Arcus Biosciences discontinues Star-121 study with Gilead due to futility

In a regulatory filing, Arcus Biosciences (RCUS) announced the discontinuation of the Phase 3 STAR-121 study, which is being conducted in collaboration with Gilead Sciences (GILD), due to futility. STAR-121 evaluated the anti-TIGIT antibody domvanalimab plus anti-PD-1 antibody zimberelimab and chemotherapy versus pembrolizumab plus chemotherapy as a first-line treatment for metastatic non-small cell lung cancer. The decision is based on the recommendation from the Independent Data Monitoring Committee, following its review of data from a pre-planned futility analysis. Safety was not assessed at this futility analysis; however, no new safety issues have been identified during regular reviews by the IDMC, Arcus added. STAR-121, along with the Phase 2 EDGE-Lung study, will be discontinued. Arcus also announced that the period for Gilead’s option rights under the Option, License and Collaboration Agreement entered into between the company and Gilead in 2020, as amended, will end on July 14, 2026, following Gilead’s decision to not make the option continuation payment to the company. Accordingly, Gilead will not have option rights to additional programs in its early-stage pipeline, including the CCR6, CD89 and CD40L programs, but will maintain its existing time-limited options to programs including AB801, AB598, AB102, and an investigational TNF small molecule inhibitor. The company has full rights to casdatifan and the casdatifan development program, other than those rights licensed to Taiho in Japan and certain other Asian territories, not including China. Shares of Arcus have dropped over 5% to $23.02 in afternoon trading.