Arcus Biosciences, Inc. provided updates on clinical programs and key milestones anticipated in 2022. Taiho Pharmaceutical Co. Ltd., exercised its option for domvanalimab and AB308 in Japan and certain other territories in Asia (excluding China).

In exchange for the exclusive license, Taiho will make an option exercise payment, as well as additional payments upon achievement of clinical, regulatory and commercialization milestones, and, if any products from the program are approved, will pay royalties on net sales of such products. Data from ARC-7, an ongoing randomized 150-patient three-arm study in first-line PD-L1=50% NSCLC, including progression-free survival data, are expected to be presented in 2H22. In addition to ARC-10, an ongoing registrational study in 1L PD-L1=50% NSCLC, and Gilead plan to initiate two new Phase 3 studies in lung and gastrointestinal (GI) cancers, as well as additional clinical studies of domvanalimab-based combinations, in 2022.

AstraZeneca and Arcus will initiate the PACIFIC-8 registrational Phase 3 study in January to evaluate domvanalimab plus durvalumab, an anti-PD-L1 antibody, in unresectable Stage 3 NSCLC with curative intent, where durvalumab is standard of care. Data from the Phase 1/1b ARC-12 study evaluating AB308, an Fc-enabled anti-TIGIT antibody, plus zimberelimab in advanced malignancies will inform future development plans. The randomized Phase 1/1b study ARC-4 did not show differentiated clinical activity for etrumadenant plus zimberelimab and pemetrexed/carboplatin compared to that of zimberelimab and pemetrexed/carboplatin in patients with metastatic, EGFRm+ NSCLC who progressed after one or more TKI therapies.

Arcus is conducting exploratory biomarker analyses to assess whether sub-populations of patients in the study derive benefit from etrumadenant-based treatment, such as those with PD-L1 high tumors. Final data from the study will be presented when available. All ongoing studies for etrumadenant will continue unchanged.

These studies are in settings where encouraging clinical activity has been observed, such as PD-L1=50% NSCLC (ARC-7), castrate-resistant prostate cancer (CRPC; ARC-6), and colorectal cancer (CRC; ARC-9). Patients whose tumors harbor EGFRm+ characteristics are excluded from the ARC-7 and ARC-10 studies. Data from the etrumadenant-containing arm of ARC-7 are anticipated to be presented in 2H22, as noted above.

Data from the randomized cohort of ARC-6 evaluating etrumadenant plus zimberelimab and docetaxel versus docetaxel in second-line (2L) metastatic CRPC are anticipated in 2H22. Additional clinical studies for etrumadenant-based combinations, including the “triplet” of etrumadenant plus domvanalimab and zimberelimab, are being planned for 2022.