Bristol-Myers Squibb has 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).
The study assessed progression-free survival (PFS) for patients with ≥5% PD-L1 expression. Previously disclosed topline results from this study showed CheckMate -026 did not meet the primary endpoint of superior PFS compared to chemotherapy.
In patients with ≥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. 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.
Dr Mark Socinski, executive medical director, Florida Hospital Cancer Institute, Orlando, and lead author of the study, said: “These findings provide additional understanding of the role of PD-1 monotherapy in treatment-naïve patients and confirm there is still a significant opportunity for improving outcomes for the majority of these patients.”