Perioperative Nivolumab in Resectable Non-Small Cell Lung Cancer: A Subanalysis of Japanese Patients From CheckMate 77T

Abstract

In the randomized phase III CheckMate 77T study, perioperative nivolumab showed statistically significant and clinically meaningful improvement in event-free survival (EFS) vs. placebo in patients with resectable, non-metastatic non-small cell lung cancer (NSCLC). Here, we report efficacy and safety outcomes in the Japanese subpopulation. Adults with resectable stage IIA-IIIB NSCLC were randomized 1:1 to neoadjuvant nivolumab plus chemotherapy or chemotherapy plus placebo every 3 weeks for ≤ 4 cycles, followed by surgery and adjuvant nivolumab or placebo every 4 weeks for ≤ 13 cycles. Assessments included EFS (primary endpoint), pathological complete response (pCR), major pathological response (MPR), and safety. A total of 68 Japanese patients were randomized to perioperative nivolumab (n = 40) or placebo (n = 28). At 24.9 months' median follow-up, median EFS was not reached (NR; 95% CI: 21.4-NR) with perioperative nivolumab vs. 12.1 (95% CI: 8.1-NR) months with placebo (hazard ratio, 0.46 [95% CI: 0.22-0.95]); 18-month EFS rates were 76.6% vs. 42.9%, respectively. The pCR rate (95% CI) was 42.5% (27.0%-59.1%) with perioperative nivolumab vs. 0% (0%-12.3%) with placebo (odds ratio [OR], not available); MPR rate (95% CI) was 52.5% (36.1%-68.5%) vs. 7.1% (0.9%-23.5%), respectively (OR, 14.37; 95% CI: 3.00-68.82). Grade 3-4 treatment-related and surgery-related adverse events with perioperative nivolumab vs. placebo occurred in 55.0% vs. 39.3% and 16.7% vs. 19.2% of patients. Consistent with the global population, perioperative nivolumab improved EFS, pCR, and MPR vs. placebo in the Japanese subpopulation, with no new safety signals reported, supporting its use in Japanese patients with resectable NSCLC. Trial Registration: ClinicalTrials.gov identifier, NCT04025879.

Keywords: Japan; carcinoma; clinical trial; immunotherapy; nivolumab; non‐small‐cell lung.