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Clinical Characteristics and Surgical Outcomes of Patients Receiving Perioperative Pembrolizumab in KEYNOTE-671.

Clinical Characteristics and Surgical Outcomes of Patients Receiving Perioperative Pembrolizumab in KEYNOTE-671. The Annals of thoracic surgery Liberman, M., Jones, D. R., Wakelee, H., Gao, S., Halmos, B., Nadal, E., Lowczak, A., Reck, M., Novello, S., Matias, D., Luft, A., Hui, R., Lee, S. H., Tsuboi, M., Kato, T., Zhu, Y., Weksler, B., Jensen, E., Samkari, A., Keller, S. M., Spicer, J. D. 2025

Abstract

The phase 3 KEYNOTE-671 study (NCT03425643) demonstrated significantly improved event-free survival (EFS) and overall survival with neoadjuvant pembrolizumab plus chemotherapy followed by surgery and adjuvant pembrolizumab versus neoadjuvant chemotherapy and surgery for early-stage non?small-cell lung cancer (NSCLC). We describe participant characteristics, surgical outcomes, and EFS in surgically relevant subgroups.Participants with untreated, resectable, stage II?IIIB (N2) NSCLC were randomized 1:1 to neoadjuvant pembrolizumab 200 mg or placebo plus cisplatin-based chemotherapy every 3 weeks for 4 cycles, then surgery and adjuvant pembrolizumab or placebo for 13 cycles. Surgery was performed =20 weeks after first neoadjuvant dose (if 4 cycles of neoadjuvant therapy) or 4?8 weeks after last neoadjuvant dose (1?3 cycles); surgery beyond this was considered surgical delay. Adjuvant therapy began 4?12 weeks after surgery. EFS 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 data cutoff (July 10, 2023), 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 resections. Pembrolizumab improved EFS irrespective of disease stage, nodal status, and type of surgery versus chemotherapy. Eight participants (pembrolizumab, n=6; placebo, n=2) died =30 days after surgery from surgery-related adverse events.Neoadjuvant pembrolizumab did not adversely affect surgical outcomes, was associated with numerically higher R0 resections, and improved EFS versus neoadjuvant chemotherapy in surgically relevant subgroups in early-stage NSCLC.

View details for DOI 10.1016/j.athoracsur.2025.10.016

View details for PubMedID 41203001