Company: RCUS
Filing Date: 2025-06-02
Form Type: 8-K
Source: 0001724521-25-000066
Chunk: 1

Company: Arcus Biosciences, Inc.
Filing Date: 2025-06-02
Form: 8-K
Item: Item 8.01
Chunk 1
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Item 8.01 Other Events.

The presentation included updated data from the interim analysis of the Company’s Phase 1/1b study clinical trial ARC-20. The data was from the study's cohort that is evaluating once-daily 100mg of casdatifan plus 60mg of cabozantinib in patients with clear cell renal cell carcinoma who had progressed on prior immunotherapy. The efficacy evaluable population included 24 patients who received any study treatment and reached a minimum of 12 weeks follow-up or discontinued due to progression or adverse event and the safety evaluable population included 42 patients who received any amount of study drug and had at least one month of safety follow-up at the data cutoff date. Specifically, the Company disclosed the following information from the interim analysis, which had a data cutoff date of March 14, 2025 (the "DCO"):

  Efficacy Evaluable                                 Casdatifan 100mg QD + Cabozantinib 60mg QD (n=24)  
  Median Follow-Up                                   5.3 months                                         
  Confirmed ORR (cORR) per RECIST v1.1 [95% CI]      46% (11)*                                          
  Best Overall Response:                             4% (1)                                             

* Inclusive of one patient who had a confirmed partial response confirmation after the DCO.

In the safety-evaluable population, no unexpected safety risks were identified at the time of DCO, and casdatifan plus cabozantinib had an acceptable safety profile with no meaningful overlapping toxicity for the two drugs.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

                          ARCUS BIOSCIENCES, INC.                                     
  Date: June 1, 2025      By:                          /s/ Terry Rosen, Ph. D.        
                                                       Terry Rosen, Ph. D.            
                                                       Chief Executive Officer