One year after BridgeBio won accelerated approval for liver cancer drug Truseltiq (infigratinib), the company is pulling a planned Phase III program due to its partner’s decision to discontinue the drug.
One year after BridgeBio and its partners won accelerated approval for liver cancer drug Truseltiq (infigratinib), the company is pulling a planned Phase III program after its partner announced plans to permanently discontinue distribution of the drug on Wednesday.
The news was announced in a brief filing with the U.S. Securities and Exchange Commission. Helsinn Healthcare SA, which holds a New Drug Application for Truseltiq in the United States, announced it will withdraw the drug and the planned application with the FDA due to “business reasons.” The filing did not discuss any clinical or safety issues related to the drug.
The partnership was valued at over $2.4 billion and shares of BridgeBio were down in early trading following the announcement. BridgeBio and its partners, Switzerland-based Helsinn and LianBio, were assessing Truseltiq in multiple cancer indications.
As a result of the planned withdrawal, BridgeBio will shutter its ongoing Phase III PROOF-301 clinical trial of infigratinib in first-line cholangiocarcinoma (CAA). LianBio, which holds the Chinese marketing rights for Truseltiq, has also been forced to terminate its activities related to the study.
With the Helsinn decision and the halting of the PROOF-301 clinical trial of infigratinib in earlier lines of CCA, LianBio will stop activities related to its development for CCA in China, the company told BioSpace.
LianBio will continue to asses infigratinib in an ongoing Phase IIa trial in patients with gastric cancer, which is an area of high unmet medical need in China, the company said.
LianBio noted in its SEC filing that it will continue to provide Truseltiq to patients in China who are currently being treated with the medication. It will do so under the Named Patient Program in Hainan Province.
Truseltiq, an oral ATP-competitive, tyrosine kinase inhibitor of FGFR, was approved in June 2021 for the treatment of patients with previously-treated locally advanced or metastatic cholangiocarcinoma (CCA) with an FGFR2 fusion or rearrangement.
An Unexpected End
Months ahead of Truseltiq’s accelerated approval, Helsinn and BridgeBio entered into a global license and collaboration agreement to commercialize the medication in the U.S. and other global markets. LianBio held marketing rights in mainland China, Hong Kong and Macau.
Beyond Truseltiq, Helsinn and BridgeBio had also partnered on the development and potential commercialization of an inhibitor that targets glutathione peroxidase 4 (GPX4). That asset is expected to be used to target undisclosed difficult-to-treat tumors.
The partnership also included the potential co-development of preclinical precision oncology programs that were in the portfolios of both companies.
