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[8-K] Arcus Biosciences, Inc. Reports Material Event

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Arcus Biosciences reported that the Phase 3 STAR-121 study in first-line metastatic non-small cell lung cancer, conducted with Gilead Sciences, has been discontinued for futility based on an Independent Data Monitoring Committee recommendation after a pre-planned futility analysis. Safety was not reassessed in that analysis, and no new safety issues have emerged in ongoing IDMC safety reviews. The related Phase 2 EDGE-Lung study will also be discontinued. The study’s exploratory arm showed zimberelimab plus chemotherapy delivering overall survival consistent with pembrolizumab plus chemotherapy.

Arcus also disclosed that Gilead will allow its broader option period to lapse on July 14, 2026 by not making an option continuation payment. Gilead will lose option rights to early-stage programs such as CCR6, CD89 and CD40L, but retains time-limited options to AB801, AB598, AB102 and an investigational TNF small molecule inhibitor. Arcus continues to hold full rights to casdatifan globally except for rights previously licensed to Taiho in Japan and certain other Asian territories, excluding China.

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Insights

Key lung cancer trial stopped for futility and Gilead limits future options.

The discontinuation of the Phase 3 STAR-121 study removes a potentially important domvanalimab/zimberelimab opportunity in first-line metastatic non-small cell lung cancer. A futility decision from an Independent Data Monitoring Committee indicates the regimen was unlikely to meet its primary efficacy objective.

Ending both STAR-121 and the Phase 2 EDGE-Lung study narrows Arcus’s near-term clinical footprint in lung cancer. At the same time, Gilead’s choice not to make an option continuation payment, ending broader option rights on July 14, 2026, suggests a more selective commitment to Arcus’s early pipeline while maintaining time-limited options on AB801, AB598, AB102 and a TNF inhibitor.

Arcus retaining full rights to casdatifan (outside territories licensed to Taiho in parts of Asia) preserves strategic flexibility for that program. Future disclosures about remaining Gilead-optioned assets and casdatifan development progress will help clarify the longer-term impact on Arcus’s portfolio balance.

Item 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
________________________________________________________
FORM 8-K
________________________________________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): April 20, 2026
________________________________________________________
Arcus Biosciences, Inc.
(Exact name of Registrant as Specified in Its Charter)
________________________________________________________
Delaware001-3841947-3898435
(State or Other Jurisdiction
of Incorporation)
(Commission File Number)
(IRS Employer
Identification No.)
3928 Point Eden Way
Hayward, California
94545
(Address of Principal Executive Offices)(Zip Code)
Registrant’s Telephone Number, Including Area Code: (510) 694-6200
(Former Name or Former Address, if Changed Since Last Report)
________________________________________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
oWritten communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
oSoliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
oPre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
oPre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading
Symbol(s)
Name of each exchange on which registered
Common Stock, Par Value $0.0001 Per ShareRCUSThe New York Stock Exchange
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o


Item 8.01 Other Events.

STAR-121 Update.

On April 20, 2026, Arcus Biosciences, Inc. (the “Company”) announced the discontinuation of the Phase 3 STAR-121 study, which is being conducted in collaboration with Gilead Sciences, Inc. (“Gilead”), due to futility. STAR-121 evaluated the anti-TIGIT antibody domvanalimab plus anti-PD-1 antibody zimberelimab and chemotherapy versus pembrolizumab plus chemotherapy as a first-line treatment for metastatic non-small cell lung cancer. The decision is based on the recommendation from the Independent Data Monitoring Committee (“IDMC”), following its review of data from a pre-planned futility analysis. Safety was not assessed at this futility analysis; however, no new safety issues have been identified during regular reviews by the IDMC.

The STAR-121 study also evaluated zimberelimab and chemotherapy as an exploratory endpoint. Zimberelimab plus chemotherapy performed consistently with respect to overall survival as compared to pembrolizumab plus chemotherapy.

STAR-121, along with the Phase 2 EDGE-Lung study, will be discontinued. Gilead is communicating with investigators to determine appropriate next steps for patients in these studies.

Gilead Collaboration Update.

On April 20, 2026, the Company announced that the period for Gilead’s option rights under the Option, License and Collaboration Agreement entered into between the Company and Gilead in 2020, as amended, will end on July 14, 2026, following Gilead’s decision to not make the option continuation payment to the Company. Accordingly, Gilead will not have option rights to additional programs in the Company’s early-stage pipeline, including the CCR6, CD89 and CD40L programs, but will maintain its existing time-limited options to programs including AB801 (an investigational small molecule AXL inhibitor), AB598 (an investigational anti-CD39 monoclonal antibody), AB102 (an investigational MRGPRX2 antagonist), and an investigational TNF small molecule inhibitor.

The Company has full rights to casdatifan and the casdatifan development program, other than those rights licensed to Taiho in Japan and certain other Asian territories (not including China).


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: April 20, 2026By:/s/ Terry Rosen, Ph. D.
Terry Rosen, Ph.D.
Chief Executive Officer
(Principal Executive Officer)

Source: View Original Filing on SEC EDGAR

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