Company: RCUS
Filing Date: 2025-10-06
Form Type: 8-K
Source: 0001724521-25-000107
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Company: Arcus Biosciences, Inc.
Filing Date: 2025-10-06
Form: 8-K
Item: Item 8.01
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Item 8.01 Other Events.

ARC-20 Updates

On October 6, 2025, Arcus Biosciences, Inc. (the “ Company”) presented updated data from the monotherapy cohorts of ARC-20, a Phase 1/1b study evaluating different doses and combinations with casdatifan, and shared new research programs in immunology and inflammation. A copy of the presentation has been posted to the Investors & Media section of the Company’s website. The presentation included updated data from four monotherapy cohorts evaluating casdatifan in patients with metastatic clear cell renal cell carcinoma, along with a pooled analysis comprising all patients from the four monotherapy cohorts. The efficacy-evaluable population included all eligible patients who received any study treatment and have at least one post-baseline efficacy assessment or who discontinued study treatment due to progressive disease or death, regardless of whether they had a scan. Below is a summary of the efficacy data as of the data cutoff date of August 15, 2025 (the “ DCO”):

                                                              50 mg BID         50 mg QD          100mg QD           150 mg QD         Pooled Analysis  
                                                              (n=31)            (n=28)            (n=31)             (n=31)            (n=121)          
 ────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────
  Efficacy                                                                                                                                              
  Median Follow-Up, months (range)                            22.8              19.7              12.4               14.4              15.2             
  Median PFS, months                                          9.7               19.2              NE                 9.7               12.2             
  18-month PFS [95% CI]                                       41% [24, 58]      50% [30, 68]      NE                 NE                43% [33, 53]     
  12-month PFS [95% CI]                                       44% [27, 61]      59% [39, 75]      60% [40,75]        40% [22, 56]      50% [41, 59]     
  Confirmed ORR [95% CI]                                      0% (0)            4% (1)            35% (19, 55)       0%