Innovent Biologics reports positive Phase 3 results for gastric cancer drug candidate

Innovent Biologics announced that its drug candidate arcotatug tavatecan, a CLDN18.2-targeted antibody-drug conjugate (ADC), reached its dual primary endpoints in the Phase 3 G-HOPE-001 clinical study. The trial assessed the drug in patients with previously treated, CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma.

The study data indicated statistically significant improvements in both progression-free survival (PFS) and overall survival (OS) compared to standard chemotherapy regimens. These results suggest a potential new treatment pathway for patients who have exhausted traditional lines of therapy for this aggressive form of cancer.

Arcotatug tavatecan utilizes a linker-payload technology designed to deliver cytotoxic agents directly to cells expressing the CLDN18.2 protein. The company plans to submit the clinical data to regulatory authorities for marketing authorization, marking a significant step in Innovent’s oncology pipeline expansion.