On August 16, 2018, the FDA accelerated the approval of nivolumab (Opdivo; Bristol-Myers Squibb) for the treatment of patients with metastatic small-cell lung cancer that progressed after platinum-based chemotherapy and ≥1 other lines of therapy.
This accelerated approval was based on a subgroup analysis of 109 patients from the multicenter, open-label CheckMate-032 clinical trial. This subgroup included patients with and without PD-1 expression who had metastatic small-cell lung cancer that progressed after platinum-based chemotherapy and ≥1 previous lines of therapy. Patients received a, infusion of nivolumab 3-mg/kg over 60 minutes every 2 weeks.
The overall response rate with nivolumab was 12% (95% confidence interval, 6.5-19.5), with durable response rates of ≥6 months in 77% of the 13 patients who responded to treatment, ≥12 months in 62% of the patients, and ≥18 months in 39% of the patients.
The most common (≥20%) adverse reactions with nivolumab in this study were fatigue, decreased appetite, musculoskeletal pain, dyspnea, nausea, diarrhea, constipation, and cough.
The most common (≥2%) serious adverse events were pneumonia, dyspnea, pneumonitis, pleural effusion, and dehydration; 10% of patients discontinued treatment because of adverse events.