NEW YORK – Shanghai-based LianBio said on Tuesday that Chinese regulators have cleared the launch of a Phase III clinical trial of infigratinib in patients with bile duct cancer whose tumors have FGFR2 gene fusions.
The China National Medical Products Administration's drug evaluation center has okayed the start of the Proof trial to study the FGFR2 inhibitor as a first-line treatment for patients with locally advanced or metastatic, unresectable cholangiocarcinoma. Researchers will evaluate the pharmacokinetic profile, efficacy, and safety of infigratinib in these patients.
"Untreated cholangiocarcinoma is usually fatal, with only 50 percent of patients surviving for one year," LianBio CEO Bing Li said in a statement. "Given the severity of the disease and increasing prevalence in China, there is a high urgency to bring innovative treatments to this patient population."
An earlier Phase II trial of infigratinib showed an overall response rate of 27 percent in bile duct cancer patients who had these mutations and had progressed on chemotherapy. About a quarter of the patients in that trial had a partial response to the treatment, though none had a complete response. In that study, the median progression-free survival was 6.8 months and median overall survival was more than a year.Â
LianBio licensed infigratinib from BridgeBio Pharma for development and commercialization in Mainland China, Hong Kong, and Macau. BridgeBio, with its affiliate QED Therapeutics, is currently studying infigratinib in two trials: a Phase III trial to treat urothelial cancer patients with a targetable FGFR3 alteration and a Phase II trial in patients with FGFR-altered solid tumors.Â