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

/ WithdrawnPhase 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 Apr 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 May 2026·LUNG CANCER

Domvanalimab combined with zimberelimab as first-line treatment in patients with PD-L1–high, advanced non-small cell lung cancer: Results from the randomized phase 2 ARC-10 study, Part 1

Article

Author: Graham, Julie R ; Bermingham, Candy ; Runglodvatana, Yotsawaj ; Naidoo, Jarushka ; Dang, Thao ; Johnson, Melissa L ; Juengsamarn, Jitlada ; Fong, Chin Heng ; How, Soon Hin ; Patel, Deepa ; Han, Sasha ; Marina, Neyssa ; Peters, Solange ; Li, Jacky Yu-Chung ; Ho, Gwo Fuang

INTRODUCTION:

TIGIT and PD-1 trigger distinct but interconnected immunosuppressive pathways. We investigated first-line domvanalimab (Fc-silent anti-TIGIT) plus zimberelimab (anti-PD-1) in PD-L1-high (≥50%), stage IIIB-IV NSCLC.

MATERIALS AND METHODS:

This phase 2, multicenter, randomized, open-label study (ARC-10, Part 1) randomized (2:2:1) patients to intravenous domvanalimab 15 mg/kg plus zimberelimab 360 mg (DZ), zimberelimab 360 mg (Z), or platinum-doublet chemotherapy every 3 weeks. The primary endpoint was progression-free survival (PFS). Secondary endpoints were overall survival (OS), confirmed objective response rate (ORR), and safety.

RESULTS:

Of 98 randomized patients, 95 received treatment (DZ, n = 38; Z, n = 40; chemotherapy, n = 17). As of May 17, 2024, median follow-up was 24.5 months; 22patients remained on first-line treatment (DZ, n = 11; Z, n = 10; chemotherapy, n = 1). Median (95% CI) PFS was 11.5 (4.0-26.2) months for DZ, 6.2 (2.5-12.3) months for Z, and 9.6 (2.6-16.4) months for chemotherapy. Median (95% CI) OS was not reached (13.7-not evaluable [NE]) for DZ, 24.4(7.8-NE) months for Z, and 11.9(2.7-NE) months for chemotherapy. DZ vs Z hazard ratio (95% CI) was 0.69 (0.40-1.18) for PFS and 0.64 (0.32-1.25) for OS. ORR (95% CI) was 44.7% (28.6-61.7) for DZ, 35.0% (20.6-51.7) for Z, and 35.3% (14.2-61.7) for chemotherapy. Grade ≥ 3 treatment-related adverse events (AEs) were lower for DZ (21.1%) and Z (15.0%) vs chemotherapy (47.1%). Immune-mediated AEs were similar between DZ (23.7%) and Z (20.0%). Infusion-related reactions were low (0%-7.9% across arms).

CONCLUSIONS:

Adding Fc-silent anti-TIGIT (domvanalimab) to anti-PD-1 (zimberelimab) led to encouraging efficacy and showed no new safety concerns in patients with previously untreated stage IIIB-IV NSCLC.

01 Jan 2026·Nature Reviews Clinical Oncology

Domvanalimab plus zimberelimab shows promise in upper-tract cancers

Article

Author: Peter Sidaway

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 .

149

News (Medical) associated with Domvanalimab

28 May 2026

·www.biospace.com

4 troubled targets that have thwarted biopharma

iStock, rudall30 The tragic tale of TIGIT is well known. However, RIPK1, myc, STING and alpha-synuclein have also left a trail of failed clinical trials, canceled partnerships and sunk investments in their wake. For a while, Gilead Sciences and Arcus Biosciences seemed like they could defy the TIGIT odds. In November 2023, their monoclonal antibody domvanalimab achieved a 59% overall response rate when used alongside anti-PD-1 treatment and chemotherapy in a Phase 2 stomach cancer trial. Domvanalimab maintained this efficacy beyond two years, the partners reported in 2024, while also demonstrating progression-free survival. Encouraged by these findings, Gilead and Arcus pushed the asset into Phase 3. But in December last year, the duo announced they were dropping development of domvanalimab in gastric and esophageal malignancies after an underwhelming performance—adding another chapter to the long and troubled tale of anti-TIGIT therapies. TIGIT, short for T cell immunoreceptor with immunoglobulin and tyrosine-based inhibitory motif domain, is a receptor that, when activated, exerts immunosuppressive effects. TIGIT is overexpressed in many malignancies, with cancer cells exploiting its natural function to weaken the body’s anti-cancer response. Many companies have sought to treat cancer by disrupting the TIGIT pathway, but to date, none have succeeded. GSK, for instance, teamed up with Belgian biotech iTeos Therapeutics in 2021 to advance its TIGIT therapy belrestotug. Disappointing mid-stage lung cancer data for the drug eventually forced GSK to pull the plug on the program and the partnership in May 2025. Not long after, iTeos shuttered its operations. Merck and Roche have also been thrown by TIGIT. The former was stymied by safety concerns while the latter failed to see a survival advantage in lung cancer. This dilemma stretches across biopharma: Promising disease targets attract a rush of investments from major drugmakers—only to leave behind a trail of disappointing readouts, discontinued studies and doomed partnerships. BioSpace takes a look at four of those targets, digging into the science behind their therapeutic potential and taking stock of the sponsors that have failed to bear these mechanisms out in the clinic. 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 Big Pharma runs into RIPK1 rough patch Last month, Eli Lilly abandoned Rigel Pharmaceuticals after struggling failing to crack another difficult drug target: RIPK1. RIPK1 —short for receptor-interacting serine/threonine-protein kinase 1—is “a central signaling node,” Stuti Mahajan, consulting manager at DelveInsight, told BioSpace in an email. “The target gained major attention after preclinical studies showed that RIPK1 inhibition could suppress inflammatory cell death and reduce tissue damage across conditions such as ALS [amyotrophic lateral sclerosis], multiple sclerosis, rheumatoid arthritis, psoriasis, and inflammatory bowel disease,” she said. GSK led the industry’s charge, winning the FDA’s first go-ahead in 2014 to conduct clinical trials on a RIPK1 candidate. Sanofi and Denali Therapeutics followed soon after with 2018 agreement to go after the target in neurological and inflammatory diseases. By 2021, Eli Lilly was playing catch-up to its Big Pharma peers, fronting $125 million and promising up to $835 million in milestones to collaborate with Rigel. But the modality’s initial promise soon gave out under the weight of clinical reality, Mahajan told BioSpace . “Clinical translation has been more difficult than initially expected,” she said, with RIPK1-targeting molecules showing “modest or inconsistent” therapeutic benefits. GSK’s candidate, dubbed GSK2982772, failed to significantly improve disease severity in a Phase 2 ulcerative colitis study , according to an August 2021 paper in BMJ Open Gastroenterology . The asset is no longer listed on the pharma’s pipeline page . Sanofi and Denali were also foiled by RIPK1 and were forced in October 2024 to abandon a mid-stage multiple sclerosis study after a disappointing performance from their candidate oditrasertib. Sanofi earlier that year also pulled the plug on a Phase 2 trial of oditrasertib in ALS, similarly due to underwhelming efficacy. Roche added to RIPK1’s losing streak in March of this year, electing to end a Phase 2 study for its asset flizasertib for acute kidney injury in patients undergoing cardiac surgery. The drug was “unable to demonstrate a statistically significant clinical benefit,” according to a federal trials database . Business Sanofi and AstraZeneca Scrap Several Early-Stage Programs in Q1 Sanofi is dropping its Sjögren’s syndrome candidate due to disappointing Phase II efficacy data, while AstraZeneca is stopping work on some early-stage assets amid a portfolio reprioritization. April 25, 2024 · 2 min read · Tyler Patchen Read more Myc, crucial cancer driver, remains undruggable Like TIGIT, myc has long been an attractive but elusive cancer target. Myc refers to a broad family of transcription factors that regulate several key cellular processes, such as growth, division and metabolism. Under healthy conditions, the myc gene is tightly regulated. But in most—if not all—malignancies, it is highly expressed, leading to deregulated pathways that drive cancer. In fact, myc “holds the distinction of being the first oncogene to be found amplified in tumor cells,” according to a 2024 review article published in the journal Signal Transduction and Targeted Therapy . “MYC is over expressed in 70% of malignancies where it drives cell division at an accelerated pace; promotes a hostile tumor microenvironment; and is responsible for resistance against multiple drug classes,” Peter Smith, executive chairman of Racura Oncology, told BioSpace in an email. Despite its prevalence, however, myc remains a largely undruggable target in cancer, owing largely to its structure—"or lack thereof,” Smith said, pointing to the oncogene’s “basic helix-loop-helix transcription factor.” This overall simple structure makes it nearly impossible for drugs to stick to it, he explained. “Using the classic lock and key analogy for a drug interacting with its target, MYC simply has no lock, no well-defined tertiary structure for a drug to bind with high affinity,” Smith added. Currently, there are no small molecule myc inhibitors in development, according to Smith, but that’s not for want of trying. Many drugmakers over the years have tried and failed to advance a myc-directed drug. Aptose Biosciences, for instance, was banking on an asset called APTO-253, which it had been testing in an early study of relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome. APTO-253 was designed to suppress the expression of myc but was discontinued in 2021 after “an internal review of the product pro performance” and prioritization of other more advanced assets. Dicerna Pharmaceuticals also took a crack at myc with its RNA interference therapy DCR-MYC, which was supposed to drive down expression of the problematic gene. The company shelved the asset in 2016 when preliminary results failed to meet the company’s expectations for further development. Faced with a string of failures, “it appears that the majority of major pharmaceutical companies, after decades of research, have simply given up trying,” Smith concluded. STING stymies immunology, oncology advancements Another target that has tripped up the industry is STING (stimulator of interferon genes), a protein involved in various immune cascades. “Activation of the STING pathway induces type I interferon production, dendritic cell activation, and downstream T-cell priming,” Arunima Dabral, assistant project manager, Clinical & Pipeline Analysis at DelveInsight, told BioSpace in an email. Preclinical data supported this mechanism, she said, not only showing potential for immune-mediated diseases but also for cancer. This promise attracted “substantial industry investment,” Dabral said, including from GSK, which in 2022 put $1.4 billion on the line to partner with Mersana Therapeutics. At the heart of this deal was the biotech’s lead asset XMT-2056, an antibody-drug conjugate (ADC) that activates the STING pathway. The partners were supposed to develop the molecule for HER2-positive cancers. GSK and Mersana had a hard time with XMT-2056, however, running into a clinical hold in March 2023 linked to a death in a Phase 1 study that was deemed related to the asset. That pause was lifted in November that year, but that wasn’t enough to make GSK stick around. The pharma ultimately axed XMT-2056 in the first quarter of this year. Policy FDA Lifts Hold on Mersana’s Antibody-Drug Conjugate Following Patient Death The regulator has released Mersana Therapeutics’ antibody-drug conjugate XMT-2056 from its clinical hold, allowing the biotech to proceed with Phase I studies of the candidate with a lower starting dose. November 1, 2023 · 2 min read · Tristan Manalac Read more Merck has also been stymied by STING. The pharma was working on an oral STING agonist ulevostinag, also called MK-1454, which it was studying as a monotherapy or as part of a combo regimen with Keytruda, for solid tumors or lymphomas. Phase 1 data in 2018 showed no partial or complete responses in patients given the STING agonist alone. Merck has since discontinued the asset. Several challenges prevent STING-targeted drugs from succeeding in the clinic, Dabral explained. “Managing the toxicity associated with systemic immune activation, ensuring effective delivery to tumor sites, and overcoming tumor heterogeneity and resistance mechanisms are critical hurdles,” she said. Nevertheless, “the STING field remains active,” Dabral continued, with newer players incorporating novel technologies such as nanoparticle delivery and more selective pathway targeting. Daiichi Sankyo, for instance, is leveraging its ADC platform to advance the STING-targeting DS3610, which in November last year entered Phase 1 testing . The asset seeks to achieve more “precise tumor targeting,” Ken Takeshita, global head of R&D, said in a statement at the time. Alpha-synuclein aggravates in neuro Outside of cancer and immunology, there’s alpha-synuclein, which, owing to its central role in the pathology, is “one of the leading targets” in Parkinson’s disease, DelveInsight’s Mahajan said. Alpha-synuclein (α-syn) is a protein found in neurons that, under healthy conditions, plays a critical role in regulating the secretion of neurotransmitters. In certain neurodegenerative diseases, however, α-syn is wrongly folded, forming toxic clumps that ultimately trigger the destruction of neurons. “Aggregated alpha-synuclein is a defining pathological hallmark of Parkinson’s disease” and related conditions, such as dementia with Lewy bodies and multiple system atrophy, Mahajan explained. Because of its central role in neurodegenerative diseases, many of the industry’s biggest players have invested heavily α-syn-targeting approaches, but results have been mixed. Biogen, for instance, shelled out $32.5 million —and promised $395 million in contingent payments—in December 2010 to acquire a Neurimmune subsidiary, gaining an α-syn-targeting antibody that would later be named cinpanemab. But more than a decade later, in February 2021, Biogen scrapped cinpanemab following a disappointing mid-stage performance. The asset, the company said at the time, failed to show significant benefit in patients with Parkinson’s and “did not achieve proof-of-concept.” Before being discontinued, Biogen was setting cinpanemab up to compete with Roche and Prothena Biosciences’ prasinezumab, another antibody designed to target α-syn. This latter asset, however, did not fare much better. In December 2024, the partners announced that prasinezumab failed the Phase 2b PADOVA study, showing no significant benefit on motor progression. Still, Roche and Prothena are pushing the asset forward to Phase 3 , buoyed by signals of efficacy in the mid-stage study, such as positive trends in biomarker outcomes. Parkinson’s disease Roche, Prothena Push Parkinson’s Drug to Phase III Despite Mid-Stage Fail Analysts at Jefferies give Roche and Prothena’s Phase III study just a 25% to 40% probability of success. June 16, 2025 · 2 min read · Tristan Manalac Read more A major stumbling block for drugmakers, Mahajan explained, is the “difficulty of targeting intracellular pathogenic aggregates using extracellular antibodies”—the modality of choice for both Biogen and Roche/Prothena. The result, she continued, is that most therapies target α-syn found outside the cells, whereas it’s the intracellular aggregates that drive disease. The good news is that α-syn development “remains highly active,” Mahajan said, as the industry continues to refine its strategies toward earlier-stage intervention and better targeting mechanisms.

Phase 2Phase 3Clinical ResultImmunotherapyPhase 1

05 May 2026

·investors.arcusbio.com

Arcus Biosciences Reports First-Quarter 2026 Financial Results and Provides a Pipeline Update

Arcus outlines development strategy to establish casdatifan as a backbone therapy across each line of treatment for clear cell renal cell carcinoma (ccRCC), including the potential to become the first HIF-2a inhibitor-based tyrosine kinase inhibitor (TKI)-free regimen in the first-line (1L) setting Phase 3 PEAK-1 study is enrolling in immunotherapy (IO)-experienced patients with ccRCC, with enrollment completion and the initiation of a 1L Phase 3 study both expected by year-end 2026 Arcus selected its first inflammation program clinical candidate AB102, an MRGPRX2 antagonist, which is expected to enter the clinic in the third quarter of 2026; its preclinical profile will be presented in an oral presentation at the Society for Investigative Dermatology Annual Meeting in May With $876 million in cash, cash equivalents and marketable securities at quarter-end, Arcus is well positioned to advance casdatifan aggressively, with cash runway until at least the second half of 2028 HAYWARD, Calif.--(BUSINESS WIRE)-- Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer and inflammatory and autoimmune diseases, today reported financial results for the first quarter ended March 31, 2026 and provided a pipeline update on its clinical-stage investigational molecules and discovery programs. “Arcus is entering a new era, with a clear path for casdatifan to be both first and best in the first-line setting, and a portfolio of wholly owned molecules for inflammation and immunology that provide a new strategic optionality as they move into and through development,” said Terry Rosen, Ph.D., chief executive officer of Arcus. “Our highest priority is to establish casdatifan as a foundational standard of care in kidney cancer so that patients have the opportunity to benefit from casdatifan-based regimens across lines of treatment.” Arcus is focused on completing enrollment for PEAK-1 and initiating a Phase 3 study in the 1L setting, where casdatifan has the potential to become the first HIF-2a inhibitor-based, TKI-free option, by year-end 2026. Casdatifan (HIF-2a inhibitor) Casdatifan Development Program: Arcus’s development strategy is designed to generate evidence to secure casdatifan as a backbone therapy in ccRCC so that every patient has the opportunity to benefit from casdatifan across each line of therapy over the course of their care. The company is aggressively executing on a holistic strategy to embed casdatifan into the treatment paradigm, including in combination with the most commonly used regimen in the 1L setting, anti-PD-1 plus anti-CTLA-4. Arcus is now enrolling a cohort in the Phase 1/1b ARC-20 study to generate the dataset that will support the initiation of the corresponding Phase 3 study at year-end 2026. Arcus’s choice of combination partners has been designed to complement this casdatifan-IO regimen, which has the opportunity to be the first and only such HIF-2a inhibitor-based TKI-sparing 1L therapy, with consecutive treatments with casdatifan-containing regimens in first-, second- and third-line-plus settings. In this context, Arcus will also begin to evaluate casdatifan plus TKI-containing regimens in 1L and late-line settings, the latter in both HIF-2a inhibitor-experienced and HIF-2a inhibitor-naive patients. IO-experienced ccRCC: Enrollment in PEAK-1, the global Phase 3 study evaluating casdatifan plus cabozantinib versus cabozantinib in IO-experienced metastatic ccRCC, is accelerating, and Arcus is on track to complete enrollment by year-end 2026. 1L ccRCC: Arcus has been focused on the evaluation of casdatifan-based TKI-free regimens, which have demonstrated a consistently low rate of primary progression across all cohorts and settings evaluated to date. Most notably, casdatifan plus zimberelimab (anti-PD-1) showed a primary progression rate of 7% (2 of 30 patients), comparing quite favorably to published rates observed with anti-PD-1 monotherapy or ipilimumab (anti-CTLA-4) plus nivolumab (anti-PD-1) in the 1L setting. This ARC-20 cohort is fully enrolled. A cohort evaluating casdatifan plus zimberelimab and ipilimumab in ARC-20 is currently enrolling, with the purpose of supporting Arcus’s first Phase 3 study in the 1L setting. Most notably, casdatifan plus zimberelimab (anti-PD-1) showed a primary progression rate of 7% (2 of 30 patients), comparing quite favorably to published rates observed with anti-PD-1 monotherapy or ipilimumab (anti-CTLA-4) plus nivolumab (anti-PD-1) in the 1L setting. This ARC-20 cohort is fully enrolled. A cohort evaluating casdatifan plus zimberelimab and ipilimumab in ARC-20 is currently enrolling, with the purpose of supporting Arcus’s first Phase 3 study in the 1L setting. Planned Data Readouts: Arcus expects to have multiple data readouts for casdatifan in 2026: More mature overall response rate data and initial progression-free survival data for approximately 45 patients treated in the ARC-20 cohort evaluating casdatifan plus cabozantinib in the IO-experienced setting will be presented at an investor event or at a medical conference. All patients will have had at least 12 months of follow-up. Initial data from the ARC-20 cohorts evaluating casdatifan in early-line settings, including the cohort evaluating casdatifan plus zimberelimab in 1L ccRCC. Updated data from ARC-20 late-line monotherapy cohorts including overall survival (OS) data. Quemliclustat (small-molecule CD73 inhibitor) Enrollment was completed for PRISM-1, a Phase 3 trial of quemliclustat combined with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in 1L metastatic pancreatic ductal adenocarcinoma, in September 2025. Results from this study are expected in the first half of 2027. Domvanalimab (Fc-silent anti-TIGIT antibody) plus Zimberelimab (anti-PD-1 antibody) Status Update: In April 2026, Arcus announced the discontinuation of the Phase 3 STAR-121 study evaluating domvanalimab plus zimberelimab and chemotherapy versus pembrolizumab plus chemotherapy as a 1L treatment for metastatic non-small cell lung cancer (NSCLC), based on the recommendation from the Independent Data Monitoring Committee following its review of data from a pre-planned futility analysis. At the futility analysis, the domvanalimab-based combination did not improve OS relative to that observed with pembrolizumab plus chemotherapy. STAR-121, along with the Phase 2 EDGE-Lung study, will be discontinued. STAR-121 also evaluated zimberelimab plus chemotherapy as an exploratory endpoint. Zimberelimab plus chemotherapy performed consistently with respect to OS as compared to pembrolizumab plus chemotherapy. STAR-121 also evaluated zimberelimab plus chemotherapy as an exploratory endpoint. Zimberelimab plus chemotherapy performed consistently with respect to OS as compared to pembrolizumab plus chemotherapy. Emerging I&I Portfolio AB102, a highly selective, oral MRGPRX2 antagonist and potential best-in-class treatment for atopic dermatitis and chronic spontaneous urticaria, is expected to enter the clinic in the third quarter of 2026. In May, Arcus will present the preclinical profile for AB102 in an oral presentation at the Society for Investigative Dermatology Annual Meeting, highlighting its ability to fully block MRGPRX2-dependent degranulation and transcriptional activation in LAD2 and primary skin mast cells and its inhibition of all common human MRGPRX2 variants. Clinical development will begin with a first-in-human healthy volunteer study followed by a proof-of-concept study, with potential for proof-of-concept data in early 2027. Arcus has selected a development candidate for an oral small-molecule TNF inhibitor, a potential treatment for rheumatoid arthritis, psoriasis and inflammatory bowel disease, and expects it to enter the clinic in early 2027. The molecule is designed to selectively block TNFR1 signaling. It is believed that this could lead to better safety and efficacy than those of approved anti-TNF antibodies that block both TNFR1 and TNFR2 signaling, the latter of which can paradoxically lead to an inflammatory response in some patients. Arcus has also selected an orally active small-molecule antagonist of CCR6 as a development candidate for potential treatment of psoriasis and expects it to enter the clinic in the first half of 2027. In May, Arcus will present the preclinical profile for AB102 in an oral presentation at the Society for Investigative Dermatology Annual Meeting, highlighting its ability to fully block MRGPRX2-dependent degranulation and transcriptional activation in LAD2 and primary skin mast cells and its inhibition of all common human MRGPRX2 variants. Clinical development will begin with a first-in-human healthy volunteer study followed by a proof-of-concept study, with potential for proof-of-concept data in early 2027. The molecule is designed to selectively block TNFR1 signaling. It is believed that this could lead to better safety and efficacy than those of approved anti-TNF antibodies that block both TNFR1 and TNFR2 signaling, the latter of which can paradoxically lead to an inflammatory response in some patients. Financial Results for First Quarter 2026: Cash, Cash Equivalents and Marketable Securities were $876 million as of March 31, 2026, compared to $1.0 billion as of December 31, 2025. The decrease during the period is primarily due to the use of cash in our research and development activities. Based on our existing business plan, we believe that our cash, cash equivalents and marketable securities will be sufficient to fund our planned level of operations until at least the second half of 2028. We also expect to end 2026 with approximately $600 million in cash. Revenues were $17 million for the first quarter 2026, compared to $28 million for the same period in 2025. The decrease in revenue was primarily driven by lower development services revenue from the Gilead collaboration. Revenues reflect the recognition of payments previously received from our collaboration partners as we satisfy underlying performance obligations over time, and fluctuate each period based on our estimated progress toward completing those obligations rather than on the timing of cash receipts. Arcus expects to recognize GAAP revenue of between $50 million and $65 million for the full year 2026. Research and Development (R&D) Expenses were flat for the first quarter 2026, with (i) late-stage development programs increasing due to our investment in casdatifan and our Phase 3 PRISM-1 study for quemliclustat, partially offset by the wind-down of studies related to domvanalimab, (ii) early-stage development activities decreasing primarily due to the absence of prior-year Phase 2 study costs for domvanalimab, and (iii) partnership reimbursements decreasing, primarily due to Gilead-led activities representing a larger share of total joint development costs and a shift towards programs fully funded by us. Non-cash stock-based compensation expense was $9 million for the first quarter 2026, compared to $8 million for the same period in 2025. For the first quarters 2026 and 2025, Arcus recognized gross reimbursements of $19 million and $38 million, respectively, for shared expenses from its collaborations. R&D expenses by quarter may fluctuate due to the timing of clinical manufacturing and standard-of-care therapeutic purchases with a corresponding impact on reimbursements. We expect R&D expenses to decline in the near term relative to what we have incurred as we wind down studies for domvanalimab. Streamlining initiatives we have undertaken across our R&D operations in connection with this wind-down, together with efficiencies we are pursuing across our programs outside the Gilead collaboration, are expected to further reduce costs. These decreases will be partially offset by our increased investment in the development of casdatifan and advancement of our small-molecule inflammation and immunology programs. General and Administrative (G&A) Expenses were $29 million for the first quarter 2026, compared to $28 million for the same period in 2025. The increase was primarily due to an increase in non-cash stock-based compensation, which was primarily attributable to a separation agreement with an officer. Non-cash stock-based compensation expense was $10 million for the first quarter 2026, compared to $8 million for the same period in 2025. Net Loss was $128 million for the first quarter 2026, compared to $112 million for the same period in 2025. Conference Call Information: Arcus will host a conference call and webcast today, May 5, 2026, at 1:30 PM PT/4:30 PM ET to discuss its first-quarter 2026 financial results and pipeline updates. To access the call, please dial +1 (585) 542-9983 (local) or +1 (833) 461-5787 (toll-free), using Meeting ID: 304747896. Participants may also register for the call online using the following link: https://events.q4inc.com/attendee/304747896. To access the live webcast and accompanying slide presentation, please visit the “Investors & Media” section of the Arcus Biosciences website at www.arcusbio.com. A replay of the webcast will be available following the live event. About Arcus Biosciences Arcus Biosciences is a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules for the treatment of cancer and inflammatory and autoimmune diseases. In partnership with industry collaborators, patients and physicians around the world, Arcus is expediting the development of its late-stage portfolio 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-2a inhibitor for clear cell renal cell carcinoma, and quemliclustat, a small-molecule CD73 inhibitor for pancreatic cancer. For more information about Arcus Biosciences’ clinical and preclinical programs, please visit www.arcusbio.com. Forward-Looking Statements This press release contains forward-looking statements. All statements regarding events or results to occur in the future contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Arcus’s development strategies and opportunities, including thepotential for casdatifan to become the first and only HIF-2a inhibitor-based TKI-free regimen in the first line setting and plans to secure casdatifan as the backbone therapy in ccRCC; the timing and achievement of milestones, including the completion of enrollment in PEAK-1, the initiation of the next Phase 3 study for casdatifan, and the advancement of AB102 into the clinic; the progression into the clinic of additional molecules from Arcus’s inflammation and immunology programs; the timing of future data presentations; and expectations regarding the decline in its operating expenses, year-end cash balance and its anticipated cash runway. All forward-looking statements involve known and unknown risks and uncertainties and other important factors that may cause Arcus’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, risks associated with: Arcus’s ability to manage the breadth and pace of its development plans for casdatifan; the unexpected emergence of adverse events or other undesirable side effects with casdatifan; difficulties or delays in initiating, enrolling and completing clinical trials, including due to regulatory review, site activation, patient identification or enrollment, or manufacturing and supply constraints of investigational or standard-of-care products for such clinical trials; interim data not being guarantees of future data or replicated in other studies evaluating casdatifan, including the Phase 3 PEAK-1 study; adverse data from toxicology studies that affect Arcus’s ability to advance development candidates from its immunology and inflammation programs; the risk that the preclinical profiles of Arcus’s development candidates may not translate in clinical trials; changes in the competitive landscape for Arcus’s programs; the inherent uncertainty associated with pharmaceutical product development and clinical trials; and risks associated with Arcus’s ability to accurately forecast financial results and changes in Arcus’s operating plans. Risks and uncertainties facing Arcus are described more fully in the “Risk Factors” section of Arcus’s most recent periodic report filed with the U.S. Securities and Exchange Commission (SEC) and in other filings that Arcus makes with the SEC from time to time, which are available at www.sec.gov. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Arcus disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release, except to the extent required by law. The Arcus name and logo are trademarks of Arcus Biosciences, Inc. All other trademarks belong to their respective owners. ARCUS BIOSCIENCES, INC. Consolidated Statements of Operations (unaudited) (In millions, except per share amounts) Three Months Ended March 31, 2026 2025 Revenues: License and development services $ 12 $ 20 Other collaboration 5 8 Total revenues 17 28 Operating expenses: Research and development 122 122 General and administrative 29 28 Total operating expenses 151 150 Loss from operations (134 ) (122 ) Non-operating income (expense): Interest and other income, net 9 11 Interest expense (3 ) (1 ) Total non-operating income, net 6 10 Loss before income taxes (128 ) (112 ) Income tax expense — — Net loss $ (128 ) $ (112 ) Net loss per share: Basic and diluted $ (1.02 ) $ (1.14 ) Shares used to compute net loss per share: Basic and diluted 125.4 98.4 Selected Consolidated Balance Sheet Data (unaudited) (In millions) March 31, 2026 December 31, 2025 (1) Cash, cash equivalents and marketable securities $ 876 $ 1,010 Total assets 997 1,139 Total liabilities 473 508 Total stockholders’ equity 524 631 (1) Derived from the audited financial statements for the year ended December 31, 2025, included in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 25, 2026. Investor & Media Inquiries: Holli Kolkey VP of Corporate Affairs (650) 922-1269 hkolkey@arcusbio.com Maryam Bassiri Director of Corporate Affairs (510) 406-8520 mbassiri@arcusbio.com

Phase 3Financial StatementPhase 2Clinical Result

23 Apr 2026

·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

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

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05568095 (STAR-221, ESMO_GI2026 \| ESMO_GCC2026)	Phase 3	HER2 Positive Adenocarcinoma of Esophagus \| HER2 negative Gastric Cancer \| HER2 negative Gastroesophageal Junction Adenocarcinoma First line HER2-negative	1,040	domvanalimab+zimberelimab+chemo	bsyuipweoi(cddxvkhprx) = xhvygnpjsz kgrcckktlq (ulpselgtny, 13.1 - 15.7) View more	Negative	02 Jul 2026
				nivolumab+chemo	bsyuipweoi(cddxvkhprx) = wudhumrges kgrcckktlq (ulpselgtny, 12.3 - 15.4) View more
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	bhmelkgrvt(chrqzilzrj) = ryynuhtill ibmbehlmrf (nokwpobyiy, 44.5 - 71.6) View more	Positive	18 Oct 2025
				Domvanalimab+Zimberelimab+FOLFOX (PD-L1 positive)	bhmelkgrvt(chrqzilzrj) = khrzuzgwcs ibmbehlmrf (nokwpobyiy, 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%))	wjjfntrtek(ofutmzrhpl) = gvmicxcarm pzhzzdhqix (hdfmaxhwif, 45 - 77) View more	Positive	17 Oct 2025
				Domvanalimab (dom) + Zimberelimab (zim) + FOLFOX (PD-L1 High (TAP ≥5%))	wjjfntrtek(ofutmzrhpl) = bvwpjhbmjr pzhzzdhqix (hdfmaxhwif, 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	ahufhnmvdd(urmaurzonp) = umvklwwdgr jdmeyuujvw (jehcmsntfk, 45 - 72) View more	Positive	12 Oct 2025
				Domvanalimab + Zimberelimab + FOLFOX (PD‐L1 Positive (TAP ≥ 1%))	ahufhnmvdd(urmaurzonp) = awvsjkhygl jdmeyuujvw (jehcmsntfk, 45 - 77) View more
NCT06790706 (IMMUNORARE5, ASCO2025)	Phase 2	Anaplastic Thyroid Carcinoma BRAFV600 mutation \| TIGIT expression	24	DOMVANALIMAB + ZIMBERELIMAB combination	baxzrntmxi(wmpoxgajrs) = qxfpokdroq nierfnovdr (zfvmgarwil )	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	xjtpatxgbt(rdajgmmoon) = sejchimgbz elhkplxmiv (xuipbrloda, 13.7 - NE) View more	Positive	05 Nov 2024
				Zimberelimab	xjtpatxgbt(rdajgmmoon) = eksczqjkof elhkplxmiv (xuipbrloda, 7.8 - NE) View more
603 (SITC2024)	Phase 2	Hepatocellular Carcinoma	29	Domvanalimab + Zimberelimab	tvsftfyzsm(wntzqkecdd) = 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%) bzobpamgyq (rumvbpqlbm )	Positive	05 Nov 2024
NCT05724563 (2024 SITC)	Phase 2	Hepatocellular Carcinoma Second line \| Third line	29	Domvanalimab+赛帕利单抗	zykrghwizm(kzsgqiegve) = iqrzuxjozi ryapmmrgwx (zyeutkvsfc ) View more	Positive	05 Nov 2024
NCT05329766 (EDGE-Gastric, BusinessWire) Manual	Phase 2	Gastrointestinal Neoplasms First line PD-L1	41	domvanalimab+Zimberelimab+ Chemotherapy	fwuprmxftk(mewfhoothl) = jcisvgobyt wbjfcsdair (supepeifpv, 9.8 - 13.8) View more	Positive	01 Jun 2024
				domvanalimab+Zimberelimab+ Chemotherapy (PD-L1-high)	fwuprmxftk(mewfhoothl) = gckagzxohb wbjfcsdair (supepeifpv, 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	jtumhscnfo(zxrzpbthop) = esjkoiilmq pvorqwltzx (gkmmdllkch, 42 - 74) View more	Positive	06 Nov 2023
				Domvanalimab+zimberelimab+chemotherapy (PD-L1-high* (TAP ≥5%))	jtumhscnfo(zxrzpbthop) = uxwwtkyoiu pvorqwltzx (gkmmdllkch, 52 - 96) View more

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