Multinational phase 3 trial of perioperative pembrolizumab plus neoadjuvant chemotherapy for early-stage non-small cell lung cancer

The multinational phase 3 KEYNOTE-671 trial evaluated perioperative pembrolizumab plus neoadjuvant chemotherapy versus perioperative placebo plus neoadjuvant chemotherapy among patients with resectable stage II, IIIA, or IIIB (N2) non-small cell lung cancer. The second interim analysis of the trial has now been published. With a median follow-up of 36.6 months (IQR 27.6-47.8) the overall survival rates at 36 months were 71% in the pembrolizumab group and 64% in the placebo group (HR 0.72; p=0.0052). The median event-free survival was 47.2 months in the pembrolizumab group and 18.3 months in the placebo group (HR 0.59; 95% CI 0.48-0.72). In the as-treated population, grade 3-5 treatment-related adverse events occurred in 45% of patients in the pembrolizumab group and 38% of patients in the placebo group. Grade 5 TRAEs occurrred in 1% of patients in both groups. The authors conclude that the trial showed a significant overall survival benefit of neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab compared with neoadjuvant chemotherapy alone among patients with resectable, early-stage NSCLC. The safety profile was manageable.