FDA approves pembrolizumab as adjuvant treatment for non-small cell lung cancer
Regulatory approval: On Jan 26, 2023, the FDA approved pembrolizumab (Keytruda) as adjuvant treatment after complete resection and platinum-based chemotherapy for stage IB (T2a ≥4 cm), II, or IIIA NSCLC. Approval was supported by KEYNOTE-091, which met its primary endpoint of improved investigator-assessed disease-free survival (DFS) in the overall population. In chemotherapy-treated patients, median DFS was 58.7 vs 34.9 months (HR 0.73).
FDA approval (Jan 26, 2023): pembrolizumab adjuvant therapy in NSCLC
The FDA approved pembrolizumab (Keytruda; Merck) for adjuvant treatment of stage IB (T2a ≥4 cm), II, or IIIA non-small cell lung cancer (NSCLC) following complete resection and platinum-based chemotherapy.
Supporting evidence: KEYNOTE-091
Efficacy was evaluated in KEYNOTE-091 (NCT02504372), a multicenter, randomized, triple-blind, placebo-controlled trial. Patients had not received neoadjuvant radiotherapy or chemotherapy. Participants were randomized 1:1 to pembrolizumab 200 mg IV every 3 weeks or placebo for up to 1 year. Of 1177 randomized patients, 1010 (86%) received adjuvant platinum-based chemotherapy after resection.
The primary efficacy endpoint was investigator-assessed disease-free survival (DFS). The trial met its primary endpoint with a statistically significant DFS improvement in the overall population. In an exploratory subgroup of 167 patients who did not receive adjuvant chemotherapy, DFS HR was 1.25 (95% CI, 0.76–2.05). Among patients who received adjuvant chemotherapy, median DFS was 58.7 months (95% CI, 39.2–NR) with pembrolizumab vs 34.9 months (95% CI, 28.6–NR) with placebo (HR 0.73; 95% CI, 0.60–0.89).
Safety and dosing
Adverse reactions were generally consistent with prior single-agent NSCLC experience, with hypothyroidism (22%), hyperthyroidism (11%), and pneumonitis (7%); two fatal myocarditis events occurred. Recommended dosing: 200 mg q3w or 400 mg q6w until recurrence, unacceptable toxicity, or up to 12 months.
The review was conducted under Project Orbis; reviews at partner agencies were ongoing at the time of the FDA action.