EDGE-Gastric Phase 2: Anti‑TIGIT + PD‑1 + FOLFOX Shows Promising Survival

The EDGE‑Gastric phase 2 arm A1 cohort reported a median overall survival of 26.7 months with domvanalimab (anti‑TIGIT) plus zimberelimab (anti‑PD‑1) and FOLFOX, marking a substantial survival readout for a first‑line advanced gastroesophageal adenocarcinoma population.

Compared with earlier chemo‑era series that typically document median OS in the low‑to‑mid teens, this 26.7‑month figure appears notable but must be interpreted cautiously because single‑arm phase 2 signals can overestimate effect size. Therefore, randomized confirmation and prospective biomarker stratification will be essential to define true incremental benefit.

The regimen combined an Fc‑silent anti‑TIGIT antibody (domvanalimab) with the anti‑PD‑1 zimberelimab plus FOLFOX in previously untreated gastric, gastroesophageal, and esophageal adenocarcinoma patients with ECOG 0–1 and measurable disease by RECIST. Median follow‑up was 26.4 months and median time on treatment was about 49 weeks, which frames generalizability for typical first‑line trial populations.

The data show a median PFS of 12.9 months, a confirmed ORR of 59%, and a 24‑month OS rate of 50.2%; PD‑L1–stratified analyses reported numerically higher responses and longer PFS in PD‑L1 ≥1% and PD‑L1 ≥5% subsets, with the PD‑L1 ≥5% subgroup not yet reaching median OS at cutoff (hypothesis‑generating). These subgroup patterns support prioritizing PD‑L1 and other biomarkers in subsequent randomized designs rather than concluding definitive predictive value now.

Safety was acceptable: immune‑mediated treatment‑emergent adverse events occurred in 22% of patients, infusion‑related reactions in 7%, and no unexpected safety signals were identified at data cutoff. In practice, monitor for immune AEs per established ICI algorithms and prepare steroid‑based management pathways and infusion‑reaction protocols when using this class of combinations.

Together, these results add to a growing field‑level focus on multi‑agent immunotherapy and biomarker‑guided strategies.