Innovent Biologics, Inc., a biopharmaceutical company that develops, manufactures, and commercialises high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology, and other major diseases, announced that China's National Medical Products Administration (NMPA) has approved the second New Drug Application (NDA) of DOVBLERON® (taletrectinib adipate capsule), a next-generation ROS1 tyrosine kinase inhibitor (TKI), for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC.

The approval is based on positive results from the pivotal Phase 2 TRUST-I trial (NCT04395677), a multicenter, open-label, single-arm trial that evaluated the safety, tolerability, and efficiency of taletrectinib in Chinese patients with advanced ROS1-positive NSCLC. The findings, presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of Clinical Oncology (JCO), demonstrated that taletrectinib continued to show high and durable overall responses and robust activity against intracranial lesions. 

"We are glad to see that DOVBLERON® has been approved for ROS1-positive NSCLC across treatment lines at a fast pace. DOVBLERON® demonstrated superior efficacy compared to the first-generation TKIs. These TRUST-I results reinforce taletrectinib's high overall response and prolonged PFS. The efficacy and safety profile of DOVBLERON® offers a more effective first-line treatment option and I look forward to its benefit in the ROS1-positive NSCLC patients in China," said Caicun Zhou, M.D., Ph.D., Director of the Department of Oncology at Shanghai East Hospital, Tongji University.

"The two NDAs approval of DOVBLERON® is a reflection of its potential best-in-class efficacy to fulfill the urgent need of patients with ROS1-positive NSCLC. We recently just launched the first batch of DOVBLERON® to market, rapidly bringing this precision therapy to NSCLC patients who need novel treatment options. Innovent's robust TKI product pipeline—including RETSEMOV®, PEMAZYRE®, DUPERT®, and DOVBLERON®—showcases our leadership and synergistic strengths in precision oncology. We endeavor to advance more innovative medicines to enhance patients' quality of life," said Dr. Hui Zhou, Senior Vice President of Innovent.

In ROS1 TKI-naïve (n=106) patients confirmed objective response rate (cORR, as assessed by an independent review committee, IRC) and intracranial cORR reached as high as 91 percent and 88 percent, respectively. After a median follow-up of 23.5 months in TKI-naïve patients, the median duration of response (IRC-assessed) and median progression-free survival (IRC-assessed) were not reached. 

In December 2024, DOVBLERON® was approved by the NMPA for treating adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have been previously treated with ROS1 TKIs. DOVBLERON® is the 13th addition to Innovent's commercial portfolio, representing an innovative precision therapy expected to benefit more lung cancer patients alongside our strong TKI franchise.