Clinical outcomes with neoadjuvant nivolumab (N) + chemotherapy (C) vs C by definitive surgery in patients (pts) with resectable NSCLC: 3-y results from the phase 3 CheckMate 816 trial.

• DOI: 10.1200/jco.2023.41.16_suppl.8521
• Publication Date: 2023-06-04T16:12:44Z
• Authors: Jonathan Spicer; Patrick M. Forde; Mariano Provencio; Shun Lu; Changli Wang; Tetsuya Mitsudomi; Stephen Broderick; Scott Swanson; Mark M. Awad; Enriqueta Felip; Julie R. Brahmer; Keith Kerr; Gene Brian Saylors; Ke-Neng Chen; Fumihiro Tanaka; Junliang Cai; Javed Mahmood; Nan Hu; Phuong Tran; Nicolas Girard
• Keywords: Clinical endpoint; Neoadjuvant Therapy

8521 Background: In CheckMate 816, neoadjuvant N + C demonstrated statistically significant and clinically meaningful improvements in event-free survival (EFS) pathologic complete response (pCR) vs pts with resectable NSCLC. Here, we report clinical outcomes or without definitive surgery following treatment (tx). Methods: Adults stage IB (tumors ≥ 4 cm) to IIIA (per AJCC 7th ed) NSCLC, ECOG PS ≤ 1, no known EGFR/ ALK mutations were randomized 1:1 3 cycles of 360 mg Q3W Q3W, followed by within 6 wk tx. Primary endpoints EFS pCR, both per blinded independent review. Exploratory analyses included (secondary definition; censoring for subsequent tx), time death distant metastasis (TTDM), EFS2 (EFS on next-line tx) surgery. Results: Among 358 pts, 149 (83%; C) 135 (75%; had Baseline characteristics similar (N C, 30; 44) between tx arms, except that a higher proportion who did not have 1 (both arms) from Europe arm). Surgery was canceled due progressive disease (PD) 11 17 (C) pts; PD locoregional 15 2 while the arm PD. At database lock (October 14, 2022; median f/u: 41.4 mo), EFS, TTDM, numerically improved surgery, regardless arm. TTDM reached (NR) 46.8 mo (HR, 0.55) respectively; 3-y rates 77% 59%. 24.8 15.6 0.63) C; 36% 13%. (57%) 28 (64%) respectively, received tx: radiotherapy 37% 41%; 3% 2%; systemic 50% 52%. Grade 3/4 tx-related AEs occurred 38% 26% 46% Conclusions: long-term benefit NSCLC receive these exploratory showed associated TTDM. Clinical trial information: NCT02998528 . [Table: see text]