Innovent's DOVBLERON Receives Second NDA Approval for Lung Cancer Treatment in China

Innovent's Recent Milestone: DOVBLERON's NDA Approval

Innovent Biologics, Inc., recognized as a leading biopharmaceutical company, has made significant strides with its latest announcement regarding DOVBLERON®. This oral medication, a next-generation ROS1 tyrosine kinase inhibitor (TKI) known formally as taletrectinib adipate capsule, has received a second New Drug Application (NDA) approval from China's National Medical Products Administration (NMPA). This approval is particularly aimed at adult patients grappling with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

The NDA approval derives from the positive outcomes observed in the pivotal Phase 2 TRUST-I trial. This trial was instrumental in assessing the safety, tolerability, and efficacy of taletrectinib specifically within the Chinese patient population suffering from advanced ROS1-positive NSCLC. Findings from this trial, which were prominently presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, unveiled that taletrectinib exhibited a commendable overall response rate (cORR) of 91% and an impressive intracranial cORR of 88% in patients who had not previously received ROS1 TKIs. Furthermore, after a median follow-up duration of 23.5 months, both the median duration of response and median progression-free survival remained unachieved, showcasing the drug's sustained effectiveness.

DOVBLERON® was initially approved in December 2024 for patients who had undergone prior treatment with ROS1 TKIs, marking a notable expansion of treatment possibilities within Innovent's pharmaceutical portfolio. This drug represents the 13th innovation from Innovent aimed at enhancing the lives of lung cancer patients, adding to their strong portfolio of cancer-targeting TKIs.

Dr. Caicun Zhou, a prominent figure in oncology at Shanghai East Hospital, lauded DOVBLERON's rapid approval process. He emphasized that this new treatment option demonstrates superior efficacy over earlier-generation TKIs, further affirming taletrectinib's effectiveness and encouraging prospects for patients suffering from ROS1-positive NSCLC in China.

In framing its approach to lung cancer treatment, Innovent’s Senior Vice President, Dr. Hui Zhou, remarked on the significance of achieving two NDA approvals for DOVBLERON®. He noted that this progression reflects the drug’s exceptional potential to meet the urgent healthcare needs of patients afflicted with ROS1-positive NSCLC. Recently, Innovent launched the first batch of DOVBLERON®, expediently delivering this precision therapy to patients seeking innovative treatment options.

Lung cancer persists as a leading cause of cancer mortality globally, with NSCLC representing approximately 85% of all lung cancer cases. In China, roughly 2.6% of NSCLC patients are identified as ROS1-positive, which underscores the pressing necessity for effective, tolerable treatments. The statistics indicate that approximately 55% of patients with metastatic ROS1-positive NSCLC exhibit tumor progression to the brain or develop resistance mutations after initial treatment, signifying the need for advanced therapeutic options.

DOVBLERON® is designed to be a potent ROS1 inhibitor, capable of penetrating the central nervous system. This next-generation therapy stands as a promising candidate for patients with advanced NSCLC, currently undergoing evaluation through pivotal clinical trials in China and globally. The drug's clinical journey includes recognition by the U.S. FDA as an Orphan Drug for treating patients with ROS1-positive NSCLC and receiving Breakthrough Therapy Designation from both the U.S. FDA and the NMPA for advanced stages of the disease.

In summary, Innovent’s unwavering commitment to innovation in biopharmaceuticals continues to foster hope for lung cancer patients in China. As the company expands its array of targeted therapies, DOVBLERON® exemplifies the transformative potential of precision medicine in addressing formidable health challenges. With an ongoing drive for scientific advancement, Innovent seeks to empower patients globally by making high-quality, impactful medications accessible and effective in the fight against serious diseases.