Ph 3 STAR-121 study of domvanalimab, zimberelimab and chemo vs pembrolizumab + chemo in 1L NSCLC to be discontinued
On April 20, 2026, Arcus Biosciences, Inc. (the “Company”) announced the discontinuation of the Phase 3 STAR-121 study, which is being conducted in collaboration with Gilead Sciences, Inc. (“Gilead”), 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 (“IDMC”), 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. The STAR-121 study also evaluated zimberelimab and chemotherapy as an exploratory endpoint. Zimberelimab plus chemotherapy performed consistently with respect to overall survival as compared to pembrolizumab plus chemotherapy. STAR-121, along with the Phase 2 EDGE-Lung study, will be discontinued. Gilead is communicating with investigators to determine appropriate next steps for patients in these studies.
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