Company: RCUS
Filing Date: 2025-10-06
Form Type: 8-K
Source: 0001724521-25-000107
Chunk: 1

Company: Arcus Biosciences, Inc.
Filing Date: 2025-10-06
Form: 8-K
Item: Item 8.01
Chunk 1
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 (0)            1% (1)           
  ORR, including responses pending confirmation [95% CI]      26% [12, 45]      36% [19, 56]      42%* [25, 61]      29% [14, 48]      33%* [25, 42]    
  Median Time to Response, months                             2.7               4.1               2.6                2.7               2.8              
  Disease Control Rate, % (n)                                 81% (25)          86% (24)          84% (26)           74% (23)          81% (98)         

CI: confidence interval; NE: not estimable

a Includes three patients who had radiological progressive disease and two patients who had clinical progression before the first scan, which have been included but do not meet the criteria for progressive disease per RECIST.

*Includes two unconfirmed responses, both of which are pending confirmation. One was recorded prior to the DCO and one was recorded after the DCO.

The safety-evaluable population includes all enrolled patients who received any amount of any study treatment. No unexpected safety signals were observed at the time of DCO and casdatifan had an acceptable and manageable safety profile. Below is a summary of the safety data as of the DCO:

                                                                     50 mg BID      50 mg QD      100mg QD      150 mg QD      Pooled Analysis  
                                                                     (n=33)         (n=31)        (n=32)        (n=31)         (n=127)          
 ────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────
  Safety                                                                                                                                        
  Any Serious Treatment-Emergent Adverse Events (TEAEs), % (n)       18% (6)        35% (11)      31% (10)      39% (12)       31% (39)         
  Grade ≥3 TEAEs related to casdatifan, % (n)                        49% (16)       39% (12)      25% (8)       52% (16)       41% (52)         
  TEAEs related to casdatifan leading to discontinuation, % (n)