The prospective trial aims to assess the safety and early efficacy of the combination therapy in clear cell renal cell carcinoma patients. Credit: Kateryna Kon/Shutterstock.

Arcus Biosciences has announced a clinical trial partnership with AstraZeneca to assess the combination of casdatifan (AB521) and volrustomig in patients with clear cell renal cell carcinoma (ccRCC).

Casdatifan is an investigational HIF-2a inhibitor of Arcus while volrustomig is AstraZeneca’s investigational PD-1/CTLA-4 bispecific antibody.

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AstraZeneca will sponsor and operationalise the trial as per the agreed deal.

This study aims to assess the safety and early efficacy of the combination therapy in patients with advanced ccRCC.

Arcus CEO Terry Rosen said: “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.

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“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.”

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This new development is said to be the second clinical collaboration between the two companies, following their 2020 announcement of a partnership for a registrational Phase III PACIFIC-8 study.

PACIFIC-8 assessed domvanalimab plus standard-of-care durvalumab in patients with unresectable Stage III non-small cell lung cancer.

Under the terms of a separate collaboration agreement between Gilead and Arcus, the former holds the option to opt into developing and commercialising casdatifan following Arcus’ delivery of a qualifying data package.

Currently, casdatifan is being assessed in the Phase I/Ib ARC-20 study in cancer patients and the Phase Ib/II STELLAR-009 study in combination with zanzalintinib to treat patients with advanced solid tumours, including ccRCC.

In June, Arcus concluded the subject enrolment in the Phase III STAR-221 trial of domvanalimab and zimberelimab plus chemotherapy in patients with locally advanced unresectable or metastatic gastric, gastroesophageal junction or oesophageal adenocarcinoma (upper GI cancers).