AstraZeneca Launches Global Phase III Trial of Rilvegostomig, the World’s First TIGIT/PD-1 Bispecific Antibody, as Adjuvant Therapy in Biliary Tract Cancer

On October 31, AstraZeneca registered a Phase III clinical study, ARTEMIDE-Bil01 (NCT06109779), on the ClinicalTrials.gov website. The study investigates Rilvegostomig in combination with chemotherapy for adjuvant treatment of biliary tract cancer post-surgery. Rilvegostomig is the world’s first TIGIT/PD1 bispecific antibody to enter Phase III clinical trials.

ARTEMIDE-Bil01 is a randomized, double-blind, placebo-controlled global multicenter Phase III clinical trial designed to evaluate the efficacy and safety of Rilvegostomig in combination with chemotherapy as adjuvant treatment for biliary tract cancer after surgery. The study plans to enroll 750 participants, randomly assigned to receive either Rilvegostomig or placebo.

The primary endpoint of the study is recurrence-free survival (RFS), and secondary endpoints include overall survival (OS), patient tolerance, and progression-free survival (PFS) after recurrence. The trial start date is December 8, 2023, and the end date is September 30, 2030.

Rilvegostomig is a TIGIT/PD1 bispecific antibody based on Compugen's TIGIT monoclonal antibody COM902. In April 2018, Compugen reached an agreement with AstraZeneca, allowing the latter to use its TIGIT-binding monoclonal antibodies (including COM902) to develop bispecific or multispecific antibodies.

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