FDA approves adjuvant Keytruda for non-small cell lung cancer
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The FDA approved pembrolizumab as adjuvant treatment for patients with stage IB, stage II or stage IIIA non-small cell lung cancer after resection and platinum-based chemotherapy.
The agency based the approval of pembrolizumab (Keytruda, Merck), an anti-PD-1 therapy, on results of the multicenter, triple-blind, randomized phase 3 KEYNOTE-091 trial.
Researchers randomly assigned 1,177 patients with completely resected stage IB to stage IIIA NSCLC in a 1:1 ratio to receive 200 mg pembrolizumab or placebo via IV every 3 weeks for no more than 1 year. Most of the patients (86%) received platinum-based chemotherapy after complete resection.
Investigator-assessed DFS served as the major efficacy outcome.
Results showed a statistically significant DFS improvement among the overall population.
An exploratory subgroup analysis showed an HR for DFS of 1.25 (95% CI, 0.76-2.05) among patients who did not undergo adjuvant chemotherapy. Median DFS among those who received adjuvant chemotherapy was 58.7 months (95% CI, 39.2 to not reached) in the pembrolizumab group and 34.9 months (95% CI, 28.6 to not reached) in the placebo group.
Patients in KEYNOTE-091 experienced generally similar adverse reactions as patients with NSCLC who received single-agent pembrolizumab, except for hypothyroidism (22%), hyperthyroidism (11%) and pneumonitis (7%). Two patients experienced fatal myocarditis.
The FDA conducted the review under Project Orbis, which provides a framework for concurrent submission and review of cancer drugs among international partners.
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