The US Food and Drug Administration (FDA) has approved nivolumab for the treatment of patients with metastatic small cell lung cancer (SCLC) who have failed platinum-based chemotherapy and at least 1 other line of therapy, according to a press release.1
This marks the first time a drug has been approved for this indication in nearly 2 decades, and also makes nivolumab the first and only available immuno-oncology agent for this patient population.
The FDA based its decision on results from a cohort of the ongoing CheckMate-032 (ClinicalTrials.gov identifier: NCT01928394) phase 1/2 study, in which researchers are investigating nivolumab in patients with advanced or metastatic tumors who have failed and experienced disease progression after platinum-based chemotherapy. For this particular cohort, 109 patients with SCLC were treated with nivolumab 3 mg/kg every 2 weeks regardless of PD-L1 status. The first tumor assessment was performed 6 weeks after treatment initiation, then every 6 weeks for 6 months, then every 12 weeks thereafter.
Results showed that 13 (12%; 95% CI, 6.5-19.5) patients had a response to therapy according to a Blinded Independent Central Review; 12 (11%) patients had a partial response and 1 (0.9%) patient had a complete response. The median duration of response was 17.9 months (95% CI, 7.9-42.1) among responsive patients.
The most frequently reported serious adverse events (AEs) occurring in at least 2% of patients were pneumonia, dyspnea, pneumonitis, pleural effusion, and dehydration. The most common AEs — occurring in at least 20% of patients — included fatigue, decreased appetite, musculoskeletal pain, dyspnea, nausea, diarrhea, constipation, and cough.
Nivolumab was granted accelerated approval based on overall response rate and duration of response; continued approval will be contingent upon confirmation of benefit from future studies.
- US Food and Drug Administration approves Opdivo (nivolumab) as the first new medication in nearly 20 years for certain patients with previously treated small cell lung cancer [press release]. Princeton, NJ: Bristol-Myers Squibb. https://news.bms.com/press-release/corporatefinancial-news/us-food-and-drug-administration-approves-opdivo-nivolumab-firs. Published August 17, 2018. Accessed August 17, 2018.