Arcus Biosciences (NYSE:RCUS) outlined plans to expand development of its casdatifan cancer program across multiple lines of clear cell renal cell carcinoma, or ccRCC, while reporting second-quarter financial results and updates on its pancreatic cancer and immunology pipelines.
Chief Executive Officer Terry Rosen said casdatifan, an investigational HIF-2 alpha inhibitor, remains the company’s top priority. Arcus is pursuing combinations designed to position the drug as a treatment option in first-line, second-line and later-line ccRCC.
Casdatifan Development Plans
Arcus’ first registrational casdatifan study, the Phase III PEAK-1 trial, is evaluating casdatifan plus cabozantinib against cabozantinib in patients with previously treated ccRCC. Rosen said enrollment remains on track to finish by the end of 2026.
Chief Medical Officer Richard Markus said Arcus expects to disclose more mature objective response rate and progression-free survival data from approximately 45 second-line patients receiving casdatifan plus cabozantinib, with at least 18 months of follow-up. The company may also have an early look at overall survival, he said.
In the first-line setting, Arcus plans to initiate PEAK-20, a registrational Phase III trial of casdatifan combined with ipilimumab and nivolumab, by the end of 2026. Rosen said the company has discussed the study with the FDA.
ARC-20 also includes a cohort evaluating casdatifan with zimberelimab, Arcus’ anti-PD-1 antibody. Markus said enrollment in that cohort was completed early this year and that the company previously reported a 7% primary-progression rate, representing two of 30 patients. Arcus expects to report objective response rate data, waterfall plots and spider plots with approximately 11 months of follow-up.
Another ARC-20 cohort is evaluating casdatifan, zimberelimab and ipilimumab. Arcus expects enrollment to complete soon and plans to share initial safety data and preliminary primary-progression data later this year.
The company also plans a first-line cohort evaluating casdatifan plus axitinib, with initiation expected in the fourth quarter. In addition, Arcus has established collaborations with Bristol Myers Squibb and Summit Therapeutics to study casdatifan with anti-PD-1/VEGF bispecific antibodies in first-line ccRCC. BMS will study casdatifan-containing regimens in its ROSETTA RCC-208 platform trial, while Arcus plans to add a casdatifan-plus-ivo cohort to ARC-20 through its Summit collaboration.
For later-line disease, Arcus is working with AVEO Oncology on casdatifan plus tivozanib. A randomized ARC-20 cohort will compare the combination with tivozanib alone in patients previously treated with belzutifan. Enrollment is expected to begin later this year and is intended to support a planned registrational strategy in HIF-2 inhibitor-experienced and HIF-2 inhibitor-naive patients.
Scientific and Commercial Outlook
Rosen pointed to recently published research in Nature examining casdatifan’s effects on erythropoietin, or EPO, and HIF-2 alpha biology. According to Rosen, the research found that deeper and sustained EPO suppression in clear cell RCC patients receiving casdatifan monotherapy correlated with higher response rates and longer progression-free survival.
Management also discussed the potential effect of previous tyrosine kinase inhibitor, or TKI, treatment. Rosen said Arcus’ analysis of approximately 120 patients in its late-line casdatifan monotherapy cohort did not show the inverse relationship between prior TKI exposure and efficacy that had been reported in certain belzutifan analyses.
Chief Financial Officer Bob Goeltz said sales of renal cell carcinoma drugs in major markets are projected to reach roughly $13 billion by 2030. Arcus estimates the second-line opportunity addressed by PEAK-1 represents more than $2 billion, while the first-line opportunity exceeds $4 billion. The company estimates total peak sales potential for casdatifan at $5 billion to $10 billion.
Arcus retains commercial rights to casdatifan outside Japan and certain other Asian territories, where Taiho holds rights.
Additional Pipeline Programs
Beyond casdatifan, Arcus said its Phase III PRISM-1 study of quemliclustat plus chemotherapy in first-line pancreatic cancer remains on track for an initial readout in the first half of 2027.
The company is also advancing an immunology portfolio. President Juan Jaen said Arcus expects to begin human dosing this month for AB102, an oral MRGPRX2 antagonist being developed for chronic spontaneous urticaria and atopic dermatitis. Pharmacokinetic data from the first healthy-volunteer cohorts are expected in the fourth quarter, followed by a planned proof-of-concept study in chronic spontaneous urticaria in mid-2027.
Arcus expects its oral, selective TNF receptor 1 inhibitor to enter the clinic in early 2027. Additional programs targeting CCR6, STAT6, CD89 and CD40 ligand are positioned to deliver IND-ready candidates through the end of 2027, according to management.
Second-Quarter Financial Results
- Cash and investments totaled $775 million as of June 30, down from $876 million at the end of the first quarter.
- GAAP revenue was $41 million in the second quarter, primarily driven by collaboration agreements.
- Arcus expects full-year 2026 GAAP revenue of $65 million to $75 million.
- Research and development expense was $113 million, net of reimbursements, while general and administrative expense was $24 million.
- Non-cash stock-based compensation totaled $15 million.
Goeltz said Arcus expects to end 2026 with approximately $600 million in cash and investments, providing runway into at least the second half of 2028. The company expects research and development spending to decline meaningfully in 2026 and 2027 compared with 2025, reflecting the wind-down of domvanalimab Phase III trials, lower quemliclustat spending and broader expense management.
By 2027, Arcus expects more than 80% of its portfolio spending to be directed toward casdatifan development.
About Arcus Biosciences (NYSE:RCUS)
Arcus Biosciences is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel cancer immunotherapies. The company’s research platform centers on modulating tumor microenvironments and immune checkpoints through both small-molecule and antibody-based candidates. Arcus aims to enhance antitumor immune responses by targeting pathways such as the adenosine axis and inhibitory receptors on immune cells.
The company’s lead clinical programs include etrumadenant, an orally administered A2A adenosine receptor antagonist being evaluated in combination with anti-PD-1 therapy, and domvanalimab, an anti-TIGIT monoclonal antibody.
