Arcus Biosciences Advances Promising Kidney Cancer Drug Casdatifan After Gilead Opts Out

Gilead Sciences' option to license casdatifan, Arcus Biosciences' experimental kidney cancer drug, has expired46.

Arcus presented new Phase 1/1b data for casdatifan at the ASCO Genitourinary Cancers Symposium, showing improvements in progression rates, overall response rate (ORR), and progression-free survival (PFS) in ccRCC patients62.

The company announced a $150 million common stock offering to fund further development of casdatifan, including the upcoming Phase 3 PEAK-1 study46.

Casdatifan demonstrated a general overall response rate of 34% and a confirmed ORR of 25% in heavily pretreated ccRCC patients2.

Arcus estimates a $5 billion market opportunity for casdatifan in the treatment of clear cell renal cell carcinoma67.

The company plans to initiate the Phase 3 PEAK-1 trial in Q2 2025 and has a clinical collaboration with AstraZeneca to evaluate casdatifan in combination therapy7.

Arcus believes casdatifan has the potential to be the best-in-class HIF-2a inhibitor in what they describe as a "two-horse race" in this drug category6.

The retention of casdatifan rights represents a significant strategic shift for Arcus, providing the company with future optionality in the oncology space6.

Sources:

2. https://www.fiercebiotech.com/biotech/arcus-new-hif-2a-data-kidney-cancer-hint-potential-edge-over-mercks-welireg-analysts-say

4. https://www.investing.com/news/company-news/arcus-biosciences-advances-cancer-drug-casdatifan-post-gilead-deal-expiry-93CH-3873954

6. https://investors.arcusbio.com/investors-and-media/press-releases/press-release-details/2025/Arcus-Biosciences-Retains-Rights-to-Casdatifan-a-Potential-Best-in-Class-HIF-2a-Inhibitor-and-Announces-Pricing-of-150-Million-Common-Stock-Offering/default.aspx

7. https://www.stocktitan.net/news/RCUS/arcus-biosciences-retains-rights-to-casdatifan-a-potential-best-in-xf79ly6upoh6.html