Bristol-Myers Announces European Commission Has Approved Nivolumab BMS in Europe

Bristol-Myers Squibb Company BMY today announced that the European Commission has approved Nivolumab BMS for the treatment of locally advanced or metastatic squamous (SQ) non-small cell lung cancer (NSCLC) after prior chemotherapy. This approval marks the first major treatment advance in SQ NSCLC in more than a decade in the European Union (EU). Nivolumab is also the first and only PD-1 immune checkpoint inhibitor to demonstrate overall survival (OS) in previously-treated metastatic SQ NSCLC. This approval allows for the marketing of nivolumab in all 28 Member States of the EU. "With the EU approval of nivolumab, patients in Europe have for the first time in more than ten years access to an entirely new treatment modality for advanced squamous non-small cell lung cancer, which has the potential to replace the current standard of care," said Emmanuel Blin, senior vice president, Head of Commercialization, Policy and Operations, Bristol-Myers Squibb. "Bristol-Myers Squibb is passionate about changing survival expectations and the way patients live with advanced cancers, and is committed to continually deliver, with speed and urgency, new approaches to pursue this goal." Approval is based on the results of CheckMate -017 and -063. In the Phase III CheckMate -017 study, nivolumab demonstrated superior clinical benefit across all endpoints versus docetaxel, the standard of care, regardless of PD-L1 (programmed death ligand-1) expression status, including a 41% reduction in the risk of death, significantly superior OS rate of 42% versus 24% for docetaxel at one-year and superior durable antitumor activity. In the Phase II CheckMate -063 study, nivolumab showed an estimated 41% one-year survival rate and a median OS of 8.2 months. The safety profile of nivolumab is consistent with previously-reported trials, and in Checkmate -017, is also favorable compared to docetaxel. "Today's approval of nivolumab for squamous non-small cell lung cancer is truly a major advance for patients fighting this devastating disease, and the providers that treat them," said Rolf Stahel, M.D., president of the European Society of Medical Oncology and Professor at University Hospital Zurich. "Nivolumab has shown statistically significant and clinically meaningful improvement in efficacy versus standard of care in this patient population. This approval reinforces the science behind Immuno-Oncology including our understanding of the role of PD-L1 expression." In Europe, incidence and mortality rates for lung cancer are on the rise, currently accounting for 20% of all cancer deaths. NSCLC is one of the most common types of the disease and accounts for approximately 85% of lung cancer cases. SQ NSCLC accounts for approximately 25% to 30% of all lung cancers. For patients with NSCLC, whose disease reoccurs or progresses despite chemotherapy, the treatment options are limited and the prognosis is poor, with a five-year survival rate of approximately 2%, globally. About CheckMate -017, -063 The European Commission's approval is based on data from two studies (Phase III CheckMate -017 and Phase II CheckMate -063). Together, the trials investigated nivolumab at a dose of 3 mg/kg every two weeks, which has been well-established across the Phase III nivolumab clinical development program for various tumors. CheckMate -017 is a landmark Phase III, open-label, randomized clinical trial that evaluated nivolumab 3mg/kg intravenously over 60 minutes every two weeks versus standard of care, docetaxel 75 mg/m2 intravenously administered every three weeks in patients with advanced SQ NSCLC who had progressed during or after one prior platinum doublet-based chemotherapy regimen. The study's primary endpoint was OS and secondary endpoints included progression-free survival (PFS) and overall response rate (ORR). The trial included patients regardless of their PD-L1 expression status. Results from CheckMate -017 showed a 41% reduction in the risk of death with a one-year survival rate of 42% for nivolumab (42.1% [95% CI: 33.7, 50.3]) versus 24% (23.7% [95% CI: 16.9, 31.1]) for docetaxel (HR 0.59, 96.8% CI: 0.43, 0.81; p=0.0002). Median OS was 9.2 months versus 6 months for nivolumab and docetaxel, respectively. Nivolumab also demonstrated consistent, statistically significant and clinically meaningful improvements across secondary endpoints, ORR and PFS, versus docetaxel in patients with previously treated advanced SQ NSCLC. Survival benefit was observed independent of PD-L1 expression across all pre-specified expression levels (1%, 5% and 10%). The safety profile of nivolumab in CheckMate -017 was consistent with prior studies and favorable versus docetaxel. Treatment-related adverse events (AEs) occurred less frequently with nivolumab (any grade, 58%; grade 3-4, 6.9%; no grade 5 events) than docetaxel (any grade, 86%; grade 3-5, 55%; grade 5, 2.3%), including both hematology and non-hematology toxicities. Treatment-related AEs led to discontinuation in 3.1% of patients in the nivolumab arm compared to 10.1% for docetaxel. Pneumonitis (1.5%) was the most common treatment-related AE leading to discontinuation in the nivolumab arm and peripheral neuropathy (3.1%) for the docetaxel arm. Findings from CheckMate -017 were recently published in The New England Journal of Medicine and presented during an oral abstract session at the 2015 American Society of Clinical Oncology Annual Meeting in May 2015. CheckMate -063 is a Phase II, single-arm, open-label trial that included patients with metastatic SQ NSCLC who had progressed after two or more lines of therapy. In this trial, the confirmed objective response rate by an independent radiology review committee, the study's primary endpoint, was 14.5% (95% CI: 8.47, 22.2) with an estimated one-year survival rate of 41% and median OS of 8.21 months (95% CI: 6.05, 10.9). The safety profile of nivolumab in CheckMate -063 was consistent with prior clinical studies and managed using established treatment algorithms.