AnHeart Therapeutics discovered breakthrough investigational ROS-1 inhibitor taletrectinib for the treatment of patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
Taletrectinib is applicable for patients with ROS1 tyrosine kinase inhibitor (TKI) treatment naïve or previously treated with crizotinib. It is a well-toleratednext-generation ROS1 inhibitordesigned to target ROS1 fusions with potential to treat both TKI-naïve and pre-treated patients.
ROS1 rearrangement acts as an oncogenic driver in approximately 1 to 2 percent of patients with NSCLC. They are also present in various other cancers such as cholangiocarcinoma, glioblastoma, ovarian, gastric, and colorectal cancers.
Taletrectinibhas resulted excellent properties against crizotinib resistance including good brain penetration and intracranial antitumor activity, and favorable safety profiles in ROS1 fusion-positive NSCLC patients.
Studies from TRUST Phase 2 trial have resulted that 67 evaluable ROS1 TKI-naïve patients suffering with ROS1 fusion-positive NSCLC,have shown 92.5% confirmed objective response rate (cORR) and 95.5%, disease control rate (DCR) respectively. In addition, 50% of the cORR and 78.9% DCR were shown among 38 evaluable crizotinib-pretreated patients.
U.S. Food and Drug Administration (FDA) grants Breakthrough Therapy Designation (BTD) for investigational ROS-1 inhibitor taletrectinib for the treatment of adult patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
