NEW YORK – AnHeart Therapeutics and Innovent Biologics said on Wednesday that they have filed for taletrectinib approval in ROS1-positive non-small cell lung cancer in China.
China's National Medical Products Administration's Center for Drug Evaluation has accepted a new drug application for taletrectinib in ROS1-positive NSCLC patients who have received prior ROS1 tyrosine kinase inhibitors.
The application is based on data from the Phase II TRUST-I clinical trial, which enrolled patients in China whose NSCLC tumors harbored ROS1 gene fusions as determined by fluorescence in situ hybridization, real-time PCR, or next-generation sequencing. The drug demonstrated encouraging efficacy and safety in TRUST-I, according to the firms, who are now evaluating the agent in the global pivotal TRUST-II trial.
AnHeart and Innovent are jointly responsible for developing taletrectinib in China, Hong Kong, Macau, and Taiwan. In 2022, the agent received breakthrough therapy designation from Chinese regulators for both ROS1 TKI-pretreated and ROS1 TKI-naïve NSCLC patients.
AnHeart is also evaluating taletrectinib in a Phase II basket trial in patients with NTRK-positive solid tumors.