PRODIGE 113 (FFCD 2314) - REWENEC 01 STUDY Randomized Trial of FOLFIRI + Zimberelimab + Domvanalimab vs FOLFIRI With a Hybrid Synthetic Control Arm in Second Line Treatment of Neuroendocrine Carcinoma of Gastro-enteropancreatic or Unknown Origin. Phase II Comparative Randomized Study - Multicentric

Background Neuroendocrine carcinomas (NECs) of gastro-entero-pancreatic (GEP) or unknown (UK) origin are rare and highly aggressive diseases. The recommended first-line (L1) treatment is platinum-etoposide combination therapy, which has a progression-free survival (PFS) of only 4-9 months and a median overall survival (OS) of approximately 12 months. All patients experience relapse, often rapidly after this first line of chemotherapy. The standard second-line (L2) chemotherapies recommended by ESMO, ENETS, and NCCN, FOLFIRI and FOLFOX, have modest efficacy with a PFS of 3 months and a median OS of 6 months. The BEVANEC study (PHRCK 2014, NCT02820857) reported no benefit of FOLFIRI + bevacizumab compared to FOLFIRI in a randomized phase II study that enrolled 150 patients in 26 centers over a period of 5 years in France.
To date, the most promising efficacy data for this highly aggressive cancer come from clinical trials of immune checkpoint inhibitors (ICIs) targeting the PD-1/PD-L1 checkpoint. For example, in France, the non-comparative phase II NIPINEC trial (NCT03591731) randomized patients to receive nivolumab +/- ipilimumab in L2/3 and achieved its primary evaluation criterion (ORR-8 weeks>10%). Other trials in Europe and worldwide have also reported efficacy data in the context of single-arm studies.
Scientific Questions and Unmet Needs:
1. New therapeutic options/perspectives are necessary for patients with GEP/UK NECs given the limited overall survival.
2. Approximately 50% of patients experienced early progression under immunotherapy in the NIPINEC trial and other trials, which may be explained by the absence of chemotherapy combined with immunotherapy and/or the existence of resistance mechanisms.
3. In the GEP/UK NEC indication, the design of these immunotherapy trials has been non-comparative single-arm studies because the realization of randomized comparative trials is considered very difficult for these very rare cancers (incidence <5/million).
Rationale for the REWENEC-01 Trial The DURIGAST PRODIGE 59 study, conducted by the FFCD, demonstrated the feasibility and safety of the FOLFIRI + double immune checkpoint inhibitor (anti-PD-1 and anti-CTLA4) combination, as well as for the combination Folfox-Domvanalimab-Zimberelimab (anti-PD-1 and anti-TIGIT). In a translational study of the immune phenotype in patients with NECs treated with the anti-PD1 pembrolizumab, an increase in TIGIT expression was observed after pembrolizumab treatment and higher TIGIT expression on T cells in the blood of patients with high Ki67 expression in their tumors. These data suggest that TIGIT is a potential complementary therapeutic target to PD-1/PD-L1 checkpoint inhibition in GEP/UK NECs. Domvanalimab has been developed as an anti-TIGIT monoclonal antibody and zimberelimab as an anti-PD-1.
Design and primary objective of the REWNEC-01 Trial The REWENEC-01 trial is a comparative phase II trial that will randomize GEP/UK NEC patients between an experimental arm FOLFIRI+Zimberelimab + Domvanalimab and a control arm FOLFIRI in L2. The FOLFIRI arm will be a "hybrid" synthetic control arm composed of patients from historical/external data from the FOLFIRI arm of BEVANEC and French retrospective studies RBNEC and CEPD, mixed with patients recruited prospectively during the trial and randomized to the control arm. The randomization ratio for patients included prospectively during the trial will be 4:1 (4 patients assigned to FOLFIRI+Zimberelimab + Domvanalimab for 1 patient assigned to FOLFIRI). The randomization algorithm will take into account "external" patients assigned progressively to the control arm to obtain a 1:1 ratio between the trial arms, with balanced distributions of stratification factors between the two arms.
With 77 patients to be included, this strategy will provide statistical power equivalent to that of a trial including 122 patients, sufficient to demonstrate an advantage in overall survival rate at 12 months from 32% to 50%.
The hypotheses related to efficacy criteria are formulated a priori, as recommended by the FDA guidance document on trials with synthetic/external control arms. The proof of concept has been reported at ESMO 2023. The primary judgment criterion will be the overall survival rate at 12 months because it is a strong and significant criterion for translating the clinical benefit of the Chemotherapy + Zimberelimab + Domvanalimab combination. The design with a hybrid synthetic control arm allows for the consideration of a randomized comparative study in a cancer as rare as neuroendocrine carcinoma.

Start Date01 Apr 2026

Sponsor / Collaborator

Hospices Civils de Lyon

[+1]

NCT07134556

/ Not yet recruitingPhase 2

A Phase II Trial Evaluating the Safety and Efficacy of the Combination of Zimberelimab, Domvanalimab and Sacituzumab Govitecan as First-line Therapy for PD-L1 Positive Advanced Triple-negative Breast Cancer

The ADJUNCT is a single-arm, phase II clinical trial to evaluate the safety and efficacy of the combination of zimberelimab, domvanalimab and sacituzumab govitecan as first-line therapy for patients with PD-L1 positive advanced or metastatic triple-negative breast cancer.

Start Date01 Mar 2026

Sponsor / Collaborator

Medica Scientia Innovation Research SL

NCT07283848

/ WithdrawnPhase 2IIT

A Single-Arm, Phase II Study of Perioperative Zimberelimab + Domvanalimab and Neoadjuvant Chemotherapy in Locally Advanced, Resectable, Gastroesophageal Adenocarcinoma

The purpose of the study is to understand whether study drugs domvanalimab and zimberelimab are safe and effective in combination with standard chemotherapy for patients with operable cancer of the esophagus, stomach, or gastroesophageal junction (where the stomach meets the esophagus).
All participants will receive the study treatment. Participants will receive chemotherapy and two immune therapies drugs (domvanalimab and zimberelimab) for up to 4 months before surgery. After surgery and at least a 4 week recovery, participants will receive domvanalimab and zimberelimab for up to 8 months. After completion of the study treatment, participants will be followed for up to 5 years per standard of care.

Start Date01 Feb 2026

Sponsor / Collaborator

The Massachusetts General Hospital

[+2]

100 Clinical Results associated with Domvanalimab

100 Translational Medicine associated with Domvanalimab

100 Patents (Medical) associated with Domvanalimab

Literatures (Medical) associated with Domvanalimab

01 Jan 2026·Nature Reviews Clinical Oncology

Domvanalimab plus zimberelimab shows promise in upper-tract cancers

Article

Author: Sidaway, Peter

01 Dec 2025·NATURE MEDICINE

Domvanalimab and zimberelimab in advanced gastric, gastroesophageal junction or esophageal cancer: a phase 2 trial

Article

Author: Prusty, Subhransu ; DuPage, Amy ; Wainberg, Zev A ; Sison, Edward Allan R ; Rha, Sun Young ; Janjigian, Yelena Y ; Pelster, Meredith ; Nelson, Sandahl ; Thompson, Amy ; Oh, Do-Youn ; Koralek, Daniel O

Dual inhibition of T cell immunoreceptor with immunoglobulin and ITIM domain (TIGIT) and programmed cell death protein 1 (PD-1) may enhance antitumor immunity in advanced gastroesophageal cancers. Here we report the EDGE-Gastric study, an ongoing, multicenter, international, phase 2 study with three cohorts, one in the first-line setting (cohort A) and two in the second-line or greater setting (cohorts B and C). Cohort A comprises four arms: two nonrandomized (A1 and A2) and two randomized (A3 and A4). In arm A1, presented here, dual blockade of TIGIT and PD-1 with domvanalimab (Fc-silent anti-TIGIT) and zimberelimab (anti-PD-1) plus oxaliplatin, leucovorin, fluorouracil (FOLFOX) was evaluated in patients with previously untreated advanced HER2-negative gastric, gastroesophageal junction or esophageal adenocarcinoma. Among 41 treated patients, the confirmed objective response rate was 59% (90% confidence interval (CI) 44.5-71.6%), median progression-free survival was 12.9 months (90% CI 9.8-14.6 months) and median overall survival was 26.7 months (90% CI 18.4 months to not estimable (NE)). In patients with tumor area positivity ≥1% (PD-L1 positive) and tumor area positivity ≥5% (PD-L1 high), respectively, the objective response rate was 62% (90% CI 45.1-77.1%) and 69% (90% CI 45.2-86.8%), median progression-free survival was 13.2 months (90% CI 11.3-15.2 months) and 14.5 months (90% CI 11.3 months-NE), and median overall survival was 26.7 months (90% CI 19.5 months-NE) and not reached (90% CI 17.4 months-NE). Immune-related adverse events were reported in 27% of patients; the safety profile was consistent with that reported for anti-PD-1 plus platinum-based chemotherapy. Dual TIGIT and PD-1 blockade with domvanalimab and zimberelimab plus chemotherapy demonstrated encouraging efficacy, and the regimen is being evaluated in the phase 3 STAR-221 trial. ClinicalTrials.gov identifier: NCT05329766 .

01 May 2024·Clinical lung cancer

STAR-121: A Phase III Randomized Study of Domvanalimab and Zimberelimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Untreated Metastatic Non–Small Cell Lung Cancer With No Actionable Gene Alterations

Article

Author: Rodriguez-Abreu, Delvys ; Johnson, Melissa ; Todd, Trever ; Gray, Jhanelle E ; Yu, Xinwei ; Chen, Xueying ; Bosch-Barrera, Joaquim ; Ahn, Myung-Ju ; Mohammad, Saad ; Reck, Martin ; Kim, Jongseok

INTRODUCTION:

Dual inhibition with a T-cell immunoreceptor with immunoglobulin and ITIM domains plus programmed death (ligand)-1 (PD[L]-1) inhibitors, with or without chemotherapy, is an emerging therapeutic strategy in metastatic non-small cell lung cancer (mNSCLC). The STAR-121 (NCT05502237) phase III, global, randomized, open-label study will investigate first-line domvanalimab (anti-TIGIT) and zimberelimab (anti-PD-1) plus chemotherapy versus pembrolizumab plus chemotherapy in mNSCLC with no actionable gene alterations.

PARTICIPANTS AND METHODS:

Approximately 720 participants (≥18 years old) with untreated mNSCLC and no EGFR and ALK mutations will be randomized into 3 groups (A, B, or C) in a 4:4:1 ratio and stratified by baseline PD-L1 expression (tumor cells <50% vs. ≥50%), histology (squamous vs. nonsquamous), and geographic region (East Asia vs. non-East Asia). Group A will receive domvanalimab 1200 mg plus zimberelimab 360 mg plus platinum-doublet chemotherapy (PT), group B will receive pembrolizumab 200 mg plus PT, and group C will receive zimberelimab 360 mg plus PT, every 3 weeks. Treatment will be administered until disease progression or intolerable toxicity. Dual primary endpoints are progression-free survival (by blinded independent central review [BICR]) and overall survival for group A versus B. Key secondary endpoints comprise overall response rate (by BICR), safety, and quality of life. Exploratory endpoints include efficacy and safety between groups A and C, pharmacokinetics, patient-reported outcomes, and biomarkers.

CONCLUSION:

Enrollment in the STAR-121 study commenced on October 12, 2022, and is currently ongoing with completion planned by September 2024. The study completion is expected by December 2027.

147

News (Medical) associated with Domvanalimab

15 hours ago

·www.taiho.co.jp

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 Pharmaceutical Co., Ltd. (“Taiho”) today announced the discontinuation of the Phase 3 STAR-121 study due to futility. STAR-121 study, which is being conducted in collaboration with Arcus Biosciences, Inc. (“Arcus”) and Gilead Sciences, Inc. (“Gilead”), evaluated the anti-TIGIT antibody domvanalimab (development code: AB154) plus anti-PD-1 antibody zimberelimab (development code: AB122) 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. Communication with investigators is being conducted to determine appropriate next steps for patients in the study. Domvanalimab and zimberelimab are investigational molecules, and this combination therapy has not received approval from any regulatory authority for any use globally, and their safety and efficacy have not been established. Lung cancer remains the most diagnosed cancer and is the leading cause of cancer‑related death, with approximately 2.5 million incident cases and 1.8 million deaths reported annually worldwide1. Lung cancer presents as small cell lung cancer (SCLC) and non–small cell lung cancer (“NSCLC”), of which the latter represents approximately 85% of all lung cancer diagnoses2. While distribution of NSCLC histology can vary depending on factors such as gender or geographic regions, adenocarcinoma (45%) and squamous (25%) subtypes account for the largest share of cases of NSCLC in the United States3. STAR-121 is a randomized, open-label, global Phase 3 trial consisting of 1) zimberelimab and domvanalimabplus chemotherapy arm, 2) pembrolizumab plus chemotherapy arm, and 3) zimberelimab plus chemotherapy arm as first-line treatment in patients with metastatic NSCLC with no Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK) mutations or other actionable genomic alteration. The primary endpoint of the study is overall survival (OS) in participants with positive PD-L1 expression (≥ 1% tumor cells) and in all randomized participants. STAR-121 Study: A Randomized, Open-Label, Phase 3 Study to Evaluate Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy for the First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer With No Epidermal Growth Factor Receptor or Anaplastic Lymphoma Kinase Genomic Tumor Aberrations Domvanalimab is an Fc-silent investigational monoclonal antibody which binds the T-cell immunoreceptor with Ig and ITIM domains (TIGIT), a checkpoint receptor on immune cells that acts as a brake on the anticancer immune response. By binding to TIGIT with Fc-silent properties, domvanalimab is believed to work by freeing up immune-activating pathways and activating immune cells to attack and kill cancer cells without depleting the peripheral regulatory T cells important in avoiding immune-related toxicity. Combined inhibition of both TIGIT and programmed cell death protein-1 (PD-1) is believed to enhance immune cell activation, as these checkpoint receptors play distinct, complementary roles in anti-tumor activity. Zimberelimab is an anti-programmed cell death protein-1 (PD-1) monoclonal antibody that binds PD-1, with the goal of restoring the antitumor activity of T cells. Zimberelimab is being evaluated globally as a foundational anti-PD-1 treatment option in multiple ongoing clinical studies. Based on the option and license agreement that Taiho and Arcus entered into in 2017, Taiho has obtained exclusive development and commercialization rights to a total of five Arcus programs in Japan and certain other territories in Asia (excluding mainland China): (1) etrumadenant, a dual A2a/b adenosine receptor antagonist program in 2018; (2) zimberelimab, the anti-PD-1 program in 2019; (3) domvanalimab, the anti-TIGIT program in 2021; (4) quemliclustat, CD73 inhibitor program in 2024, and (5) casdatifan, HIF-2α inhibitor in 2025. Arcus Biosciences is a clinical-stage, global biopharmaceutical company developing differentiated molecules and combination therapies for people with cancer, inflammatory and autoimmune diseases. In partnership with industry collaborators, patients and physicians around the world, Arcus is expediting the development of first- and/or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has advanced multiple investigational medicines into registrational clinical trials including casdatifan, a HIF-2α inhibitor for clear cell renal cell carcinoma, and quemliclustat, a small-molecule CD73 inhibitor for pancreatic cancer. World Health Organization (WHO). Cancer today: Data Visualization tools for exploring the global cancer burden in 2024. Available at: https://gco.iarc.fr/today/home. Accessed: April 2026. Cheng TY, Cramb SM, Baade PD, Youlden DR, Nwogu C, Reid ME. The International Epidemiology of Lung Cancer: Latest Trends, Disparities, and Tumor Characteristics J Thorac Oncol 2016;11 (10):1653-71. Houston KA, Henley SJ, Li J, White MC, Richards TB. Patterns in lung cancer incidence rates and trends by histologic type in the United States, 2004-2009. Lung Cancer 2014;86 (1):22-8. The content above comes from the network. if any infringement, please contact us to modify.

License out/inImmunotherapyDrug Approval

21 Apr 2026

·www.fiercebiotech.com

Gilead loosens ties to Arcus after TIGIT dream finally ends in phase 3 failure

The end of the road for their TIGIT plans won’t come as a huge surprise to anyone at Gilead or Arcus headquarters. \n Gilead Sciences and Arcus Biosciences’ domvanalimab, one of the last anti-TIGIT antibodies still standing, has failed another trial—leading Gilead to pull further away from their once wide-ranging collaboration. The phase 3 Star-221 study was testing domvanalimab with Arcus’ experimental anti-PD-1 drug zimberelimab, plus chemotherapy, versus Keytruda in patients with untreated metastatic non-small cell lung cancer (NSCLC). The trial kicked off in October 2022 and was due to run through June 2028.But Arcus revealed in an April 20 Securities and Exchange Commission filing that the study had been ended for futility after an interim analysis of the data to date. No new safety issues were identified, the biopharma noted.A phase 2 study assessing domvanalimab and zimberelimab in patients with NSCLC has also been canned.Along with the end of their TIGIT dream, Arcus disclosed that Gilead has further loosened the ties between the two companies. Gilead has surrendered its option to license a range of early-stage programs at Arcus focused on targets like CCR6, CD89 and CD40L, according to the filing.However, Gilead has retained the option to license a pair of Arcus’ clinical-stage candidates—namely, the AXL inhibitor AB801 and the anti-CD39 monoclonal antibody AB102—as well as two preclinical assets in the form of the MRGPRX2 antagonist AB102 and an unnamed TNF small-molecule inhibitor. The end of the road for their TIGIT plans won’t come as a huge surprise to anyone at Gilead or Arcus headquarters. While domvanalimab showed a glimmer of hope in certain gastric and esophageal cancers in the midstage Edge-Gastric study back in October 2025, the TIGIT drug has since failed in a head-to-head against Bristol Myers Squibb’s Opdivo in the same indication.That failure already persuaded Arcus to refocus its efforts outside of TIGIT, specifically on its asset casdatifan, an HIF-2a inhibitor once backed by Gilead, as well as its earlier-stage small-molecule inflammatory and autoimmune programs.Domvanalimab was one of the last TIGIT candidates still standing after high-profile clinical failures saw the likes of Roche, GSK and BeOne Medicines retreat from a modality that was once hailed as the future of immuno-oncology.Most of those discarded candidates were Fc-enabled, meaning the antibodies retain a fully functional Fc region to bind to Fc receptors found on the cell surface and contribute to the protective antitumor functions of the immune system. In contrast, domvanalimab is known as Fc-silent, meaning the Fc function has been mutated out.The only other TIGIT candidate still in the running—AstraZeneca’s TIGIT/PD-1 bispecific antibody rilvegostomig—uses an Fc-silent anti-TIGIT antibody from Compugen.

Phase 3Phase 2Immunotherapy

21 Apr 2026

·www.biospace.com

Gilead, Arcus tumble again in TIGIT, triggering 2 trial culls

iStock, dickcraft The Phase 3 failure has prompted Gilead Sciences and Arcus Biosciences to terminate a mid-stage study of their TIGIT asset in lung cancer. Gilead Sciences and Arcus Biosciences are discontinuing a late-stage study of their investigational TIGIT drug domvanalimab “due to futility,” prompting Gilead to start rolling back its years-long cancer collaboration with Arcus. The trial, STAR-121, was testing domvanalimab in combination with a PD-1 blocker and chemotherapy for metastatic non-small cell lung cancer (NSCLC). Arcus didn’t provide specific data from the study in the legal filing, noting only that an independent data panel found the comparison against Merck’s Keytruda plus chemotherapy to be futile. No new safety issues were found during regular check-ins with the data board, though the latest futility analysis did not include a safety assessment. Arcus made the disclosure in a securities filing dated April 20, noting that Gilead has decided not to make an option continuation payment, a decision that will cut off the pharma’s access to a clutch of early-stage TIGIT therapies. Gilead’s opportunity to participate in the development of new Arcus early-stage programs will officially end on July 14. Gilead, however, will retain its “existing time-limited options” to certain programs, including the small-molecule AXL blocker AB801, the anti-CD39 antibody AB598 and the MRGPRX2 antagonist AB102. The document doesn’t outline when these options are set to expire. Aside from triggering Gilead’s pullback, STAR-121’s failure has pushed the partners to end the Phase 2 EDGE-Lung study of domvanalimab in NSCLC. Immuno-oncology Four Therapies Hanging On in Troubled TIGIT Space TIGIT-targeting therapies have largely disappointed in recent months, with failed studies, terminated partnerships and shuttered businesses. Here are five biopharma players staying alive with differentiated candidates against the once promising immuno-oncology target. July 7, 2025 · 9 min read · Tristan Manalac Read more Gilead and Arcus linked up in May 2020 to work on next-generation cancer therapies, an effort that involved TIGIT programs. Initially, the partners saw some success as other TIGIT players struggled. In June 2024, for instance, long-term data from the Phase 2 EDGE-Gastric study showed a 58.5% overall response rate in patients with upper gastrointestinal cancers after treatment with domvanalimab plus an anti-PD-1 therapy. Meanwhile, other players in the TIGIT arena were stumbling. A month after the EDGE-Gastric readout, Roche discontinued a Phase 2/3 lung cancer study after its TIGIT therapy tiragolumab, combined with Tecentriq, failed to significantly improve survival when compared to Keytruda plus chemotherapy. Merck itself ran into some TIGIT hardships and, in May 2024, terminated a late-stage study of its TIGIT candidate vibostolimab, which it was studying in combination with Keytruda for melanoma. Last year, GSK and partner iTeos Therapeutics abandoned their TIGIT therapy belrestotug after a disappointing midstage readout. The class’s troubles ultimately caught up to Gilead and Arcus. In December last year, a domvanalimab regimen flopped in a late-stage study of gastric and esophageal cancer, forcing the partners to abandon their plans in the indication. The TIGIT tale has been rife not just with clinical failures but also with sunk upfront costs. As per a BioSpace analysis , companies have paid at least $1.4 billion upfront in partnership contracts centered on TIGIT drugs, almost all of which did not pay off. Milestones, which could potentially hit $5 billion in value, largely remain unpaid. Business TIGIT Turmoil: How Pharma Burned Billions on Failed Immuno-Oncology Projects Leading companies spent $1.4 billion upfront on licensing deals and embarked on vast R&D programs. Clinical setbacks mean many companies are unlikely to ever recoup their investments. June 25, 2025 · 5 min read · Nick Paul Taylor Read more

100 Deals associated with Domvanalimab

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Adenocarcinoma of Esophagus	Phase 3	United States	Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.	21 Nov 2022
Adenocarcinoma of Esophagus	Phase 3	Japan	Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.	21 Nov 2022
Adenocarcinoma of Esophagus	Phase 3	Argentina	Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.	21 Nov 2022
Adenocarcinoma of Esophagus	Phase 3	Australia	Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.	21 Nov 2022
Adenocarcinoma of Esophagus	Phase 3	Belgium	Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.	21 Nov 2022
Adenocarcinoma of Esophagus	Phase 3	Brazil	Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.	21 Nov 2022
Adenocarcinoma of Esophagus	Phase 3	Canada	Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.	21 Nov 2022
Adenocarcinoma of Esophagus	Phase 3	Chile	Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.	21 Nov 2022
Adenocarcinoma of Esophagus	Phase 3	France	Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.	21 Nov 2022
Adenocarcinoma of Esophagus	Phase 3	Georgia	Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.	21 Nov 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05329766 (EDGE-Gastric, Pubmed \| Nat Med)	Phase 2	Esophageal Carcinoma \| Advanced gastric carcinoma \| Advanced Gastroesophageal Junction Adenocarcinoma First line HER2-negative	41	Domvanalimab+Zimberelimab+FOLFOX	ywynmutdxq(ivqrcrxghn) = bnjdyytrbc duuqmwblcm (gmxfxjbeys, 44.5 - 71.6) View more	Positive	18 Oct 2025
				Domvanalimab+Zimberelimab+FOLFOX (PD-L1 positive)	ywynmutdxq(ivqrcrxghn) = vvcewtafma duuqmwblcm (gmxfxjbeys, 45.1 - 77.1) View more
NCT05329766 (EDGE-Gastric, ESMO2025)	Phase 2	Advanced Gastric Adenocarcinoma \| Adenocarcinoma of Esophagus \| Advanced Gastroesophageal Junction Adenocarcinoma First line HER-2-negative	41	Domvanalimab (dom) + Zimberelimab (zim) + FOLFOX (PD-L1 Positive (TAP ≥1%))	jdvxpwlvhg(eevatvuplb) = qmjytkvolu jealnakzmj (kqeypiuzyt, 45 - 77) View more	Positive	17 Oct 2025
				Domvanalimab (dom) + Zimberelimab (zim) + FOLFOX (PD-L1 High (TAP ≥5%))	jdvxpwlvhg(eevatvuplb) = kttuvugjce jealnakzmj (kqeypiuzyt, 45 - 87) View more
NCT05329766 (EDGE-Gastric, Company_Website) Manual	Phase 2	Adenocarcinoma of Esophagus \| Locally Advanced Gastroesophageal Junction Adenocarcinoma \| Locally Advanced Unresectable Gastric Adenocarcinoma	41	Domvanalimab + Zimberelimab + FOLFOX	dsvbikgmzv(vzcdvdyryg) = ltfyzgglzy hhprbruiak (hbdaszsueo, 45 - 72) View more	Positive	12 Oct 2025
				Domvanalimab + Zimberelimab + FOLFOX (PD‐L1 Positive (TAP ≥ 1%))	dsvbikgmzv(vzcdvdyryg) = rhpxqwzhzz hhprbruiak (hbdaszsueo, 45 - 77) View more
NCT06790706 (IMMUNORARE5, ASCO2025)	Phase 2	Anaplastic Thyroid Carcinoma BRAFV600 mutation \| TIGIT expression	24	DOMVANALIMAB + ZIMBERELIMAB combination	sxsgqysneg(lvdmszmonm) = zeovbibhcg pjivpmcogb (ulwpfsimhh )	Positive	30 May 2025
NCT04736173 (ARC-10, BusinessWire) Manual	Phase 1	PD-L1 positive Non-Small Cell Lung Cancer PD-L1 High Expression	98	Domvanalimab plus Zimberelimab	bukbixerku(sespdubqel) = vpfqefiuqy ecgpcmhqcd (drvnkqatxt, 13.7 - NE) View more	Positive	05 Nov 2024
				Zimberelimab	bukbixerku(sespdubqel) = rpghnfbkuq ecgpcmhqcd (drvnkqatxt, 7.8 - NE) View more
603 (SITC2024)	Phase 2	Hepatocellular Carcinoma	29	Domvanalimab + Zimberelimab	lxmtxzypzh(nebumxbyre) = Treatment-related adverse events (TRAE) defined as any adverse event that was at least possibly attributed to domvanalimab plus zimberelimab occurred in 16 patients (55.2%) and SAEs attributed to study treatment occurred in 2 patients (6.9%). TRAEs that were grade 3 or greater occurred in 3 patients (10.3%) jnvxcwiztl (lrxnioviql )	Positive	05 Nov 2024
NCT05724563 (2024 SITC)	Phase 2	Hepatocellular Carcinoma Second line \| Third line	29	Domvanalimab+赛帕利单抗	potbkxhhag(aksszaxyoa) = vhryjtakex cixfkpkvoo (hmykbrbvrq ) View more	Positive	05 Nov 2024
NCT05329766 (EDGE-Gastric, BusinessWire) Manual	Phase 2	Gastrointestinal Neoplasms First line PD-L1	41	domvanalimab+Zimberelimab+ Chemotherapy	evyzlgglgw(cxxwnpgbtp) = ehzyqgigut blwztnbdki (tfpugtavcm, 9.8 - 13.8) View more	Positive	01 Jun 2024
				domvanalimab+Zimberelimab+ Chemotherapy (PD-L1-high)	evyzlgglgw(cxxwnpgbtp) = kcfgslkarz blwztnbdki (tfpugtavcm, 11.3 - NE) View more
NCT05329766 (EDGE-Gastric, Corporate Publications) Manual	Phase 2	Adenocarcinoma of Esophagus \| Locally Advanced Unresectable Gastric Adenocarcinoma \| Metastatic Gastroesophageal Junction Adenocarcinoma First line	41	Domvanalimab+zimberelimab+chemotherapy	dqrjfeyqqn(fzewikjenm) = hekedauypt twjjaloihg (veirzzhbkb, 42 - 74) View more	Positive	06 Nov 2023
				Domvanalimab+zimberelimab+chemotherapy (PD-L1-high* (TAP ≥5%))	dqrjfeyqqn(fzewikjenm) = payxffzivz twjjaloihg (veirzzhbkb, 52 - 96) View more
NCT04262856 (ARC-7, Corporate Publications) Manual	Phase 2	Non-Small Cell Lung Cancer First line	150	zimberelimab	jrmqvtofzs(scnceomjws) = jgbidvjybu okqiidhpkc (ofterucvvs, 17.9 - 44.6) View more	Positive	03 Jun 2023
				domvanalimab + zimberelimab	jrmqvtofzs(scnceomjws) = fapfqvbiuv okqiidhpkc (ofterucvvs, 26.4 - 54.8) View more

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis