NEW YORK – BridgeBio Pharma and LianBio said on Wednesday they have dosed the first patient in a Phase IIa trial in China of infigratinib (Truseltiq) in patients with advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 gene amplification and with other advanced solid tumors with FGFR alterations.
The single-arm study will evaluate infigratinib's activity in these patients. The primary endpoint is objective response rate, and secondary endpoints include duration of response, safety, disease control rate, progression-free survival, and overall survival. In a preclinical study, infigratinib caused tumor regression in FGFR2-amplified gastric cancer cell lines.
"Given the disproportionately high prevalence rate of gastric cancer in China, LianBio is pursuing a region-specific development strategy focused on this area of great unmet need," LianBio CEO Yizhe Wang said in a statement. "This study marks LianBio's first trial initiation and demonstrates our continued progress in delivering potentially transformational medicines to patients in Asia."
In 2020, Shanghai-based LianBio in-licensed infigratinib for development and commercialization in mainland China, Hong Kong, and Macau from QED Therapeutics, an affiliate of BridgeBio. LianBio is also studying infigratinib in a Phase III trial involving bile duct cancer patients with FGFR2 gene fusions.
The US Food and Drug Administration granted Palo Alto, California-headquartered BridgeBio and the Helsinn Group accelerated approval for infigratinib in May for previously treated, FGFR2 fusion-positive, locally advanced or metastatic cholangiocarcinoma patients. QED is also studying the drug in FGFR3-altered urothelial cancer.