• Data, including overall survival, from ARC-10, a randomized study evaluating domvanalimab plus zimberelimab in front-line, PD-L1-high, locally advanced or metastatic non-small cell lung cancer (NSCLC), will be presented in a late-breaking poster presentation
• An oral presentation will highlight data from an Investigator Sponsored Trial for domvanalimab and zimberelimab in anti-PD-1 refractory hepatocellular carcinoma, demonstrating further proof of concept for the Fc-silent anti-TIGIT antibody domvanalimab
• Arcus will discuss the ARC-10 results in more detail on its earnings call at 2:00 PM PT / 5:00 PM ET on Wednesday, November 6, 2024

Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with cancer, today announced four accepted abstracts at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, taking place in Houston, Texas, November 6 – 10, 2024.

A late-breaking poster presented by Melissa L. Johnson, M.D., director, lung cancer research, Sarah Cannon Research Institute, will highlight safety and efficacy data, including objective response rate, progression-free survival and overall survival from ARC-10. This study is a randomized, open-label, three-arm study evaluating domvanalimab, an Fc-silent anti-TIGIT monoclonal antibody, plus zimberelimab, an anti-PD-1 monoclonal antibody, versus zimberelimab or chemotherapy, in patients with front-line locally advanced or metastatic squamous or non-squamous NSCLC with a PD-L1 tumor proportion score of ≥50% without the presence of any tumor genomic aberration or driver mutation for which a targeted therapy is approved. ARC-10 was initially initiated and conducted as a randomized Phase 3 trial; the protocol was subsequently amended to evaluate domvanalimab plus zimberelimab versus pembrolizumab. The study was conducted in partnership with Gilead Sciences.

“The ARC-10 late-breaking poster will include the first overall survival results to be reported for the combination of domvanalimab and zimberelimab, and further build on the evidence that an Fc-silent anti-TIGIT antibody may provide differentiated efficacy and safety relative to the Fc-enabled anti-TIGIT antibodies,” said Terry Rosen, Ph.D., chief executive officer of Arcus.

Four Accepted Abstracts Will Be Presented

About Arcus Biosciences

Arcus Biosciences is a clinical-stage, global biopharmaceutical company developing differentiated molecules and combination medicines for people with cancer. In partnership with industry collaborators, patients and physicians around the world, Arcus is expediting the development of first- or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has expedited the development of multiple investigational medicines into clinical studies, including new combination approaches that target TIGIT, PD-1, HIF-2a, CD73, dual A2a/A2b receptor, CD39, and AXL. For more information about Arcus Biosciences’ clinical and preclinical programs, please visit www.arcusbio.com.

Domvanalimab, zimberelimab and etrumadenant are investigational molecules. Arcus and Gilead have not received approval from any regulatory authority for any commercial use globally, and their safety and efficacy have not been established.

Forward Looking Statements

This press release contains forward-looking statements. All statements regarding events or results to occur in the future contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the statements in Dr. Rosen’s quote and statements regarding: the mechanisms of action for any of our investigational products; and current or future combinations involving our investigational products, including the potential benefit or effect of any such combinations. All forward-looking statements involve known and unknown risks and uncertainties and other important factors that may cause Arcus’s actual results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, risks associated with: interim data not being replicated in future studies evaluating the same investigational molecules or regimen; the unexpected emergence of adverse events or other undesirable side effects in Arcus’s investigational products, including domvanalimab and zimberelimab; risks associated with the manufacturing or supplying product for such clinical trials; Arcus’s dependence on the collaboration with Gilead for the successful development and commercialization of its optioned molecules; and the inherent uncertainty associated with pharmaceutical product development and clinical trials. Risks and uncertainties facing Arcus are described more fully in the “Risk Factors” section of Arcus’s most recent periodic report filed with the U.S. Securities and Exchange Commission. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Arcus disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release except to the extent required by law.

The Arcus name and logo are trademarks of Arcus Biosciences, Inc. All other trademarks belong to their respective owners.

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