Taletrectinib Gets Second NDA for ROS1-Positive Lung Cancer

Taletrectinib Gets Second NDA for ROS1-Positive Lung Cancer

By, Admin 6 March 2024

AnHeart Therapeutics and Innovent Announce China's NMPA Acceptance of Second New Drug Application for Taletrectinib in First-Line Treatment of ROS1-Positive Lung Cancer

Overview

AnHeart Therapeutics, a global biopharmaceutical company specializing in precision cancer therapies, and Innovent Biologics, Inc., a leading biopharmaceutical firm focusing on oncology and other major diseases, have jointly announced that the National Medical Products Administration (NMPA) of China has accepted a second New Drug Application (NDA) for taletrectinib. Taletrectinib is a next-generation ROS1 tyrosine kinase inhibitor (TKI) intended for use as a first-line treatment for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have not previously undergone treatment with ROS1 TKIs.

Previous NDA

  • Previously, in 2023, the NMPA accepted the first NDA for taletrectinib, granting Priority Review Designation for adult patients with locally advanced or metastatic ROS1-positive NSCLC who had received prior treatment with ROS1 TKIs. 
  • These NDAs are based on positive results from the Phase 2 TRUST-I trial (NCT04395677), with interim analysis data presented at the European Lung Cancer Congress (ELCC) 2023 and additional data planned for presentation at a forthcoming medical meeting in 2024.

Words from Principal Investigator

Professor Caicun Zhou, Principal Investigator and Oncologist at Shanghai Pulmonary Hospital, welcomed the acceptance of the second NDA for taletrectinib, emphasizing the importance of additional treatment options for newly diagnosed patients with advanced or metastatic ROS1-positive NSCLC.

Words from AnHeart China

Bing Yan, MD, President of AnHeart China, underscored the potential of taletrectinib as a first-line treatment and the company's dedication to advancing transformative therapies for cancer patients in partnership with Innovent.

Innovent Leadership on NDA Acceptance 

Dr. Hui Zhou, Senior Vice President of Innovent, expressed optimism about taletrectinib's clinical benefits and its acceptance by the NMPA, highlighting the goal of making this targeted therapy available to all eligible patients with ROS1-positive NSCLC as an initial treatment choice.

About Taletrectinib

  • Taletrectinib, an oral, potent, brain-penetrant, selective next-generation ROS1 inhibitor, is currently undergoing evaluation in two Phase 2 trials: TRUST-I in China (NCT04395677) and TRUST-II (NCT04919811), a global pivotal trial.
  • In 2022, taletrectinib received Breakthrough Therapy Designation from the NMPA for the treatment of advanced or metastatic ROS1-positive NSCLC in both TKI-naïve patients and those previously treated with ROS1 TKIs. 
  • It also obtained Breakthrough Therapy Designation in the United States for the same indication from the FDA.

Motto Behind Agreement

AnHeart and Innovent entered into an exclusive license agreement in 2021 for the co-development and commercialization of taletrectinib in Greater China, including mainland China, Hong Kong, Macau, and Taiwan.

ROS1-Positive NSCLC

  • In China, approximately 3% of NSCLC patients are ROS1-positive. While there are approved first-generation TKIs for newly diagnosed patients, there are no approved therapies for those whose cancer has progressed after initial treatment. 
  • Moreover, a significant proportion of patients with metastatic ROS1-positive NSCLC develop brain metastases, emphasizing the urgent need for effective treatments in this population.

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