Arcus and AstraZeneca Enter Collaboration for Clinical Trial in Renal Cell Carcinoma
The study will evaluate the safety and efficacy of a casdatifan plus volrustomig combination for the treatment of clear cell renal cell carcinoma.
Arcus Biosciences has announced a clinical trial collaboration agreement with AstraZeneca to evaluate casdatifan (AB521), Arcus’s investigational HIF-2a inhibitor, alongside volrustomig, AstraZeneca’s investigational PD-1/CTLA-4 bispecific antibody in patients with clear cell renal cell carcinoma (ccRCC). This marks the second time these organizations have collaborated, with the first being in 2020.1
As part of the agreement, AstraZeneca will sponsor and operationalize a trial to evaluate the safety and efficacy of the casdatifan-volrustomig combination.
“We believe casdatifan has best-in-class potential, based on the observed PK and PD profiles and the emerging clinical data from our ARC-20 study in patients with ccRCC,” said Terry Rosen, PhD, chief executive officer of Arcus in a press release. “This agreement will enable Arcus and AstraZeneca to collaborate and assess the potential for the novel combination of casdatifan with volrustomig to improve outcomes for patients with ccRCC.”
In the same press release, Cristian Massacesi, chief medical officer and oncology chief development officer, AstraZeneca added, “Renal cell carcinoma is a known CTLA-4-responsive tumor type, and our first-in-human study with volrustomig monotherapy demonstrated encouraging efficacy in first-line advanced ccRCC. “We are excited by the potential to build on this by combining HIF-2a inhibition with volrustomig to drive deeper and more durable responses for patients.”
In 2020, Arcus and AstraZeneca collaborated on PACIFIC-8, a registrational Phase III trial of domvanalimab, an Fc-silent anti-TIGIT antibody, added to standard-of-care durvalumab, an anti-PD-L1 antibody in patients with non-small cell lung cancer.
Alongside Gilead, Arcus is exploring domvanalimab as a first-line treatment for upper gastrointestinal (GI) cancers. Earlier in June, Arcus shared positive results from the Phase II EDGE-Gastric study which is evaluating the safety and efficacy of various combinations of domvanalimab plus the anti-PD-1 monoclonal antibody zimberelimab and chemotherapy.2
Efficacy and safety results from Arm A1 of the trial show consistent objective response rate and provide mature progression-free survival in patients with locally advanced unresectable or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma.
In a press release, Yelena Y. Janjigian, MD, chief, gastrointestinal oncology, Memorial Sloan Kettering Cancer Center, and a principal investigator for the EDGE-Gastric study said, “I am encouraged to see that patients treated with domvanalimab plus zimberelimab and chemotherapy had a median progression-free survival beyond one year, which exceeds the historical benchmarks for anti-PD-1 plus chemotherapy alone. Notably, nearly 60% of patients in the EDGE-Gastric study achieved progression-free survival at 12 months. These promising results reinforce our confidence in the ongoing Phase III STAR-221 study, which evaluates the same regimen in the same patient population and has the potential to address a high unmet need for people with these cancers.”
EDGE-Gastric (NCT05329766) is an ongoing, multi-arm, multi-cohort global Phase II study. Patients in Arm A1 with previously untreated forms of GI cancer received 1600 mg of domvanalimab intravenously every four weeks plus 480 mg of zimberelimab IV + FOLFOX (oxaliplatin 85 mg/m2 IV, leucovorin 400 mg/m2 IV, fluorouracil 400 mg/m2 IV bolus + 2400 mg/m2 continuous 46-48-hour IV infusion) every two weeks.
This new data from the EDGE-Gastric study supports the ongoing STAR-221 Phase III trial which was expected to complete enrollment by mid-year 2024.
References
1. Arcus Biosciences Announces Clinical Trial Collaboration Agreement to Evaluate Casdatifan in Combination with Volrustomig in Renal Cell Carcinoma. News release. Arcus. October 2, 2024. Accessed October 3, 2024. https://investors.arcusbio.com/investors-and-media/press-releases/press-release-details/2024/Arcus-Biosciences-Announces-Clinical-Trial-Collaboration-Agreement-to-Evaluate-Casdatifan-in-Combination-with-Volrustomig-in-Renal-Cell-Carcinoma/default.aspx
2. Gilead and Arcus Announce Anti-TIGIT Domvanalimab Plus Zimberelimab and Chemotherapy Exceeded One Year of Median Progression-Free Survival as a First-Line Treatment for Upper GI Cancers. News release. Arcus. June 1, 2024. Accessed October 3, 2024. https://investors.arcusbio.com/investors-and-media/press-releases/press-release-details/2024/Gilead-and-Arcus-Announce-Anti-TIGIT-Domvanalimab-Plus-Zimberelimab-and-Chemotherapy-Exceeded-One-Year-of-Median-Progression-Free-Survival-as-a-First-Line-Treatment-for-Upper-GI-Cancers/default.aspx
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