A second interim analysis of the KEYNOTE-671 study showed that neoadjuvant pembrolizumab in combination with chemotherapy followed by resection and adjuvant pembrolizumab yields improved overall survival (OS) in patients with resectable stage II, IIIA, or IIIB non-small cell lung cancer. The findings were presented at the European Society for Medical Oncology Congress 2023.
In this study, 797 patients with resectable stage II, IIIA, or IIIB (N2) NSCLC were randomized 1:1 to pembrolizumab 200 mg (n=397) or placebo (n=400). The 2 primary end points were event-free survival (EFS) and OS.
The findings showed that OS was significantly improved in the pembrolizumab arm of the study (hazard ratio [HR], 0.72; 95% CI, 0.56-0.93; P=.00517). Also, EFS continued to be improved in the pembrolizumab arm (HR, 0.59; 95% CI, 0.48-0.72; median, 47.2 months [95% CI, 2.9 to not reached] vs 18.3 months [95% CI, 14.8-22.1], respectively; 36-month rate, 54.3% vs 35.4%) compared with the placebo arm.
“Neoadjuvant [pembrolizumab plus chemotherapy] followed by resection and adjuvant [pembrolizumab] provided a statistically significant and clinically important improvement in OS compared with neoadjuvant [chemotherapy] and resection alone in [patients] with resectable stage II, IIIA, or IIIB (N2) NSCLC,” the researchers concluded.
They added that the “OS gains seen in KEYNOTE-671 with the absence of new safety signals establish the perioperative [pembrolizumab] regimen as a new standard of care for resectable early-stage NSCLC.”
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