Takeda Reports Phase 3 Success for Arcotatug in Gastric Cancer

Osaka, Japan, and Cambridge, Massachusetts, U.S., October 23, 2026

Arcotatug Tavatecan Demonstrates Significant Survival Benefits

The Phase 3 G-HOPE-001 clinical trial evaluated arcotatug tavatecan against treatment of physician’s choice, which included irinotecan, paclitaxel or trifluridine/tipiracil. The study enrolled 464 patients in China and Japan whose CLDN18.2-positive gastric or gastroesophageal junction cancer had progressed after two to four prior systemic treatment regimens. The second interim analysis, with a data cutoff of September 3, 2026, showed that arcotatug tavatecan reduced the risk of death by approximately 43% compared with the control group, with a hazard ratio of 0.57 and a p-value below 0.0001. The treatment also reduced the risk of disease progression or death, with a PFS hazard ratio of 0.45. Median overall survival improved by 3.3 months, while median progression-free survival more than doubled from 3.1 months to 7.1 months. The study had already demonstrated a significant PFS benefit in its first prespecified interim analysis. Together, the findings indicate that the candidate may offer a new treatment option for patients with advanced CLDN18.2-positive disease who have limited options after earlier therapies.

Response Rates and Safety Profile Support Further Evaluation

The trial reported a confirmed objective response rate of 37.4% with arcotatug tavatecan, compared with 7.7% for treatment of physician’s choice, based on independent radiological review. The safety analysis indicated that the investigational ADC had a generally manageable profile. Grade 3 or higher treatment-related adverse events occurred in 47.4% of patients receiving arcotatug tavatecan, compared with 55.9% in the control group. Common severe adverse events included anemia, decreased neutrophil counts and decreased white blood cell counts. Grade 3 or higher nausea, vomiting and diarrhoea occurred in 0.9%, 2.6% and 1.3% of patients receiving arcotatug tavatecan, respectively. Treatment-related discontinuation was uncommon, occurring in 1.7% of patients in the investigational treatment group. However, one treatment-related fatal adverse event, reported as sudden death of unknown cause, occurred in the arcotatug tavatecan arm. These safety findings are important when evaluating the candidate’s potential clinical value and will require continued monitoring as development progresses.

Takeda Advances CLDN18.2-Targeted Cancer Drug Development

Arcotatug tavatecan is a next-generation antibody-drug conjugate targeting CLDN18.2, a protein found in the stomach lining that can be abnormally expressed on certain cancer cells. The candidate combines an anti-CLDN18.2 antibody with exatecan, a cytotoxic topoisomerase I inhibitor designed to damage cancer cells. Its Fc-silenced structure is intended to reduce certain unwanted immune-mediated effects. By directing a potent anticancer payload toward CLDN18.2-expressing tumour cells, the treatment aims to provide targeted activity in gastric and other gastrointestinal cancers. Takeda holds rights to develop, manufacture and commercialize the candidate worldwide outside greater China through a collaboration with Innovent. The company plans to use the G-HOPE-001 results to support a regulatory filing in Japan and to initiate global Phase 3 studies in gastric and pancreatic cancer. In China, Innovent’s new drug application has been accepted for Priority Review by the National Medical Products Administration. Arcotatug tavatecan has also received U.S. FDA Fast Track Designation for certain patients with CLDN18.2-positive advanced pancreatic cancer. The candidate remains investigational and has not been approved by the FDA or other regulatory authorities.

Source: Takeda press release