Efficacy of bintrafusp alfa (M7824) in patients with gastrointestinal tumors: A meta-analysis.

e16077 Background: This meta-analysis aims to evaluate the efficacy and safety of Bintrafusp Alfa (M7824) in patients with gastrointestinal tumors. Methods: A comprehensive search of PUBMED, Cochrane Library, Scopus, and Web of Science was conducted up to January 25, 2025. Studies were eligible if they were observational or clinical trials in English, reported at least one outcome of interest (objective response rate [ORR], disease control rate [DCR], progression-free survival [PFS], overall survival [OS], or adverse events [AEs]), and included patients with gastrointestinal tumor. Meta-analysis was conducted using Comprehensive Meta-Analysis (CMA) software. Results: The search yielded 1,400 records, of which 13 studies comprising 938 patients met inclusion criteria. Most studies were cohort designs conducted across Asia, Europe, and North America. The pooled ORR was 17.9% (95% CI: 11.7–26.4%, p &lt; 0.001), with high heterogeneity (I² = 72.5%). DCR was estimated at 33.1% (95% CI: 32.9–44.0%, p &lt; 0.001), with sensitivity analyses reducing heterogeneity to I² = 32.7% (p = 0.15). The pooled mean PFS was 1.496 months (95% CI: 1.47–1.52), and OS was 8.969 months (95% CI: 5.662–12.316). Grade 3 or higher AEs were reported with an event rate of 28.8% (95% CI: 20.3–39.1%, p &lt; 0.001), which decreased to 23.1% (p &lt; 0.001) after excluding three studies, reducing heterogeneity to I² = 5.01% (p = 0.39). Conclusions: Bintrafusp Alfa demonstrated modest efficacy in gastrointestinal tumors and limited survival benefits (PFS: 1.496 months; OS: 8.969 months). The treatment was associated with a significant incidence of Grade 3 or higher adverse events, necessitating careful patient monitoring. Further large-scale trials are required to validate these findings and optimize treatment strategies. The Outcomes(ORR, DCR, PFS, OS, Adverse Events). Study ID Objective Response Rate (ORR) Disease Control Rate (DCR) Progression-Free Survival (PFS) Overall Survival (OS) Adverse Events (Grade 3 or Higher) Number of Events T Number of Events T M SD N M SD N Number of Events T Doi et al., 2020 0 9 1 9 1.3 0.485 9 4.4 3.14 9 4 9 Kang et al., 2020 5 31 8 31 1.3 0.357 31 10.1 2.12 31 6 31 Lim et al., 2023 (HCC dose expansion cohort) 6 68 17 68 1.4 0.13 68 13.5 2.40 68 17 68 Lim et al., 2023 (HCC dose escalation cohort) 4 38 13 38 1.5 2.36 38 13.8 24.06 38 7 38 Lin et al., 2021 (Independent review committee) 3 30 9 30 1.4 0.383 30 7 30 Morris et al., 2022 0</