherapy are standard postremission strategies for adult acute lymphoblastic leukemia in first complete remission, but the optimal strategy remains controversial. There are no randomized trials of allogeneic HCT. In the present study, updated individual patient data were collected and analyzed from studies with information on availability of matched sibling donor (used to mimic randomization) and from randomized trials of autograft versus chemotherapy. Data from 13 studies including 2962 patients, excluding Philadelphia chromosome-positive patients, showed a survival benefit for having a matched sibling donor for patients < 35 years of age (OR = 0.79; 95% CI, 0.70-0.90, P = .0003) but not for those ≥ 35 years of age (OR = 1.01; 95% CI, 0.85-1.19, P = .9; heterogeneity P = .03) because of the higher absolute risk of nonrelapse mortality for older patients. No differences were seen by risk group. There was a trend toward inferior survival for autograft versus chemotherapy (OR = 1.18; 95% CI, 0.99-1.41; P = .06). No beneficial effect of autografting was seen compared with chemotherapy in this analysis. We conclude that matched sibling donor myeloablative HCT improves survival only for younger patients, with an absolute benefit of approximately 10% at 5 years. Improved chemotherapy outcomes and reduced nonrelapse mortality associated with allogeneic HCT may change the relative effects of these treatments in the future. © 2013 by The American Society of Hematology.

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