Poor showing for Bristol-Myers' Opdivo in NSCLC, but better in other cancers, ESMO Congress hears

At the annual meeting of the European Society for Medical Oncology (ESMO)Congress, US pharma major Bristol-Myers Squibb (NYSE: BMY) on Sunday presented 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 ≥1%, which disappointed.

The study was powered to assess progression-free survival (PFS) for patients with ≥5% PD-L1 expression. The top-line 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 ≥5% PD-L1 expression, the median PFS was 4.2 months with Opdivo and 5.9 months with platinum-based doublet chemotherapy (stratified hazard ratio [HR]=1.15 [95% CI: 0.91, 1.45, p=0.25]). Overall survival was 14.4 months for Opdivo versus 13.2 months for chemotherapy (HR=1.02 [95% CI: 0.80, 1.30]), and 60% of patients on the chemotherapy arm received subsequent Opdivo use after progression either through crossover or commercial access.

Bristol-Myers’ shares, which had already slumped 19% this year, fell 6.5% to $55.43 in New York pre-market trading this morning.