Arcus Biosciences, Inc. Announces Anti-TIGIT Domvanalimab-Based Combinations Clinical Activity in People with Metastatic, PDL1-High Non-Small Cell Lung Cancer at First Interim Analysis of Arcus Biosciences’ Randomized Phase 2 ARC-7 Study
June 23, 2021 at 04:10 pm
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Arcus Biosciences, Inc. announced that, at the first interim analysis of the three-arm randomized Phase 2 ARC-7 study, both arms with domvanalimab-based combinations showed encouraging clinical activity (measured by overall response rate; ORR) when given as an initial treatment (first-line) to people with metastatic, PD-L1=50% non-small cell lung cancer (NSCLC). The zimberelimab monotherapy arm showed activity similar to that of marketed anti-PD-1 antibodies studied by other companies in this setting. At the time of data cut off, no unexpected safety signals were observed; and the current safety profile for each arm of the study appears to be consistent with known immune checkpoint inhibitors in this setting. All three arms of the ARC-7 trial, and the ongoing ARC-10 Phase 3 registrational study, will continue to enroll as planned; and ARC-7 data will be submitted later this year for presentation at a medical conference. About ARC-7 and the domvanalimab Development Program: ARC-7 is an open-label randomized Phase II study evaluating the safety and efficacy of domvanalimab plus zimberelimab (anti-PD1 antibody) vs. zimberelimab alone vs. domvanalimab plus zimberelimab and etrumadenant (dual adenosine A2a/A2b receptor antagonist) in 150 people as a first-line treatment for PD-L1 = 50% and EGFR/ALK wild-type, metastatic NSCLC. Participants are being randomized 1:1:1 across three study arms and treated until disease progression or loss of clinical benefit. Co-primary endpoints are objective response rate (ORR) and progression-free survival (PFS). Secondary endpoints include safety, duration of response and disease control rates. In this first interim analysis, data were not mature, and PFS was not assessed. In addition to ARC-7, domvanalimab is currently being evaluated in ARC-10, an ongoing registrational Phase 3 study evaluating domvanalimab plus zimberelimab vs. zimberelimab alone vs. chemotherapy in first-line locally advanced or metastatic, PD-L1>50% NSCLC. Based on the ARC-7 data, additional Phase 3 studies are planned for domvanalimab-based combination across various cancer types. About domvanalimab and Arcus’ anti-TIGIT program: Domvanalimab, Arcus’ most advanced anti-TIGIT candidate, is an Fc-silent investigational monoclonal antibody that binds to TIGIT, a protein receptor on immune cells that acts as a brake on the immune response. Cancer cells can exploit TIGIT to avoid detection by the immune system. Domvanalimab binds to TIGIT to free up immune activating pathways and activate immune cells to attack and kill cancer cells. Arcus is developing a second anti-TIGIT candidate, AB308, an Fc-enabled investigational monoclonal antibody in clinical development, with a potential focus on hematological malignancies. AB308 is currently in Phase I studies for advanced malignancies.
Arcus Biosciences, Inc. is a clinical-stage biopharmaceutical company developing differentiated molecules and combination therapies for people with cancer. The Company involves in a portfolio of investigational products, which are in clinical development with its advanced molecule, an anti-TIGIT antibody targeting lung and gastrointestinal cancers. The Company has approximately seven clinical programs that are focused on targets, including TIGIT, PD-1, adenosine A2a and A2b receptors, CD73, CD39, HIF-2a, and AXL. The Company is engaged in co-developing four investigational products, including zimberelimab (Arcuss anti-PD-1 molecule), domvanalimab (Arcuss anti-TIGIT antibody), etrumadenant (Arcuss adenosine receptor antagonist) and quemliclustat (Arcuss CD73 inhibitor). It is engaged in pursuing a Phase II and Phase III development program for domvanalimab in combination with its anti-PD-1 antibody, zimberelimab, in multiple settings, including lung and gastrointestinal cancer.
Arcus Biosciences, Inc. Announces Anti-TIGIT Domvanalimab-Based Combinations Clinical Activity in People with Metastatic, PDL1-High Non-Small Cell Lung Cancer at First Interim Analysis of Arcus Biosciences’ Randomized Phase 2 ARC-7 Study