Arcus Biosciences Completes Patient Enrollment in Phase 3 Trial Evaluating a Domvanalimab-Containing Regimen in First-Line Metastatic Upper GI Cancers
Arcus Biosciences (NYSE:RCUS) has completed patient enrollment for its Phase 3 STAR-221 trial. This trial evaluates the combination of domvanalimab, an anti-TIGIT antibody, with zimberelimab and chemotherapy for treating advanced metastatic upper gastrointestinal (GI) adenocarcinomas. The significance of this trial lies in its potential to introduce the first anti-TIGIT antibody treatment to the market for this patient demographic. Earlier Phase 2 EDGE-Gastric study results showed promising efficacy, with a median progression-free survival (PFS) of 12.9 months and nearly 60% achieving PFS at 12 months without unexpected safety issues. The readout for the Phase 3 trial is anticipated soon.
- Completion of patient enrollment ahead of schedule for Phase 3 STAR-221 trial.
- Potential to introduce the first anti-TIGIT antibody for upper GI adenocarcinomas.
- Promising results from Phase 2 EDGE-Gastric study with a median PFS of 12.9 months.
- Nearly 60% of patients achieved PFS at 12 months in the Phase 2 trial.
- No unexpected safety signals observed up to data cutoff.
- Domvanalimab and zimberelimab regimen generally well tolerated.
- Domvanalimab and zimberelimab are still investigational and not approved by any regulatory authority.
- Safety and efficacy for the treatment of gastrointestinal cancers have not been established.
- Possible financial risks if the Phase 3 trial does not meet anticipated efficacy and safety benchmarks.
Insights
Completion of patient enrollment in a Phase 3 trial signals a critical milestone in clinical research. Specifically, this milestone is for evaluating a combination therapy involving domvanalimab, zimberelimab and chemotherapy for treating upper GI cancers. This combination aims to address a high unmet medical need in patients with advanced and metastatic stages of the disease.
Given that domvanalimab is the only anti-TIGIT antibody in Phase 3 for these cancers, it holds significant potential as a first-to-market therapy. Historically, first-to-market drugs often capture a substantial market share and establish essential groundwork for subsequent therapies. Importantly, the promising results from the Phase 2 EDGE-Gastric study—that showed a median progression-free survival (PFS) of 12.9 months—further bolster the potential efficacy of this regimen.
For retail investors, this development suggests that Arcus Biosciences is on a promising trajectory. However, it’s necessary to remain cautious as the investigational status means that the final approval depends on future regulatory reviews. The absence of unexpected safety signals so far is encouraging, but ongoing monitoring will be crucial. Understanding these dynamics will help investors make informed decisions about the company's future prospects.
The progress in the clinical trial pipeline could positively impact Arcus Biosciences’ stock. Historically, successful Phase 3 completions and promising preliminary results have been catalysts for stock price appreciation. The involvement of Gilead Sciences adds credibility and resources, which can accelerate development timelines and market access.
The positive data from the Phase 2 EDGE-Gastric study also adds a layer of confidence. Achieving a median PFS of 12.9 months compared to historical benchmarks sets an optimistic stage for potential FDA approval. If the Phase 3 results align with these findings, the probability of regulatory approval increases, potentially translating into a revenue stream for Arcus Biosciences.
Nonetheless, investors should remain vigilant about the risks. The investigational status of domvanalimab and zimberelimab implies uncertainties around final safety and efficacy results. Additionally, market competition and the readiness to scale production post-approval are factors to consider. These elements contribute to the long-term financial health and viability of Arcus Biosciences.
- Domvanalimab is the only anti-TIGIT antibody in Phase 3 for upper gastrointestinal (GI) adenocarcinomas with the potential to be first-to-market for this patient population
“STAR-221 completed enrollment well ahead of schedule, driven by significant interest from the global medical community in the potential for an anti-TIGIT-based regimen to address the high unmet need in this setting,” said Dimitry S.A. Nuyten, M.D., Ph.D., chief medical officer of Arcus Biosciences. “Domvanalimab is the first and only anti-TIGIT antibody to be studied in a Phase 3 trial in upper gastrointestinal adenocarcinoma. We are now preparing for the readout and look forward to the potential opportunity to make a meaningful difference for patients with this disease.”
Earlier this month at the American Society of Clinical Oncology (ASCO) Annual Meeting, Arcus and Gilead presented results from Arm A1 of the Phase 2 EDGE-Gastric study evaluating the same regimen in the same setting as the STAR-221 Phase 3 study. Data from this arm of EDGE-Gastric showed that patients treated with domvanalimab plus zimberelimab and chemotherapy had a median progression-free survival (PFS) of 12.9 months, which exceeds the historical benchmarks for anti-PD-1 plus chemotherapy alone. Notably, nearly
Domvanalimab and zimberelimab are investigational molecules. Neither Gilead nor Arcus has received approval from any regulatory authority for any use of these molecules, and their safety and efficacy for the treatment of gastrointestinal cancers have not been established.
About the STAR-221 Study
The ongoing, global STAR-221 trial (NCT05568095) enrolled approximately 1,050 participants with locally advanced unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. The primary endpoints of the study are overall survival in PD-L1-high tumors and in the intent-to-treat population (all PD-L1 levels); secondary endpoints include progression-free survival, objective response rate and duration of response. Participants were randomized 1:1 between two arms:
- 1600 mg of domvanalimab intravenously (IV) every four weeks plus 480 mg of zimberelimab IV every four weeks plus FOLFOX (oxaliplatin, leucovorin, fluorouracil) every two weeks or 1200 mg of domvanalimab plus 360 mg of zimberelimab every three weeks plus CAPOX (capecitabine and oxaliplatin) every three weeks
- 240 mg of nivolumab IV every two weeks plus FOLFOX every two weeks or 360 mg of nivolumab plus CAPOX every three weeks
About Domvanalimab
Domvanalimab is the first and most clinically advanced Fc-silent investigational monoclonal antibody that is specifically designed with Fc-silent properties to block and bind to the T-cell immunoreceptor with Ig and ITIM domains (TIGIT), a checkpoint receptor on immune cells that acts as a brake on the anticancer immune response. By binding to TIGIT with Fc-silent properties, domvanalimab is believed to work by freeing up immune-activating pathways and activate immune cells to attack and kill cancer cells without depleting the peripheral regulatory T cells important in avoiding immune-related toxicity.
Combined inhibition of both TIGIT and programmed cell death protein-1 (PD-1) is believed to significantly enhance immune cell activation, as these checkpoint receptors play distinct, complementary roles in anti-tumor activity. Domvanalimab is being evaluated in combination with anti-PD-1 monoclonal antibodies, including zimberelimab, as well as other investigational cancer immunotherapies and A2a/A2b adenosine receptor antagonist etrumadenant, in multiple ongoing and planned early and late-stage clinical studies in various tumor types.
About Zimberelimab
Zimberelimab is an anti-programmed cell death protein-1 (PD-1) monoclonal antibody that binds PD-1, with the goal of restoring the antitumor activity of T cells. Zimberelimab has demonstrated high affinity, selectivity and potency in various tumor types.
Zimberelimab is being evaluated in the
Guangzhou Gloria Biosciences Co. Ltd., which holds commercialization rights for zimberelimab in greater
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, the adenosine axis (CD73 and dual A2a/A2b receptor), HIF-2a, CD39 and AXL. For more information about Arcus Biosciences’ clinical and preclinical programs, please visit www.arcusbio.com.
Arcus 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. Nuyten’s quote and statements regarding the potential for domvanalimab to be first anti-TIGIT to market for upper GI cancers. 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; uncertainties in timelines associated with the conduct of clinical studies and with respect to the regulatory application process; Arcus’s dependence on the collaboration with Gilead for the successful development and commercialization of its optioned molecules; difficulties associated with the management of the collaboration activities with our strategic partners or expanded clinical programs; changes in the competitive landscape for Arcus’s programs; 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
The Arcus name and logo are trademarks of Arcus Biosciences, Inc. All other trademarks belong to their respective owners.
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Investor Inquiries:
Pia Eaves
VP of Investor Relations & Strategy
(617) 459-2006
peaves@arcusbio.com
Media Inquiries:
Holli Kolkey
VP of Corporate Communications
(650) 922-1269
hkolkey@arcusbio.com
Source: Arcus Biosciences
FAQ
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