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Biotech Drug Report Generated Oct 24, 2026

domvanalimab

RCUS·Arcus Biosciences, Inc.
BEARISH
Drug Impact Rating3/10
Trial Phase
Phase 3 (discontinued)
Time to Market
Unknown — program largely discontinued; no path to market
Why 3/10
No hard dated binary catalyst in the next ~12 months. The Phase 3 programs (STAR-121, STAR-221) have been discontinued due to futility. No PDUFA date, no upcoming pivotal readout, and no regulatory submission. The drug is effectively a failed program. ImpactScore is 3 — an already-failed program at a company that has pivoted to other pipeline assets (casdatifan).
Actionable Insight ▼ BEARISH

Domvanalimab is effectively a failed program after two Phase 3 discontinuations for futility. Arcus has pivoted to its HIF2 inhibitor casdatifan (casdatifan) as the lead pipeline asset. Investors should watch for the Q3 2026 earnings (Oct 26 or Nov 11) for cash runway updates and casdatifan Phase 3 PEAK-1 enrollment data — those are now the real value drivers for RCUS, not domvanalimab.

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Executive Summary

Domvanalimab (AB154) is an Fc-silent anti-TIGIT antibody developed by Arcus Biosciences (NYSE: RCUS) in partnership with Gilead Sciences. The drug failed two Phase 3 trials — STAR-221 (gastric/esophageal cancer, discontinued Dec 2025) and STAR-121 (non-small cell lung cancer, discontinued Apr 2026) — both discontinued due to futility. Gilead has loosened its collaboration ties with Arcus after the TIGIT failures. The company has pivoted to its HIF2 inhibitor casdatifan as the lead asset. Analyst consensus on RCUS remains strong (16 Buy/Strong Buy, mean PT $41, ~135% upside), but that thesis rests on casdatifan, not domvanalimab. The stock trades near its 52-week low of $16.87.

How It Works

Domvanalimab is an antibody drug that blocks a protein called TIGIT on immune cells. Tumors use TIGIT to turn off the body's immune attack. Domvanalimab is designed to be 'Fc-silent' — a special engineering tweak that prevents it from accidentally killing helpful immune cells while blocking the TIGIT 'off switch'. It was tested alongside PD-1 blockers (another class of immunotherapy) and chemotherapy to treat multiple cancer types.

Trial Status

Two Phase 3 trials (STAR-221 in gastric/esophageal cancer and STAR-121 in NSCLC) were discontinued due to futility. Several Phase 2 trials completed. One Phase 2 GI trial (NCT05329766) remains active but not recruiting. One Gilead-sponsored Phase 2 head/neck cancer trial (NCT06727565) is active but not recruiting. No new trials enrolling.

The Two-Sided Case

▲ Bull Case4
Domvanalimab showed some encouraging Phase 2 data in combination with zimberelimab in PD-L1-high NSCLC (ARC-7 study) and in immunotherapy-refractory HCC and BTC (Nature Communications publications).
The Fc-silent design is mechanistically differentiated from Roche's tiragolumab and may still have potential in certain niches or earlier lines.
Analyst consensus on RCUS remains strong: 16 Buy/Strong Buy vs 3 Hold, mean price target $41 (134.6% upside from $18.54), suggesting the Street sees value in the rest of the pipeline.
Arcus has ~$694M cash ($694M as of Sep 30, 2026) providing runway into H2 2028, and the pipeline has shifted focus to casdatifan (HIF2 inhibitor) which showed promising Phase 2 data in ccRCC (SEC 8-K filing).
▼ Bear Case5
Domvanalimab failed two Phase 3 trials (STAR-221 in gastric/esophageal cancer and STAR-121 in NSCLC) — both discontinued due to futility — representing a total loss of the TIGIT program's value (Gilead press release Dec 2025; Taiho press release Apr 2026).
Gilead has loosened its collaboration ties with Arcus after the TIGIT failures, ending broader option rights in July 2026, reducing partnership revenue potential (FierceBiotech reporting).
The entire TIGIT class has struggled in the clinic — Roche's tiragolumab also failed multiple Phase 3 trials — raising questions about the mechanism itself.
Arcus is pre-revenue with no approved products; Q3 2026 cash burn accelerated to ~$182M, and the company now relies on casdatifan success for any path to commercialization (SEC 8-K filing analysis).
A shareholder lawsuit investigation was announced in Oct 2026 regarding potential fiduciary breaches (PRNewswire).

Upcoming Catalysts

  • No domvanalimab-specific catalysts — the program is effectively discontinued. RCUS Q3 2026 earnings (Oct 26 or Nov 11, 2026) for cash runway and casdatifan pipeline update.

Source Filing

The SecBot filing or press-release report that triggered this drug report:

Arcus Biosciences, Inc. 8-K RCUS ·Originating report

Sources · 6

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