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Late-Breaking Abstract to Feature New Data from First Phase 3 Registrational Study of Arcotatug Tavatecan in Previously Treated Advanced Gastric Cancer
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TAK-928 Presentations Reinforce Potential in Patients with Immunotherapy-Resistant Non-Small Cell Lung Cancer (NSCLC) and Previously Untreated NSCLC
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Takeda Continues to Progress Clinical Development of Arcotatug Tavatecan and TAK-928; New Non-Squamous NSCLC Sub-Trial Added to Global Phase 3 MarsLight-11 Study Evaluating TAK-928 vs. Docetaxel Monotherapy
OSAKA, Japan and CAMBRIDGE, Massachusetts, September 22, 2026 – Takeda (TSE:4502/NYSE:TAK) announced that new data from its oncology pipeline and portfolio will be presented at the European Society for Medical Oncology (ESMO) Congress, taking place October 23-27, 2026, in Madrid, Spain. Key data will include a late-breaking abstract on arcotatug tavatecan (TAK-921; Innovent R&D code: IBI343*) and two presentations on TAK-928 (Innovent R&D code: IBI363*). Clinical and real-world analyses of ALUNBRIG® (brigatinib) and FRUZAQLA® (fruquintinib) will also be shared at the congress.
“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 and immunotherapy-resistant and previously untreated non-small cell lung cancer,” 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. Together, our late-stage oncology pipeline and portfolio of thoracic and gastrointestinal cancer medicines are helping address patients’ needs today while building possibilities for the future.”
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). Arcotatug tavatecan is an investigational Claudin 18.2-targeted antibody-drug conjugate (ADC) with an exatecan payload and 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.
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. TAK-928 is a potential first-in-class PD-1/alpha-biased IL-2 bispecific fusion protein. Based on data showing promising efficacy and manageable safety in NSCLC to date, Takeda is conducting the global Phase 3 MarsLight-11 study (NCT07217301) evaluating TAK-928 vs. docetaxel 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 U.S. In addition, Takeda will expand the MarsLight-11 study to include a new sub-trial for patients with non-squamous NSCLC.
Takeda is committed to developing oncology medicines in three strategic areas of focus: hematologic, thoracic and gastrointestinal cancers. Further presentations at ESMO 2026 will highlight clinical and real-world analyses spanning Takeda’s approved medicines across thoracic and gastrointestinal cancers, including:
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Real-world interim results on treatment patterns and outcomes with ALUNBRIG as a first-line treatment for adults with anaplastic lymphoma kinase positive (ALK+) NSCLC to be presented as an e-poster
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Updated results from a global FRUZAQLA Expanded Access Program for patients with previously treated metastatic colorectal cancer (mCRC) to be presented as a poster
Arcotatug tavatecan and TAK-928 are investigational compounds that have not been approved for use by the U.S. FDA or any other regulatory authorities.
*Innovent refers to arcotatug tavatecan (TAK-921) and TAK-928 as IBI343 and IBI363, respectively. Takeda entered into a license and collaboration agreement with Innovent. Under the agreement, Takeda holds the 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 has exclusive commercialization rights outside the U.S. and Greater China.
About Takeda
Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries.