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Gilead and Arcus Biosciences Announce Positive Update on Joint TIGIT Program From Interim Analysis of ARC-7 Study in Non-Small Cell Lung Cancer

Tuesday, November 29, 2022

Gilead Sciences, Inc., and Arcus Biosciences announced a positive update from the fourth interim analysis of the randomized, open-label Phase 2 ARC-7 study in patients with first-line metastatic non-small cell lung cancer (NSCLC) with PD-L1 tumor proportion score (TPS) ≥50% without epidermal growth factor receptor or anaplastic lymphoma kinase (EGFR/ALK) mutations. ARC-7 is evaluating the combinations of anti-TIGIT antibody domvanalimab plus anti-PD-1 antibody zimberelimab (doublet), and domvanalimab plus zimberelimab and etrumadenant, an A2a/b adenosine receptor antagonist (triplet), versus zimberelimab alone, and represents the first randomized Phase 2 study of an Fc-silent anti-TIGIT/anti-PD-1 combination. The protocol-specified fourth interim analysis was conducted when the trial reached full enrollment, with a clinical data cutoff date of August 31, 2022. A total of 150 patients have been randomized across the three study arms.

For the current interim analysis, efficacy was evaluated in study patients who had at least 13 weeks of potential follow-up and were eligible for at least two imaging scans (n=133). Both domvanalimab combinations continued to show clinically meaningful differentiation compared to zimberelimab monotherapy across multiple efficacy measures, including objective response rates (ORR), progression-free survival (PFS) and six-month landmark PFS.

“The efficacy measures observed, including PFS, reinforce confidence in the TIGIT pathway. The interim results show that combining two checkpoint inhibitors – an anti-TIGIT and an anti-PD-1 – delivered added benefit beyond anti-PD-1 monotherapy in this setting,” said Melissa L. Johnson, M.D., Director Lung Cancer Research, Sarah Cannon Research Institute at Tennessee Oncology, and Lead Investigator for the ARC-7 study. “These data are important for the lung cancer research field, and I look forward to presenting the dataset at the upcoming virtual ASCO Monthly Plenary on December 20th.”

At time of data cutoff, no unexpected safety signals were observed across the three study arms. Both domvanalimab-containing arms were generally well tolerated and showed an overall safety profile consistent with the known safety profiles for each individual molecule to date.

“We are thrilled that Dr. Melissa Johnson will present the full results for the current interim analysis of ARC-7, including ORR, PFS and disease control rate, in the coming weeks, given the importance of these data for the immuno-oncology field,” said Dimitry S.A. Nuyten, M.D., Ph.D., Chief Medical Officer of Arcus Biosciences. “The consistency of the efficacy and safety data from both of the domvanalimab-containing arms observed at this interim analysis support our continued strong conviction in the domvanalimab program.”

“These results strengthen our belief in the potential of domvanalimab and the promise of our anti-TIGIT approach to meaningfully impact the outlook for people with metastatic lung cancer,” said Bill Grossman, M.D., Ph.D., Senior Vice President, Therapeutic Area Head, Gilead Oncology. “We will continue to accelerate our TIGIT development program with Arcus, with four ongoing registrational studies in NSCLC and upper GI malignancies.”

Detailed results from this fourth interim analysis and an exploratory analysis on 12 patients who crossed over from zimberelimab monotherapy arm to triplet therapy will be presented on December 20, 2022, at the Monthly Plenary Series, a new virtual forum for presentation and discussion of the latest cancer research. According to ASCO, live presentations are accessible to virtual attendees and available on-demand, and abstract presentations are accompanied by a discussant presentation and followed by a live Q&A session. Abstracts accepted for the Monthly Plenary Session are also placed at the ASCO Annual Meeting in June 2023. During the ASCO Annual Meeting, additional results from further analysis of the ARC-7 dataset will be presented.

Domvanalimab, zimberelimab and etrumadenant are investigational molecules and neither Arcus or Gilead have received approval from any regulatory authority for any use globally, including for the treatment of lung cancer. Their efficacy and safety for the treatment of lung cancer have not been established.

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