Yutuo (zimberelimab) / Gloria Pharma, WuXi AppTec, Arcus Biosciences, Ligand, Otsuka, Gilead, Taiho - LARVOL DELTA

ARIAN, a Phase III, Randomized Study of Adjuvant Treatment With Sacituzumab and Zimberelimab in Resected Patients (IASLC-WCLC 2026) - "The combination of PD-1/PD-L1 agents and antibody-drug conjugates (ADCs), such as sacituzumab govitecan, (a TROP-2 directed ADC), has emerged as a promising therapeutic option in clinical practice. Survival outcomes will be analyzed using Cox proportional hazard models, log-rank tests, and Kaplan-Meier curves, while categorical and numerical variables will be analyzed using Pearson's chi-squared or Fisher's exact tests and Kruskal-Wallis tests, respectively.The study was approved by health authorities on 19 August 2024. As of the data cut off in February 2026, 39 patients have been screened and 26 enrolled in the study: 9 patients in arm 1, 9 patients in arm 2, and 8 patients in arm 3."

Clinical • IO biomarker • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Clinical Characteristics Analysis of a Single-Cell and Spatial Transcriptomics Cohort Treated with Zimberelimab Combined with Chemoradiotherapy for Intermediate- and Advanced-Stage Cervical Cancer (ESMO 2026) - No abstract available

Clinical • Metastases • Cervical Cancer • Oncology • Solid Tumor

Sacituzumab Govitecan (SG) Combined With Enfortumab Vedotin (EV) and Zimberelimab (ZIM) in Treatment-Naive Metastatic Urothelial Cancer (mUC): Interim Results From Phase 1b TROPHY-U-01 Cohort 7 (ESMO 2026) - No abstract available

Metastases • P1 data • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Immune-Related Adverse Events and Infections in Cancer Patients With Splenectomy Receiving Immune Checkpoint Inhibitor Therapy (ACG 2026) - "59.8 % of irAE patients required systemic steroids, with 17.1% needing high-dose therapy (â¥1mg/kg prednisone equivalent)...cImmunosuppressants: bevacizumab, rituximab, imatinib, lenalidomide, 5-azacitinide dICI agents by class: Anti-PD-1: pembrolizumab, nivolumab, cemiplimab, tislelizumab, toripalimab, zimberelimab. Total 293 patients met the inclusion criteria. Primary malignancies: 31.7 % GI, 18.8% GU, and 11.3% lung. Asplenic patients had lower irAE severity compared to general populations: high-grade irAEs (⥠3) occurred in 10.6% of all patients versus 19.7% in general ICI-treated populations, despite 20.5% of patients receiving combination ICI therapy."

Adverse events • Checkpoint inhibition • Clinical • Hematological Malignancies • Infectious Disease • Nephrology • Oncology • Pneumonia • Respiratory Diseases

Zimberelimab plus lenvatinib in patients with advanced cervical cancer who progressed after prior immune checkpoint inhibitors: a multicenter, single-arm, phase II trial (SGO 2025) - No abstract available

Checkpoint inhibition • Clinical • Metastases • P2 data • Cervical Cancer • Oncology • Solid Tumor

A Study of GLS-010 Plus Platinum-containing Chemotherapy±Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer (clinicaltrials.gov) - P3 | N=424 | Recruiting | Sponsor: Guangzhou Gloria Biosciences Co., Ltd. | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2026 ➔ Dec 2030 | Trial primary completion date: May 2025 ➔ Dec 2029

Enrollment open • Trial completion date • Trial primary completion date • Cervical Cancer • Oncology • Solid Tumor • PD-L1

ARC-9: A randomized study to evaluate etrumadenant based treatment combinations in previously treated metastatic colorectal cancer (mCRC). (ASCO 2024) - P1/2 | "ARC-9 (NCT04660812), a Phase Ib/II trial evaluating the safety and efficacy of E combined with zimberelimab (Z) (anti-PD-1 antibody), and FOLFOX/bevacizumab (bev) regimens or novel therapies in 3 cohorts of patients (pts) with mCRC... Cohort B enrolled pts who previously progressed on both oxaliplatin and irinotecan containing regimens.Pts were randomized 2:1 to EZFB: E (150 mg orally [PO] once daily [QD]) + Z (240 mg intravenous [IV] once every 2 weeks [Q2W]) + mFOLFOX-6 + bev (5 mg/kg IV Q2W), or regorafenib (rego) (160 mg PO QD [days 1-21 every 4 weeks])... In this randomized phase II clinical trial, EZFBsignificantlyimproved efficacy outcomes compared to rego in refractory mCRC pts previously treated with 5-FU, oxaliplatin and irinotecan regimens with no unexpected toxicities. Further investigation of this promising regimen is warranted given the clinically meaningful PFS and OS improvement. Table"

Clinical • Metastases • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

ARC-8: A Study to Evaluate the Safety and Tolerability of AB680 in Participants With Gastrointestinal Malignancies (clinicaltrials.gov) - P1 | N=196 | Completed | Sponsor: Arcus Biosciences, Inc. | Trial completion date: May 2027 ➔ Jul 2026 | Trial primary completion date: May 2027 ➔ Jul 2026 | Active, not recruiting ➔ Completed

Trial completion • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Phase 2 randomized study of domvanalimab combined with zimberelimab in front-line, PD-(L)1 high, locally advanced or metastatic non-small cell lung cancer (NSCLC): results from ARC-10 part 1 (SITC 2024) - P3 | "Ethics Approval At each site, the study was conducted in full accordance with the 21 Code of Federal Regulations, International Council for Harmonisation guidelines, institutional review board and independent ethics committee guidelines, and all other applicable local or regional regulations. All patients provided written informed consent before enrollment.View this table:View inline View popup Download powerpoint Abstract 1461 Table 1 ARC-10 study efficacy endpointsDownload figure Open in new tab Download powerpoint Abstract 1461 Figure 1 Kaplan-Meier estimate of progression-free survivalDownload figure Open in new tab Download powerpoint Abstract 1461 Figure 2 Kaplan-Meier estimate of overall survival"

Clinical • IO biomarker • Late-breaking abstract • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • TIGIT

ARC-7: Randomized phase 2 study of domvanalimab + zimberelimab ± etrumadenant versus zimberelimab in first-line, metastatic, PD-L1-high non-small cell lung cancer (NSCLC). (ASCO Plenary Dec 2022) - P2 | "NCT04262856"

Clinical • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Updates on Abstract 397600: ARC-7: Randomized phase 2 study of domvanalimab + zimberelimab ± etrumadenant versus zimberelimab in first-line, metastatic, PD-L1-high non-small cell lung cancer (NSCLC) (ASCO 2023) - No abstract available

Clinical • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

A phase 2 single-arm study testing SBRT, adenosine signaling modulation, and immune checkpoint inhibition for men with hormone-sensitive oligometastatic prostate cancer (SBRT-AMICO). (ASCO-GU 2024) - P2 | " SBRT-AMICO is a single-arm phase 2 trial testing the combination of a CD73 inhibitor (AB680), A2AR/A2BR inhibitor (AB928), and anti-PD-1 (AB122) with metastasis-directed SBRT for omHSPC. Arterioscler Thromb Vasc Biol, 2012. Clinical trial information: NCT05915442."

Checkpoint inhibition • Metastases • P2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD73 • ENTPD1

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 | Completed | Sponsor: Arcus Biosciences, Inc. | Active, not recruiting ➔ Completed

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

STAR-221: A phase III study of first-line (1L) domvanalimab (D), zimberelimab (Z), and chemotherapy (chemo) vs nivolumab (N) + chemo in advanced HER2-negative gastric, gastroesophageal junction, or esophageal adenocarcinoma (GC/GEJC/EAC) (ESMO-GI 2026) - P3 | "No new safety findings were identified. Table: 493O"

Clinical • Metastases • P3 data • Esophageal Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2 • TIGIT

VELOCITY-HNSCC: Study of Novel Treatment Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma Regardless of PD-L1 Expression Status; Substudy-01 (clinicaltrials.gov) - P2 | N=39 | Active, not recruiting | Sponsor: Gilead Sciences | N=100 ➔ 39 | Trial completion date: Aug 2026 ➔ Mar 2027 | Trial primary completion date: Aug 2026 ➔ Mar 2027

Enrollment change • IO biomarker • Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Updates on Abstract 433248: EDGE-Gastric Arm A1: Phase 2 Study of Domvanalimab, Zimberelimab, and FOLFOX in First-Line (1L) Advanced Gastroesophageal Cancer (ASCO 2024) - No abstract available

Clinical • Metastases • P2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Updated results of surufatinib combined with gemcitabine and cisplatin and immune checkpoint inhibitor (ICI) for unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma. (ASCO 2026) - P4 | "Pts received surufatinib (250mg, orally, once daily), ICI (Zimberelimab or Toripalimab, 240mg, intravenous infusion, d1, q3w), and chemotherapy (gemcitabine 1000mg/m2 intravenous infusion, 30min, d1, d8, q3w; cisplatin 25mg/m2 intravenous infusion, 2h, d1, d8, q3w) until disease progression, death, surgery, intolerable toxicity, or withdrawal of consent. Surufatinib plus gemcitabine and cisplatin combined with immune checkpoint inhibitor, the chemotherapy regimen as the standard treatment in combination with targeted and immunotherapy showed preliminary anti-tumor activity and manageable toxicity for the 1L treatment of ICC, providing an additional treatment option for pts with ICC. This study has been completed and the paper has been prepared for submission, the final results details will be published after the conference."

Checkpoint inhibition • Metastases • Biliary Cancer • Cholangiocarcinoma • Hypertension • Infectious Disease • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • CSF1R • FGFR1 • FLT1

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) - P2, P3 | "EDGE-Gastric (NCT05329766), Arm A1 evaluated the efficacy and safety of 1L dom (Fc-silent anti-TIGIT), zim (anti–PD-1), and FOLFOX (oxaliplatin, leucovorin, and fluorouracil) in patients (pts) with previously untreated advanced HER-2-negative GC/GEJC/EAC. The safety profile was consistent with that of anti–PD-1 + FOLFOX. The phase 3 STAR-221 trial (NCT05568095) comparing 1L dom + zim + chemotherapy vs nivolumab + chemotherapy in advanced GC/GEJC/EAC is fully enrolled."

Clinical • Metastases • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Oncology • Solid Tumor • HER-2 • PD-L1 • TIGIT

A phase 1 study of futibatinib in combination with zimberelimab and chemotherapy in first-line unresectable advanced or metastatic biliary tract cancer (ESMO-GI 2026) - P1 | "Treatment consisted of zimberelimab 360 mg on day 1, futibatinib 20 mg (dose level [DL] 1) once daily, and gemcitabine 1000 mg/m 2 plus cisplatin 25 mg/m 2 on days 1 and 8 of a 3 week cycle. Conclusions Futibatinib in combination with zimberelimab and chemo showed manageable safety profile and encouraging signs of antitumor activity in pts with UR/M BTC, supporting follow-up. A phase 3 trial involving multiple countries is planned to compare futibatinib + zimberelimab + chemo with the investigator's choice of anti–PD-(L)1 antibody + chemo as 1L UR/M BTC."

Clinical • Combination therapy • Metastases • P1 data • Biliary Cancer • Biliary Tract Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CAFs

EDGE-Gastric Arm A1: Phase 2 study of domvanalimab, zimberelimab, and FOLFOX in first-line (1L) advanced gastroesophageal cancer (ASCO Plenary Nov 2023) - P2 | "NCT05329766"

Clinical • Metastases • P2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

TROPHY-U-01 Cohort 4 (C4): Sacituzumab govitecan (SG) in combination with cisplatin (cis) as first-line (1L) therapy, followed by maintenance avelumab plus (+) SG or zimberelimab (zim) + SG in patients (pts) with treatment (Tx)-naïve metastatic urothelial cancer (mUC). (ASCO 2023) - P2 | "Enrollment is ongoing; up to 57 pts expected across ~120 sites in North America and Europe. Clinical trial information: NCT03547973."

Clinical • Combination therapy • Metastases • Genito-urinary Cancer • Hematological Disorders • Interstitial Lung Disease • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Urothelial Cancer

Study of Denikitug (GS-1811) Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=304 | Active, not recruiting | Sponsor: Gilead Sciences | Recruiting ➔ Active, not recruiting

Enrollment closed • First-in-human • Monotherapy • Oncology • Solid Tumor

Tumor Biomarker Analysis of Anti-CD39 Monoclonal Antibody AB598 in a First-In-Human Phase I Trial in Patients with Advanced Solid Tumors (SITC 2025) - P1 | "ARC-25 (NCT05891171) is a phase 1/1b trial to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AB598 monotherapy and combination therapy with zimberelimab (anti-PD-1) and standard-of-care chemotherapy. Enrollment at any clinical study site did not begin prior to that site receiving approval from the ethics committee of record for the protocol and all materials provided to potential patients. All participants provided informed consent prior to any clinical research sample collection."

Biomarker • Clinical • First-in-human • IO biomarker • Metastases • P1 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • ENTPD1

ZODIAC: Zimberelimab Anti-PD1 +/- Domvanalimab in Resectable Mmrd Gastric Cancer (clinicaltrials.gov) - P2 | N=50 | Suspended | Sponsor: Royal Marsden NHS Foundation Trust | Recruiting ➔ Suspended

dMMR • Mismatch repair • Trial suspension • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Microsatellite Instability • Oncology • Solid Tumor • MLH1 • MSH2 • MSH6 • MSI

MODULE 4: Other Novel Agents and Strategies Under Evaluation for Advanced Gastroesophageal Cancers (ASCO-GI 2026) - "This event is organized and accredited by Research To Practice and supported by educational grants from Astellas, BeOne, Gilead Sciences Inc, and Jazz Pharmaceuticals Inc. Potential immunotherapy targets beyond PD-1/PD-L1 and CTLA-4 in gastroesophageal cancers; proposed rationale for targeting TIGIT Updated efficacy findings, including overall survival outcomes, documented with the combination of the anti-TIGIT monoclonal antibody domvanalimab, the anti-PD-1 antibody zimberelimab and chemotherapy as first-line therapy for advanced gastroesophageal adenocarcinoma in arm A1 of the EDGE-Gastric study Emerging outcomes from the Phase III STAR-221 trial comparing domvanalimab/zimberelimab/chemotherapy to nivolumab/chemotherapy for previously untreated advanced gastric, GEJ and esophageal adenocarcinoma Mechanism of action of and early findings with the PD-1/TIGIT bispecific antibody rilvegostomig for advanced gastroesophageal cancers Ongoing Phase III ARTEMIDE-Gastric01 study..."

Metastases • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18 • HER-2 • TIGIT