Abstract 594P
Background
In the global phase III CheckMate 77T trial, perioperative NIVO significantly improved event-free survival (EFS) vs neoadjuvant (neoadj) chemo (C) followed by adjuvant (adj) placebo (PBO) in resectable stage II–IIIB NSCLC. Here, we report clinical outcomes in the Chinese population in CheckMate 77T.
Methods
Adults with untreated resectable stage IIA (>4 cm) ─ IIIB (N2) NSCLC, no EGFR mutations/known ALK alterations, and ECOG performance status ≤1 were randomized 1:1 to NIVO 360 mg + platinum-doublet C or PBO + platinum-doublet C, Q3W 4 cycles, followed by surgery and adj NIVO 480 mg or PBO, Q4W 13 cycles. Chinese pts from CheckMate 77T (n = 68) were included. The primary endpoint was EFS (RECIST v1.1 by blinded independent central review [BICR]). Secondary endpoints included pathological complete response (pCR) and major pathological response (MPR) by blinded independent pathological review (BIPR) and safety. Exploratory endpoint was objective response rate (ORR) by BICR.
Results
Baseline characteristics were generally balanced between arms (NIVO, n = 37; PBO, n = 31). At median (range) follow-up of 29.1 (16.0–44.5) months, median EFS (95% CI) was not reached (22.6 mo─not evaluable [NE]] with NIVO vs 12.6 mo (3.5─NE) with PBO; HR (95% CI), 0.40 (0.17–0.92); 1-year EFS rate was 77.2% vs 51.1%, respectively. NIVO also improved pCR rates (35.1% vs 3.2%), MPR rates (51.4% vs 6.5%), and ORR (78.4% vs 32.3%) vs PBO (Table). Definitive surgery rates were 81% (NIVO) vs 61% (PBO). Grade 3/4 treatment-related adverse events (TRAEs) were 54% (NIVO) and 40% (PBO). Table: 594P
| Efficacy | NIVO (n = 37) | PBO (n = 31) |
| Median EFSa (95% CI), months | NR (22.6–NE) | 12.6 (3.5–NE) |
| HR (95% CI) | 0.40 (0.17–0.92) | |
| pCR,b,d n (%); 95% CI | 13 (35.1); 20.2–52.5 | 1 (3.2); 0.1–16.7 |
| Difference in pCR, % (95% CI) | 31.9 (13.3–48.2) | |
| MPR,c,d n (%); 95% CI | 19 (51.4); 34.4–68.1 | 2 (6.5); 0.8–21.4 |
| Difference in MPR, % (95% CI) | 44.9 (23.9–60.8) | |
| ORR,a n (%); 95% CI | 29 (78.4); 61.8–90.2 | 10 (32.3); 16.7–51.4 |
| Estimate of odds ratio (95% CI) | 7.61 (2.57–22.55) | |
| Safety, n (%) | (n = 37) | (n = 30) |
| Any-grade TRAEs | 36 (97.3) | 28 (93.3) |
| Grade 3/4 TRAEs | 20 (54.1) | 12 (40.0) |
aPer BICR using RECIST v1.1. b0% residual viable tumor in primary tumor and lymph nodes. c≤10% RVT cells after surgery in primary tumor and lymph nodes. dper BIPR NR, not reached
Conclusions
In Chinese pts with resectable stage IIA–IIIB NSCLC, NIVO showed clinically meaningful improvement in EFS, pCR, and MPR vs PBO, with no new safety signals. Limited sample size warrants caution in interpretation.
Clinical trial identification
CA20977T, NCT04025879.
Editorial acknowledgement
Medical writing assistance was provided by Pearl Toh, PhD, of Parexel.
Legal entity responsible for the study
Bristol Myers Squibb.
Funding
Bristol Myers Squibb.
Disclosure
K. Chen: Other, Personal and Institutional, Writing Engagement, Provision of study materials: BMS. J. Shih: Other, Personal and Institutional, Writing Engagement: BMS; Financial Interests, Personal and Institutional, Speaker, Consultant, Advisor: ACTgenomics, Amgen, AstraZeneca, Boehringer Ingelheim, BMS, Chugai Pharma, CStone Pharmaceuticals, Daiichi Sankyo, Eli Lilly, Genconn Biotech, GSK, Janssen, Lotus Pharmaceutical Co, Merck Sharp & Dohme, Novartis, Ono Pharmaceutical, Orient EuroPharma, Pfizer, Roche, Takeda, TSH Biopharm, TTY Biopharm ; Financial Interests, Personal and Institutional, Other, Support for attending meetings and/or travel: AstraZeneca, Roche, Pfizer, Chugai Pharma. H. Sun, W. Kang, H. Zhang: Financial Interests, Personal and Institutional, Full or part-time Employment: BMS. S. Lu: Financial Interests, Personal and Institutional, Research Funding: AstraZeneca, Hutchison, BMS, Hengrui Therapeutics, Beigene, Roche, Hansoh; Financial Interests, Personal and Institutional, Speaker, Consultant, Advisor, Consulting fees and speaker fees, Advisor: AstraZeneca; Financial Interests, Personal and Institutional, Speaker, Consultant, Advisor, Consulting fees: Hutchison, Zai Lab; Financial Interests, Personal and Institutional, Speaker, Consultant, Advisor, Consulting fees, Advisor: Yuhan Corporation; Financial Interests, Personal and Institutional, Speaker, Consultant, Advisor, speaker fees: Roche, Hansoh, Hengrui Therapeutics; Other, Personal, Advisory Board, Scientific advisor: InventisBio Co. Ltd., Simcere Zaiming Pharmaceutical Co., Ltd, Shanghai Fosun Pharmaceutical, Phanes Therapeutics, Inc. All other authors have declared no conflicts of interest.