Takeda's $11.4 billion investment in Chinese biotech Innovent Biologics is starting to pay off, as the company seeks regulatory approval for its stomach cancer drug, arcotatug tavatecan, in its home country following successful phase III clinical trials.
In the Phase III G-HOPE-001 study (NCT06238843), conducted at centers across China and Japan, Innovent is comparing its CLDN18.2-targeted antibody-drug conjugate (ADC) to Pfizer's Campto (irinotecan) or a combination of the oral chemotherapy drug trifluridine and the chemotherapy booster tipirachi. The study enrolled patients with refractory, locally advanced, unresectable, or metastatic CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma (G/GEJA) as third-line treatment.
At the first per-protocol interim analysis, arcotatug tavatecan significantly improved progression-free survival (PFS) in patients receiving third-line or later treatment, meeting the primary objective of the study.
According to Professor Lin Shen, director of the gastrointestinal oncology department at Beijing Cancer Hospital, the drug also demonstrated a "manageable" safety profile, potentially offering new options for patients and "promoting the implementation of accurate diagnosis and treatment of gastrointestinal tumors with targeted therapy.".
Arcotatug tavatecan, a biomarker-guided therapy, was developed by Innovent for use in precision medicine—selectively delivering the highly effective exatecan to tumor cells. Innovent also optimized the drug to minimize tumor toxicity. Previously, in October 2025, Takeda acquired rights to this ADC outside of China in a mega-deal worth $11.4 billion.
Next steps for arcotatug tevatecan
While Innovent has not yet disclosed further details about the G-HOPE-001 study results, it noted that the National Medical Products Administration (NMPA) of China has accepted its New Drug Application (NDA) for arcotatug tevatecan for the third-line treatment of CLDN18.2-positive glioblastoma/hepatocellular epidermolysis and will be given priority review by the regulator.
If approved, this drug would be the first CLDN18.2-targeted ADC to receive regulatory approval, providing patients with refractory disease with a new treatment option in settings with limited options and poor prognosis.
According to an article published in journal Clinical Oncology , 35% to 40% tumors in patients with unresectable or metastatic gastroenteropathy/hepatoendothelial alopecia exhibit high CLDN18.2 expression, while Innovent estimates that approximately 80% tumors are CLDN18.2-positive, highlighting its potential as a target for patients with this indication.
While arcotatug tevatecan may be the first ADC to target CLDN18.2, it is not the first drug to use this target, as Astellas Pharma previously received US approval in 2024 for another CLDN18.2 inhibitor, Vyloy (zolbetuximab), which is approved for use in combination with chemotherapy in patients with HER2-negative gastroesophageal reflux disease.
According to the GlobalData Pharmaceutical Intelligence Center, more than 100 clinical trials of CLDN18.2 for the treatment of stomach cancer are currently underway, with the majority of them in phase II.
GlobalData is the parent company Clinical Trials Arena.
The article "Innovent considers third-line gastric cancer drug after successful completion of Phase III clinical trial" was originally created and published by Clinical Trials Arena, a brand owned by GlobalData.
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