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Gilead, Arcus announce results from fourth interim analysis of ARC-7 study
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Gilead, Arcus announce results from fourth interim analysis of ARC-7 study

Gilead (GILD) and Arcus Biosciences (RCUS) announced results from the fourth interim analysis of the ARC-7 study in patients with first-line, metastatic non-small cell lung cancer, or NSCLC, with PD-L1 tumor proportion score, or TPS, greater than or equal to 50% without epidermal growth factor receptor or anaplastic lymphoma kinase, or EGFR/ALK, mutations. ARC-7 is a Phase 2, multicenter, three-arm, randomized, open-label study evaluating the combinations of Fc-silent anti-TIGIT monoclonal antibody domvanalimab plus anti-PD-1 monoclonal antibody zimberelimab and domvanalimab plus zimberelimab and etrumadenant, an A2a/b adenosine receptor antagonist (triplet), versus zimberelimab monotherapy. These results will be presented tomorrow during the American Society of Clinical Oncology, or ASCO, Monthly Plenary Series, a new, virtual forum for presentation and discussion of the latest cancer research. At the time of data cutoff, efficacy was evaluated in patients who had at least 13 weeks of follow-up and were therefore potentially eligible for at least two imaging scans, and safety was evaluated in all enrolled patients. With a median follow-up time for efficacy duration of approximately 12 months, both the doublet and triplet combinations demonstrated clinically meaningful improvements in median progression-free survival and six-month landmark PFS rates compared to zimberelimab monotherapy, with a 45% reduction in risk of disease progression or death for the doublet and 35% for the triplet. Each of the domvanalimab-containing study arms also demonstrated clinically meaningful improvements in objective response rate, or ORR, compared to zimberelimab monotherapy. Confirmed ORR was 27%, 41% and 40% for the zimberelimab monotherapy arm and the domvanalimab-doublet and -triplet arms, respectively. While the triplet arm did not show an improvement over the doublet arm, it reinforces the results observed in the doublet arm, and the study will continue to monitor PFS, as well as overall survival, for the triplet arm as these data mature. No unexpected safety signals were observed across the three study arms at the time of data cutoff. The domvanalimab-containing study arms appeared to be generally well tolerated and showed an overall safety profile consistent with the known safety profiles of each individual molecule to date. Grade =3 treatment-emergent adverse events occurred in 58% of participants in the zimberelimab monotherapy study arm, 47% of the doublet arm, and 52% of the triplet arm. Incidence of infusion-related reactions was low across all treatment arms: 4%, 4% and 10% for zimberelimab monotherapy and the domvanalimab-doublet and -triplet arms, respectively. Immune-related adverse events, including the incidences and grades of rash and pruritus, were generally low and manageable with topical corticosteroids.This interim analysis was conducted as of the clinical data cutoff date of August 31, 2022, with a total of 150 patients randomized across the three study arms. Patients in the study will continue to receive treatment per protocol, and an updated analysis including efficacy evaluation for all 150 patients is expected to be presented at the ASCO Annual Meeting in June 2023. The protocol-specified primary PFS analysis will be conducted later in 2023 once a specified number of events are achieved. Domvanalimab, zimberelimab and etrumadenant are investigational molecules. Neither Gilead nor Arcus has received approval from any regulatory authority for any use globally, and their safety and efficacy for the treatment of lung cancer have not been established.

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