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Bristol-Myers Squibb Receives Positive CHMP Opinion in the European Union for Nivolumab (Opdivo, Nivolumab BMS) for the Treatment of Advanced Squamous Non-Small Cell Lung Cancer in Previously-Treated PatientsBristol-Myers Squibb Company (NYSE:BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA (News - Alert)) has adopted a positive opinion recommending that nivolumab, a PD-1 immune checkpoint inhibitor, be granted approval for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults. The CHMP positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union (EU). "We are moving at a ground-breaking pace to deliver on a mission that looks to transform cancer treatment options for patients," said Michael Giordano, senior vice president, Head of Development, Oncology. "Last month, we received a CHMP positive opinion for nivolumab for the treatment of advanced melanoma. Today's announcement of a positive opinion for nivolumab in NSCLC brings us closer to delivering on our promise of changing the standard of care for lung cancer." Positive Opinion based on CheckMate -017 and -063 The CHMP positive opinion is based on data from CheckMate -017 and CheckMate -063, two trials that demonstrated the efficacy and safety of nivolumab in patients with advanced or metastatic squamous NSCLC who had progressed following previous chemotherapy treatment. CheckMate -017 was a Phase III, randomized, open-label trial that included patients who had experienced disease progression during or after one prior platinum doublet-based chemotherapy regimen. Results from a prespecified interim analysis of CheckMate -017, demonstrated significantly superior overall survival (OS) with nivolumab vs. docetaxel, with a 41% reduction in the risk of death (hazard ratio: 0.59 [95% CI: 0.44, 0.79; p=0.00025]). This benefit was observed regardless of PD-L1 expression status. The estimated one-year survival rate was nearly doubled with nivolumab (42% [95% CI: 34, 50]) compared to docetaxel (24% [95% CI: 17, 31]). The median OS was 9.2 months in the nivolumab arm (95% CI: 7.3, 13.3) and 6 months in the docetaxel arm (95% CI: 5.1, 7.3). A second study, CheckMate -063, was a Phase II single-arm, multinational, multicenter trial that included patients with metastatic squamous NSCLC who had progressed after receiving a platinum-based therapy and at least one additional systemic treatment regimen (65% of patients had received = 3 prior therapies). In CheckMate -063, confirmed objective response rate, the study's primary endpoint, was 14.5% (17/117) (95% CI = 8.7, 22.2) with an estimated one-year survival rate of 40.8% (95% CI: 31.6, 49.7) and median overall survival of 8.2 months (95% CI: 6.1, 10.9). In both CheckMate -017 and -063, there was consistent nivolumab dosing of 3 mg/kg every two weeks. The safety profile of nivolumab has been evaluated in thousands of patients enrolled in the broader clinical program and treatment-related adverse events (AEs) were generally managed using established safety algorithms. In CheckMate -017, the safety profile of nivolumab was consistent with prior studies and favorable versus docetaxel. Treatment-related adverse events occurred less frequently with nivolumab than docetaxel (grade 3-4, 6.9% vs. 55%, respectively). About Nivolumab Bristol-Myers Squibb has a broad, global development program to study nivolumab in multiple tumor types consisting of more than 50 trials - as monotherapy or in combination with other therapies - in which more than 8,000 patients have been enrolled worldwide. Nivolumab became the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world on July 4, 2014 when Ono Pharmaceutical Co. announced that it received manufacturing and marketing approval in Japan for the treatment of patients with unresectable melanoma. In the U.S., the U.S. Food and Drug Administration (FDA) granted its first approval for nivolumab for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor. On March 4, 2015, nivolumab received its second FDA approval for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. In addition, nivolumab is being investigated in patients with advanced non-squamous NSCLC. On April 17, 2015, an open-label, randomized Phase III study (CheckMate -057) evaluating nivolumab versus docetaxel in previously treated patients with advanced non-squamous NSCLC was stopped early because an assessment conducted by the independent Data Monitoring Committee (DMC) concluded that the study met its endpoint, demonstrating superior overall survival in patients receiving nivolumab compared to docetaxel. The company plans to share these data with health authorities. About Lung Cancer Lung cancer is the leading cause of cancer deaths globally, resulting in more than 1.5 million deaths each year, according to the World Health Organization. NSCLC is one of the most common types of the disease and accounts for approximately 85 percent o cases. Survival rates vary depending on the stage and type of the cancer when it is diagnosed. Globally, the five-year survival rate for Stage I NSCLC is between 47 and 50 percent; for Stage IV NSCLC, the five-year survival rate drops to two percent. IMPORTANT SAFETY INFORMATION Immune-Mediated Pneumonitis
Immune-Mediated Colitis
Immune-Mediated Hepatitis
Immune-Mediated Nephritis and Renal Dysfunction
Immune-Mediated Hypothyroidism and Hyperthyroidism
Other Immune-Mediated Adverse Reactions
Embryofetal Toxicity
Lactation
Serious Adverse Reactions
Common Adverse Reactions
Please see US Full Prescribing Information for OPDIVO. Immuno-Oncology at Bristol-Myers Squibb Surgery, radiation, cytotoxic or targeted therapies have represented the mainstay of cancer treatment over the last several decades, but long-term survival and a positive quality of life have remained elusive for many patients with advanced disease. To address this unmet medical need, Bristol-Myers Squibb is leading research in an innovative field of cancer research and treatment known as immuno-oncology, which involves agents whose primary mechanism is to work directly with the body's immune system to fight cancer. The company is exploring a variety of compounds and immunotherapeutic approaches for patients with different types of cancer, including researching the potential of combining immuno-oncology agents that target different pathways in the treatment of cancer. Bristol-Myers Squibb is committed to advancing the science of immuno-oncology, with the goal of changing survival expectations and the way patients live with cancer. About Bristol-Myers Squibb Bristol-Myers Squibb is a global pharmaceutical 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 www.bms.com, or follow us on Twitter (News - Alert) at http://twitter.com/bmsnews. Bristol-Myers Squibb Forward-Looking Statement 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 nivolumab will receive regulatory approval in the European Union or, if approved, that it will become a commercially successful product. 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, 2014 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.
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