Drugs / Domvanalimab
Trials 22
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04656535 | Apr 2021 → Mar 2026 overdue | glioblastoma | Yale University | Active not recruiting | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT03628677 | Sep 2018 → Jan 2025 | cancer | Arcus Biosciences, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05419479 | Nov 2022 → May 2026 | pancreatic adenocarcinoma, pancreatic adenosquamous carcinoma | James Cleary, MD, PhD | Suspended | No outcome recorded |
| Phase 216 trials · 1 missed | ||||||
| Phase 2 | NCT07337447 | Apr 2026 → Apr 2029 expected | neuroendocrine carcinoma | Hospices Civils de Lyon | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07134556 | Apr 2026 → May 2028 | triple-negative breast carcinoma | MedSIR | Withdrawn | No outcome recorded |
| Phase 2 | NCT07283848 | Feb → Dec 2026 | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | Massachusetts General Hospital | Withdrawn | No outcome recorded |
| Phase 2 | NCT06790706 | Oct 2025 → Nov 2028 expected | carcinoid tumor, digestive system neuroendocrine neoplasm, gestational trophoblastic neoplasm, peritoneal mesothelioma +2 | Hospices Civils de Lyon | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06250036 | Feb 2025 → Mar 2027 expected | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | Royal Marsden NHS Foundation Trust | Recruiting | No outcome recorded |
| Phase 2 | NCT06727565 | Feb 2025 → Mar 2027 expected | head and neck squamous cell carcinoma | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06133517 | Jan 2025 → Jan 2030 expected | infiltrating bladder urothelial carcinoma | Fundación para el Progreso de la Oncología en Cantabria | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05724563 | Jun 2023 → Dec 2027 expected | cholangiocarcinoma, hepatocellular carcinoma | University of Texas Southwestern Medical Center | Active not recruiting | Missed primary |
| Phase 2 | NCT05633667 | Mar 2023 → Sep 2029 expected | non-small cell lung carcinoma | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05676931 | Feb 2023 → Dec 2027 expected | non-small cell lung carcinoma | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05329766 | Jun 2022 → Jan 2027 expected | digestive system cancer | Arcus Biosciences, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05130177 | Mar 2022 → Feb 2026 overdue | melanoma | Diwakar Davar | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04791839 | Aug 2021 → Oct 2026 expected | non-small cell lung carcinoma | Washington University School of Medicine | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04736173 | Feb 2021 → May 2027 expected | non-small cell squamous lung carcinoma | Arcus Biosciences, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04262856 | May 2020 → Jul 2025 | non-small cell squamous lung carcinoma | Arcus Biosciences, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03547973 | Aug 2018 → Apr 2030 expected | urothelial carcinoma | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 33 trials · 2 missed | ||||||
| Phase 3 | NCT05568095 | Nov 2022 → Aug 2026 | adenocarcinoma | Arcus Biosciences, Inc. | Completed | Missed primary |
| Phase 3 | NCT05502237 | Oct 2022 → Jun 2028 expected | non-small cell lung carcinoma | Gilead Sciences | Active not recruiting | Missed primary |
| Phase 3 | NCT05211895 | Feb 2022 → Jul 2028 expected | non-small cell lung carcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT04999761 Background | Jun 2021 → May 2026 overdue | alveolar soft part sarcoma, biliary tract cancer, colorectal cancer, esophageal cancer +4 | Taiho Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 20
| Date | Issuer | Release |
|---|---|---|
| 2026-04-21 | Taiho Oncology, Inc. | Results 非小細胞肺がんに対する抗TIGIT抗体domvanalimabと抗PD-1抗体zimberelimab併用の第III相STAR-121試験について taiho.co.jp ↗
大鵬薬品工業株式会社（本社：東京都千代田区、 代表取締役社長：小林将之、 以下「大鵬薬品」）は、 Arcus Biosciences, Inc. （アーカス・バイオサイエンシズ、 本社：米国カリフォルニア州、 Chief Executive Officer：Terry Rosen、 以下「Arcus社」）およびGilead Sciences, Inc. （ギリアド・サイエンシズ、 本社：米国カリフォルニア州、 Chairman and Chief Executive Officer：Daniel O’Day、 以下「Gilead社」）と実施している転移性非小細胞肺がんの1次治療として、 抗TIGIT抗体domvanalimab （開発コード：AB154）+抗PD-1抗体zimberelimab （開発コード：AB122）+化学療法併用群と、 ペムブロリズマブ+化学療法併用群を比較評価する第III相STAR-121試験について、 有効性が認められなかったことによる中止をお知らせします. |
| 2026-04-21 | Taiho Oncology, Inc. | Results Update on the Phase 3 STAR-121 Study of Anti-TIGIT Antibody Domvanalimab and Anti-PD-1 Antibody Zimberelimab in Non-Small Cell Lung Cancer taiho.co.jp ↗
Taiho Pharmaceutical Co., Ltd. (“Taiho”) today announced the discontinuation of the Phase 3 STAR-121 study due to futility. |
| 2025-12-12 | Arcus Biosciences, Inc. | Results Arcus Provides Update on Phase 3 STAR-221 Study and Concentrates Its R&D Investment on Casdatifan and Emerging Inflammation and Immunology Portfolio arcusbio.com ↗
At the interim analysis, the domvanalimab-based combination did not improve OS relative to that of nivolumab plus chemotherapy. |
| 2025-10-12 | Arcus Biosciences, Inc. | Results Anti-TIGIT Domvanalimab Plus Anti-PD-1 Zimberelimab and Chemotherapy Showed 26.7 Months of Median Overall Survival as First-Line Treatment of Unresectable or Advanced Gastroesophageal Adenocarcinomas in the Phase 2 EDGE-Gastric Study arcusbio.com ↗
today announced the first OS results from Arm A1 of the Phase 2 EDGE-Gastric study in patients with locally advanced unresectable or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma. |
| 2024-11-06 | Arcus Biosciences, Inc. | Results Arcus Biosciences Reports Third-Quarter 2024 Financial Results and Provides a Pipeline Update arcusbio.com ↗
domvanalimab plus zimberelimab reduced the risk of death in first-line metastatic non-small cell lung cancer (NSCLC) by 36% compared to zimberelimab |
| 2024-11-05 | Arcus Biosciences, Inc. | Results Arcus Biosciences Announces that Domvanalimab Plus Zimberelimab Improved Overall Survival in ARC-10, a Randomized Study in Patients with PD-L1-High Non-Small Cell Lung Cancer arcusbio.com ↗
Domvanalimab plus zimberelimab was associated with greater progression-free survival, overall survival, and objective response rate compared with those of zimberelimab or chemotherapy |
| 2024-06-01 | Gilead Sciences | Results Gilead and Arcus Announce Anti-TIGIT Domvanalimab Plus Zimberelimab and Chemotherapy Exceeded One Year of Median Progression-Free Survival as a First-Line Treatment for Upper GI Cancers gilead.com ↗
“I am encouraged to see that patients treated with domvanalimab plus zimberelimab and chemotherapy had a median progression-free survival beyond one year, which exceeds the historical benchmarks for anti-PD-1 plus chemotherapy alone,” said Dr. Janjigian. |
| 2024-06-01 | Arcus Biosciences, Inc. | Results Gilead and Arcus Announce Anti-TIGIT Domvanalimab Plus Zimberelimab and Chemotherapy Exceeded One Year of Median Progression-Free Survival as a First-Line Treatment for Upper GI Cancers arcusbio.com ↗
I am encouraged to see that patients treated with domvanalimab plus zimberelimab and chemotherapy had a median progression-free survival beyond one year, which exceeds the historical benchmarks for anti-PD-1 plus chemotherapy alone, |
| 2023-11-07 | Arcus Biosciences, Inc. | Results Arcus Biosciences Reports Third Quarter 2023 Financial Results and Provides a Pipeline Update arcusbio.com ↗ |
| 2023-11-06 | Gilead Sciences | Results Gilead and Arcus Announce New Data Showing Encouraging Clinical Activity of Anti-TIGIT Domvanalimab-Containing Regimen as First-line Treatment for Upper GI Cancers gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) and Arcus Biosciences, Inc. (NYSE: RCUS) today announced that domvanalimab plus zimberelimab and chemotherapy showed encouraging overall response rate (ORR) and six-month progression-free survival (PFS) rate results in a preliminary analysis from Arm A1 of the EDGE-Gastric study. |
| 2023-11-06 | Arcus Biosciences, Inc. | Results Gilead and Arcus Announce New Data Showing Encouraging Clinical Activity of Anti-TIGIT Domvanalimab-Containing Regimen as First-Line Treatment for Upper GI Cancers arcusbio.com ↗
Preliminary data from Arm A1 of the Phase 2 EDGE-Gastric study showed promising ORR and six-month PFS results, irrespective of PD-L1 expression |
| 2023-06-03 | Gilead Sciences | Results Gilead and Arcus Announce Anti-TIGIT Domvanalimab Continues to Demonstrate Consistent Improvement in Progression-Free Survival in Non-Small Cell Lung Cancer Study gilead.com ↗
Clinically Meaningful Reduction in Risk of Progression or Death Was Observed in the Domvanalimab-Containing Study Arms Compared to Zimberelimab Monotherapy in First-Line, PD-L1-High NSCLC |
| 2023-06-03 | Arcus Biosciences, Inc. | Results Gilead and Arcus Announce Anti-TIGIT Domvanalimab Continues to Demonstrate Consistent Improvement in Progression-Free Survival in Non-Small Cell Lung Cancer Study arcusbio.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) and Arcus Biosciences, Inc. (NYSE: RCUS) today announced updated results from an interim analysis of the ARC-7 study in patients with first-line, metastatic non-small cell lung cancer (NSCLC) with PD-L1 tumor proportion score (TPS) ≥50% without epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations. |
| 2022-12-19 | Gilead Sciences | Results Anti-TIGIT Domvanalimab-Containing Study Arms Improve Progression-Free Survival Compared to Anti-PD1 Alone in Phase 2 Non-Small Cell Lung Cancer Study gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) and Arcus Biosciences, Inc. (NYSE: RCUS) today announced positive results from the fourth interim analysis of the ARC-7 study in patients with first-line, metastatic non-small cell lung cancer (NSCLC) with PD-L1 tumor proportion score (TPS) ≥50% without epidermal growth factor receptor or anaplastic lymphoma kinase (EGFR/ALK) mutations. |
| 2022-12-19 | Arcus Biosciences, Inc. | Results Anti-TIGIT Domvanalimab-Containing Study Arms Improve Progression-Free Survival Compared to Anti-PD1 Alone in Phase 2 Non-Small Cell Lung Cancer Study arcusbio.com ↗
35-45% Reduction in Risk of Progression or Death and a Doubling of mPFS Were Observed in the Domvanalimab-Containing Study Arms, Compared to Zimberelimab Monotherapy in First-Line, PD-L1-High NSCLC |
| 2022-11-28 | Gilead Sciences | Results Gilead and Arcus Biosciences Announce Positive Update on Joint TIGIT Program From Interim Analysis of ARC-7 Study in Non-Small Cell Lung Cancer gilead.com ↗
Fourth Interim Analysis Shows Continued Clinically Meaningful Differentiation Across All Efficacy Measures, Including PFS, in Both Domvanalimab-Containing Arms Compared to the Anti-PD-1 Zimberelimab Monotherapy Arm in First-Line NSCLC Patients |
| 2022-11-28 | Arcus Biosciences, Inc. | Results Gilead and Arcus Biosciences Announce Positive Update on Joint TIGIT Program From Interim Analysis of ARC-7 Study in Non-small Cell Lung Cancer arcusbio.com ↗
Fourth Interim Analysis Shows Continued Clinically Meaningful Differentiation Across All Efficacy Measures, Including PFS, in Both Domvanalimab-Containing Arms Compared to the Anti-PD-1 Zimberelimab Monotherapy Arm in First-Line NSCLC Patients |
| 2022-05-09 | Arcus Biosciences, Inc. | Results Arcus Biosciences Reports First Quarter 2022 Financial Results and Provides a Pipeline Update, Including from the Third Interim Analysis for the ARC-7 Study arcusbio.com ↗
In this interim analysis, both domvanalimab-containing arms continued to show meaningful differentiation compared to zimberelimab alone across multiple efficacy measures, including overall response rate (ORR) and duration of response (DoR). |
| 2021-11-08 | Arcus Biosciences, Inc. | Results Arcus Biosciences Reports Third Quarter 2021 Financial Results and Provides an Update on our anti-TIGIT Domvanalimab arcusbio.com ↗
Both domvanalimab-containing arms demonstrated differentiated clinical activity compared to that of zimberelimab alone in a second interim analysis of ARC-7, our randomized Phase 2 study in first-line metastatic non-small cell lung cancer (NSCLC) |
| 2021-06-23 | Arcus Biosciences, Inc. | Results Anti-TIGIT Domvanalimab-Based Combinations Showed Encouraging Clinical Activity in People with Metastatic, PDL1-High Non-Small Cell Lung Cancer at First Interim Analysis of Arcus Biosciences’ Randomized Phase 2 ARC-7 Study arcusbio.com ↗ |
All press releases naming this drug 23 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 23 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Domvanalimab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05329766 ↗ |
| Known as | AB154 | “This is a Phase III, randomised, double-blind, placebo-controlled, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) and domvanalimab...” NCT05211895 ↗3“Domvanalimab (AB 154) is a humanized immunoglobulin G1 (IgG1) monoclonal antibody that targets TIGIT.” NCT04656535 ↗ “* Domvanalimab (also known as AB154)” NCT05419479 ↗ |
| Known as | DOM | “Zimberelimab (ZIM) +Domvanalimab (DOM) + Chemotherapy” NCT05502237 ↗1“Drug: Domvanalimab (DOM)” NCT07134556 ↗ |
| Action | Inhibit | “TIGIT inhibitor domvanalimab” NCT05130177 ↗ |
| Modality | Monoclonal antibody | “humanized monoclonal antibody” NCT04262856 ↗ |
| Route | Intravenous | “Administered intravenously” NCT03547973 ↗ |
| Target | TIGIT | “targeting human TIGIT” NCT04262856 ↗ |