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Marseille, France, Nov. 12, 2016 (GLOBE NEWSWIRE) -- Interim Phase 1/2 Data Show Encouraging Clinical Benefit for Lirilumab in Combination With Opdivo (Nivolumab) in Patients With Advanced Platinum Refractory Squamous Cell Carcinoma of the Head and Neck Objective response rate (ORR) was 24% in 29 evaluable patients and increased in inflamed (PD-L1 positive) tumors, with ORR of 41% in patients with 1% PD-L1 expression First disclosure of data for clinical activity with the combination of anti-KIR and anti-PD-1 therapy will include results for diverse biomarker subgroups (PRINCETON, N.J., and MARSEILLE, France, November 12, 2016) - Bristol-Myers Squibb Company (NYSE:BMY) and Innate Pharma SA (Euronext Paris: FR0010331421 - IPH) today announced an interim efficacy analysis from a Phase 1/2 study of the combination of lirilumab and Opdivo (nivolumab) in the cohort of advanced platinum refractory squamous cell carcinoma of the head and neck (SCCHN), including exploratory biomarker analyses of patient response by level of PD-L1 expression. Among 29 evaluable patients with SCCHN, the objective response rate (ORR), a secondary endpoint measured by Response Evaluation Criteria In Solid Tumors (RECIST), was 24% (n=7). Seventeen percent (n=5) of these evaluable patients had deep responses, with reductions in tumor burden greater than 80%. Early signals of enhanced clinical benefit were observed in PD-L1 positive tumors, with an ORR of 41% (7/17) in patients with 1% PD-L1 expression. Lirilumab is directed against the inhibitory killer-cell immunoglobulin-like receptors (KIRs) expressed predominantly on natural killer (NK) cells, which belong to the innate immune system, while Opdivo blocks the inhibitory function of the PD-1 receptor on T cells. These data mark the first report of potential efficacy with an anti-KIR antibody in combination with an anti-PD-1 therapy, and were presented at a late-breaking oral presentation (abstract 456) at the Society for Immunotherapy of Cancer (SITC) 31 Annual Meeting on November 12 at 11:15 a.m. EST in National Harbor, Maryland. Preliminary efficacy and exploratory biomarker analyses of patient response by biomarker subgroups were presented. The safety profile associated with lirilumab in combination with Opdivo was generally consistent with that observed with Opdivo monotherapy. The overall rate of treatment-related adverse events (TRAEs) was reported as 72% (114/159) and the rate of Grade 3-4 TRAEs was 15% (24/159). Discontinuations due to TRAEs occurred in 8% of patients (12/159). These safety data were also reported at the 2016 European Society for Medical Oncology (ESMO) Congress. "The interim efficacy results indicate that targeting both the KIR and PD-1 pathways with lirilumab and Opdivo, respectively, may provide enhanced clinical activity, particularly in PD-L1 positive tumors, with deep and durable responses in some patients," said Rom Leidner, Medical Oncologist, Earle A. Chiles Research Institute, Providence Cancer Center, and lead author of the study. "We look forward to continuing the study of this novel combination in patients with advanced platinum refractory squamous cell carcinoma of the head and neck, which is the seventh-leading cause of cancer globally." "The preliminary signals of anti-tumor activity we are seeing with the combination of lirilumab and Opdivo in head and neck cancer patients compare favorably to data previously presented on Opdivo monotherapy in a similar patient population. We are encouraged by the suggestion of enhanced benefit, particularly in inflamed tumors as defined by increasing PD-L1 expression," said Tim Reilly, head of Oncology Early Assets Development at Bristol-Myers Squibb. "We aim to apply what we have been learning about these complementary mechanisms and biomarker subgroups to maximize the potential clinical benefit of lirilumab and Opdivo across a range of tumor types and are excited about continuing to expand our study of Opdivo with complementary pathways." "We are very encouraged by these interim efficacy data and are eagerly awaiting the next steps of the clinical development of the combination of lirilumab and Opdivo" said Pierre Dodion, Chief Medical Officer of Innate Pharma. "These clinical data constitute crucial progress that validates our pioneering work on the role of innate immunity and NK cells in cancer. They support our ambition to be at the forefront of developing novel combination immunotherapies." About CA223-001: A Phase 1/2 Dose Escalation and Cohort Expansion Study of the Safety, Tolerability and Efficacy of Anti-KIR (Lirilumab) Administered in Combination With Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors CA223-001 is a Phase 1/2 dose escalation and cohort expansion study of lirilumab in combination with nivolumab in 159 patients with advanced solid tumors. In this trial, patients received lirilumab (0.1, 0.3, 1.0, or 3.0 mg/kg) once every 4 weeks and nivolumab (3 mg/kg) once every 2 weeks. During dose escalation, patients with advanced solid tumors who progressed after at least 1 prior therapy received lirilumab 0.1-3.0 mg/kg once every 4 weeks (Q4W) plus nivolumab 3.0 mg/kg Q2W. Cohort expansion was initiated at the maximum dose of lirilumab 3.0 mg/kg Q4W plus nivolumab 3.0 mg/kg Q2W in patients with advanced solid tumors. The data reported at SITC pertain to an expansion cohort in SCCHN. Key study endpoints include safety (primary), objective response rate (ORR), disease control rate (DCR), duration of response (DOR), and biomarker assessments. The purpose of this Phase 1/2 open label study is to determine the safety of the combination of lirilumab and nivolumab and to explore the preliminary anti-tumor activity of the combination in patients with a range of advanced solid tumors. Lirilumab is a fully human monoclonal antibody that is designed to act as a checkpoint inhibitor by blocking the interaction between KIR2DL-1,-2,-3 inhibitory receptors and their ligands. Blocking these receptors facilitates activation of NK cells and potentially some subsets of T cells, ultimately leading to destruction of tumor cells. Lirilumab is licensed to Bristol-Myers Squibb Company. As part of the agreement with Innate Pharma, Bristol-Myers Squibb holds exclusive worldwide rights to develop, manufacture and commercialize lirilumab and related compounds blocking KIR receptors, for all indications. Under the agreement, Innate Pharma conducts the development of lirilumab through Phase II in acute myeloid leukemia ("AML"). Innate Pharma is currently testing lirilumab in a randomized, double-blind, placebo-controlled Phase II trial as maintenance treatment in elderly patients with AML in first complete remission ("EffiKIR" trial). In addition, lirilumab is also being evaluated by Bristol-Myers Squibb in clinical trials in combination with other agents in a variety of tumor types. Cancers that are known as head and neck cancers usually begin in the squamous cells that line the moist mucosal surfaces inside the head and neck, such as inside the mouth, the nose and the throat. Head and neck cancer is the seventh most common cancer globally, with an estimated 400,000 to 600,000 new cases per year and 223,000 to 300,000 deaths per year. The five-year survival rate is reported as less than 4% for metastatic Stage IV disease. Squamous cell carcinoma of the head and neck (SCCHN) accounts for approximately 90% of all head and neck cancers with global incidence expected to increase by 17% between 2012 and 2022. Risk factors for SCCHN include tobacco and alcohol consumption. The Human Papilloma Virus (HPV) infection is also a risk factor leading to rapid increase in oropharyngeal SCCHN in Europe and North America. Quality of life is often impacted for SCCHN patients, as physiological function (breathing, swallowing, eating, drinking), personal characteristics (appearance, speaking, voice), sensory function (taste, smell, hearing), and psychological/social function can be affected. Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body's own immune system to help restore anti-tumor immune response. By harnessing the body's own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers. Opdivo's leading global development program is based on Bristol-Myers Squibb's scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has enrolled more than 25,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression. In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 57 countries, including the United States, the European Union and Japan. In October 2015, the company's Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 47 countries, including the United States and the European Union. OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. OPDIVO® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. OPDIVO® (nivolumab) is indicated for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. OPDIVO® (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy. YERVOY can result in severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY. Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests (LFTs), adrenocorticotropic hormone (ACTH) level, and thyroid function tests at baseline and before each dose. OPDIVO can cause immune-mediated pneumonitis. Fatal cases have been reported. Monitor patients for signs with radiographic imaging and for symptoms of pneumonitis. Administer corticosteroids for Grade 2 or more severe pneumonitis. Permanently discontinue for Grade 3 or 4 and withhold until resolution for Grade 2. In patients receiving OPDIVO monotherapy, fatal cases of immune-mediated pneumonitis have occurred. Immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated pneumonitis occurred in 6% (25/407) of patients. In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 4.9% (13/263) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 3.4% (9/263) of patients receiving OPDIVO: Grade 3 (n=1) and Grade 2 (n=8). OPDIVO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4 colitis. Withhold OPDIVO monotherapy for Grade 2 or 3 and permanently discontinue for Grade 4 or recurrent colitis upon re-initiation of OPDIVO. When administered with YERVOY, withhold OPDIVO and YERVOY for Grade 2 and permanently discontinue for Grade 3 or 4 or recurrent colitis. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated colitis occurred in 26% (107/407) of patients including three fatal cases. In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal (diarrhea of at least 7 stools above baseline, fever, ileus, peritoneal signs; Grade 3-5) immune-mediated enterocolitis occurred in 34 (7%) patients. Across all YERVOY-treated patients in that study (n=511), 5 (1%) developed intestinal perforation, 4 (0.8%) died as a result of complications, and 26 (5%) were hospitalized for severe enterocolitis. OPDIVO can cause immune-mediated hepatitis. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater transaminase elevations. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated hepatitis occurred in 13% (51/407) of patients. In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal hepatotoxicity (AST or ALT elevations >5x the ULN or total bilirubin elevations >3x the ULN; Grade 3-5) occurred in 8 (2%) patients, with fatal hepatic failure in 0.2% and hospitalization in 0.4%. In a separate Phase 3 study of YERVOY 3 mg/kg, 1 case of fatal Guillain-Barré syndrome and 1 case of severe (Grade 3) peripheral motor neuropathy were reported. OPDIVO can cause immune-mediated hypophysitis, immune-mediated adrenal insufficiency, autoimmune thyroid disorders, and Type 1 diabetes mellitus. Monitor patients for signs and symptoms of hypophysitis, signs and symptoms of adrenal insufficiency, thyroid function prior to and periodically during treatment, and hyperglycemia. Administer hormone replacement as clinically indicated and corticosteroids for Grade 2 or greater hypophysitis. Withhold for Grade 2 or 3 and permanently discontinue for Grade 4 hypophysitis. Administer corticosteroids for Grade 3 or 4 adrenal insufficiency. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 adrenal insufficiency. Administer hormone-replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism. Withhold OPDIVO for Grade 3 and permanently discontinue for Grade 4 hyperglycemia. In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients. In patients receiving OPDIVO with YERVOY, hypophysitis occurred in 9% (36/407) of patients. In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994) of patients. In patients receiving OPDIVO with YERVOY, adrenal insufficiency occurred in 5% (21/407) of patients. In patients receiving OPDIVO monotherapy, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 9% (171/1994) of patients. Hyperthyroidism occurred in 2.7% (54/1994) of patients receiving OPDIVO monotherapy. In patients receiving OPDIVO with YERVOY, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (89/407) of patients. Hyperthyroidism occurred in 8% (34/407) of patients receiving OPDIVO with YERVOY. In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients. In patients receiving OPDIVO with YERVOY, diabetes occurred in 1.5% (6/407) of patients. In a separate Phase 3 study of YERVOY 3 mg/kg, severe to life-threatening immune-mediated endocrinopathies (requiring hospitalization, urgent medical intervention, or interfering with activities of daily living; Grade 3-4) occurred in 9 (1.8%) patients. All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism. 6 of the 9 patients were hospitalized for severe endocrinopathies. OPDIVO can cause immune-mediated nephritis. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grades 2-4 increased serum creatinine. Withhold OPDIVO for Grade 2 or 3 and permanently discontinue for Grade 4 increased serum creatinine. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated nephritis and renal dysfunction occurred in 2.2% (9/407) of patients. OPDIVO can cause immune-mediated rash, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some cases with fatal outcome. Administer corticosteroids for Grade 3 or 4 rash. Withhold for Grade 3 and permanently discontinue for Grade 4 rash. For symptoms or signs of SJS or TEN, withhold OPDIVO and refer the patient for specialized care for assessment and treatment; if confirmed, permanently discontinue. In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated rash occurred in 22.6% (92/407) of patients. In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal immune-mediated dermatitis (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade 3-5) occurred in 13 (2.5%) patients. 1 (0.2%) patient died as a result of toxic epidermal necrolysis. 1 additional patient required hospitalization for severe dermatitis. OPDIVO can cause immune-mediated encephalitis. Evaluation of patients with neurologic symptoms may include, but not be limited to, consultation with a neurologist, brain MRI, and lumbar puncture. Withhold OPDIVO in patients with new-onset moderate to severe neurologic signs or symptoms and evaluate to rule out other causes. If other etiologies are ruled out, administer corticosteroids and permanently discontinue OPDIVO for immune-mediated encephalitis. In patients receiving OPDIVO monotherapy, encephalitis occurred in 0.2% (3/1994) of patients. Fatal limbic encephalitis occurred in one patient after 7.2 months of exposure despite discontinuation of OPDIVO and administration of corticosteroids. Encephalitis occurred in one patient receiving OPDIVO with YERVOY (0.2%) after 1.7 months of exposure. Based on the severity of adverse reaction, permanently discontinue or withhold treatment, administer high-dose corticosteroids, and, if appropriate, initiate hormone-replacement therapy. Across clinical trials of OPDIVO the following clinically significant immune-mediated adverse reactions occurred in <1.0% of patients receiving OPDIVO: uveitis, iritis, pancreatitis, facial and abducens nerve paresis, demyelination, polymyalgia rheumatica, autoimmune neuropathy, Guillain-Barré syndrome, hypopituitarism, systemic inflammatory response syndrome, gastritis, duodenitis, sarcoidosis, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), myositis, myocarditis, rhabdomyolysis, motor dysfunction, vasculitis, and myasthenic syndrome. OPDIVO can cause severe infusion reactions, which have been reported in <1.0% of patients in clinical trials. Discontinue OPDIVO in patients with Grade 3 or 4 infusion reactions. Interrupt or slow the rate of infusion in patients with Grade 1 or 2. In patients receiving OPDIVO monotherapy, infusion-related reactions occurred in 6.4% (127/1994) of patients. In patients receiving OPDIVO with YERVOY, infusion-related reactions occurred in 2.5% (10/407) of patients. Complications, including fatal events, occurred in patients who received allogeneic HSCT after OPDIVO. Outcomes were evaluated in 17 patients from Checkmate 205 and 039, who underwent allogeneic HSCT after discontinuing OPDIVO (15 with reduced-intensity conditioning, 2 with myeloablative conditioning). Thirty-five percent (6/17) of patients died from complications of allogeneic HSCT after OPDIVO. Five deaths occurred in the setting of severe or refractory GVHD. Grade 3 or higher acute GVHD was reported in 29% (5/17) of patients. Hyperacute GVHD was reported in 20% (n=2) of patients. A steroid-requiring febrile syndrome, without an identified infectious cause, was reported in 35% (n=6) of patients. Two cases of encephalitis were reported: Grade 3 (n=1) lymphocytic encephalitis without an identified infectious cause, and Grade 3 (n=1) suspected viral encephalitis. Hepatic veno-occlusive disease (VOD) occurred in one patient, who received reduced-intensity conditioned allogeneic HSCT and died of GVHD and multi-organ failure. Other cases of hepatic VOD after reduced-intensity conditioned allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptor blocking antibody before transplantation. Cases of fatal hyperacute GVHD have also been reported. These complications may occur despite intervening therapy between PD-1 blockade and allogeneic HSCT. Follow patients closely for early evidence of transplant-related complications such as hyperacute GVHD, severe (Grade 3 to 4) acute GVHD, steroid-requiring febrile syndrome, hepatic VOD, and other immune-mediated adverse reactions, and intervene promptly. Based on their mechanisms of action, OPDIVO and YERVOY can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with an OPDIVO- or YERVOY- containing regimen and for at least 5 months after the last dose of OPDIVO. It is not known whether OPDIVO or YERVOY is present in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from an OPDIVO-containing regimen, advise women to discontinue breastfeeding during treatment. Advise women to discontinue nursing during treatment with YERVOY and for 3 months following the final dose. In Checkmate 037, serious adverse reactions occurred in 41% of patients receiving OPDIVO (n=268). Grade 3 and 4 adverse reactions occurred in 42% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse drug reactions reported in 2% to <5% of patients receiving OPDIVO were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase. In Checkmate 066, serious adverse reactions occurred in 36% of patients receiving OPDIVO (n=206). Grade 3 and 4 adverse reactions occurred in 41% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse reactions reported in greater than or equal to 2% of patients receiving OPDIVO were gamma-glutamyltransferase increase (3.9%) and diarrhea (3.4%). In Checkmate 067, serious adverse reactions (73% and 37%), adverse reactions leading to permanent discontinuation (43% and 14%) or to dosing delays (55% and 28%), and Grade 3 or 4 adverse reactions (72% and 44%) all occurred more frequently in the OPDIVO plus YERVOY arm (n=313)  relative to the OPDIVO arm (n=313). The most frequent (greater than or equal to 10%) serious adverse reactions in the OPDIVO plus YERVOY arm and the OPDIVO arm, respectively, were diarrhea (13% and 2.6%), colitis (10% and 1.6%), and pyrexia (10% and 0.6%). In Checkmate 017 and 057, serious adverse reactions occurred in 46% of patients receiving OPDIVO (n=418). The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were pneumonia, pulmonary embolism, dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure. In Checkmate 025, serious adverse reactions occurred in 47% of patients receiving OPDIVO (n=406). The most frequent serious adverse reactions reported in greater than or equal to 2% of patients were acute kidney injury, pleural effusion, pneumonia, diarrhea, and hypercalcemia. In Checkmate 205 and 039, among all patients (safety population [n=263]), adverse reactions leading to discontinuation (4.2%) or to dosing delays (23%) occurred.  The most frequent serious adverse reactions reported in greater than or equal to 1% of patients were infusion-related reaction, pneumonia, pleural effusion, pyrexia, rash and pneumonitis. Ten patients died from causes other than disease progression, including 6 who died from complications of allogeneic HSCT. Serious adverse reactions occurred in 21% of patients in the safety population (n=263) and 27% of patients in the subset of patients evaluated for efficacy (efficacy population [n=95]).  In Checkmate 141, serious adverse reactions occurred in 49% of patients receiving OPDIVO.  The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were pneumonia, dyspnea, respiratory failure, respiratory tract infections, and sepsis. In Checkmate 037, the most common adverse reaction (greater than or equal to20%) reported with OPDIVO (n=268) was rash (21%). In Checkmate 066, the most common adverse reactions (greater than or equal to20%) reported with OPDIVO (n=206) vs dacarbazine (n=205) were fatigue (49% vs 39%), musculoskeletal pain (32% vs 25%), rash (28% vs 12%), and pruritus (23% vs 12%). In Checkmate 067, the most common (greater than or equal to20%) adverse reactions in the OPDIVO plus YERVOY arm (n=313) were fatigue (59%), rash (53%), diarrhea (52%), nausea (40%), pyrexia (37%), vomiting (28%), and dyspnea (20%). The most common (greater than or equal to 20%) adverse reactions in the OPDIVO (n=313) arm were fatigue (53%), rash (40%), diarrhea (31%), and nausea (28%). In Checkmate 017 and 057, the most common adverse reactions (greater than or equal to 20%) in patients receiving OPDIVO (n=418) were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite. In Checkmate 025, the most common adverse reactions (greater than or equal to 20%) reported in patients receiving OPDIVO (n=406) vs everolimus (n=397) were asthenic conditions (56% vs 57%), cough (34% vs 38%), nausea (28% vs 29%), rash (28% vs 36%), dyspnea (27% vs 31%), diarrhea (25% vs 32%), constipation (23% vs 18%), decreased appetite (23% vs 30%), back pain (21% vs 16%), and arthralgia (20% vs 14%). In Checkmate 205 and 039, among all patients (safety population [n=263]) and the subset of patients in the efficacy population (n=95), respectively, the most common adverse reactions (greater than or equal to 20%) were fatigue (32% and 43%), upper respiratory tract infection (28% and 48%), pyrexia (24% and 35%), diarrhea (23% and 30%), and cough (22% and 35%). In the subset of patients in the efficacy population (n=95), the most common adverse reactions also included rash (31%), musculoskeletal pain (27%), pruritus (25%), nausea (23%), arthralgia (21%), and peripheral neuropathy (21%).  In Checkmate 141, the most common adverse reactions (greater than or equal to 10%) in patients receiving OPDIVO were cough and dyspnea at a higher incidence than investigator's choice. In a separate Phase 3 study of YERVOY 3 mg/kg, the most common adverse reactions (greater than or equal to 5%) in patients who received YERVOY at 3 mg/kg were fatigue (41%), diarrhea (32%), pruritus (31%), rash (29%), and colitis (8%). Checkmate 067 - advanced melanoma alone or in combination with YERVOY; Checkmate 037 and 066 - advanced melanoma; Checkmate 017  - squamous non-small cell lung cancer (NSCLC); Checkmate 057 - non-squamous NSCLC; Checkmate 025 - renal cell carcinoma; Checkmate 205/039 - classical Hodgkin lymphoma; Checkmate 141 - squamous cell carcinoma of the head and neck. Please see U.S. Full Prescribing Information for OPDIVO and YERVOY, including Boxed WARNING regarding immune-mediated adverse reactions for YERVOY.                 Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook. Bristol-Myers Squibb: At the Forefront of Immuno-Oncology Science & Innovation              At Bristol-Myers Squibb, patients are at the center of everything we do. Our vision for the future of cancer care is focused on researching and developing transformational Immuno-Oncology (I-O) medicines that will raise survival expectations in hard-to-treat cancers and will change the way patients live with cancer. We are leading the scientific understanding of I-O through our extensive portfolio of investigational and approved agents - including the first combination of two I-O agents in metastatic melanoma - and our differentiated clinical development program, which is studying broad patient populations across more than 20 types of cancers with 12 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs uniquely position us to advance the science of combinations across multiple tumors and potentially deliver the next wave of I-O combination regimens with a sense of urgency. We also continue to pioneer research that will help facilitate a deeper understanding of the role of immune biomarkers and inform which patients will benefit most from I-O therapies. We understand making the promise of I-O a reality for the many patients who may benefit from these therapies requires not only innovation on our part, but also close collaboration with leading experts in the field. Our partnerships with academia, government, advocacy and biotech companies support our collective goal of providing new treatment options to advance the standards of clinical practice. This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that Opdivo, Yervoy or any of the compounds mentioned in this release will receive regulatory approval for an initial or additional indication. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2015 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. About Innate Pharma             Innate Pharma S.A. is a clinical-stage biotechnology company with a focus on discovering and developing first-in-class therapeutic antibodies that harness the innate immune system to improve cancer treatment and clinical outcomes for patients. Innate Pharma specializes in immuno-oncology, a new therapeutic field that is changing cancer treatment by mobilizing the power of the body's immune system to recognize and kill cancer cells. The Company's aim is to become a commercial stage biopharmaceutical company in the area of immunotherapy and focused on serious unmet medical needs in cancer. Innate Pharma has pioneered the discovery and development of checkpoint inhibitors to activate the innate immune system. Innate Pharma's innovative approach has resulted in three first-in-class, clinical-stage antibodies targeting natural killer cell receptors that may address a broad range of solid and hematological cancer indications as well as additional preclinical product candidates and technologies. Targeting receptors involved in innate immunity also creates opportunities for the Company to develop therapies for inflammatory diseases. The Company's expertise and understanding of natural killer cell biology have enabled it to enter into major alliances with leaders in the biopharmaceutical industry including AstraZeneca, Bristol-Myers Squibb, Novo Nordisk A/S and Sanofi. Based in Marseille, France, Innate Pharma has more than 140 employees and is listed on Euronext Paris. Learn more about Innate Pharma at www.innate-pharma.com. This press release contains certain forward-looking statements. Although the company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. For a discussion of risks and uncertainties which could cause the company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risque") section of the Document de Reference prospectus filed with the AMF, which is available on the AMF website (http://www.amf-france.org) or on Innate Pharma's website. This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.


Boys & Girls Clubs of America's Alumni Hall of Fame "Class of 2017" inductees include the following: Anthony Anderson, Actor, "Black-ish"; Paul "Triple H" Levesque, WWE Executive Vice President and WWE Superstar; Jason Witten, All-Pro Tight End, Dallas Cowboys; Skylar Diggins, All-Star Guard, Dallas Wings; Dante Lauretta, Professor of Planetary Science and Cosmochemistry, University of Arizona; Philip Schein, Medical Oncologist; and Tony Clark, Executive Director, Major League Baseball Players Association. "Every day at Boys & Girls Clubs nationwide, kids and teens are inspired to follow their dreams and reach their full potential," said Jim Clark, president & CEO of Boys & Girls Clubs of America. "Each year it is such an honor to recognize a new class of impressive individuals who serve as role models for the next generation and prove that great futures are within reach for all kids." Boys & Girls Clubs Alumni & Friends Club estimates there are nearly 16 million living Boys & Girls Club alumni today. More on this year's inductees: Anthony Anderson – Actor, "Blackish" Anthony attended, and is active supporter of, what is now the Watts/Willowbrook Boys & Girls Club in Los Angeles. He found his way to acting through his mother, who worked as a background actor. After graduating from the High School for the Performing Arts in Los Angeles, he was awarded a scholarship to attend Howard University, where he earned his theater arts degree. In 1993, he landed his first significant movie role in the Eddie Murphy/Martin Lawrence comedy, "Life." Anthony's versatility as an actor has served him well, with roles in comedies, dramas and action movies, including "Me, Myself & Irene," "Barbershop," "The Departed" and "Transformers." Well known for playing Detective Kevin Bernard on TV's "Law & Order," Anthony now stars in the popular family sit-com, "Black-ish." Paul "Triple H" Levesque – WWE Executive Vice President and WWE Superstar Growing up, Paul was a member of the Boys & Girls Club of Nashua and was a huge WWE fan. Watching his first wrestling match at the age of 5, a televised bout featuring Chief Jay Strongbow, he became a voracious fan. After graduating from high school, Paul focused on competitive body building and was crowned Mr. Teenage New Hampshire when he was 19. In 1992, he enrolled in a wrestling school run by legend, Killer Kowalski, and then made his WWE debut in 1995. Now a WWE executive vice president, responsible for overseeing talent development, live events and creative, Paul also continues to compete as Triple H, his iconic alter ego who has captured every major championship, headlined thousands of events and entertained millions of fans around the world. Jason Witten – All-Pro Tight End, Dallas Cowboys  Jason joined the Boys & Girls Club when he moved to Tennessee at the age of 11. He knew people there cared about him, and the Club became a big part of his life. A four-year starter at linebacker and tight end in high school, Jason was named USA Today's Tennessee Player of the Year as a senior. He enrolled at the University of Tennessee, and was one of the most productive tight ends in the school's history. A 10-time Pro Bowl selection, his 1,089 career receptions place him among the top 10 receivers in NFL history. His off-the-field actions are just as impressive, and include the creation of Jason Witten Learning Centers at Boys & Girls Clubs in Texas and Tennessee. In 2012, he was named the Walter Payton NFL Man of the Year for his community service. Skylar Diggins – All-Star Guard, Dallas Wings The Boys & Girls Clubs of St. Joseph County first welcomed Skylar through its doors as a first-grader. From the start, she never wanted to leave. Her friends were there, she got to play, have fun and just be a kid. At the Club after-school, Skylar honed her basketball skills. While numerous colleges recruited her, Skylar chose to stay in South Bend and attend Notre Dame. She went on to become a four-time college All-American and earn a bachelor's degree in business from the university. Now an All-Star for the WNBA's Dallas Wings, Skylar is just as active off the court. She founded Skylar's Scholars, which honors teenagers for academic achievements. She also created Shoot 4 The Sky Basketball Camp Tour, which helps kids ages 7 to 18 improve their basketball skills. Dante Lauretta – Professor of Planetary Science and Cosmochemistry, University of Arizona Dante found a fun, safe haven at the Boys & Girls Clubs of Metro Phoenix, where Club staff helped shape his developing leadership skills. After graduating from high school, Dante obtained a dual bachelor's degree in physics and mathematics at the University of Arizona, then a doctorate in earth and planetary sciences from Washington University. In 2011, Dr. Lauretta's desire to give back came full-circle when NASA appointed him Principal Investigator of the seven-year mission, OSIRIS-REx. It inspired him to create "Xtronaut," a STEM curriculum that reinforces concepts including math, science, vocabulary and cooperative-learning. He piloted Xtronaut at the Boys & Girls Clubs of Tucson, and later brought it to the Metro Phoenix Clubs. Dr. Lauretta is Professor of Planetary Science and Cosmochemistry for the University of Arizona's Lunar and Planetary Laboratory. Philip Schein – Medical Oncologist Just 13 when his fire fighter father perished in the line of duty, Phil found a second home at the Asbury Park Boys Club (now Boys & Girls Clubs of Monmouth County).  Earlier, at age 11 the Club sponsored Phil in a national scholarship competition to study piano, which he won. The young man was also active in the Boy Scout troop affiliated with the Club, achieving the rank of Eagle Scout.  Today, Dr. Schein is one of the world's leading authorities in the treatment of cancer, a former President of the American Society of Clinical Oncology and a White House appointee to the National Cancer Advisory Board.  He served as a Senior Investigator at the National Cancer Institution, Scientific Director of the Lombardi Cancer Research Center and CEO of US Bioscience.  Currently he helps manage the US National Laboratory on the International Space Station as Vice Chairman, Center for the Advancement of Science in Space.  He has been awarded 11 patents and has published over 350 articles and texts concerning cancer research and drug development. Dr. Schein graduated from Rutgers College, where he has also received an Honorary Doctorate in Science, and then obtained his medical degree from the Upstate Medical University. Tony Clark – Executive Director, Major League Baseball Players Association Growing up, Tony was an outstanding baseball and basketball player, and member of the Boys & Girls Club of Greater San Diego – Encanto Branch. As a high school senior, he averaged 43.7 points per game and broke Bill Walton's San Diego high school single-season scoring record. But baseball was his bread and butter. The Detroit Tigers drafted Tony with the second pick of the 1990 draft. Over a 15-year Major League Baseball career, the 6-foot-7 first baseman nicknamed "Tony the Tiger" batted .262 with 251 home runs and 824 RBIs. In retirement, Tony accepted an offer to join the Major League Baseball Players Association as director of player relations in 2010. In 2013, players unanimously elected him executive director of the MLBPA, making Tony the first former player, and first person of color, to hold one of baseball's most powerful positions. For more information on Boys & Girls Clubs Alumni & Friends Club go to www.bgca.org/alumni About Boys & Girls Clubs of America For more than 150 years, Boys & Girls Clubs of America (BGCA.org) has enabled young people most in need to achieve great futures as productive, caring, responsible citizens. Today, more than 4,300 Clubs serve nearly 4 million young people through Club membership and community outreach. Clubs are located in cities, towns, public housing and on Native lands throughout the country, and serve military families in BGCA-affiliated Youth Centers on U.S. military installations worldwide. They provide a safe place, caring adult mentors, fun and friendship, and high-impact youth development programs on a daily basis during critical non-school hours. Club programs promote academic success, good character and citizenship, and healthy lifestyles. In a Harris Survey of alumni, 54 percent said the Club saved their lives. National headquarters are located in Atlanta. Learn more at Facebook and Twitter. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/boys--girls-clubs-of-america-inducts-seven-leading-entertainers-athletes-and-professionals-into-27th-annual-alumni-hall-of-fame-300455307.html


"I often see new treatments that might be more effective, but are also usually more toxic," said lead author Dr Chee Lee, Medical Oncologist, St George Hospital Cancer Care Centre, New South Wales, Australia. "Osimertinib not only increases progression-free survival but it is well-tolerated, which makes a big difference for patients." AURA3 included 419 patients with advanced epidermal growth factor receptor (EGFR) mutation non-small-cell lung cancer (NSCLC) who had progressed after first-line EGFR-tyrosine kinase inhibitor (TKI) therapy. They were randomised to receive the oral TKI osimertinib or chemotherapy. The researchers found that osimertinib significantly reduced many lung cancer symptoms, primarily appetite loss, fatigue, breathlessness and chest pain. Dr Lee said: "It generally took longer for these symptoms to get worse in patients taking the osimertinib tablet compared to chemotherapy." Compared to chemotherapy, osimertinib significantly improved global health status, physical functioning, role functioning and social functioning scores. "Patients taking osimertinib were more able to do normal daily activities and socialise than those on chemotherapy," said Dr Lee. Dr Lee concluded: "For patients with incurable cancer, prolonging only progression-free survival probably has little meaning. However, treatment that can additionally improve symptoms and maintain quality of life probably means a lot for these patients." ESMO is the leading professional organisation for medical oncology, with over 15,000 members representing oncology professionals from over 130 countries worldwide.


"I often see new treatments that might be more effective, but are also usually more toxic," said lead author Dr Chee Lee, Medical Oncologist, St George Hospital Cancer Care Centre, New South Wales, Australia. "Osimertinib not only increases progression-free survival but it is well-tolerated, which makes a big difference for patients." AURA3 included 419 patients with advanced epidermal growth factor receptor (EGFR) mutation non-small-cell lung cancer (NSCLC) who had progressed after first-line EGFR-tyrosine kinase inhibitor (TKI) therapy. They were randomised to receive the oral TKI osimertinib or chemotherapy. The researchers found that osimertinib significantly reduced many lung cancer symptoms, primarily appetite loss, fatigue, breathlessness and chest pain. Dr Lee said: "It generally took longer for these symptoms to get worse in patients taking the osimertinib tablet compared to chemotherapy." Compared to chemotherapy, osimertinib significantly improved global health status, physical functioning, role functioning and social functioning scores. "Patients taking osimertinib were more able to do normal daily activities and socialise than those on chemotherapy," said Dr Lee. Dr Lee concluded: "For patients with incurable cancer, prolonging only progression-free survival probably has little meaning. However, treatment that can additionally improve symptoms and maintain quality of life probably means a lot for these patients." ESMO is the leading professional organisation for medical oncology, with over 15,000 members representing oncology professionals from over 130 countries worldwide.


Geneva, Switzerland, 05 May 2017 - Some advanced lung cancer patients benefit from immunotherapy even after the disease has progressed as evaluated by standard criteria, according to research presented at the European Lung Cancer Conference (ELCC).1 The findings pave the way for certain patients to continue treatment if the disease is not progressing according to new, more specific, criteria. The Response Evaluation Criteria in Solid Tumours (RECIST) evaluates changes in tumour size and identifies whether patients are responding to treatment or progressing. An enlarging tumour on a CT scan signals that patients are progressing, and treatment is changed to best supportive care or a different drug. Immune-related RECIST was developed to account for the fact that tumours enlarge temporarily in patients taking immunotherapy. "Immunotherapy causes lymphocytes, the white blood cells that fight against tumour cells, to infiltrate the tumour leading to a transient increase in size," said lead author Dr Angel Artal-Cortes, Medical Oncologist, University Hospital Miguel Servet, Zaragoza, Spain. "With chemotherapy, tumour enlargement indicates that the tumour is growing and the disease is progressing." The study presented today is a post hoc analysis of the phase 2 POPLAR trial, which randomised patients with non-small cell lung cancer (NSCLC) who had progressed on platinum-based chemotherapy to second-line treatment with the anti-programmed death ligand 1 (PD-L1) antibody atezolizumab or chemotherapy with docetaxel. Response to treatment was assessed with RECIST and immune-related RECIST criteria. As previously reported, atezolizumab significantly improved survival compared with docetaxel.2 The study protocol allowed patients to continue atezolizumab treatment if they had not progressed according to immune-related RECIST and had no major toxicities, even if conventional RECIST indicated progression. The post hoc analysis evaluated overall survival and performance status in the 61 patients who continued atezolizumab after standard progression. The investigators found that the tumours in 82% of these patients subsequently stabilised or shrank. Median overall survival was 11.8 months and objective response rate increased when immune-related RECIST was used. Artal-Cortes said: "We found that there was a benefit for some patients continuing with the drug even after a CT scan suggested progressive disease. Atezolizumab can control lung cancer for a longer period of time than was initially thought. Patients who were maintained on atezolizumab had no major increase in toxic side-effects since most of these occur in the first few months." He concluded: "Our results suggest that immune-related RECIST should be kept in mind to decide whether or not to continue atezolizumab treatment in patients who are responding to the drug, have a good performance status, no serious toxicities from the drug, and no major symptoms from the tumour." Commenting on the research, Marina Garassino, MD, Head of Thoracic Medical Oncology, National Cancer Institute of Milan (Fondazione IRCCS Istituto Nazionale dei Tumori), Italy, said: "This study shows that conventional RECIST may not be the best criteria to evaluate response to immunotherapy. It found that immune-related RECIST better predicted outcome with immunotherapy than RECIST." "The research suggests that immunotherapy can be prolonged when the new criteria are used," she added. "Patients continuing atezolizumab based on immune-related RECIST benefited from the drug even though it was a progressive disease by the RECIST criteria. This was a post hoc analysis of a phase 2 trial and so the results need to be confirmed in other studies." 1 Abstract 96PD - 'Evaluation of non-classical response by immune-modified RECIST and efficacy of atezolizumab beyond disease progression in advanced NSCLC: results from the randomized Phase II study POPLAR' will be presented by Dr Angel Artal-Cortes during the Poster Discussion session 'Epidemiology and innovations in biomarker development': on Saturday, 6 May, 16:45 (CEST). 2 Fehrenbacher L, et al. Atezolizumab versus docetaxel for patients with previously treated non-small-cell lung cancer (POPLAR): a multicentre, open-label, phase 2 randomised controlled trial. Lancet. 2016;387(10030):1837-1846. doi: 10.1016/S0140-6736(16)00587-0. Epub 2016 Mar 10. This press release contains information provided by the authors of the highlighted abstracts and reflects the content of those abstracts. It does not necessarily reflect the views or opinions of ESMO or IASLC who cannot be held responsible for the accuracy of the data. Commentators quoted in the press release are required to comply with the ESMO Declaration of Interests policy and the ESMO Code of Conduct. The European Lung Cancer Conference (ELCC) is the reference event in Europe for professionals treating lung cancers. It is organised by the European Society for Medical Oncology and the International Association for the Study of Lung Cancer in partnership with ESTRO and ETOP. ELCC provides a comprehensive multidisciplinary overview of the latest as well as of the state-of-the-art knowledge in thoracic malignancies, covering different aspects such as prevention, screening, diagnosis, treatment modalities and the results of basic, clinical and translational research, presented by top international academic experts. Around 2,000 attendees are expected from throughout Europe and the rest of the world. ESMO is the leading professional organisation for medical oncology. With more than 15,000 members representing oncology professionals from over 130 countries worldwide, ESMO is the society of reference for oncology education and information. We are committed to supporting our members to develop and advance in a fast-evolving professional environment. http://www. The International Association for the Study of Lung Cancer (IASLC) is the only global organization dedicated to the study of lung cancer. Founded in 1974, the association's membership includes more than 5,000 lung cancer specialists in over 100 countries. Visit http://www. for more information.


News Article | May 4, 2017
Site: www.eurekalert.org

Geneva, Switzerland, May , 2017 - Osimertinib improves cancer-related symptoms in patients with advanced lung cancer, according to an analysis of patient-reported outcomes from the AURA3 phase III clinical trial presented at the European Lung Cancer Conference (ELCC).1 "With my past experience conducting clinical trials, I often see new treatments that might be more effective, but are also usually more toxic," said lead author Dr Chee Lee, Medical Oncologist, St George Hospital Cancer Care Centre, New South Wales, Australia. "Osimertinib not only increases progression-free survival but it is well-tolerated, which makes a big difference for our patients." AURA3 included 419 patients with advanced epidermal growth factor receptor (EGFR) mutation non-small-cell lung cancer (NSCLC) who had progressed after first-line EGFR-tyrosine kinase inhibitor (TKI) therapy. They were randomised to receive the oral TKI osimertinib or chemotherapy. Patients taking osimertinib had significantly longer progression-free survival of 10.1 months versus those on chemotherapy with 4.4 months (hazard ratio 0.30; 95% confidence interval 0.23, 0.41; p Today researchers presented the findings on patient-reported outcomes from the AURA3 trial. Information was collected using two standardised European Organisation for Research and Treatment of Cancer (EORTC) questionnaires, the QLQ-LC13 that assessed lung cancer specific symptoms and the QLQ-C30 that assessed general cancer symptoms. Patients completed both questionnaires at baseline and then at regular intervals until disease progression and beyond. The researchers then analysed the findings to see if control of symptoms was better with osimertinib or chemotherapy. The researchers found that osimertinib significantly reduced many lung cancer symptoms, primarily appetite loss, fatigue, breathlessness and chest pain. There was a trend for osimertinib to reduce cough but it was not statistically significant. Dr Lee said: "It generally took longer for these symptoms to get worse in patients taking the osimertinib tablet compared to chemotherapy." In patients who had symptoms at the start of the study, appetite loss improved significantly faster on osimertinib compared to chemotherapy, and patients became less fatigued and less breathless. Compared to chemotherapy, osimertinib significantly improved global health status, physical functioning, role functioning and social functioning scores. There was a trend towards improved emotional and cognitive function with osimertinib but it was not statistically significant. "Patients taking osimertinib were more able to do normal daily activities and socialise than those on chemotherapy," said Dr Lee. He continued: "Patients with metastatic lung cancer receiving first-line treatment are really quite sick. Patients in the AURA3 trial had progressed on first-line treatment and were receiving second-line therapy, so they were even sicker. To be able to reduce cancer symptoms and improve quality of life in addition to progression-free survival for these patients is a major leap." Dr Lee concluded: "For patients with incurable cancer, prolonging only progression-free survival probably has very little meaning for them. However, treatment that can additionally improve symptoms and maintain quality of life probably means a lot for these patients." Commenting on the importance of the trial, Prof Solange Peters, Head of Medical Oncology, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland, said: "The AURA3 trial has made it clear that when patients progress on first-line targeted therapy for EGFR mutation NSCLC with a T790M resistance mutation, they should stay on targeted therapy using a new generation inhibitor rather than switching to traditional chemotherapy for the second line of therapy. Patients taking second-line osimertinib had longer progression-free survival and less toxicity than those on chemotherapy." "The data presented today shows that second-line osimertinib also significantly improved time to deterioration of important lung cancer symptoms like cough, chest pain and dyspnoea, and improved general health status," continued Peters. "Before these results clinicians had the feeling that second-line osimertinib would be efficient and better tolerated than chemotherapy but it was a subjective assumption. We now have proof that the drug has better activity, less toxicity, and improves quality of life." Regarding the need for future studies, Peters said: "Patients with EGFR mutation NSCLC should now receive frontline TKI (first or second generation) and second-line osimertinib when they have a T790M resistance mutation. We need to know if there are options other than chemotherapy for the subsequent third line of therapy." "We also have to keep in mind that osimertinib is only effective in the 55% of EGFR mutation NSCLC patients whose resistance to frontline TKI is caused by this T790M gatekeeper mutation," she continued. "More research is needed to find better second-line treatments for patients with a different mechanism of resistance, for whom chemotherapy is currently the only option. Finally, the opportunity for frontline prescription of osimertinib in all EGFR mutated NSCLC will be described by the FLAURA trial which is comparing first generation TKI to osimertinib as the very initial treatment and should report later this year." 1 Abstract 85O - 'Patient-reported symptoms and impact of treatment with osimertinib vs chemotherapy for advanced non-small-cell lung cancer, 'will be presented by Dr Chee Lee during the Proferred Paper session 'Immunotherapies and targeted therapies in advanced NSCLC' on Saturday, 6 May, 14:45 (CEST). 2 Mok TS, et al. Osimertinib or platinum-pemetrexed in EGFR T790M-positive lung cancer. N Engl J Med. 2017;376(7):629-640. doi: 10.1056/NEJMoa1612674. This press release contains information provided by the authors of the highlighted abstracts and reflects the content of those abstracts. It does not necessarily reflect the views or opinions of ESMO or IASLC who cannot be held responsible for the accuracy of the data. Commentators quoted in the press release are required to comply with the ESMO Declaration of Interests policy and the ESMO Code of Conduct. The European Lung Cancer Conference (ELCC) is the reference event in Europe for professionals treating lung cancers. It is organised by the European Society for Medical Oncology and the International Association for the Study of Lung Cancer in partnership with ESTRO and ETOP. ELCC provides a comprehensive multidisciplinary overview of the latest as well as of the state-of-the-art knowledge in thoracic malignancies, covering different aspects such as prevention, screening, diagnosis, treatment modalities and the results of basic, clinical and translational research, presented by top international academic experts. Around 2,000 attendees are expected from throughout Europe and the rest of the world. About the European Society for Medical Oncology (ESMO) ESMO is the leading professional organisation for medical oncology. With more than 15,000 members representing oncology professionals from over 130 countries worldwide, ESMO is the society of reference for oncology education and information. We are committed to supporting our members to develop and advance in a fast-evolving professional environment. http://www. About the International Association for the Study of Lung Cancer (IASLC) The International Association for the Study of Lung Cancer (IASLC) is the only global organization dedicated to the study of lung cancer. Founded in 1974, the association's membership includes more than 5,000 lung cancer specialists in over 100 countries. Visit http://www. for more information.


Marseille, France, Nov. 30, 2016 (GLOBE NEWSWIRE) -- FIRST CLINICAL DATA FOR MONALIZUMAB as a single agent in cancer patients show favorable SAFETY PROFILE Innate Pharma SA (the "Company" - Euronext Paris: FR0010331421 - IPH) today announces preliminary safety results from the dose-ranging part of a Phase I/II trial investigating monalizumab as a single agent in patients with advanced gynecologic malignancies. The data are presented today as a poster at the EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium (Munich, Germany) 10:15 a.m. - 5:00 p.m. CET and will be discussed by Dr Anna Tinker, Medical Oncologist (British Columbia Cancer Agency, Vancouver) on behalf of CCTG during the Spotlight session at 1:10 - 1:20 p.m. CET. Monalizumab is Innate Pharma's first-in-class anti-NKG2A antibody partnered with AstraZeneca. The trial is sponsored and conducted by the Canadian Cancer Trials Group (CCTG). In this dose-ranging part of the study, 18 patients with advanced, heavily pretreated ovarian cancer were randomized to receive three dose levels of monalizumab (1, 4 and 10mg/kg, every two weeks - six patients at each dose level). The data showed that monalizumab was well tolerated in this patient population, with no dose-limiting toxicities observed. No major differences in terms of safety were observed across the different dose levels. The most common adverse events (AEs) reported include fatigue and headaches. AEs were mostly low grade and rarely resulted in treatment delays. Preliminary efficacy data showed short-term disease stabilization in 41% of patients, including one patient with a mixed response. Lesley Seymour, MD, PhD, Professor in Oncology at Queen's University in Kingston, Ontario and Director of the Investigational New Drug Program at CCTG, said: "Monalizumab was well tolerated in this patient population with advanced gynecologic malignancies. These refractory tumors are an area of unmet need, and are typically treated with cytotoxic chemotherapy which is often poorly tolerated. Building on these initial results, further investigation of monalizumab in these patients is warranted and we are therefore continuing to enroll patients with relapsed and refractory gynecologic malignancies into the expansion phase of the study." Pierre Dodion, Chief Medical Officer of Innate Pharma, said: "These are the first clinical data reported with monalizumab in cancer patients and they suggest a favorable safety profile. Preliminary results support the continuation of the ongoing cohort expansion part of this study and we look forward to its results. A comprehensive exploratory clinical plan investigating monalizumab in several indications, as both a monotherapy and combination treatment, is underway. We look forward to reporting further data as we move into 2017." The cohort expansion part of this trial (up to 98 patients) is ongoing at the recommended Phase II dose (10 mg/kg) in patients with platinum sensitive ovarian cancer, platinum-resistant ovarian cancer, epithelial endometrial cancer and squamous cell carcinoma of the cervix. The poster #296 is available on Innate Pharma's website. This is an open-label Phase I/II dose escalation trial to evaluate monalizumab as a single agent in patients with gynecologic malignancies. The primary objective is to confirm the recommended Phase II dose of monalizumab as a single agent in patients with gynecologic malignancies. The secondary objectives include assessing the safety, pharmacokinetics, pharmacodynamics and immunogenicity of monalizumab. The first patient in the trial was treated in September 2015. In the first part of the trial, patients will receive 1, 4, or 10 mg/kg of monalizumab every two weeks. In the second part of the trial, patients will receive the recommended phase II dose (RP2D). Sponsored by the Canadian Cancer Trials Group, the trial will enroll up to 98 patients. Gynecologic malignancies encompass ovarian, fallopian tube, peritoneal, cervical and endometrial cancer. Vulval and vaginal cancers are sometimes also included within this diverse group of tumors affecting the female reproductive system. With the exception of cervical cancer, most occur in women aged 50 and over. According to the National Cancer Institute and Cancer Research UK, cervical cancer is the fourth most common cancer in women, representing 5% of all female cancers, with 5-year survival reported as approximately 67.5%. Ovarian cancer is the sixth most common, representing 4% of all cancers in women, with 5-year survival at approximately 46%. Endometrial cancer is the most common gynecological cancer affecting 25.4 per 100,000 women per year with 5-year survival at approximately 81.7%. The U.S. Department of Health has stated that the incidence of these cancers is likely to increase in the near future due to a number of driving factors including the improvement of diagnosis, ageing population and increased oncogenic HPV infections, among others. Across all gynecologic malignancies, a substantial fraction of patients are diagnosed with advanced or metastatic disease at initial presentation or experience relapse following primary local therapy. Standard treatment varies according to the exact origin of the cancer. Most gynecologic malignancies treatments are limited to surgery, radiotherapy and platinum-based chemotherapy. Endometrial cancer can also be treated with hormone therapy. No highly effective or curative therapies are available and platinum-based chemotherapy is considered as the mainstay systemic therapy. Overall, gynecologic malignancies refractory to prior systemic therapies remain an area of a significant unmet medical need. Monalizumab is a first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8 T lymphocytes and NK cells. NKG2A is an inhibitory receptor binding HLA-E. By expressing HLA-E, cancer cells can protect themselves from killing by NKG2A+ immune cells. HLA-E is frequently up-regulated and widely expressed on cancer cells of many solid tumors or hematological malignancies. In some cancers, HLA-E expression is associated with poor prognosis. Monalizumab, a humanized IgG4, blocks the binding of NKG2A to HLA-E allowing activation of NK and cytotoxic T cell responses. By blocking the inhibitory NKG2A receptors, monalizumab may re-establish a broad anti-tumor response mediated by NK and T cells. Monalizumab may also enhance the cytotoxic potential of other therapeutic antibodies. Monalizumab is partnered with AstraZeneca and MedImmune, AstraZeneca's global biologics research and development arm, through a co-development and commercialization agreement. The initial development plan includes a combination trial with durvalumab in solid tumors conducted by AstraZeneca as well as multiple Phase II trials conducted by Innate Pharma, to study monalizumab efficacy as a monotherapy and in combinations with currently approved treatments in several cancer indications. As previously announced, under the terms of this agreement, Innate Pharma is eligible to cash payments of up to $1.275 billion as well as double digit royalties on sales. In addition to the initial payment of $250 million, AstraZeneca will pay Innate Pharma a further $100 million at the decision to go into Phase III development, as well as additional regulatory and sales-related milestones of up to $925 million. AstraZeneca will book all sales and will pay Innate Pharma double-digit royalties on net sales. The arrangement includes the right for Innate Pharma to co-promote in Europe for a 50% profit share in the territory. The Canadian Cancer Trials Group is a cooperative oncology group which carries out clinical trials in cancer therapy, supportive care and prevention across Canada and internationally. It is one of the national programmes and networks of the Canadian Cancer Society Research Institute (CCSRI), and is supported by the Canadian Cancer Society (CCS). Its Central Operations and Statistics Centre is located at Queen's University in Kingston, Ontario, Canada. Innate Pharma S.A. is a clinical-stage biotechnology company with a focus on discovering and developing first-in-class therapeutic antibodies that harness the innate immune system to improve cancer treatment and clinical outcomes for patients. Innate Pharma specializes in immuno-oncology, a new therapeutic field that is changing cancer treatment by mobilizing the power of the body's immune system to recognize and kill cancer cells. The Company's aim is to become a commercial stage biopharmaceutical company in the area of immunotherapy and focused on serious unmet medical needs in cancer. Innate Pharma has pioneered the discovery and development of checkpoint inhibitors to activate the innate immune system. Innate Pharma's innovative approach has resulted in three first-in-class, clinical-stage antibodies targeting natural killer cell receptors that may address a broad range of solid and hematological cancer indications as well as additional preclinical product candidates and technologies. Targeting receptors involved in innate immunity also creates opportunities for the Company to develop therapies for inflammatory diseases. The Company's expertise and understanding of natural killer cell biology have enabled it to enter into major alliances with leaders in the biopharmaceutical industry including AstraZeneca, Bristol-Myers Squibb and Sanofi. Based in Marseille, France, Innate Pharma has more than 140 employees and is listed on Euronext Paris. Learn more about Innate Pharma at www.innate-pharma.com. This press release contains certain forward-looking statements. Although the company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. For a discussion of risks and uncertainties which could cause the company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risque") section of the Document de Reference prospectus filed with the AMF, which is available on the AMF website (http://www.amf-france.org) or on Innate Pharma's website. This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.


News Article | November 8, 2016
Site: www.eurekalert.org

A weight loss condition that affects patients with cancer has provided clues as to why cancer immunotherapy - a new approach to treating cancer by boosting a patient's immune system -- may fail in a substantial number of patients. Cancer immunotherapies involve activating a patient's immune cells to recognise and destroy cancer cells. They have shown great promise in some cancers, but so far have only been effective in a minority of patients with cancer. The reasons behind these limitations are not clear. Now, researchers at the Cancer Research UK Cambridge Institute at the University of Cambridge have found evidence that the mechanism behind a weight loss condition that affects patients with cancer could also be making immunotherapies ineffective. The condition, known as cancer cachexia, causes loss of appetite, weight loss and wasting in most patients with cancer towards the end of their lives. However, cachexia often starts to affect patients with certain cancers, such as pancreatic cancer, much earlier in the course of their disease. In research published today in the journal Cell Metabolism, the scientists have shown in mice that even at the early stages of cancer development, before cachexia is apparent, a protein released by the cancer changes the way the body, in particular the liver, processes its own nutrient stores. "The consequences of this alteration are revealed at times of reduced food intake, where this messaging protein renders the liver incapable of generating sources of energy that the rest of the body can use," explains Thomas Flint, an MB/PhD student from the University of Cambridge School of Clinical Medicine and co-first author of the study. "This inability to generate energy sources triggers a second messaging process in the body - a hormonal response -- that suppresses the immune cell reaction to cancers, and causes failure of anti-cancer immunotherapies." "Cancer immunotherapy might completely transform how we treat cancer in the future -- if we can make it work for more patients," says Dr Tobias Janowitz, Medical Oncologist and Academic Lecturer at the Department of Oncology at the University of Cambridge and co-first author. "Our work suggests that a combination therapy that either involves correction of the metabolic abnormalities, or that targets the resulting hormonal response, may protect the patient's immune system and help make effective immunotherapy a reality for more patients." The next step for the team is to see how this discovery might be translated for the benefit of patients with cancer. "If the phenomenon that we've described helps us to divide patients into likely responders and non-responders to immunotherapy, then we can use those findings in early stage clinical trials to get better information on the use of new immunotherapies," says Professor Duncan Jodrell, director of the Early Phase Trials Team at the Cambridge Cancer Centre and co-author of the study. "We need to do much more work in order to transform these results into safe, effective therapies for patients, however," adds Professor Douglas Fearon, Emeritus Sheila Joan Smith Professor of Immunology at the University of Cambridge and the senior author, who is now also working at Cold Spring Harbor Laboratory and Weill Cornell Medical College. "Even so, the results raise the distinct possibility of future cancer therapies that are designed to target how the patient's own body responds to cancer, with simultaneous benefit for reducing weight loss and boosting immunotherapy." The research was largely funded by Cancer Research UK, the Lustgarten Foundation, the Wellcome Trust and the Rosetrees Trust.


Preliminary Phase 1/2 Efficacy Data of Lirilumab in Combination with Opdivo (Nivolumab) in Patients With Advanced Platinum Refractory Squamous Cell Carcinoma of the Head and Neck to be presented during SITC meeting MARSEILLE, France, Nov. 08, 2016 (GLOBE NEWSWIRE) -- Innate Pharma SA (the "Company" - Euronext Paris: FR0010331421 - IPH) today announces the publication of the late-breaking abstract on an interim efficacy analysis from a Phase 1/2 study of the combination of lirilumab and Opdivo (nivolumab) in the cohort of advanced platinum refractory squamous cell carcinoma of the head and neck (SCCHN). The abstract is available on the Society for Immunotherapy of Cancer's (SITC) website. In the abstract, data reports that among 29 evaluable patients with SCCHN, the objective response rate (ORR), as measured by Response Evaluation Criteria In Solid Tumors (RECIST), was 24 percent (n=7) and the disease control rate (DCR) was 52 percent (n=15). Seventeen percent (n=5) of these evaluable patients had deep responses, with reductions in tumor burden greater than 80 percent. Preliminary efficacy of lirilumab plus nivolumab in patients with advanced platinum-refractory SCCHN suggests clinical benefit with encouraging response rates and potential for deep and durable responses. Lirilumab is directed against the inhibitory killer-cell immunoglobulin-like receptors (KIRs) expressed predominantly on natural killer (NK) cells, which belong to the innate immune system, while Opdivo blocks the inhibitory function of the PD-1 receptor on T cells. Detailed data will be presented at a late-breaking oral presentation (Late-Breaking Abstract Session II) at SITC Annual Meeting on November 12 at 11:15 a.m. ET in National Harbor, Maryland, by Rom Leidner, Medical Oncologist, Earle A. Chiles Research Institute, Providence Cancer Center (Portland, OR, U.S.) and lead author of the study. ***** Innate Pharma will host a conference call to discuss these data for institutional investors and sell-side analysts on November 14th, 2016, at 2:00 p.m. CET (8:00 a.m. ET). During the call, the Company's management team will discuss lirilumab and IPH4102 data published at the most recent scientific meetings Conference call details will be communicated on Innate Pharma's website on November 10th,2016 The presentation will be available on the Company's website 15 minutes before the webcast begins A replay will be available following the webcast on Innate Pharma's website About CA223-001: A Phase 1/2 Dose Escalation and Cohort Expansion Study of the Safety, Tolerability and Efficacy of Anti-KIR (Lirilumab) Administered in Combination With Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors CA223-001 is a Phase 1/2 dose escalation and cohort expansion study of lirilumab in combination with nivolumab in 159 patients with advanced solid tumors. In this trial, patients received lirilumab (0.1, 0.3, 1.0, or 3.0 mg/kg) once every 4 weeks and nivolumab (3 mg/kg) once every 2 weeks. The data reported at SITC pertain to an expansion cohort in SCCHN. During dose escalation, patients with advanced solid tumors who progressed after at least 1 prior therapy received lirilumab 0.1-3.0 mg/kg once every 4 weeks (Q4W) plus nivolumab 3.0 mg/kg Q2W. Cohort expansion was initiated at the maximum dose of lirilumab 3.0 mg/kg Q4W plus nivolumab 3.0 mg/kg Q2W in patients with advanced solid tumors. Key study endpoints include safety (primary), objective response rate (ORR), disease control rate (DCR), duration of response (DOR), and biomarker assessments. The purpose of this Phase 1/2 open label study is to determine the safety of the combination of lirilumab and nivolumab and to explore the preliminary anti-tumor activity of the combination in patients with a range of advanced solid tumors. The safety profile associated with lirilumab in combination with Opdivo was as expected based on prior studies and was generally consistent with that observed with Opdivo monotherapy. The overall rate of treatment-related adverse events (TRAEs) was reported as 72 percent (114/159) and the rate of Grade 3-4 TRAEs was 15 percent (24/159). Discontinuations due to TRAEs occurred in 8 percent of patients (12/159). These safety data were reported at the 2016 European Society for Medical Oncology (ESMO) Congress. Lirilumab is a fully human monoclonal antibody that is designed to act as a checkpoint inhibitor by blocking the interaction between KIR2DL-1,-2,-3 inhibitory receptors and their ligands. Blocking these receptors facilitates activation of NK cells and potentially some subsets of T cells, ultimately leading to destruction of tumor cells. Lirilumab is licensed to Bristol-Myers Squibb Company. As part of the agreement with Innate Pharma, Bristol-Myers Squibb holds exclusive worldwide rights to develop, manufacture and commercialize lirilumab and related compounds blocking KIR receptors, for all indications. Under the agreement, Innate Pharma conducts the development of lirilumab through Phase II in acute myeloid leukemia ("AML"). Innate Pharma is currently testing lirilumab in a randomized, double-blind, placebo-controlled Phase II trial as maintenance treatment in elderly patients with AML in first complete remission ("EffiKIR" trial). In addition, lirilumab is also being evaluated by Bristol-Myers Squibb in clinical trials in combination with other agents in a variety of tumor types. Cancers that are known as head and neck cancers usually begin in the squamous cells that line the moist mucosal surfaces inside the head and neck, such as inside the mouth, the nose and the throat. Head and neck cancer is the seventh most common cancer globally, with an estimated 400,000 to 600,000 new cases per year and 223,000 to 300,000 deaths per year. The five-year survival rate is reported as less than 4% for metastatic Stage IV disease. Squamous cell carcinoma of the head and neck (SCCHN) accounts for approximately 90% of all head and neck cancers with global incidence expected to increase by 17% between 2012 and 2022. Risk factors for SCCHN include tobacco and alcohol consumption. The Human Papilloma Virus (HPV) infection is also a risk factor leading to rapid increase in oropharyngeal SCCHN in Europe and North America. Quality of life is often impacted for SCCHN patients, as physiological function (breathing, swallowing, eating, drinking), personal characteristics (appearance, speaking, voice), sensory function (taste, smell, hearing), and psychological/social function can be affected. Innate Pharma S.A. is a clinical-stage biotechnology company with a focus on discovering and developing first-in-class therapeutic antibodies that harness the innate immune system to improve cancer treatment and clinical outcomes for patients. Innate Pharma specializes in immuno-oncology, a new therapeutic field that is changing cancer treatment by mobilizing the power of the body's immune system to recognize and kill cancer cells. The Company's aim is to become a commercial stage biopharmaceutical company in the area of immunotherapy and focused on serious unmet medical needs in cancer. Innate Pharma has pioneered the discovery and development of checkpoint inhibitors to activate the innate immune system. Innate Pharma's innovative approach has resulted in three first-in-class, clinical-stage antibodies targeting natural killer cell receptors that may address a broad range of solid and hematological cancer indications as well as additional preclinical product candidates and technologies. Targeting receptors involved in innate immunity also creates opportunities for the Company to develop therapies for inflammatory diseases. The Company's expertise and understanding of natural killer cell biology have enabled it to enter into major alliances with leaders in the biopharmaceutical industry including AstraZeneca, Bristol-Myers Squibb, Novo Nordisk A/S and Sanofi. Based in Marseille, France, Innate Pharma has more than 140 employees and is listed on Euronext Paris. Learn more about Innate Pharma at www.innate-pharma.com. This press release contains certain forward-looking statements. Although the company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. For a discussion of risks and uncertainties which could cause the company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risque") section of the Document de Reference prospectus filed with the AMF, which is available on the AMF website or on Innate Pharma's website. This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.


The International Association of HealthCare Professionals is pleased to welcome Joseph Mignone, MD, Medical Oncologist, to their prestigious organization with his upcoming publication in The Leading Physicians of the World. Dr. Joseph Mignone is a highly trained and qualified physician with an extensive expertise in all facets of his work, especially internal medicine, hematology, palliative care medicine, and integrative oncology. Dr. Mignone has been in practice for 14 years and is currently serving patients within 21st Century Oncology in Jacksonville, Florida. Dr. Joseph Mignone graduated Cum Laude from Wagner College in Staten Island, New York, before gaining his Medical Degree in 1997 from St. George’s University School of Medicine in Grenada, West Indies. He subsequently completed his Internal Medicine residency and Medical Oncology fellowship at the University of Florida Health Science Center in Jacksonville, Florida. Dr. Mignone is triple board certified in Palliative Care, Internal Medicine, and in Medical Oncology. Dr. Mignone currently serves on the cancer committee for the University of Florida and Memorial Hospital in Jacksonville, Department of Medical Quality Review and Clinical Professional Review Committee. He also serves as Clinical Practice Vice Chair of the Florida Society of Clinical Oncology. Dr. Mignone maintains professional memberships with the American Society of Clinical Oncology, the American Society of Hematology, the Duval County Medical Society, the Florida Society of Clinical Oncology, the Society for Integrative Oncology, and is a Board Member of the Leukemia and Lymphoma Society. He attributes his success to the relationship he builds with his patients, and when he is not working, Dr. Mignone enjoys playing tennis and traveling. Learn more about Dr. Mignone here: https://www.21co.com/ and be sure to read his upcoming publication in The Leading Physicians of the World. FindaTopDoc.com is a hub for all things medicine, featuring detailed descriptions of medical professionals across all areas of expertise, and information on thousands of healthcare topics.  Each month, millions of patients use FindaTopDoc to find a doctor nearby and instantly book an appointment online or create a review.  FindaTopDoc.com features each doctor’s full professional biography highlighting their achievements, experience, patient reviews and areas of expertise.  A leading provider of valuable health information that helps empower patient and doctor alike, FindaTopDoc enables readers to live a happier and healthier life.  For more information about FindaTopDoc, visit http://www.findatopdoc.com

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