Final analysis of Phase III study shows Opdivo (nivolumab) monotherapy failed to meet PFS endpoint in non-small cell lung cancer- BMS

Bristol-Myers Squibb announced the final primary analysis of CheckMate -026, a trial investigating the use of Opdivo (nivolumab) monotherapy as first-line therapy in patients with advanced non-small cell lung cancer (NSCLC) whose tumors expressed PD-L1 greater than 1%. The study was powered to assess progression-free survival (PFS) for patients with greater than 5% PD-L1 expression. The topline results from this study were previously disclosed and showed CheckMate -026 did not meet the primary endpoint of superior PFS compared to chemotherapy. In patients with more than 5% PD-L1 expression, the median PFS was 4.2 months with Opdivo and 5.9 months with platinum-based doublet chemotherapy.

Overall survival was 14.4 months for Opdivo versus 13.2 months for chemotherapy, and 60% of patients on the chemotherapy arm received subsequent Opdivo use after progression either through crossover or commercial access. The safety of Opdivo was consistent with the known safety profile of the drug in previous studies. Among all-treated patients, treatment-related adverse events (AE) of any grade and Grade 3/4 occurred in 71% and 18% of Opdivo-treated patients and 92% and 51% of chemotherapy-treated patients, respectively. These data will be presented at the 2016 European Society for Medical Oncology (ESMO) Congress.