NEW YORK – Shanghai-based LianBio on Tuesday said that it has received permission from regulators in China to begin evaluating infigratinib in patients with FGFR2 gene-amplified, locally advanced, or metastatic gastric or gastroesophageal junction cancer.
The multi-center, single-arm, Phase IIa trial, which the China National Medical Products Administration's Center for Drug Evaluation has cleared, is designed to assess the safety, efficacy, and pharmacokinetic profile of the selective pan-FGFR inhibitor infigratinib in this patient population.
Infigratinib is a product of QED Therapeutics, an affiliate of Palo Alto, California-based BridgeBio Pharma. However, as part of a strategic collaboration announced in August between LianBio and BridgeBio, LianBio is responsible for developing and commercializing the drug in mainland China, Hong Kong, and Macau.
"This clearance by the China NMPA to conduct the Phase IIa trial of infigratinib in gastric cancer will enable LianBio to work towards addressing the significant unmet medical need for this growing patient population," LianBio CEO Bing Li said in a statement.
LianBio is also conducting a Phase III study of the agent in patients with bile duct cancer whose tumors harbor FGFR2 gene fusions. QED, meanwhile, is evaluating infigratinib as a treatment for patients with urothelial cancer and targetable FGFR3 alterations and as a treatment for patients with metastatic solid tumors with FGFR1-3 gene fusions/translocations or other FGFR alterations.