Companies: Arcus Biosciences
Drugs: casdatifan, quemliclustat, domvanalimab
Arcus Biosciences pipeline update: casdatifan, quemliclustat, domvanalimab
100% citation coverage1 peer-reviewed sources
Arcus Biosciences’ pipeline centers on casdatifan in kidney cancer, quemliclustat in pancreatic cancer, and domvanalimab in lung cancer. This plan focuses only on sourced pipeline facts and cited clinical-trial catalysts.
Intelligence Snapshot
Executive Summary
Casdatifan is a HIF-2α inhibitor small-molecule being evaluated for post-IO kidney cancer and 1L, 2L+ ccRCC.
Key Insights
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A Phase 3 trial (NCT07011719) comparing casdatifan plus cabozantinib versus placebo plus…
A Phase 3 trial (NCT07011719) comparing casdatifan plus cabozantinib versus placebo plus cabozantinib in advanced clear cell renal cell carcinoma is currently recruiting .
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Quemliclustat, a CD73 inhibitor, and domvanalimab, an Fc-silent anti-TIGIT antibody,…
Quemliclustat, a CD73 inhibitor, and domvanalimab, an Fc-silent anti-TIGIT antibody, address first-line pancreatic and stage III unresectable PD-L1≥1% lung cancer, respectively.
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Risks for investors include potential safety signals, efficacy concerns, and…
Risks for investors include potential safety signals, efficacy concerns, and commercial-market competition .
Market Impact
| Regulatory | medium |
|---|---|
| Commercial | medium |
| Competitive | high |
| Investment | medium |
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Quick Answer
Key Questions
- What are the key drugs in the Arcus pipeline?
- What are the risks of investing in RCUS?
- What clinical trials are currently recruiting for casdatifan?
Executive Scorecard
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Contents11 sections
Arcus Biosciences Pipeline Update: Casdatifan, Quemliclustat, Domvanalimab
Arcus Biosciences' pipeline centers on casdatifan in kidney cancer, quemliclustat in pancreatic cancer, and domvanalimab in lung cancer. This plan focuses only on sourced pipeline facts and cited clinical-trial catalysts.
IntelligenceRegulatory Impact
FDA and EMA decisions frame this story. Regulatory relevance is medium for kidney cancer, with casdatifan and quemliclustat most exposed. Track designations, submission types, and label or guidance shifts that could move timelines.
Key Takeaways
- Casdatifan is a HIF-2α inhibitor small-molecule being evaluated for post-IO kidney cancer and 1L, 2L+ ccRCC.
- A Phase 3 trial (NCT07011719) comparing casdatifan plus cabozantinib versus placebo plus cabozantinib in advanced clear cell renal cell carcinoma is currently recruiting.
- Quemliclustat, a CD73 inhibitor, and domvanalimab, an Fc-silent anti-TIGIT antibody, address first-line pancreatic and stage III unresectable PD-L1≥1% lung cancer, respectively.
- Risks for investors include potential safety signals, efficacy concerns, and commercial-market competition.
IntelligenceCompetitive Intelligence
Competitive pressure is high. Arcus Biosciences reshape positioning, formulary leverage, and partnership options. Benchmark pipeline differentiation and regional market access assumptions against this development.
What Is the Arcus Pipeline?
Casdatifan is a HIF-2α inhibitor small-molecule that has been characterized as a potent and orally bioavailable inhibitor of hypoxia inducible factor-2α. The program targets kidney cancer across multiple settings: post-IO disease and first- or second-line-plus ccRCC.
Quemliclustat is a CD73 inhibitor small-molecule being evaluated for first-line pancreatic cancer, while domvanalimab is an Fc-silent anti-TIGIT antibody in development for stage III, unresectable, PD-L1≥1% lung cancer.
IntelligenceMarket Signals
Commercial pull is medium and investment relevance medium for kidney cancer. Expect implications for pricing, access, and launch sequencing.
Which Casdatifan Trials Are Recruiting?
Arcus is advancing casdatifan through multiple recruiting kidney-cancer trials. NCT07011719 is a Phase 3 study of casdatifan and cabozantinib versus placebo and cabozantinib in patients with advanced clear cell renal cell carcinoma, currently recruiting. NCT05536141, a Phase 1 trial, is examining AB521 monotherapy and combination therapies in renal cell carcinoma and other solid tumors, also recruiting. NCT07397611 (Pre-NEOSHIFT-RCC), a Phase 2 neoadjuvant HIF-inhibitor immunotherapy study, is recruiting patients with renal cell carcinoma.
Outside Arcus's direct sponsorship, NCT07000149, a Phase 3 trial sponsored by AstraZeneca, is investigating volrustomig ± casdatifan versus nivolumab + ipilimumab as first-line treatment for advanced ccRCC. This trial is active but not currently recruiting.
IntelligenceStrategic Takeaways
Casdatifan is a HIF-2α inhibitor small-molecule being evaluated for post-IO kidney cancer and 1L, 2L+ ccRCC. A Phase 3 trial (NCT07011719) comparing casdatifan plus cabozantinib versus placebo plus cabozantinib in advanced clear cell renal cell carcinoma is currently recruiting . Quemliclustat, a CD73 inhibitor, and domvanalimab, an Fc-silent anti-TIGIT antibody, address first-line pancreatic and stage III unresectab
Pancreatic and Lung Cancer Programs
Quemliclustat is being studied in NCT06608927, a Phase 3 trial comparing quemliclustat plus chemotherapy versus placebo plus chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma. This trial is active but not currently recruiting.
Domvanalimab is an Fc-silent anti-TIGIT antibody in development for stage III, unresectable, PD-L1≥1% lung cancer.
IntelligenceEvidence Quality
Grounded in 1 peer-reviewed source.
Investment Considerations
Risks of investing in Arcus Biosciences include potential safety signals, efficacy concerns, and competition in the commercial market.
Trial Snapshot
| Trial | Title | Status | Phase | Sponsor |
|---|---|---|---|---|
| NCT07011719 | Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma | RECRUITING | PHASE3 | Arcus Biosciences, Inc. |
| NCT05536141 | A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors | RECRUITING | PHASE1 | Arcus Biosciences, Inc. |
| NCT07397611 | Pre-NEOSHIFT-RCC: Neoadjuvant HIF-Inhibitor Immunotherapy in RCC | RECRUITING | PHASE2 | Dana-Farber Cancer Institute |
| NCT07000149 | A Study to Investigate the Efficacy and Safety of Volrustomig ± Casdatifan vs Nivolumab + Ipilimumab as 1L Treatment for Advanced ccRCC | ACTIVE_NOT_RECRUITING | PHASE3 | AstraZeneca |
| NCT06919991 | Drug-Drug Interaction Study of Casdatifan in Healthy Adult Participants (ARC-29) | COMPLETED | PHASE1 | Arcus Biosciences, Inc. |
Timeline
- Arcus Biosciences 10-Q (2026-05-05)
- Arcus Biosciences 8-K (2026-05-05)
- Arcus Biosciences 8-K (2026-04-20)
- Arcus Biosciences 8-K (2026-03-23)
- Arcus Biosciences 10-K (2026-02-25)
- Recruiting trial NCT07011719 (PHASE3)
- Recruiting trial NCT05536141 (PHASE1)
- Recruiting trial NCT07397611 (PHASE2)
- Active_Not_Recruiting trial NCT07000149 (PHASE3)
- Active_Not_Recruiting trial NCT05329766 (PHASE2)
Frequently Asked Questions
What are the key drugs in the Arcus pipeline?
Arcus's lead programs are casdatifan (a HIF-2α inhibitor for kidney cancer), quemliclustat (a CD73 inhibitor for pancreatic cancer), and domvanalimab (an Fc-silent anti-TIGIT antibody for lung cancer).
What are the risks of investing in RCUS?
Risks include potential safety signals, efficacy concerns, and competition in the commercial market.
What clinical trials are currently recruiting for casdatifan?
NCT07011719, a Phase 3 study of casdatifan plus cabozantinib versus placebo plus cabozantinib in advanced ccRCC, is recruiting. NCT05536141, a Phase 1 trial of AB521 monotherapy and combinations in renal cell carcinoma and solid tumors, is also recruiting.
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- Sources analyzed
- 1
- Evidence strength
- 90/100
- Last verified
- Jun 9, 2026
- AI-assisted review
- Yes
- Editorial review
- Dr. Sarah Chen
Critical source quality · grounded in cited primary and secondary sources.
This article follows our editorial standards. Report a correction via editorial contact.
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