Abstract CT081: Neoadjuvant nivolumab (NIVO) + chemotherapy (chemo) vs chemo in Chinese patients (pts) with resectable NSCLC in CheckMate 816

Background: In the global, randomized phase 3 CheckMate 816 study (NCT02998528), neoadjuvant NIVO + chemo demonstrated statistically significant and clinically meaningful improvements in event-free survival (EFS) and pathologic complete response (pCR) vs chemo in pts with resectable NSCLC. Here, we report results from the Chinese subgroup of this study. Methods: Adults with stage IB (≥ 4 cm)-IIIA (per AJCC 7th edition) resectable NSCLC, ECOG PS ≤ 1, and no known EGFR/ALK mutations were randomized to NIVO 360 mg + chemo Q3W or chemo Q3W for 3 cycles followed by surgery. EFS and pCR (per blinded independent review) were primary endpoints; major pathologic response (MPR) and time to death or distant metastasis (TTDM) were secondary endpoints. Presented results are from an updated analysis of EFS (DBL, Oct 14, 2022), and the final analysis of pCR (DBL, Sep 16, 2020). Results: The Chinese subgroup comprised 97 pts (NIVO + chemo, 44; chemo, 53). Baseline characteristics were generally balanced between treatment (tx) arms, except for a higher proportion of pts with stage IIIA NSCLC in the chemo arm. At 38.2 mo’s minimum follow-up, NIVO + chemo improved EFS vs chemo (HR, 0.47; 95% CI, 0.25-0.88). The pCR rate (95% CI) was higher with NIVO + chemo (25.0% [13.2-40.3]) vs chemo (1.9% [0.0-10.1]); MPR and TTDM also favored NIVO + chemo (table). Overall, 36 (81.8%) and 41 (77.4%) pts in the NIVO + chemo and chemo arms, respectively, had definitive surgery. Grade 3-4 tx-related and surgery-related adverse events occurred in 18 (41.9%) and 5 (13.9%) pts in the NIVO + chemo arm, respectively, vs 22 (41.5%) and 9 (22.0%) in the chemo arm. Conclusions: Consistent with results in the global population of CheckMate 816, neoadjuvant NIVO + chemo improved EFS and pCR vs chemo in Chinese pts. The addition of NIVO to neoadjuvant chemo maintained tx tolerability and did not impact the feasibility of surgery. These results support neoadjuvant NIVO + chemo as a tx option for Chinese pts with resectable NSCLC. NIVO + chemo (n = 44) Chemo (n = 53) Median EFS (95% CI), mo NR (23.4-NR) 13.9 (8.3-34.3) HR (95% CI) 0.47 (0.25-0.88) 3-year EFS rate (95% CI), % 58.7 (40.6-73.0) 35.4 (21.8-49.2) pCR rate (95% CI), % 25.0 (13.2-40.3) 1.9 (0.0-10.1) Differencea (95% CI), % 20.9 (7.7-34.1) Odds ratio (95% CI) 11.05 (1.41-86.49) MPR rate (95% CI), % 34.1 (20.5-49.9) 7.5 (2.1-18.2) Differencea (95% CI), % 28.1 (11.9-44.3) Odds ratio (95% CI) 7.42 (1.92-28.65) Median TTDM (95% CI), mo NR (NR-NR) 28.8 (14.8-46.8) HR (95% CI) 0.27 (0.12-0.60) aCalculated using the stratified Cochran-Mantel-Haenszel method. NR, not reached. Citation Format: Changli Wang, Ke-Neng Chen, Qixun Chen, Lin Wu, Qun Wang, Xiaofei Li, Kejing Ying, Wenxiang Wang, Jian Zhao, Lunxu Liu, Junke Fu, Chunfang Zhang, Jichun Liu, Yi Hu, Mark M. Awad, Ives Ntambwe, Junliang Cai, Judith Bushong, Phuong Tran, Shun Lu. Neoadjuvant nivolumab (NIVO) + chemotherapy (chemo) vs chemo in Chinese patients (pts) with resectable NSCLC in CheckMate 816 [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 2 (Clinical Trials and Late-Breaking Research); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(8_Suppl):Abstract nr CT081.