China-based LianBio (OTCMKTS: LIANY) revealed in an SEC filing that it is canceling work on a Phase III trial in China for Truseltiq (infigratinib). The decision follows an announcement by BridgeBio Pharma Inc. (NASDAQ: BBIO), the drug’s discoverer, that the ongoing global Phase III PROOF-301 trial is being closed. This closure is due to Helsinn Healthcare SA, BridgeBio’s partner on infigratinib, deciding to permanently discontinue distribution of the drug and withdraw a current New Drug Application (NDA) filing with the US FDA.
Background on Infigratinib
Originally developed by BridgeBio, infigratinib is a pan-fibroblast growth factor receptor (FGFR) kinase inhibitor. It received accelerated (conditional) approval from the US FDA in May 2021 for the treatment of unresectable locally advanced or metastatic cholangiocarcinoma in adults with a fibroblast growth factor receptor 2 (FGFR2) fusion or another rearrangement. This conditional approval led Helsinn to sign a deal worth up to USD 2.45 billion with BridgeBio to take development and commercial rights to the drug in November 2021. The deal focused on global rights outside Greater China, while LianBio was awarded rights to develop infigratinib in Greater China in 2020.
Reason for Discontinuation
According to a separate SEC filing from BridgeBio, Helsinn’s decision to discontinue the drug was based on “commercial considerations,” with no reference made to the drug’s safety or clinical efficacy. LianBio was working on the China arm of the global Phase III PROOF-301 trial for infigratinib as a first-line cholangiocarcinoma treatment and had also begun a Named Patient Program providing early access to the product in Hainan province.
Future Outlook
LianBio stated in its filing that activities related to the PROOF-301 study in China are being discontinued. However, patients who have accessed the drug via the access program in Hainan will continue to be supported. Meanwhile, LianBio expects to continue with a Phase IIa proof of concept trial for infigratinib in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 genetic amplification and other solid tumors with FGFR alterations.-Fineline Info & Tech
