Takeda’s $11.4bn bet on assets from Chinese biotech, Innovent Biologics, is showing early signs of paying off, as the latter is seeking the regulatory go-ahead for its gastric cancer asset, arcotatug tavatecan, on home turf following a Phase III win.
In the Phase III G-HOPE-001 study (NCT06238843), which is ongoing at sites across China and Japan, Innovent is pitting its CLDN18.2-targeting antibody-drug conjugate (ADC) against Pfizer’s Campto (irinotecan) or a combination of oral chemotherapy agent, trifluridine and chemotherapy ‘booster’ drug, tipiraci. The study enrolled patients with refractory, locally advanced, unresectable or metastatic CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma (G/GEJA) as a third-line therapy.
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At the per-protocol first interim analysis, arcotatug tavatecan offered a significant boost to progression-free survival (PFS) in third-line-plus patients – meeting the trial’s primary endpoint.
According to Professor Lin Shen, director of gastrointestinal oncology at the Beijing Cancer Hospital, the drug also demonstrated a “manageable” safety profile, potentially offering patients new options, while “helping the adoption of precision diagnosis and treatment for gastrointestinal tumours with targeted therapies”.
Arcotatug tavatecan, a biomarker-guided therapy, has been designed by Innovent to act as a precision medicine – selectively delivering a high-potency exatecan payload to tumour cells. Innovent has also optimised the drug to minimise off-tumour toxicities. Takeda previously secured the rights to the ADC outside of China through its $11.4bn mega-deal in October 2025.
Next steps for arcotatug tevatecan
While Innovent is yet to divulge further details on the G-HOPE-001 outcomes, the company did note that China’s National Medical Products Administration (NMPA) has accepted its new drug application (NDA) for arcotatug tevatecan in third-line, CLDN18.2-positive G/GEJA, which the regulator will assess under priority review.
If approved, the drug would become the first CLDN18.2-targeting ADC to get the regulatory greenlight – offering refractory patients a new treatment option while choice remains limited and prognosis remains poor in this setting.
According to a paper published in the Journal of Clinical Oncology, between 35% and 40% of tumours in patients with unresectable or metastatic G/GEJA demonstrate a high expression of CLDN18.2, while Innovent estimates that around 80% of tumours are CLDN18.2-positive – highlighting its potential as a target for patients with this indication.
While arcotatug tevatecan could become the first CLDN18.2-directed ADC, it is not the first drug to harness this target, as Astellas Pharma previously secured a US approval for its fellow CLDN18.2 inhibitor, Vyloy (zolbetuximab) back in 2024, which is greenlit for use alongside chemotherapy in patients with HER2-negative G/GEJ.
According to GlobalData’s Pharmaceutical Intelligence Center, there are over 100 ongoing gastric cancer clinical trials focused on CLDN18.2, with the largest proportion of these being in Phase II.
GlobalData is the parent company of Clinical Trials Arena.
