arcotatug tavatecan (TAK-921) / Innovent Biologics, Takeda, Fortvita Biologics - LARVOL DELTA

Arcotatug tavatecan (IBI343/TAK-921) versus treatment of physician's choice (TPC) in previously treated, advanced gastric or gastroesophageal junction adenocarcinoma (G/GEJA): First interim analysis of the randomized, open-label, phase 3, G-HOPE-001 study (ESMO 2026) - No abstract available

Clinical • Late-breaking abstract • Metastases • P3 data • P3 data: top line • Gastric Adenocarcinoma • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Antibody-Drug Conjugates in the Treatment of Esophageal Cancer. (PubMed, Curr Treat Options Oncol) - "For HER2-negative gastroesophageal adenocarcinoma, trophoblast cell-surface antigen 2 represents a promising target given its high prevalence of moderate to strong expression in nearly 80% of cases, and sacituzumab tirumotecan is currently under phase III investigation in this setting...For Nectin-4-expressing tumors, enfortumab vedotin may be considered as a later-line alternative despite modest activity. Notably, the bispecific ADC targeting both epidermal growth factor receptor and human epidermal growth factor receptor 3, BL-B01D1, has demonstrated compelling efficacy in immunotherapy-refractory esophageal squamous cell carcinoma, and I consider it a breakthrough option in this subtype. For claudin-18.2-positive gastroesophageal junction adenocarcinoma, several ADCs including CMG901, IBI343, and tecotabart vedotin represent promising later-line choices. I emphasize that patient selection should be guided by validated predictive biomarkers, and treatment decisions..."

Biomarker • IO biomarker • Journal • Review • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Interstitial Lung Disease • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma • CLDN18 • ERBB3 • HER-2 • NECTIN4

Takeda Highlights Late-Stage Oncology Pipeline Progress and Solid Tumor Portfolio Research, Led by Late-Breaking Phase 3 Arcotatug Tavatecan (TAK-921) Data, at ESMO 2026 (Businesswire) - "Late-breaking data from the Phase 3 G-HOPE-001 study (NCT06238843) of arcotatug tavatecan being conducted in Japan and China in patients with previously treated advanced gastric or gastroesophageal junction adenocarcinoma (G/GEJA) will be presented during the ESMO proffered paper session on October 23, 13:30-15:00 CEST (Abstract LBA77)....Additionally, new findings for TAK-928 plus bevacizumab in immunotherapy-resistant non-small cell lung cancer (NSCLC) and TAK-928 plus chemotherapy in first-line NSCLC will be featured in two presentations."

Late-breaking abstract • P1 data • P3 data • Non Small Cell Lung Cancer

Anti-claudin18.2 (CLDN18.2) antibody-drug conjugate (ADC) IBI343 in patients (pts) with advanced pancreatic ductal adenocarcinoma (PDAC): Updated results from a phase I study (ESMO Asia 2024) - P1 | "Results As of July 6, 2024, 43 pts were enrolled from China and Australia (median age: 60.0 years, males: 55.8%, prior treatments ≥2L: 53.5%, prior irinotecan therapy: 46.5%, prior immunotherapy: 22.0%). Conclusions IBI343 was well tolerated and continued to show favorable safety profiles and encouraging efficacy in CLDN18.2-positive PDAC. The trial continues to enroll and more data will be presented at the meeting."

Clinical • IO biomarker • Metastases • P1 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • CLDN18

Beyond Zolbetuximab: Next-Generation Targeting Strategies for CLDN18.2. (PubMed, J Gastrointest Cancer) - "Tissue immunohistochemistry remains the reference method for treatment selection; circulating tumor DNA cannot currently reproduce membranous protein intensity or spatial distribution, and liquid-biopsy approaches for CLDN18.2 reassessment remain investigational."

Journal • Review • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Hematological Disorders • Oncology • Solid Tumor • CLDN18

Safety and efficacy of IBI343 (anti-claudin18.2 antibody-drug conjugate) in patients with advanced pancreatic ductal adenocarcinoma or biliary tract cancer: Preliminary results from a phase 1 study. (ASCO 2024) - P1 | "IBI343 was well tolerated with favorable safety profiles and encouraging efficacy in CLDN18.2-positive PDAC and BTC."

Clinical • Metastases • P1 data • Anemia • Biliary Cancer • Biliary Tract Cancer • Gastrointestinal Cancer • Hematological Disorders • Hepatology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CLDN18

Anti-claudin 18.2 (CLDN18.2) antibody-drug conjugate (ADC) IBI343 in patients (pts) with solid tumors and gastric/gastro-esophageal junction adenocarcinoma (G/GEJ AC): A phase I study (ESMO-GI 2024) - P1 | "IBI343 was well tolerated in all pts with encouraging efficacy in CLDN18.2-postive G/GEJ AC."

Clinical • IO biomarker • P1 data • Anemia • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Gastrointestinal Disorder • Hematological Disorders • Oncology • Solid Tumor • CLDN18

Claudin18.2 (CLDN18.2) expression and efficacy in pancreatic ductal adenocarcinoma (PDAC): Results from a phase I dose expansion cohort evaluating IBI343. (ASCO 2025) - P1 | "IBI343 was well tolerated and continues to show encouraging efficacy in pts with PDAC. Efficacy benefit was most pronounced in those with CLDN18.2 expression ≥60%, suggesting that CLDN18.2 can be a predictive biomarker for response to IBI343 in PDAC. The trial is enrolling in Australia, China, and US."

Clinical • P1 data • Anemia • Hematological Disorders • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • CLDN18

CLDN18.2-targeting antibody-drug conjugate IBI343 in advanced gastric or gastroesophageal junction adenocarcinoma: a phase 1 trial. (PubMed, Nat Med) - P1 | "IBI343 was well tolerated, with a manageable safety profile and promising efficacy in G/GEJ adenocarcinoma. Further research is required to understand optimal sequencing, and biomarker-informed combination therapy, in G/GEJ tumors given the development of multiple therapies targeting CLDN18.2 in addition to human epidermal growth factor receptor 2 and programmed cell death 1 ligand 1.ClinicalTrials.gov registration: NCT05458219 ."

Journal • P1 data • Esophageal Cancer • Febrile Neutropenia • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Hematological Disorders • Interstitial Lung Disease • Neutropenia • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • CLDN18 • HER-2 • PD-1 • PD-L1

Dragon15: IBI343 Combined With Sintilimab Plus Chemotherapy in Gastric Cancer (clinicaltrials.gov) - P1/2 | N=55 | Recruiting | Sponsor: Ruijin Hospital | Trial primary completion date: Jun 2026 ➔ Jul 2027

Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18

IBI343 in Combination With Sintilimab and SOX Regimen for Perioperative Treatment of Resectable, Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18

INNOVENT BIO...announced that the international Phase III clinical study (G-HOPE-001, NCT06238843) of IBI343 for patients with advanced gastric cancer has completed its first interim analysis as pre-specified and met the primary endpoint. (iis.aastocks.com) - "Based on these positive clinical results, the company has submitted a New Drug Application (NDA) for IBI343 to the National Medical Products Administration of China. The application has been accepted and granted priority review for the treatment of locally advanced unresectable or metastatic CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma in patients who have received at least two prior systemic therapies."

China filing • P3 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

IBI343 in Combination Therapy for Advanced Malignant Solid Tumors (clinicaltrials.gov) - P2 | N=389 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

A Multicenter, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, HER2-negative, Gastric or Gastroesophageal Junction Adenocarcinoma (G-HOPE-001) (clinicaltrials.gov) - P3 | N=464 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Monotherapy • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18

TAK-921: Proof of concept data readout from P1 trial (NCT05458219) for 1L gastric/gastroesophageal junction adenocarcinoma/ 1L PDAC in FY 2026/FY2027 (Takeda) - Q4 FY2025 Results

P1 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Pancreatic Ductal Adenocarcinoma

TAK-921: Regulatory filing in Japan for 3L gastric cancer in FY 2027 (Takeda) - Q4 FY2025 Results

Japan filing • Gastric Cancer • Gastrointestinal Cancer • Oncology

Pre-clinical characterization of IBI343, a site-specifically conjugated anti-Claundin18.2 ADC, for treating solid tumors (AACR 2024) - P1 | "These pre-clinical findings show that IBI343 is a promising anti-cancer agent with large therapeutic window, and support clinical exploration of IBI343 in patients with Claudin18.2-expressing tumors. A companion late-breaking abstract of clinical phase 1 study results (NCT05458219) will also be presented in AACR 2024."

ADC • Late-breaking abstract • Preclinical • Breast Cancer • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

VBC108: a first-in-class CDH17/CLDN18.2 targeted bispecific antibody drug conjugate (ADC) to overcome tumor heterogeneity of gastrointestinal cancers (GC, PADC, CRC, etc.) (AACR 2025) - "However, these therapies face challenges due to the heterogeneous expression of CLDN18.2, leading to inconsistent efficacy and the need of patient stratification, as observed with Zolbetuximab, AZD0901 and IBI343. VBC108 also exhibited excellent developability in a comprehensive developability assessment (DA) test, making it a strong candidate for further CMC development. In summary, VBC108, with its unique design, shows the potential as a first-in-class ADC for GI cancer and supports the advancement to clinical trials."

ADC • Bispecific • Heterogeneity • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CDH17 • CLDN18

IBI343 in Combination Therapy for Advanced Malignant Solid Tumors (clinicaltrials.gov) - P2 | N=389 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

New P2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

IBI343 in Combination With Sintilimab and SOX Regimen for Perioperative Treatment of Resectable, Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P2 | N=90 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

New P2 trial • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18

IBI343 Combined With Chemotherapy as Neoadjuvant Therapy in Borderline Resectable Pancreatic Cancer (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Zhejiang University

New P2 trial • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CLDN18

IBI343 combined with Sintilimab and SOX as first-Line therapy for CLDN18.2-positive locally advanced unresectable or metastatic HER2-negative gastric/gastroesophageal junction adenocarcinoma (G/GEJ AC) (ESMO Asia 2025) - P1/2 | "This study is recruiting at Ruijin Hospital affiliated with Shanghai Jiao Tong University School of Medicine. To date, 7 pts have been enrolled, and dose escalation is ongoing."

Clinical • IO biomarker • Metastases • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18 • HER-2

Innovent Biologics Announces Closing of Global Strategic Partnership with Takeda for Next-Generation IO and ADC Therapies (PRNewswire) - "Takeda will pay Innovent an upfront payment of US$1.2 billion, including a US$100 million equity investment in Innovent through new share issuance at premium, i.e., HK$112.56 per share. Furthermore, Innovent is eligible for development and sales milestone payments for IBI363, IBI343, and IBI3001 (if option exercised) totaling up to approximately $10.2 billion, for a total deal value of up to $11.4 billion. Innovent is also eligible to receive potential royalty payments for each molecule outside Greater China, except with respect to IBI363 in the U.S...."

Licensing / partnership • Solid Tumor

CIBI343A101: A First-in-human Study of IBI343 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=470 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Jun 2027

First-in-human • IO biomarker • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CLDN18 • PD-L1

Antibody-drug conjugates targeting the cadherin, claudin and nectin families of adhesion molecules. (PubMed, Front Mol Med) - "Enfortumab vedotin is an NECTIN4-targeting antibody-drug conjugate that is approved for the treatment of urothelial cancer, whereas other ADCs or derivatives that target NECTIN4, such as bulumtatug fuvedotin, SHR-A2102 and zelenectide pevedotin, are being studied in randomized phase III clinical trials. In contrast, arcotatug tavatecan, garetatug rezetecan, sonesitatug vedotin and tecotabart vedotin are anti-CLDN18.2 ADCs in phase III clinical trials for the treatment of CLDN18.2-positive gastric or gastroesophageal junction adenocarcinomas, and raludotatug deruxtecan is an anti-CDH6 ADC in a phase II/III clinical trial for the treatment of platinum-resistant ovarian cancer. ADCs that target cell-cell adhesion molecules are a rapidly emerging class of cancer therapeutics, and bispecific ADCs and longitudinal companion diagnostics are emerging to further improve the clinical benefits of conventional ADCs."

Journal • Review • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Genito-urinary Cancer • Oncology • Ovarian Cancer • Solid Tumor • Urothelial Cancer • CDH17 • CDH6 • CLDN18 • CLDN6