On October 25, 2021 AnHeart Therapeutics ("AnHeart"), a clinical-stage global biopharmaceutical company committed to developing novel cancer therapies, reported that the first patient has been dosed in the global Phase 2 trial of taletrectinib in ROS1 fusion-positive lung cancer (TRUST-II) (Press release, AnHeart Therapeutics, OCT 25, 2021, View Source [SID1234591910]). Taletrectinib, the company’s lead candidate, is an investigational next-generation tyrosine kinase inhibitor (TKI) designed to effectively target ROS1 and NTRK fusion mutations.
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ROS1 rearrangement is estimated to be an oncogenic driver in approximately 2 to 3 percent of patients with advanced NSCLC, and NTRK rearrangement is estimated to be an oncogenic driver in approximately 0.5 percent of patients with other advanced solid tumors. By targeting ROS1, taletrectinib is designed to deliver cancer-fighting therapeutics selectively to tumor cells, while sparing normal cells.
"Taletrectinib dosing of the first patient in our global Phase 2 ROS1 fusion-positive TRUST-II lung cancer trial represents a key milestone for our lead ROS1-directed clinical program," said Bing Yan, MD, Co-Founder and Chief Medical Officer of AnHeart Therapeutics. "Based on the broad expression of ROS1 fusions across different cancer types, and our recent clinical data presented at ASCO (Free ASCO Whitepaper) and CSCO showing taletrectinib antitumor activity with a promising safety and efficacy profile, we are proud of advancing this investigational candidate as a potential new therapy for ROS1 fusion-positive lung cancer."
The global Phase 2 study (TRUST-II) is a multicenter, single-arm, open label study of taletrectinib in patients of NSCLC harboring with ROS1 fusion gene. A total of 119 patients will be enrolled and divided into four cohorts, depending on past history of ROS1 tyrosine kinase inhibitor treatment. Taletrectinib will be administered 600 mg once-daily in 21-day cycles. The primary endpoint of the study is confirmed overall response rate (ORR). For additional information about the clinical trial (NCT04919811), visit www.clinicaltrials.gov.
About Taletrectinib
Taletrectinib is an investigational next-generation tyrosine kinase inhibitor (TKI) designed to effectively target ROS1 and NTRK fusion mutations with potential to treat TKI-naive or pre-treated patients. ROS1 rearrangement is estimated to be an oncogenic driver in approximately 2 to 3 percent of patients with advanced NSCLC, and NTRK rearrangement is estimated to be an oncogenic driver in approximately 0.5 percent of patients with other advanced solid tumors. More information about the ongoing China TRUST (Taletrectinib ROS1 LUng STudy) trial, global TRUST II trial and the basket trial in NTRK fusion positive solid tumors of taletrectinib (NCT04395677, NCT04919811 and NCT04617054, respectively) at www.clinicaltrials.gov.