Background
Randomized phase III KEYNOTE-671 trial, N=797, in resectable stage II, IIIA, or IIIB (N2) NSCLC. Patients were treatment-naive and eligible for surgical resection.
Interventions and follow up
Arm A: Pembrolizumab 200 mg IV Q3W + cisplatin-based chemotherapy for 4 cycles (neoadjuvant) → surgery → pembrolizumab 200 mg IV Q3W for 13 cycles (adjuvant)
Arm B: Placebo IV Q3W + cisplatin-based chemotherapy for 4 cycles (neoadjuvant) → surgery → placebo Q3W for 13 cycles (adjuvant)
Primary endpoint: EFS, OS
mFollow up: 36.6 mo
Arm B: Placebo IV Q3W + cisplatin-based chemotherapy for 4 cycles (neoadjuvant) → surgery → placebo Q3W for 13 cycles (adjuvant)
Primary endpoint: EFS, OS
mFollow up: 36.6 mo
Results
EFS: 47.2 vs 18.3 mo, HR 0.59, 95% CI 0.48–0.72, P<.001
3-yr OS: 71% vs 64% at 36 mo, HR 0.72, 95% CI 0.56–0.93, P=.005
pCR: 18% vs 4%
3-yr OS: 71% vs 64% at 36 mo, HR 0.72, 95% CI 0.56–0.93, P=.005
pCR: 18% vs 4%
Adverse events
Overall: Grade 3–5 treatment-related AE 45% vs 38%
Note: Safety profile consistent with the known effects of pembrolizumab and platinum chemotherapy
Note: Safety profile consistent with the known effects of pembrolizumab and platinum chemotherapy
Conclusions
Perioperative pembrolizumab significantly improved both EFS and OS vs chemotherapy alone in early-stage resectable NSCLC, with a manageable safety profile.
Key Limitations
Pooled neoadjuvant + adjuvant design does not isolate the contribution of each phase; subgroup benefit by PD-L1 not fully detailed in this readout.
Clinical Context
Perioperative pembrolizumab + chemotherapy is FDA/EMA approved for resectable NSCLC and is a standard perioperative chemoimmunotherapy option per ASCO/ESMO.