The US Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in the adjuvant setting for patients with stage IB-IIIA non–small cell lung cancer (NSCLC) following resection and platinum-based chemotherapy.
The immunotherapy has already been approved for several other NSCLC indications, including as first-line treatment along with pemetrexed and platinum chemotherapy for patients with metastatic nonsquamous NSCLC without EGFR or ALK genomic tumor aberrations. The current approval expands the use of pembrolizumab to the adjuvant setting.
The FDA’s decision was based on the results of the multicenter, triple-blind, randomized phase 3 KEYNOTE-091 trial, which demonstrated a significant improvement in disease-free survival (DFS).
Researchers randomly assigned 1177 patients who had undergone complete resection to receive either pembrolizumab 200 mg or placebo intravenously every 3 weeks for up to 1 year. Patients had not received neoadjuvant radiotherapy or chemotherapy.
Among the 1010 patients who received adjuvant platinum-based chemotherapy, the median DFS was 58.7 months in the pembrolizumab arm (n = 506) and 34.9 months in the placebo arm (hazard ratio, 0.73). In an exploratory subgroup analysis of the 167 patients who did not receive adjuvant chemotherapy, the DFS hazard ratio was 1.25.
Overall survival data were not yet mature.
Adverse reactions were largely similar to those observed in patients with NSCLC who receive pembrolizumab as a single agent. They included fatigue, pain, rash, diarrhea, pyrexia, constipation, and nausea. Adverse effects that were different included hypothyroidism (22%), hyperthyroidism (11%), and pneumonitis (7%). Two patients experienced fatal myocarditis.
The recommended dose is 200 mg every 3 weeks or 400 mg every 6 weeks until disease recurrence, unacceptable toxicity, or up to 12 months of treatment.
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