Arcus Biosciences Inc. filed SEC Form 8-K: Regulation FD Disclosure, Other Events
$RCUS
Biotechnology: Pharmaceutical Preparations
Health Care
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 1, 2025
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Item 7.01 Regulation FD Disclosure.
On June 1, 2025, Arcus Biosciences, Inc. (the “Company”) presented updated information about its portfolio and development programs. An updated corporate presentation has been posted to the Investors & Media section of the Company’s website.
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)* [26,67] | ||||
| Best Overall Response: - Complete Response - Partial Response - Stable Disease - Progressive Disease | 4% (1) 42% (10)* 50% (12) 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 (Principal Executive Officer) | ||||||||