Editorial acknowledgement Legal entity responsible for the study With additional follow-up data, adjuvant nivolumab continues to demonstrate clinically meaningful efficacy and a well-tolerated safety profile, further supporting its use as a new standard of care for patients with resected EC/GEJC who received neoadjuvant CRT and have residual pathologic disease. Table: 1381P EfficacyĪny-grade TRAEs leading to discontinuation The safety profile was consistent with that reported previously and most treatment-related adverse events (TRAEs) were grade 1 or 2 (Table). Adjuvant nivolumab showed approximately 13 mo improvement in median DMFS compared to placebo (Table). DFS benefit was observed across multiple subgroups. With a minimum follow-up of 14 mo, adjuvant nivolumab showed a doubling of median DFS vs placebo (Table). In both groups, approximately 70% of patients had adenocarcinoma and almost 60% had a pathologic lymph node status ≥ypN1. Resultsħ94 patients were randomized (nivolumab, 532 placebo, 262). Exploratory endpoints included distant metastasis–free survival (DMFS). MethodsĪdults with resected (R0) stage II/III EC/GEJC who received neoadjuvant CRT and had residual pathologic disease were randomized 2:1 to nivolumab 240 mg or placebo Q2W for 16 weeks, followed by nivolumab 480 mg or placebo Q4W. Here, we report efficacy and safety with an additional 8 mo follow-up. Statistically significant and clinically meaningful improvement in disease-free survival (DFS) was demonstrated for nivolumab vs placebo (median, 22.4 vs 11.0 months HR 0.69 96.4% CI 0.56–0.86 P = 0.0003) with a well-tolerated safety profile in patients with resected EC/GEJC who received neoadjuvant CRT in the global, randomized, phase III CheckMate 577 study. The risk of recurrence after neoadjuvant CRT followed by surgery (trimodality therapy) remains high in EC/GEJC. Sammons Cancer Center at Baylor University Medical Center, TX 75246 - Dallas/US 19 Medical Oncology, Dana Farber Cancer Institute, MA 02215 - Boston/US.
18 Ww Medical Lead, Bristol Myers Squibb, 08540 - Princeton/US.17 Clinical Research, Bristol Myers Squibb, 08540 - Princeton/US.16 Biostatistics, Bristol Myers Squibb, 08540 - Princeton/US.
15 Biometrics, Bristol Myers Squibb, 08540 - Princeton/US.14 Service Of Digestive Oncology, UZ Gent, 9000 - Gent/BE.13 Gastrointestinal Oncology, Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, 1066 CX - Amsterdam/NL.12 Medical Oncology, Princess Margaret Cancer Center, M5G 2M9 - Toronto/CA.11 Medical Oncology, Duke University Institute, 27710 - Durham/US.10 Gastroenterology And Gi Oncology, CHU Pontchaillou, 35000 - Rennes/FR.9 Esophageal Surgery, Akita University Hospital, 1-1-1 Hondo - Akita/JP.
Medicine, Johannes-Gutenberg University Clinic, 55131 - Mainz/DE