Five-Year Outcomes of Perioperative Pembrolizumab for Early-Stage Non-Small-Cell Lung Cancer From the Randomized KEYNOTE-671 Study
In brief
Perioperative pembrolizumab doubles 5-year event-free survival in resectable NSCLC
In the phase 3 KEYNOTE-671 trial, adding pembrolizumab to neoadjuvant chemotherapy raised five-year event-free survival to 50% versus 27% with chemotherapy alone, and improved overall survival to about 65% versus 54%. Benefits persisted without quality-of-life loss, supporting this regimen as a new standard for early-stage, resectable lung cancer.
- Journal
- Annals of oncology : official journal of the European Society for Medical Oncology (Q1)
- Published
- 21 August 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- H Wakelee, J D Spicer, S Gao, M Liberman, M Tsuboi, T Kato, et al.
- PMID
- 42628840
- DOI
- 10.1016/j.annonc.2026.08.005
Why clinicians should know about it
- Picked for Surgery (top studies of the week, 23 August 2026): Lung cancer immunotherapy trial, not GI surgery
- Picked for Oncology and Radiation Oncology (paper of the day, 23 August 2026): Five‑year outcomes of perioperative pembrolizumab in early‑stage NSCLC
- Picked for Breast and Endocrine Surgery (top studies of the week, 23 August 2026): Pembrolizumab in NSCLC, not relevant to breast/endocrine
Abstract
BACKGROUND: Adding perioperative pembrolizumab to neoadjuvant chemotherapy significantly improved survival outcomes compared with neoadjuvant chemotherapy and surgery alone in participants with early-stage non-small-cell lung cancer (NSCLC) in the phase 3, randomized KEYNOTE-671 study. We report results from KEYNOTE-671 after 5 years of follow-up. PATIENTS AND METHODS: Eligible participants with previously untreated, resectable stage II, IIIA, or IIIB (N2) NSCLC were randomized 1:1 to 4 cycles of pembrolizumab 200 mg or placebo every 3 weeks, plus platinum-doublet chemotherapy, followed by surgery then adjuvant pembrolizumab or placebo every 3 weeks for up to 13 cycles. Dual primary endpoints were event-free survival (EFS) per RECIST v1.1 by investigator assessment and overall survival (OS). RESULTS: 797 participants were randomized to pembrolizumab (n=397) or placebo (n=400). Median time from randomization to data cutoff (July 3, 2025) was 60.4 (range, 42.6‒85.8) months. Five-year EFS was 49.9% (95% CI, 44.6‒55.0) in the pembrolizumab arm and 26.5% (95% CI, 21.7‒31.5) in the placebo arm (HR, 0.58; 95% CI, 0.48‒0.69); 5-year OS was 64.6% (95% CI, 59.5‒69.2) and 53.6% (95% CI, 48.3‒58.6), respectively (HR, 0.74; 95% CI, 0.59‒0.92). No detriment to health-related quality of life was identified in the pembrolizumab versus placebo arm with longer follow-up. Safety was consistent with the known profiles of each treatment. CONCLUSIONS: After 5 years of follow-up, EFS was nearly double with perioperative pembrolizumab plus neoadjuvant chemotherapy, along with continued improvement in OS compared with neoadjuvant chemotherapy and surgery alone. The durable and clinically meaningful benefits observed support use of this treatment as a standard of care for patients with resectable early-stage NSCLC (ClinicalTrials.gov, NCT03425643).
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.