On March 31, 2023 AnHeart Therapeutics ("AnHeart"), a clinical-stage global biopharmaceutical company developing novel precision oncology therapeutics, announced today updated efficacy and safety data from a regional Phase 2 clinical trial of taletrectinib (TRUST-I) in patients with ROS1-positive non-small cell lung cancer (ROS1+ NSCLC) in an oral presentation at the European Lung Cancer Congress (ELCC) 2023 (Press release, AnHeart Therapeutics, MAR 31, 2023, View Source [SID1234629679]). Taletrectinib is a potent, next-generation, central nervous system (CNS)-active ROS1 tyrosine kinase inhibitor (TKI) with selectivity over TRKB.
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The oral presentation reported the updated efficacy and safety data of the TRUST-I Phase 2 trial in China (NCT04395677) with about 1.5-year follow-up time. The confirmed objective response rate (ORR) was 92.5% (62/67) in ROS1 TKI-naïve patients and 52.6% (20/38) in crizotinib-pretreated patients. The intracranial ORR was 91.7% (11/12) regardless of prior ROS1 TKI treatment history. The ORR in patients with a ROS1 G2032R resistance mutation was 80.0% (4/5).
The oral presentation also reported the updated results from a pooled analysis including patients from the TRUST-I Phase 2 trial and two Phase 1 trials conducted in the US and Japan (NCT02279433 and NCT02675491). The median progression-free survival (PFS) was 33.2 months (N=78) in ROS1 TKI-naïve patients and 11.8 months (N=46) in crizotinib-pretreated patients.
In 178 patients treated with taletrectinib at 600 mg once daily (QD), most treatment-emergent adverse events (TEAEs) were grades 1 or 2. Taletrectinib demonstrated a well-tolerable safety profile with low incidence of neurological adverse events (AEs).
"We’re excited to see that, with longer follow-up time, taletrectinib continues to demonstrate robust efficacy outcomes and favorable safety profiles in patients with ROS1 TKI-naïve or crizotinib-pretreated ROS1+ NSCLC," said Prof. Caicun Zhou, Shanghai Pulmonary Hospital and Thoracic Cancer Institute, Tongji University School of Medicine, Shanghai, China. "Additionally, taletrectinib hits a unique balance of strong intracranial activity and low incidence of neurological AEs."
TRUST-I is a multicenter, open-label, single-arm clinical trial with two cohorts: ROS1 TKI-naïve and crizotinib-pretreated patients. The key study endpoints included IRC-confirmed ORR, duration of response (DoR), disease control rate (DCR), PFS and safety.
A pivotal global Phase 2 trial of taletrectinib (TRUST-II, NCT04919811) is actively enrolling patients at clinical sites in North America, Europe and Asia.
Taletrectinib has been granted Breakthrough Therapy Designation (BTD) by both US FDA and China NMPA for the treatment of patients with advanced or metastatic ROS1+ NSCLC, who are either ROS1 TKI treatment naïve or previously treated with crizotinib.