Arcus Biosciences Inc.

10/06/2025 | Press release | Distributed by Public on 10/06/2025 08:03

Material Event (Form 8-K)

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
(n=31)
50 mg QD
(n=28)
100mg QD
(n=31)
150 mg QD
(n=31)
Pooled Analysis
(n=121)
Efficacy
Median Follow-Up, months (range) 22.8
(14.4, 26.0)
19.7
(15.9, 21.3)
12.4
(6.3, 13.5)
14.4
(12.5, 15.5)
15.2
(6.3, 26.0)
Median PFS, months
[95% CI]
9.7
[5.3, NE]
19.2
[5.3, NE]
NE
[5.7, NE]
9.7
[2.7, NE]
12.2
[9.4, 20.6]
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]
Complete Response, % (n)
Partial Response, % (n)
Stable Disease, % (n)
Progressive Disease, % (n)
26% (12, 45)
0% (0)
26% (8)
55% (17)
19% (6)
36% (19, 56)
4% (1)
32% (9)
50% (14)
14% (4)
35% (19, 55)
0% (0)
35% (11)
48% (15)
16% (5)a
29% (14, 48)
0% (0)
29% (9)
45% (14)
26% (8)
31% (23, 40)
1% (1)
31% (37)
50% (60)
19% (23)
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)
[95% CI]
81% (25)
[63, 93]
86% (24)
[67, 96]
84% (26)
[66, 95]
74% (23)
[55, 88]
81% (98)
[63, 88]
CI: confidence interval; NE: not estimable
aIncludes 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
(n=33)
50 mg QD
(n=31)
100mg QD
(n=32)
150 mg QD
(n=31)
Pooled Analysis
(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)
Anemiaa
Hypoxiaa
52% (17)
49% (16)
9% (3)
42% (13)
39% (12)
10% (3)
38%(12)
25% (8)
9% (3)
65% (20)
52% (16)
16% (5)
49% (62)
41% (52)
11% (14)
TEAEs related to casdatifan leading to discontinuation, % (n)
Anemiab
Hypoxiab
0
0
0
3% (1)
0
3% (1)
3% (1)
0
3% (1)
6% (2)
0
3% (1)
3% (4)
0
2% (3)
aGrade ≥3 TEAEs related to casdatifan that occurred in more than 5% of patients in the pooled analysis.
bPrespecified events of interest.
Expansion into Immunology and Inflammation (I&I)
The advanced discovery and preclinical programs disclosed by the Company in the presentation provide multiple opportunities to advance into the clinic in 2026. The Company expects the first clinical study from one or more of these programs to be initiated in 2026. Potential new drug candidates include:
•MRGPRX2 small-molecule inhibitor, a potential treatment for atopic dermatitis and chronic spontaneous urticaria
•TNF-a (TNFR1) small-molecule inhibitor, a potential treatment for rheumatoid arthritis (RA), psoriasis and inflammatory bowel disease (such as ulcerative colitis)
•CCR6 small-molecule inhibitor, a potential treatment for psoriasis
•CD89 monoclonal antibody, a potential treatment for RA
•CD40L small-molecule inhibitor, a potential treatment for multiple sclerosis and systemic lupus erythematosus
Arcus Biosciences Inc. published this content on October 06, 2025, and is solely responsible for the information contained herein. Distributed via SEC EDGAR on October 06, 2025 at 14:03 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]