LBA57 Neoadjuvant nivolumab (N) + chemotherapy (C) in the phase III CheckMate 816 study: 3-y results by tumor PD-L1 expression

In CheckMate 816, neoadjuvant N + C vs C significantly improved the primary endpoints of event-free survival (EFS) and pathological complete response (pCR) in patients with resectable NSCLC; 3-y EFS benefit with N + C vs C was also demonstrated. Here, we report clinical outcomes by baseline tumor PD-L1 expression. Adults with stage IB (≥ 4 cm)–IIIA (AJCC v7) resectable NSCLC were randomized 1:1 to receive N 360 mg + C Q3W or C Q3W for 3 cycles. Exploratory analyses included EFS, overall survival (OS), pCR, major pathological response (MPR), surgical outcomes, and safety in patients with tumor PD-L1 ≥ 1% or < 1%. In patients with tumor PD-L1 ≥ 1% (N + C, 89; C, 89) and PD-L1 < 1% (78; 77), baseline characteristics were generally similar between PD-L1 subgroups and treatment arms. A higher proportion of patients with tumor PD-L1 < 1% had ECOG PS 1 (both arms). At database lock (14 Oct 2022; median follow-up, 41.4 mo), N + C showed improvement vs C across all efficacy endpoints in patients with tumor PD-L1 ≥ 1% (Table); 3-y EFS and OS rates were 72% vs 47% and 85% vs 66%, respectively. Similar efficacy benefit was seen in patients with tumor PD-L1 ≥ 1% and stage II–IIIA NSCLC (data to be presented). In patients with tumor PD-L1 < 1%, EFS, OS, pCR, and MPR also favored N + C vs C (Table); 3-y EFS and OS rates were 42% vs 39% and 71% vs 60%, respectively. Definitive surgery rates with N + C vs C were 84% vs 74% in patients with tumor PD-L1 ≥ 1% and 81% vs 77% in patients with tumor PD-L1 < 1%; R0 resection rates were 91% vs 82% and 79% vs 76%, respectively. Grade 3–4 treatment-related AE rates with N + C vs C were 34% vs 44% in patients with tumor PD-L1 ≥ 1% and 36% vs 34% in patients with tumor PD-L1 < 1%. These exploratory analyses from CheckMate 816 reinforce the clinical benefit and manageable safety profile of neoadjuvant N + C in patients with resectable NSCLC regardless of tumor PD-L1 expression.Table: LBA57Efficacy outcomes by tumor PD-L1 expressionTumor PD-L1 ≥ 1%Tumor PD-L1 < 1%N + C (n = 89)C (n = 89)N + C (n = 78)C (n = 77)EFSMedian, mo (95% CI)NR (44.4–NR)26.7 (13.4–NR)26.4 (14.8–NR)20.8 (13.9–42.1)HR (95% CI)0.46 (0.28–0.77)0.87 (0.57–1.35)OSMedian, mo (95% CI)NR (NR–NR)NR (45.1–NR)NR (48.6–NR)NR (31.2–NR)HR (95% CI)0.37 (0.20–0.71)0.81 (0.48–1.36)pCR rate, % (95% CI)32.6 (23.0–43.3)2.2 (0.3–7.9)16.7 (9.2–26.8)2.6 (0.3–9.1)MPR rate, % (95% CI)44.9 (34.4–55.9)5.6 (1.8–12.6)29.5 (19.7–40.9)14.3 (7.4–24.1)NR, not reached. Open table in a new tab