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AnHeart Therapeutics Receives FDA Breakthrough Therapy Designation for Taletrectinib in ROS1-Positive Non-Small Cell Lung Cancer

AnHeart Therapeutics Receives FDA Breakthrough Therapy Designation for Taletrectinib in ROS1-Positive Non-Small Cell Lung Cancer

AnHeart Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to its investigational ROS-1 inhibitor taletrectinib for the treatment of adult patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who are ROS1 tyrosine kinase inhibitor (TKI) treatment naïve or previously treated with crizotinib.

The FDA decision was supported by the preliminary clinical data of taletrectinib from an ongoing Phase 2 trial (TRUST) in Chinese ROS1-positive NSCLC patients and two completed Phase 1 clinical trials conducted in the United States and Japan.

The preliminary clinical data from the ongoing TRUST Phase 2 trial was recently presented at the 2022 American Society of Clinical Oncology (ASCO) meeting. In 67 evaluable ROS1 TKI-naïve patients with ROS1 fusion-positive NSCLC, the confirmed objective response rate (cORR) and disease control rate (DCR) was 92.5% and 95.5%, respectively. In 38 evaluable crizotinib-pretreated patients, the cORR and DCR were 50% and 78.9%, respectively.

In 12 patients with brain metastasis and measurable brain lesions at baseline, the intracranial cORR and intracranial DCR were 91.7% and 100%, respectively. In five patients with ROS1 G2032R resistant mutation, 4/5 achieved confirmed partial response (cPR), and 1/5 achieved stable disease (SD). Taletrectinib was generally well tolerated. Low incidence of neurological adverse events (AEs) was observed, likely reflecting taletrectinib’s selective inhibition of ROS1 over tropomyosin receptor kinase B (TRKB).

"There is a high unmet need for this specific patient population in lung cancer, where very few treatment options are available," said Lian Li, M.D. Ph.D., Chief Medical Officer (US) of AnHeart. "In the TRUST Phase 2 trial, taletrectinib showed promising antitumor activity against ROS1-fusion and resistant mutations in adult patients with ROS1-positive NSCLC, with a favorable safety profile. Taletrectinib also showed better brain penetration and intracranial antitumor activity in comparison to other ROS1 inhibitors. Patients with ROS1-positive NSCLC desperately need new therapeutic options, and we look forward to our ongoing dialogue with the FDA to accelerate the development of taletrectinib for patients in the US.”

The FDA states that Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy. A Breakthrough Therapy Designation conveys all the fast-track program features, more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and eligibility for rolling review and priority review.


Taletrectinib is a novel potential best-in-class next-generation ROS1 inhibitor designed to effectively target ROS1 fusions with potential to treat both TKI-naïve and pre-treated patients. ROS1 rearrangement is estimated to be an oncogenic driver in approximately 1 to 2 percent of patients with NSCLC. ROS1 fusions are also observed in several other cancers such as cholangiocarcinoma, glioblastoma, ovarian, gastric, and colorectal cancers. Taletrectinib has demonstrated excellent potency against crizotinib resistance, good brain penetration and intracranial antitumor activity, and favorable safety profiles in ROS1 fusion-positive NSCLC patients. In these patients, few neurological adverse events were observed, which likely benefits from the selective inhibition of ROS1 over TRKB by taletrectinib. More information about the ongoing China TRUST (Taletrectinib ROS1 LUng STudy) phase 2 trial and the global TRUST-II phase 2 trial may be found by searching clinical trial identifiers NCT04395677 and NCT04919811, respectively at https://clinicaltrials.gov.


AnHeart Therapeutics (“AnHeart”) is a clinical-stage global biopharmaceutical group company developing a broad pipeline of novel 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 trials for ROS1 TKI-naïve and TKI-pretreated patients with ROS1 fusion-positive non-small cell lung cancer (NSCLC). The Company’s pipeline also includes AB-218, 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, please visit https://www.anhearttherapeutics.com/.

Aug. 5, 2022


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