KEY TAKEAWAYS
- The CheckMate 816 phase 3 trial aimed to report clinical outcomes stratified by baseline tumor PD-L1 expression.
- The reported exploratory outcomes were EFS, OS, pCR, MPR, surgical outcomes, and safety.
- The result demonstrated the clinical benefit and manageable safety profile of clinical efficacy and safety of neoadjuvant N + C in resectable NSCLC patients across varying tumor PD-L1.
The CheckMate 816 study showed that adding immunotherapy nivolumab (N) to chemotherapy (C) before surgery (neoadjuvant) significantly improved both long-term survival (event-free survival) and the complete disappearance of cancer cells (pathological complete response) in resectableNon-Small Cell Lung Cancer (NSCLC) patients.
For a study, researchers aimed to report clinical outcomes stratified by baseline tumor PD-L1 expression. The study randomized (1:1) the resectable NSCLC patients who were in stages IB (≥ 4 cm)–IIIA (AJCC v7) to receive either neoadjuvant N at 360 mg plus C every 3 weeks or C alone every 3 weeks for 3 cycles. The exploratory analyses were EFS, overall survival (OS), pCR, major pathological response (MPR), surgical outcomes, and safety assessments stratified by tumor PD-L1 expression (≥ 1% or < 1%).
The result demonstrated that for patients with tumor PD-L1 ≥ 1% (N + C: 89; C:89) and PD-L1 < 1% ((78; 77)), baseline characteristics were generally comparable between PD-L1 subgroups and treatment arms. A higher proportion of patients with tumor PD-L1 < 1% exhibited ECOG PS 1 in both arms. At the database lock (October 14, 2022; median follow-up: 41.4 months), N + C demonstrated improvement compared to C across all efficacy endpoints in patients with tumor PD-L1 ≥ 1%; 3-year EFS and OS rates were 72% vs 47% and 85% vs 66%, respectively. Similar efficacy benefits were observed 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; 3-year 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 adverse event 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%.
The study reported the clinical advantages and well-tolerated safety profile of neoadjuvant nivolumab + chemotherapy in resectable NSCLC patients, irrespective of tumor PD-L1 expression.
Clinical Trial: https://clinicaltrials.gov/study/NCT02998528
Provencio Pulla M, Forde PM, Spicer JD, Wang C, Lu S, Mitsudomi T, Awad MM, Felip E, Broderick S, Swanson SJ, Brahmer JR, Kerr KM, Saylors G, Tanaka F, Chen K, Tran MP, Cai JL, Mahmood J, Meadows-Shropshire S, Girard N. Neoadjuvant nivolumab (N) + chemotherapy (C) in the phase III CheckMate 816 study: 3-year results by tumor PD-L1 expression. Abstract LBA57. ESMO Congress2023, October 2023.
