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AnHeart, Innovent File for Frontline ROS1-Positive NSCLC Taletrectinib Approval in China

NEW YORK – AnHeart Therapeutics and Innovent Biologics on Monday said they have filed a new drug application in China seeking first-line taletrectinib approval in ROS1-positive lung cancer.

The Center for Drug Evaluation of China's National Medical Products Administration (NMPA) will now review the application, which would make the ROS1 inhibitor taletrectinib available in China for advanced non-small cell lung cancer patients whose tumors harbor ROS1 alterations and who haven't received prior ROS1-targeted tyrosine kinase inhibitors.

The filing comes after AnHeart and Innovent filed for Chinese taletrectinib approval for previously treated ROS1-positive NSCLC patients in November.

Both this new application and the later-line application draw on data from the Phase II TRUST-I clinical trial, in which taletrectinib demonstrated encouraging efficacy and safety in NSCLC patients whose tumors harbored ROS1 gene fusions as determined by fluorescence in situ hybridization, real-time PCR, or next-generation sequencing. The firms said they plan to report TRUST-I data during a medical meeting in 2024.

AnHeart and Innovent, which jointly develop taletrectinib in China, Hong Kong, Macau, and Taiwan, are also evaluating the drug in a global Phase II trial dubbed TRUST-II. In December 2023, AnHeart inked a deal with Roche subsidiary Foundation Medicine to develop Foundation's genomic profiling tests as companion diagnostics for taletrectinib in the US. That deal followed an earlier one, announced in February 2023, in which AnHeart and Guardant Health teamed up to develop Guardant's tissue- and blood-based sequencing tests to identify patients eligible for taletrectinib.