The New England Journal of MedicinePerioperative Pembrolizumab for Early-Stage Non–Small-Cell Lung Cancer

Pembrolizumab Enhances Outcomes in Early-Stage NSCLC: A Phase 3 Trial Analysis

In the pursuit of improved treatment outcomes for early-stage non-small-cell lung cancer (NSCLC), a phase 3 trial evaluated the efficacy of perioperative pembrolizumab.

• The trial involved patients with resectable stage II, IIIA, or IIIB (N2 stage) NSCLC, randomized to receive either neoadjuvant pembrolizumab or placebo, both in conjunction with cisplatin-based chemotherapy, followed by surgery and adjuvant pembrolizumab or placebo.
• The dual primary endpoints were event-free survival and overall survival, with secondary endpoints including major pathological response, pathological complete response, and safety.
• A total of 797 participants were involved, with 397 assigned to the pembrolizumab group and 400 to the placebo group.
• Event-free survival at 24 months was significantly higher in the pembrolizumab group (62.4%) compared to the placebo group (40.6%).
• Major pathological response and pathological complete response were also significantly higher in the pembrolizumab group.
• The 24-month overall survival was 80.9% in the pembrolizumab group and 77.6% in the placebo group, a difference that did not meet the significance criterion.
• Treatment-related adverse events of grade 3 or higher occurred in 44.9% of the pembrolizumab group and 37.3% of the placebo group.