Domvanalimab Shows Encouraging Phase II OS Data in Gastroesophageal Adenocarcinoma

Gilead and Arcus Biosciences reported promising results for their anti-TIGIT monoclonal antibody, domvanalimab, in a Phase II trial for gastroesophageal adenocarcinoma. The EDGE-Gastric study (NCT05329766) evaluated the Fc-silent TIGIT antibody in combination with PD-1 inhibitor zimberelimab and chemotherapy in the first-line setting.

In the A1 cohort, overall survival (OS) reached 26.7 months, with 50% of patients living beyond two years. Median progression-free survival (PFS) was 12.9 months, and the objective response rate (ORR) was 59%. The combination demonstrated a favorable safety profile, with immune-related treatment-emergent adverse events reported in 22% of patients.

These results revive interest in the anti-TIGIT class, which has faced multiple late-stage failures, including Roche’s tiragolumab and GSK/iTeos’ belrestotug.

Gilead and Arcus are advancing Phase III STAR-221 (NCT05568095), expected to complete primary endpoints by the end of 2026. Analysts at GlobalData forecast that, if approved, domvanalimab could approach $974 million in sales by 2032.

19-10-2025