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FDA Approves Pembrolizumab as Adjuvant Treatment for Non-Small Cell Lung Cancer
On January 26, 2023, The US Food and Drug Administration (FDA) granted approval to pembrolizumab as an adjuvant treatment following resection and platinum-based chemotherapy for stage 1B (T2a ≥4 cm), 2, or 3A for patients with non-small cell lung cancer (NSCLC).
This approval was based on results from the phase 3, multicenter, randomized, triple-blind, placebo-controlled KEYNOTE-091 trial. In this trial, 1177 patients with NSCLC who had undergone resection with or without standard adjuvant chemotherapy were randomized (1-to-1) into 2 treatment arms. Patients in arm 1 received 200 mg intravenous pembrolizumab every 3 weeks for up to 1 year. Patients in arm 2 were treated with a placebo every 3 weeks for up to 1 year. The primary outcome was investigator-assessed disease-free survival (DFS).
The trial met the primary end point with a statistically significant improvement in DFS in the overall population. Patients in treatment arm 1 who received adjuvant chemotherapy had a median DFS was 58.7 months (95% CI, 39.2 to not reached) while patients in the placebo arm who received adjuvant chemotherapy had a median DFS of 34.9 months (95% CI, 28.6 to not reached; HR 0.73 [95% CI, 0.6 to 0.89]).
While most common adverse reactions among patients were similar to other treatment-related adverse events that had been observed among patients with NSCLC treated with pembrolizumab alone, there were also instances of hypothyroidism (22%), hyperthyroidism (11%), and pneumonitis (7%) in this trial. There were also 2 patients who experienced fatal adverse reactions of myocarditis.
The recommended pembrolizumab dose is 200 mg every 3 weeks or 400 mg every 6 weeks, delivered intravenously until disease recurrence, unacceptable toxicity, or up to 12 months.
Source:
FDA Approves Pembrolizumab as Adjuvant Treatment for Non-Small Cell Lung Cancer. United States Food and Drug Administration. January 26, 2023. Accessed January 27, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-adjuvant-treatment-non-small-cell-lung-cancer
