Astra extends its big pivotal TIGIT plan

Despite the numerous setbacks that TIGIT-targeting assets have faced in the past few years, AstraZeneca is continuing to bet on rilvegostomig. According to a new listing on clinicaltrials.gov, the company is preparing to launch another phase 3 study. Artemide-Biliary-02, to start in December, will evaluate the anti-TIGIT x PD-1 bispecific antibody plus chemo versus the current standard of care, Imfinzi plus chemo, in first-line biliary tract cancer. Interestingly, while the trial does not restrict enrolment to PD-(L)1-positive patients, the primary endpoint, overall survival, will be assessed only in that subgroup, with overall survival in the intent-to-treat population serving as a secondary endpoint. This will mark rilvegostomig’s eleventh phase 3 trial, with the programme set to enrol more than 9,000 patients, almost double the roughly 5,000 patients Roche treated before discontinuing its TIGIT monoclonal antibody, tiragolumab. This is an ambitious effort for a target that has yet to deliver convincing pivotal data. Still, AstraZeneca believes that its Fc-silent approach could offer a meaningful advantage. Arcus, the other contender still standing, is pursuing the same Fc-silent approach with the Gilead-partnered domvanalimab. However, its programme is more limited with only three phase 3 trials under way.

Rilvegostomig phase 3 trials

Source: OncologyPipeline.