On March 1, Innovent Biopharmaceutical Group and Baoyuan Pharmaceutical jointly announced that Taletrectinib (Innovent R&D code: IBI-344, Baoyuan R&D code: AB-106) has been approved by the National Drug Administration of China The Center for Drug Evaluation (CDE) of the National Supervision Administration (NMPA) has included the list of breakthrough therapy drugs, and the proposed indications are ROS1 fusion-positive non-small cell patients who have not been treated with ROS1 tyrosine kinase inhibitor (TKI) or who have received ROS1 TKI treatment in the past. lung cancer patients.
Tabratinib is a novel, best-in-class next-generation ROS1 inhibitor designed to effectively target and treat ROS1 fusion mutations. ROS1 gene fusion mutations are estimated to be an oncogenic driver in approximately 1% to 2% of non-small cell lung cancer patients.
The National Medical Products Administration’s Breakthrough Therapy Drug Review is designed to expedite the development of new drugs for serious diseases that have shown significant efficacy over existing treatments in preliminary clinical trials. Breakthrough therapy drug review can not only allow drug candidates to obtain rapid review, but also allow sponsors to obtain timely advice and communication from the drug review center, speed up the drug approval and marketing process, and solve the clinical treatment needs of patients.
Taratinib was included in the Breakthrough Therapy category, based on the results of the Phase 2 TRUST trial of its use as a next-generation potent ROS1 inhibitor in patients with ROS1 fusion-positive non-small cell lung cancer. According to the data presented at the 2021 Chinese Society of Clinical Oncology Conference (CSCO) (as of June 16, 2021, patients received at least 2 tumor assessments after enrollment), the group of patients who had not previously been treated with crizotinib (N=21) had an objective response rate (ORR) of 90.5% (19/21) and a disease control rate (DCR) of 90.5% (19/21). The ORR in the group of patients previously treated with crizotinib (N=16) was 43.8% (7/16), and the DCR was 75.0% (12/16). In addition, taratinib showed encouraging efficacy in patients with G2032R mutation resistant to crizotinib, also had intracranial antitumor activity in patients with brain metastases, and had few neurological adverse events. Tabratinib was well tolerated, and its treatment-related adverse events mainly included gastrointestinal adverse events and reversible aspartate aminotransferase (AST) and alanine aminotransferase (ALT) elevations.
Dr. Hui Zhou, Senior Vice President of Innovent, said: “Existing treatment options for ROS1 fusion-positive patients are very limited. Talatinib has shown promising efficacy and safety results, and has the potential to become one of these A new therapy that patients are eagerly waiting for.”
Bing Yan, MD, co-founder and chief medical officer of Baoyuan Medicine, said: “The medical needs of patients with lung cancer with ROS1 fusion mutations are far from being met. The results of the phase 2 trial in patients with ROS1 fusion mutations are encouraging and provide a solid foundation for us to submit to the regulatory authorities for this indication in the future.” (Reporter She Huimin, Economic Daily)