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 2, 2024
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Item 7.01 Regulation FD Disclosure.
On June 2, 2024, 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 an interim analysis of the Company’s Phase 2 clinical trial EDGE-Gastric, which is evaluating domvanalimab plus zimberelimab and chemotherapy in upper gastrointestinal cancers. Specifically, the Company disclosed the following information from the interim analysis, which had a data cutoff date (DCO) of March 12, 2024:
Endpoint | Overall* n=41 | PD-L1-high (TAP ≥5%) n=16 | PD-L1-low (TAP <5%) n=24 | ||||||||
Progression-Free Survival (PFS) | |||||||||||
Median in Months (95% CI) | 12.9 mos. (9.8, 13.8) | 13.8 mos. (11.3, NE) | 11.3 mos. (5.5, 13.8) | ||||||||
12-month PFS Rate (95% CI) | 57.6% (41.7,73.5) | 68.8% (46.0, 91.5) | 46.8% (24.7, 68.9) | ||||||||
Objective Response Rate (ORR) per RECIST v1.1 | |||||||||||
Confirmed ORR (95% CI) | 58.5% (42.1, 73.7) | 68.8% (41.3, 89.0) | 50.0% (29.1, 70.9) | ||||||||
Complete Response | 3 (7.3%) | 1 (6.3%) | 1 (4.2%) | ||||||||
Partial Response | 21 (51.2%) | 10 (62.5%) | 11 (45.8%) | ||||||||
Stable Disease | 14 (34.1%) | 5 (31.3%) | 9 (37.5%) | ||||||||
Progressive Disease Confirmed | 2 (4.9%) | 0 | 2 (8.3%) | ||||||||
Not Evaluable** | 1 (2.4%) | 0 | 1 (4.2%) | ||||||||
Median Duration of Response (DOR) in Months | 12.4 mos. (9.9, NE) | NE (11.5, NE) | 10.2 mos. (4.0, 12.4) | ||||||||
*One subject with no tissue available for central PD-L1 testing. From local lab results, the subject is PD-L1 low via 22-C3 assay. This subject achieved confirmed complete response.
** One subject has no post baseline scans
CI: confidence interval
NE: not evaluable
TAP: tumor area positivity
No unexpected safety signals were observed at the time of DCO. The domvanalimab plus zimberelimab and chemotherapy regimen was generally well tolerated and showed an overall safety profile consistent with the known safety profiles of each individual molecule to date. Infusion-related reactions were observed in 19.5% of the total subjects, and the majority were related to chemotherapy.
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 thereunto duly authorized.
| ARCUS BIOSCIENCES, INC. | ||||||||
| Date: June 3, 2024 | By: | /s/ Terry Rosen, Ph. D. | ||||||
| Terry Rosen, Ph.D. | ||||||||
Chief Executive Officer (Principal Executive Officer) | ||||||||