domvanalimab (AB154) / Arcus Biosci, Gilead, Otsuka - LARVOL DELTA

AB154 Combined With AB122 for Recurrent Glioblastoma (clinicaltrials.gov) - P1 | N=46 | Recruiting | Sponsor: Yale University | Active, not recruiting ➔ Recruiting

Enrollment open • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

ARC-7: Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=151 | Completed | Sponsor: Arcus Biosciences, Inc. | Active, not recruiting ➔ Completed

Monotherapy • Trial completion • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Phase 2 Study of Sacituzumab Govitecan (SG), Domvanalimab (dom), and Zimberelimab (zim) in Metastatic Non–Small Cell Lung Cancer (mNSCLC): VELOCITY-Lung Substudy-01 (ESMO 2025) - No abstract available

Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

ADJUNCT: Phase II Trial Evaluating the Safety and Efficacy of the Combination of Zimberelimab, Domvanalimab and Sacituzumab Govitecan as 1L Therapy for PD-L1 Positive Advanced TNBC (clinicaltrials.gov) - P2 | N=25 | Not yet recruiting | Sponsor: MedSIR

New P2 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

IMMUNORARE5: A national platform of 5 academic phase II trials coordinated by Lyon University Hospital to assess the safety and the efficacy of the IMMUNOtherapy (Domvanalimab + Zimberelimab) in patients with advanced RARE cancers: THE NEUROENDOCRINE TUMORS COHORT. (ESMO 2025) - No abstract available

Clinical • Metastases • P2 data • Neuroendocrine Tumor • Oncology • Solid Tumor

Domvanalimab (dom), Zimberelimab (zim), and FOLFOX in First-Line (1L) Advanced Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (GC/GEJC/EAC): 26-Month Update From EDGE-Gastric, Arm A1 (ESMO 2025) - No abstract available

Clinical • Metastases • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Oncology • Solid Tumor

VELOCITY-Lung: Study of Novel Treatment Combinations in Patients With Lung Cancer (clinicaltrials.gov) - P2 | N=593 | Recruiting | Sponsor: Gilead Sciences | Trial completion date: Jan 2027 ➔ Dec 2028

Trial completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1

Safety and Efficacy of Zimberelimab (AB122) in Combination With Domvanalimab (AB154) and Etrumadenant (AB928) in Patients With Previously Treated Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: Washington University School of Medicine | Trial primary completion date: Jul 2025 ➔ Oct 2025 | Trial completion date: Sep 2029 ➔ Dec 2029

Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Arcus Biosciences Reports Second-Quarter 2025 Financial Results and Provides a Pipeline Update (Businesswire) - "Pipeline Highlights:... Domvanalimab (Fc-silent anti-TIGIT antibody) plus Zimberelimab (anti-PD-1 antibody): Planned Data Readouts: (i) An abstract describing OS data from the Phase 2 EDGE-Gastric study, evaluating domvanalimab plus zimberelimab and chemotherapy in upper GI adenocarcinomas, has been accepted for presentation at the 2025 ESMO Congress in October; (ii) The first Phase 3 OS data readout for domvanalimab plus zimberelimab will be from the ongoing Phase 3 study STAR-221, evaluating domvanalimab plus zimberelimab plus chemotherapy in PD-L1 all-comer 1L unresectable or metastatic upper GI adenocarcinomas. Results for this trial are event-driven, and OS data are expected in 2026."

P2 data • P3 data • Esophageal Adenocarcinoma • Gastric Adenocarcinoma • Gastroesophageal Junction Adenocarcinoma

Imfinzi + domvanalimab: Data from P3 PACIFIC-8 trial (NCT05211895) for stage 3 NSCLC post 2026 (AstraZeneca) - H1 and Q2 2025 Results

P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Zimberelimab + domvanalimab: Completion of P3 STAR-121 trial (NCT05502237) for stage IV NSCLC in Jun 2028 (Otsuka) - Q2 FY2025 Results

Trial completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology

AB154 Combined With AB122 for Recurrent Glioblastoma (clinicaltrials.gov) - P1 | N=46 | Active, not recruiting | Sponsor: Yale University | Trial primary completion date: Jun 2025 ➔ Nov 2025

Trial primary completion date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

A randomised phase II study of zimberelimab ± domvanalimab immunotherapy in resectable mismatch repair deficient (dMMR) gastric and gastroesophageal junctional (G/GOJ) adenocarcinoma (ZODIAC) (ESMO-GI 2025) - P2 | "The study includes serial blood and tissue collection for planned translational analyses. ZODIAC is open to recruitment."

Clinical • dMMR • IO biomarker • Mismatch repair • P2 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • TIGIT

Dual TIGIT and PD-1 blockade with domvanalimab plus zimberelimab in hepatocellular carcinoma refractory to anti-PD-1 therapies: the phase 2 LIVERTI trial. (PubMed, Nat Commun) - P2 | "Despite the primary endpoint failing to meet the protocol-specified threshold, these results indicate that targeting TIGIT in anti-PD-1/L1 therapy refractory HCC is well-tolerated, associated with anti-tumor effects, and may be guided by ctDNA assessment. ClinicalTrials.gov registration: NCT05724563."

IO biomarker • Journal • P2 data • Hepatocellular Cancer • Oncology • Solid Tumor • TIGIT

IMMUNORARE5: A national platform of 5 academic phase II trials coordinated by Lyon University Hospital to assess the safety and the efficacy of the immunotherapy with domvanalimab + zimberelimab combination in patients with advanced rare cancers—The B3 Thymomas and Thymic Carcinomas Cohort. (ASCO 2025) - P2 | "Translational research projects will be developed aiming at deciphering cellular and molecular mechanisms involved in response to treatment. Moreover, data from the prospective database of the RYTHMIC network will be investigated to build a synthetic historical arm representative of the efficacy of the standard treatments in a similar population of patients."

Clinical • Metastases • P2 data • Oncology • Solid Tumor • Thoracic Cancer • Thymic Carcinoma • Thymoma • Thymus Cancer • TIGIT

IMMUNORARE5: A national platform of 5 academic phase II trials coordinated by Lyon University Hospital to assess the safety and the efficacy of the immunotherapy with domvanalimab + zimberelimab combination in patients with advanced rare cancers—The Anaplastic Thyroid Carcinomas Cohort. (ASCO 2025) - P2 | "In such patients carrying the BRAFV600 mutation (20-30%), the standard 1st-line treatment relies on dabrafenib & trametinib...In DUTHY trial (Durvalumab + tremelimumab), the 6month-OS was 65.6% in ATC...Translational research projects will be developed aiming at deciphering cellular and molecular mechanisms involved in response to treatment. Moreover, data from the prospective database of the ENDOCAN-TUTHYREF network will be investigated to build a synthetic historical arm representative of the efficacy of the standard treatments in a similar population of patients."

Clinical • IO biomarker • Metastases • P2 data • Endocrine Cancer • Oncology • Solid Tumor • Thyroid Gland Anaplastic Carcinoma • Thyroid Gland Carcinoma • BRAF • TIGIT

A phase 2 study of first-line (1L) domvanalimab (dom), zimberelimab (zim), and chemotherapy (chemo) in patients (pts) with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC): Substudy-01 of the VELOCITY-HNSCC platform trial. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT06727565 Background: Pembrolizumab (anti–PD-1 monoclonal antibody [mAb]) ± chemo is a recommended 1L treatment strategy for pts with R/M HNSCC...Chemo will consist of paclitaxel 175 mg/m2 + carboplatin AUC 5 administered IV Q3W for up to 6 cycles...Two-sided 90% and/or 95% confidence intervals will be calculated for ORR, and the Kaplan–Meier method will be used for survival estimates. Safety data will be summarized descriptively."

Clinical • IO biomarker • Metastases • P2 data • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1 • TIGIT

IMMUNORARE5: A national platform of 5 academic phase II trials coordinated by Lyon University Hospital to assess the safety and the efficacy of the immunotherapy with domvanalimab + zimberelimab combination in patients with advanced rare cancers—The Gestational Trophoblastic Tumors Cohort. (ASCO 2025) - P2 | "Several case reports suggest that immune checkpoint inhibitors (ICIs) may be active, and a phase II trial with Camrelizumab + Apatinib showed a 50% cure rate. Translational research projects will be developed to unravel the cellular and molecular mechanisms involved in treatment response. Moreover, data from the prospectively implemented database of the French Gestational Trophoblastic Disease Center will be analyzed to create a synthetic historical arm representative of the efficacy of the standard treatments in a similar patient population."

Clinical • Metastases • P2 data • Gestational Trophoblastic Neoplasia • Oncology • TIGIT

IMMUNORARE5: A national platform of 5 academic phase II trials coordinated by Lyon University Hospital to assess the safety and the efficacy of the immunotherapy with domvanalimab + zimberelimab combination in patients with advanced rare cancers—The Peritoneal Mesotheliomas Cohort. (ASCO 2025) - P2 | "The standard 1st-line treatment of peritoneal mesothelioma relies on platinum and pemetrexed, with no validated 2nd-line treatment so far. Several studies suggested that immunotherapy, such as ipilimumab + nivolumab or atezolizumab + bevacizumab, is active in this disease...Translational research projects will be developed aiming at deciphering cellular and molecular mechanisms involved in response to treatment. Moreover, data from the prospectively-maintained RENAPE database will be investigated to build a synthetic historical arm representative of the efficacy of the standard treatments in a similar population of patients."

Clinical • Metastases • P2 data • Mesothelioma • Oncology • Peritoneal Mesothelioma • Solid Tumor • TIGIT

STAR-221: A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body (clinicaltrials.gov) - P3 | N=1040 | Active, not recruiting | Sponsor: Arcus Biosciences, Inc. | Trial completion date: May 2026 ➔ Feb 2027 | Trial primary completion date: May 2026 ➔ Dec 2026

Trial completion date • Trial primary completion date • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor

EDGE-Gastric: A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies (clinicaltrials.gov) - P2 | N=332 | Active, not recruiting | Sponsor: Arcus Biosciences, Inc. | Trial primary completion date: Sep 2026 ➔ Jan 2027

IO biomarker • Trial primary completion date • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Disorder • Oncology • PD-L1

STU-2022-1076: Domvanalimab and Zimberelimab in Advanced Liver Cancers (clinicaltrials.gov) - P2 | N=58 | Active, not recruiting | Sponsor: University of Texas Southwestern Medical Center | Recruiting ➔ Active, not recruiting

Enrollment closed • Pan tumor • Biliary Cancer • Cholangiocarcinoma • Gallbladder Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Domvanalimab: Protection of compound patent in US/EU until 2037 (Gilead) - Annual Meeting Of Stockholders 2025

Patent • Oncology

STAR-121: Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=1069 | Recruiting | Sponsor: Gilead Sciences | Active, not recruiting ➔ Recruiting

Enrollment open • IO biomarker • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • NTRK • PD-L1 • RET

Safety and Efficacy of Zimberelimab (AB122) in Combination With Domvanalimab (AB154) and Etrumadenant (AB928) in Patients With Previously Treated Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: Washington University School of Medicine | Trial completion date: Apr 2029 ➔ Sep 2029 | Trial primary completion date: Jan 2025 ➔ Jul 2025

Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1