CLINICAL CHARACTERISTICS AND SURGICAL OUTCOMES OF PATIENTS RECEIVING PERIOPERATIVE PEMBROLIZUMAB IN KEYNOTE-671

Abstract

This article presents the most recent data from the phase 3 KEYNOTE-671 study. Patients with treatment naïve,resectable, stage II-IIIB (N2) non-small cell lung cancer (NSCLC) were randomized 1:1 to neoadjuvant pembrolizumab 200 mg or placebo plus cisplatin-based chemotherapy every 3 weeks for 4 cycles. After that, surgery and adjuvant pembrolizumab or placebo for 13 cycles were prescribed. Surgery was performed ≤20 weeks after the first neoadjuvant dose (if 4 cycles of neoadjuvant therapy) or 4-8 weeks after the last neoadjuvant dose (1–3 cycles). Surgical treatment beyond this period was considered a surgical delay. Adjuvant therapy began 4–12 weeks after surgery. Event-free survival was assessed in the surgical population. Of 397 participants randomized to pembrolizumab and 400 to placebo, 325 (82.1%) and 317 (79.4%), respectively, underwent surgery. At July 10, 2023 (data cutoff), 4.9% (pembrolizumab) and 7.6% (placebo) of participants experienced surgical delay; 38.9% and 28.4%, respectively, experienced nodal downstaging; 78.8% and 75.1% underwent lobectomy; and 92.0% and 84.2% had R0 resection Pembrolizumab improved EFS despite disease stage, nodal status, and type of surgery compared with the placebo arm. Eight participants (two in pembrolizumab, six in the placebo group) died ≤30 days after surgery from surgery related adverse events. In conclusion, neoadjuvant pembrolizumab did not adversely affect surgical outcomes and was also associated with numerically higher R0 resections. The KEYNOTE-671 clinical trial showed that neoadjuvant treatment with pembrolizumab in combination with cisplatin-based chemotherapy, followed by surgery and adjuvant pembrolizumab therapy, significantly improved event-free survival and overall survival in the treatment of early-stage non-small cell lung cancer.