NEW YORK--(BUSINESS WIRE)--AnHeart Therapeutics, a clinical-stage global biopharmaceutical company committed to developing novel precision oncology therapeutics, announced today the publication of clinical trial design of TRUST-II, a global Phase 2 clinical study of taletrectinib in ROS1-positive non-small cell lung cancer and other solid tumors, in the peer-reviewed medical journal, Future Oncology.
The paper, “TRUST-II: A global phase II study of taletrectinib in ROS1-positive non-small cell lung cancer and other solid tumors,” describes the rationale and design of TRUST-II, a global Phase 2 study of taletrectinib in patients with locally advanced/metastatic ROS1+ NSCLC and other ROS1+ solid tumors. The primary endpoint is objective response rate by IRC. Key secondary endpoints include duration of response, progression-free survival, overall survival, and safety. This trial is currently enrolling patients globally. The paper is published online and can be accessed at: www.futuremedicine.com/doi/10.2217/fon-2022-1059.
“Many patients develop resistance to first-generation inhibitors such as crizotinib within two years of treatment due to progression in the brain or emergence of secondary mutations such as G2032R,” said Dr. Misako Nagasaka, lead author, a medical oncologist at the University of California Irvine. “There is a significant unmet medical need for a next-generation ROS1 inhibitor, such as taletrectinib, which is potent against secondary mutations and effectively treats brain metastases while maintaining a favorable safety profile.”
“Taletrectinib, a novel next-generation ROS1 inhibitor, was designed specifically to improve efficacy and overcome resistance to first-generation ROS1 inhibitors, and address brain metastasis while conferring fewer neurological adverse events,” said Lian Li, M.D., Ph.D., US Chief Medical Officer of AnHeart Therapeutics. “We look forward to advancing the TRUST-II study and bringing the potential effective therapy to patients across the globe who are in desperate need for novel therapies that have improved safety and efficacy. The publication in Future Oncology is critical for the medical community to learn about the rationale and details of the study design.”
In another ongoing taletrectinib regional Phase 2 trial (TRUST-I, NCT04395677), the interim data showed an ORR of 92.5% (95% CI: 83.4-97.5) and 50.0% (95% CI: 33.4-66.6) in 67 ROS1 TKI-naïve patients and 38 ROS1 TKI-pretreated patients, respectively. Among the 5 patients with the ROS1 G2032R resistance mutation, 4 of them achieved partial response (PR) and 1 achieved stable disease (SD). In 12 patients with measurable baseline CNS metastases, the IC-ORR was 91.7% (95% CI: 61.5-99.8). Taletrectinib was well-tolerated and most adverse events observed were mild and reversible.
Based on the clinical data accumulated to date, taletrectinib has received Breakthrough Therapy Designation (BTD) from both the 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.
ABOUT ANHEART THERAPEUTICS
AnHeart Therapeutics (“AnHeart”) is a clinical-stage global biopharmaceutical company developing a broad pipeline of novel or next-generation precision oncology therapeutics with high unmet medical needs. Its lead asset, taletrectinib, is a potential best-in-class next-generation ROS1 inhibitor currently in Phase 2 registrational trials for the first-line TKI-naïve and second-line TKI-pre-treated patients with ROS1 fusion-positive non-small cell lung cancer (NSCLC). Taletrectinib has received Breakthrough Therapy Designation (BTD) from both the 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. The Company’s pipeline also includes safusidenib, a mIDH1 inhibitor in Phase 2 trials with good brain penetration for multiple solid tumors with mIDH1 mutations and AB-329, an AXL inhibitor in Phase 1 studies to be used in combination with checkpoint inhibitor or chemotherapies in NSCLC or other solid tumors. The Company operates from offices in the US and China. For more information, visit www.anhearttherapeutics.com.