Innovent Announces Approval of DOVBLERON® for Non-Small Cell Lung Cancer Treatment
Friday, January 03, 2025
Innovent Biologics announced the approval of a second New Drug Application (NDA) for DOVBLERON® (taletrectinib adipate capsule) by China’s National Medical Products Administration (NMPA).
Lung cancer remains one of the most common and deadly cancers worldwide, with NSCLC making up approximately 85% of cases. In China, around 2.6% of NSCLC patients are ROS1-positive.
For those with advanced ROS1-positive NSCLC, there is a persistent need for more effective and better-tolerated treatments. Taletrectinib’s demonstrated efficacy against brain metastases and resistance mutations, such as G2032R, positions it as a promising first-line therapy to improve patient outcomes.
DOVBLERON® is a next-generation, orally administered ROS1 inhibitor that also exhibits central nervous system activity. It has been evaluated in the TRUST-I and TRUST-II clinical studies.
The drug has received Orphan Drug Designation from the US FDA for ROS1-positive NSCLC and related indications. It has also been granted Breakthrough Therapy Designations by both the US FDA and China’s NMPA for locally advanced or metastatic ROS1-positive NSCLC.
This approval covers its use as a treatment for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
The decision is based on results from the pivotal Phase 2 TRUST-I trial (NCT04395677), which assessed the drug’s safety, tolerability, and efficacy in Chinese patients. The study demonstrated a high and durable response rate, including significant intracranial activity. Among ROS1 tyrosine kinase inhibitor (TKI)-naïve patients, the confirmed objective response rate reached 91%, with an intracranial response rate of 88%. Median progression-free survival and duration of response were not reached after a median follow-up of 23.5 months.
In December 2024, DOVBLERON® received its first NMPA approval for patients with ROS1-positive NSCLC who had already been treated with ROS1 TKIs. It is the 13th product in Innovent’s commercial portfolio, highlighting its growing role in precision oncology.
In June 2021, Innovent partnered with AnHeart Therapeutics (Hangzhou) Co. Ltd., a Nuvation Bio Inc. company, to co-develop and commercialise taletrectinib in Greater China. Based on pooled data from the TRUST studies, Nuvation Bio submitted a separate NDA to the US FDA, which was accepted for priority review in December 2024.
Innovent’s growing TKI portfolio, including DOVBLERON®, reflects its commitment to advancing innovative therapies that improve the quality of life for patients with unmet medical needs.
Source: prnewswire.com
