June 5, 2020—The Food and Drug Administration approved the combination of nivolumab (Opdivo, Bristol-Myers Squibb) plus ipilimumab (Yervoy, BMS) and two cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations.
Efficacy was investigated in CHECKMATE-9LA, a randomized, open-label trial in patients with metastatic or recurrent NSCLC. Patients were randomized to receive either the combination of nivolumab plus ipilimumab and two cycles of platinum-doublet chemotherapy (n=361) or platinum-doublet chemotherapy for four cycles (n=358). The trial demonstrated a statistically significant benefit in overall survival for patients treated with nivolumab plus ipilimumab plus chemotherapy compared with those who received chemotherapy. Median overall survival was 14.1 months (95 percent CI: 13.2, 16.2) versus 10.7 months (95 percent CI: 9.5, 12.5), (HR 0.69; 96.71 percent CI: 0.55, 0.87).