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Arcus, Bristol Myers Team Up to Advance Kidney Cancer Study
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Key Takeaways
RCUS will supply casdatifan for new treatment arms in BMY's phase I/II ROSETTA RCC-208 study.
RCUS sees HIF-2 alpha inhibition with PD-L1 and VEGF-A blockade as a TKI-free kidney cancer option.
RCUS expects PEAK-1 enrollment completion and a first-line metastatic ccRCC phase III launch by 2026.
Arcus Biosciences (RCUS - Free Report) announced a clinical trial collaboration and supply agreement with Bristol Myers Squibb (BMY - Free Report) to evaluate casdatifan in combination with PD L1/VEGF A bispecific immunomodulator.
This collaboration is aimed at developing a novel treatment regimen that delivers more sustained tumor control in kidney cancer, a cancer of high unmet medical need.
Casdatifan is an oral, once-daily small-molecule HIF-2α inhibitor designed to provide deep and durable pathway suppression.
More on RCUS-BMY Collaboration
Per the terms of the agreement, clinical-stage, global biopharmaceutical company Arcus will provide casdatifan for evaluationin BMY’s phase I/II ROSETTA RCC-208 study.
This study evaluates pumitamig (BNT327/BMS986545), an investigational PD-L1/VEGF-A bispecific antibody, being jointly developed by BMY and partner BioNTech (BNTX - Free Report) , alone or in combination with other potential treatment options in advanced renal cell carcinoma (RCC).
Under the collaboration, two new treatment arms evaluating casdatifan-based combinations will be incorporated into the ROSETTA RCC-208 study. The agreement is non-exclusive, with both companies retaining full development and commercialization rights to their respective programs.
Arcus believes the combination of HIF-2α inhibition with PD-L1 and VEGF-A blockade could provide a promising tyrosine kinase inhibitor (TKI)-free treatment option for kidney cancer patients. The partnership supports the company’s broader strategy of establishing casdatifan as a foundational therapy across multiple lines of treatment for clear cell renal cell carcinoma (ccRCC).
Early clinical studies have demonstrated encouraging antitumor activity and a favorable safety profile, supporting casdatifan’s evaluation in combination regimens.
Arcus is currently studying the drug across first-line, second-line, and late-line treatment settings through its ARC-20 platform study. It is also enrolling patients in the phase III PEAK-1 study, which compares casdatifan plus cabozantinib against cabozantinib alone in immunotherapy-experienced metastatic ccRCC.
Arcus expects to complete patient enrollment in the PEAK-1 study and initiate a phase III study in first-line metastatic ccRCC by the end of 2026.
Taiho holds development and commercialization rights for casdatifan in Japan and select Asian markets outside China, while Arcus Biosciences retains exclusive rights to the therapy in all other global territories.
In 2025, BMY collaborated with BioNTech for the global co-development and co-commercialization of pumitamig across numerous solid tumor types.
BNTX and BMY are advancing pumitamig through an extensive clinical development program that includes more than 20 ongoing or planned studies evaluating the therapy as both a standalone treatment and in combination with other anticancer approaches across more than 10 solid tumor types.
Arcus Biosciences’ Pipeline Programs
RCUS has advanced several investigational therapies into registrational-stage clinical trials, including casdatifan, a HIF-2α inhibitor for clear cell renal cell carcinoma, and quemliclustat, a small-molecule CD73 inhibitor for pancreatic cancer.
Shares of the company have gained 7.5% year to date against the industry's decline of 8.2%.
Image Source: Zacks Investment Research
RCUS had earlier collaborated with Gilead Sciences, Inc. (GILD - Free Report) to advance its pipeline.
However, in April 2026, Arcus announced that Gilead’s option rights under the companies’ 2020 collaboration agreement, as amended, will expire on July 14, 2026, after Gilead elected not to make the option continuation payment.
As a result, Gilead will no longer hold option rights to additional early-stage pipeline programs, including CCR6, CD89, and CD40L. However, the company will retain its existing time-limited options for several programs, including AB801, an investigational AXL inhibitor; AB598, an investigational anti-CD39 monoclonal antibody; AB102, an investigational MRGPRX2 antagonist; and an investigational TNF small-molecule inhibitor.
In March 2026, Arcus and AstraZeneca decided not to resume patient enrollment in eVOLVE-RCC02. This is a phase Ib/III study sponsored and managed by AstraZeneca that is evaluating casdatifan in combination with volrustomig, AstraZeneca’s investigational anti-PD-1/CTLA-4 bispecific antibody, for the treatment of first-line advanced or metastatic ccRCC.
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Image: Bigstock
Arcus, Bristol Myers Team Up to Advance Kidney Cancer Study
Key Takeaways
Arcus Biosciences (RCUS - Free Report) announced a clinical trial collaboration and supply agreement with Bristol Myers Squibb (BMY - Free Report) to evaluate casdatifan in combination with PD L1/VEGF A bispecific immunomodulator.
This collaboration is aimed at developing a novel treatment regimen that delivers more sustained tumor control in kidney cancer, a cancer of high unmet medical need.
Casdatifan is an oral, once-daily small-molecule HIF-2α inhibitor designed to provide deep and durable pathway suppression.
More on RCUS-BMY Collaboration
Per the terms of the agreement, clinical-stage, global biopharmaceutical company Arcus will provide casdatifan for evaluationin BMY’s phase I/II ROSETTA RCC-208 study.
This study evaluates pumitamig (BNT327/BMS986545), an investigational PD-L1/VEGF-A bispecific antibody, being jointly developed by BMY and partner BioNTech (BNTX - Free Report) , alone or in combination with other potential treatment options in advanced renal cell carcinoma (RCC).
Under the collaboration, two new treatment arms evaluating casdatifan-based combinations will be incorporated into the ROSETTA RCC-208 study. The agreement is non-exclusive, with both companies retaining full development and commercialization rights to their respective programs.
Arcus believes the combination of HIF-2α inhibition with PD-L1 and VEGF-A blockade could provide a promising tyrosine kinase inhibitor (TKI)-free treatment option for kidney cancer patients. The partnership supports the company’s broader strategy of establishing casdatifan as a foundational therapy across multiple lines of treatment for clear cell renal cell carcinoma (ccRCC).
Early clinical studies have demonstrated encouraging antitumor activity and a favorable safety profile, supporting casdatifan’s evaluation in combination regimens.
Arcus is currently studying the drug across first-line, second-line, and late-line treatment settings through its ARC-20 platform study. It is also enrolling patients in the phase III PEAK-1 study, which compares casdatifan plus cabozantinib against cabozantinib alone in immunotherapy-experienced metastatic ccRCC.
Arcus expects to complete patient enrollment in the PEAK-1 study and initiate a phase III study in first-line metastatic ccRCC by the end of 2026.
Taiho holds development and commercialization rights for casdatifan in Japan and select Asian markets outside China, while Arcus Biosciences retains exclusive rights to the therapy in all other global territories.
In 2025, BMY collaborated with BioNTech for the global co-development and co-commercialization of pumitamig across numerous solid tumor types.
BNTX and BMY are advancing pumitamig through an extensive clinical development program that includes more than 20 ongoing or planned studies evaluating the therapy as both a standalone treatment and in combination with other anticancer approaches across more than 10 solid tumor types.
Arcus Biosciences’ Pipeline Programs
RCUS has advanced several investigational therapies into registrational-stage clinical trials, including casdatifan, a HIF-2α inhibitor for clear cell renal cell carcinoma, and quemliclustat, a small-molecule CD73 inhibitor for pancreatic cancer.
Shares of the company have gained 7.5% year to date against the industry's decline of 8.2%.
Image Source: Zacks Investment Research
RCUS had earlier collaborated with Gilead Sciences, Inc. (GILD - Free Report) to advance its pipeline.
However, in April 2026, Arcus announced that Gilead’s option rights under the companies’ 2020 collaboration agreement, as amended, will expire on July 14, 2026, after Gilead elected not to make the option continuation payment.
As a result, Gilead will no longer hold option rights to additional early-stage pipeline programs, including CCR6, CD89, and CD40L. However, the company will retain its existing time-limited options for several programs, including AB801, an investigational AXL inhibitor; AB598, an investigational anti-CD39 monoclonal antibody; AB102, an investigational MRGPRX2 antagonist; and an investigational TNF small-molecule inhibitor.
In March 2026, Arcus and AstraZeneca decided not to resume patient enrollment in eVOLVE-RCC02. This is a phase Ib/III study sponsored and managed by AstraZeneca that is evaluating casdatifan in combination with volrustomig, AstraZeneca’s investigational anti-PD-1/CTLA-4 bispecific antibody, for the treatment of first-line advanced or metastatic ccRCC.
RCUS Zacks Rank
RCUS currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.