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AnHeart Therapeutics Begins Phase II Taletrectinib Study in ROS1 Fusion-Positive Lung Cancer

NEW YORK – AnHeart Therapeutics on Tuesday said the first advanced, ROS1-positive non-small cell lung cancer patient has received taletrectinib in a Phase II trial.

The single-arm trial will enroll 119 patients into four cohorts based on previous ROS1 tyrosine kinase inhibitor treatment. The primary endpoint of the trial is overall response rate, and researchers will also assess safety, pharmacokinetics, progression-free survival, and intracranial progression-free survival and response rate for patients with brain metastases.

Earlier data from another study of taletrectinib in ROS1-positive NSCLC showed an overall response rate of 90.5 percent in patients who had not previously received the ROS1 and ALK inhibitor crizotinib (Pfizer's Xalkori), and a response rate of 43.8 percent in patients who had received prior crizotinib therapy.

New York-based AnHeart is studying taletrectinib as both a first- and second-line treatment for NSCLC with ROS1 fusions. The company also has an ongoing basket trial of the drug in various NTRK-positive solid tumors. AnHeart's pipeline also includes an IDH1 inhibitor in Phase II studies and an AXL inhibitor in Phase I trials.