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 11th 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 anti-TIGIT MAb tiragolumab. This is an ambitious effort for a target that has yet to deliver convincing pivotal data. Still, AstraZeneca believes that its Fc-reduced approach could offer a meaningful advantage. Arcus, the other contender still standing, is pursuing a similar, 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.