FDA Approves Pembrolizumab as Adjuvant Therapy for NSCLC

By: JNCCN 360 Staff
Posted: Friday, February 3, 2023

On January 26, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for adjuvant treatment after resection and platinum-based chemotherapy in patients with stage IB (T2a, ≥ 4 cm), II, or IIIA non–small cell lung cancer (NSCLC). The recommended pembrolizumab dose is 200 mg every 3 weeks or 400 mg every 6 weeks until disease recurrence, unacceptable toxicity, or for up to 12 months.

Efficacy was evaluated in the KEYNOTE-091 trial, a multicenter, randomized, triple-blind, placebo-controlled trial. Patients had not received neoadjuvant radiotherapy or chemotherapy. They were randomly assigned 1:1 to receive pembrolizumab at 200 mg or placebo intravenously every 3 weeks for up to 1 year. Of the 1,177 patients who were randomly assigned, 1,010 (86%) received adjuvant platinum-based chemotherapy after complete resection.

The major efficacy outcome measure was investigator-assessed disease-free survival. The trial met its primary endpoint, demonstrating a statistically significant improvement in disease-free survival in the overall population. In an exploratory subgroup analysis of the 167 patients who did not receive adjuvant chemotherapy, the disease-free survival hazard ratio was 1.25 (95% confidence interval [CI] = 0.76–2.05). For patients who received adjuvant chemotherapy, the median disease-free survival was 58.7 months with pembrolizumab (95% CI = 39.2 months to not reached) and 34.9 months with placebo (95% CI = 28.6 months to not reached; hazard ratio = 0.73; 95% CI = 0.60–0.89).

The adverse reactions observed in KEYNOTE-091 were generally similar to those occurring in other patients with NSCLC receiving pembrolizumab as a single agent, with the exception of hypothyroidism (22%), hyperthyroidism (11%), and pneumonitis (7%). Two fatal adverse reactions of myocarditis occurred.

U.S. Food and Drug Administration

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