FDA Grants Accelerated Approval to Nivolumab for Small Cell Lung Cancer
The decision was based on the ongoing CheckMate-032 phase 1/2 study, in which researchers are investigating nivolumab in patients with advanced or metastatic tumors.
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.