Gilead Sciences and Arcus Biosciences discontinued the phase 3 STAR-221 study testing domvanalimab (anti-TIGIT) with zimberelimab and chemotherapy in untreated metastatic NSCLC after interim analysis showed futility.1
Arcus revealed the termination in an April 20 SEC filing; a related phase 2 NSCLC study was also canceled.1
Gilead surrendered options to license Arcus' early-stage programs (CCR6, CD89, CD40L) but retained options for clinical-stage AB801 (AXL inhibitor), AB102 (anti-CD39), and two preclinical assets.1
Domvanalimab failures follow prior setbacks, including head-to-head loss to Opdivo in gastric/esophageal cancers; Arcus is refocusing on casdatifan (HIF-2a inhibitor) and inflammation/immunology programs.12
TIGIT class faces multiple high-profile failures from Roche, GSK, Merck, adding to domvanalimab's discontinuation.24
Sources:
1. https://www.fiercebiotech.com/biotech/gilead-loosens-ties-arcus-after-tigit-dream-finally-ends-phase-3-failure
2. https://www.biospace.com/drug-development/au-revoir-tigit-gilead-arcus-cut-gastro-cancer-drug-after-late-stage-failure
4. https://www.biopharmadive.com/news/arcus-gilead-domvanalimab-trial-terminate/807761/