Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, together with AnHeart Therapeutics (“AnHeart”), a clinical-stage global biopharmaceutical company committed to developing novel precision oncology therapies, today jointly announced that the Center for Drug Evaluation (CDE) of China’s Nation Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to taletrectinib (Innovent R&D code: IBI-344, Anheart R&D code: AB-106) for both first-line tyrosine kinase inhibitor (TKI)-naïve and second-line TKI-pretreated patients with ROS1-positive non-small cell lung cancer (NSCLC).
The NMPA Breakthrough Therapy Designation was based on results from the Phase 2 TRUST trial of ROS1 fusion-positive NSCLC patients treated with taletrectinib, a new generation of potent ROS1 inhibitors. According to the data presented (cut-off date: June 16, 2021) at the Chinese Society of Clinical Oncology (CSCO) 2021 Annual Meeting, in the crizotinib treatment-naïve patient group (n=21), the confirmed objective response rate (ORR) was 90.5% (19/21) and the disease control rate (DCR) was 90.5% (19/21). In the crizotinib pre-treated patient group (n=16), the confirmed ORR was 43.8% (7/16); and the DCR was 75.0% (12/16). In addition, taletrectinib showed promising efficacy in patients with crizotinib-resistant G2032R mutation, intracranial antitumor activity in brain metastatic patients with few neurological adverse events. Taletrectinib was well-tolerated and treatment-related adverse events primarily included gastrointestinal adverse events and reversible aspartate aminotransferase (AST) and alanine aminotransferase (ALT) increased.
“We are glad to see the NMPA grant Breakthrough Therapy Designation based on the Phase 2 data of taletrectinib,” said Dr. Hui Zhou, Senior Vice President of Innovent. “ROS1 fusion-positive patients currently have limited treatment options. Taletrectinib has demonstrated good efficacy and safety results, which indicated its potential to be a novel therapy for those patients in urgently need. We look forward to obtaining more data from the ongoing Phase 2 trial and bringing hope to patients with ROS1 fusion-positive NSCLC.”
“There is a high unmet medical need for lung cancer patients with ROS1 fusion mutations,” said Bing Yan, MD, Co-Founder and Chief Medical Officer at AnHeart Therapeutics. “The results from the Phase 2 trial evaluating taletrectinib in patients with ROS1 fusion mutations are encouraging and provide a strong basis for our future potential regulatory filing in this indication.”
NMPA Breakthrough Therapy Designation is intended to facilitate and expedite development and review of an investigational drug to treat serious disease or condition when preliminary clinical evidence indicates that the drug has demonstrated substantial improvement over current therapies. The BTD will not only qualify a drug candidate to receive status for rapid review by the CDE, but also allow the sponsor to obtain timely advice and communications from the CDE to accelerate the approval and launch in order to address the unmet clinical needs of patients at an accelerated pace. Click here for the published list of drugs which have been granted BTD by NMPA.