Takeda to Present Late-Breaking Phase 3 Data for Claudin 18.2 ADC Arcotatug Tavatecan at ESMO 2026
核心洞察
Takeda will present late-breaking Phase 3 G-HOPE-001 data for arcotatug tavatecan (搜索) (TAK-921), a Claudin 18.2 (搜索)-targeted antibody-drug conjugate, in previously treated advanced gastric and gastroesophageal junction adenocarcinoma (搜索).
The G-HOPE-001 study was conducted in Japan and China, and pending final results, its data could support a potential regulatory filing for this indication in Japan.
Two ESMO presentations will cover TAK-928 (搜索), a first-in-class PD-1 (搜索)/alpha-biased IL-2 bispecific fusion protein, in immunotherapy-resistant and first-line non-small cell lung cancer (搜索).
Takeda will present late-breaking data from the first Phase 3 registrational study of arcotatug tavatecan (搜索) (TAK-921) in previously treated advanced gastric cancer (搜索) at the European Society for Medical Oncology (ESMO) Congress, taking place October 23-27, 2026, in Madrid, Spain. The company announced the presentations, which also include two datasets for TAK-928 (搜索) in non-small cell lung cancer (搜索) (NSCLC) and clinical and real-world analyses of its approved medicines ALUNBRIG (brigatinib) and FRUZAQLA (fruquintinib).
G-HOPE-001 in Gastric and Gastroesophageal Junction Adenocarcinoma
The late-breaking abstract (LBA77) comes from the Phase 3 G-HOPE-001 study (NCT06238843), conducted in Japan and China in patients with previously treated advanced gastric or gastroesophageal junction adenocarcinoma (搜索) (G/GEJA). Results will be presented during the ESMO proffered paper session on October 23, 13:30-15:00 CEST.
Arcotatug tavatecan (搜索) is an investigational Claudin 18.2 (搜索)-targeted antibody-drug conjugate (ADC) carrying an exatecan payload, with an Fc-silenced backbone designed to reduce Fc-mediated toxicities. Pending evaluation of final study results, data from G-HOPE-001 could support a potential regulatory filing for this indication in Japan.
"Takeda's data at ESMO reflect our commitment to delivering rapid progress for patients living with some of the most prevalent and challenging cancers, including advanced gastric cancer (搜索) and immunotherapy-resistant and previously untreated non-small cell lung cancer (搜索)," said Phuong Khanh (P.K.) Morrow, M.D., Head of the Oncology Therapeutic Area Unit at Takeda. "Our mission is to advance new therapeutic approaches for patients who need more options or who remain underserved by current standards of care."
TAK-928 in Immunotherapy-Resistant and First-Line NSCLC
Two presentations will feature new findings for TAK-928 (搜索), a potential first-in-class PD-1 (搜索)/alpha-biased IL-2 bispecific fusion protein. The datasets cover TAK-928 plus bevacizumab in immunotherapy-resistant NSCLC and TAK-928 plus chemotherapy in first-line NSCLC.
Based on data showing promising efficacy and manageable safety in NSCLC to date, Takeda is conducting the global Phase 3 MarsLight-11 study (NCT07217301), which evaluates TAK-928 (搜索) against docetaxel monotherapy in patients with squamous NSCLC whose disease has progressed on or after chemotherapy and immunotherapy. Enrollment is ongoing at trial sites globally, including in the United States. Takeda will also expand MarsLight-11 to include a new sub-trial for patients with non-squamous NSCLC.
Real-World and Clinical Analyses of Approved Medicines
Additional ESMO 2026 presentations will cover Takeda's marketed thoracic and gastrointestinal cancer medicines. Real-world interim results on treatment patterns and outcomes with ALUNBRIG as a first-line treatment for adults with anaplastic lymphoma kinase positive (ALK (搜索)+) NSCLC will be presented as an e-poster. Updated results from a global FRUZAQLA Expanded Access Program for patients with previously treated metastatic colorectal cancer (搜索) (mCRC) will be presented as a poster.
ALUNBRIG is a kinase inhibitor indicated for adult patients with ALK (搜索)-positive metastatic NSCLC as detected by an FDA-approved test. FRUZAQLA is indicated for adult patients with mCRC previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.
Licensing and Development Scope
Arcotatug tavatecan (搜索) and TAK-928 (搜索) are investigational compounds that have not been approved for use by the U.S. FDA or any other regulatory authorities. Innovent (搜索) refers to arcotatug tavatecan and TAK-928 as IBI343 and IBI363, respectively. Under a license and collaboration agreement with Innovent, Takeda holds rights to develop, manufacture and commercialize arcotatug tavatecan worldwide outside of greater China. For TAK-928, Takeda will lead global co-development and U.S. co-commercialization and holds exclusive commercialization rights outside the U.S. and Greater China.
Takeda's oncology development efforts are focused on three strategic areas: hematologic, thoracic and gastrointestinal cancers.