The trial is investigating Taletrectinib to treat ROS1-positive non-small cell lung cancer patients. Credit: National Cancer Institute on Unsplash.

AnHeart Therapeutics has reported updated data from a regional Phase II TRUST-I clinical trial of taletrectinib (AB-106) in patients with ROS1-positive non-small cell lung cancer (ROS1+ NSCLC) patients.

The single- arm, multicentre, open-label TRUST-I clinical trial was designed for assessing the pharmacokinetics, safety, and efficacy of AB-106 monotherapy in advanced NSCLC treatment.

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It includes ROS1 TKI-naïve and crizotinib pretreated patient cohorts.

Duration of response (DoR), safety, progression-free survival (PFS), IRC-confirmed objective response rate (ORR), and disease control rate (DCR) are some of the trial’s key endpoints.

According to the findings, the confirmed ORR was 92.5% and 52.6% in ROS1 TKI-naïve patients and crizotinib-pretreated patients, respectively.

Patients with a ROS1 G2032R resistance mutation had 80% ORR. Patients regardless of previous ROS1 TKI treatment had 91.7% intracranial ORR.

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The study results showed that the ROS1 TKI-naïve patients had 33.2 months median PFS and in crizotinib-pretreated patients it was 11.8 months.

Taletrectinib showed a well tolerable safety profile with low neurological adverse events (AEs) incidence.

Thoracic Cancer Institute, Tongji University School of Medicine, Shanghai, China and Shanghai Pulmonary Hospital professor Caicun Zhou said: “We’re excited to see that, with longer follow- up time, taletrectinib continues to demonstrate robust efficacy outcomes and favourable safety profiles in patients with ROS1 TKI-naïve or crizotinib-pretreated ROS1+ NSCLC.

“Additionally, taletrectinib hits a unique balance of strong intracranial activity and low incidence of neurological AEs.”

Taletrectinib is a next-generation, potent, central nervous system (CNS)-active tyrosine kinase inhibitor (TKI) of ROS1 over TRKB.

The US Food and Drug Administration (FDA) and China National Medical Products Administration (NMPA) granted breakthrough therapy designation (BTD) for taletrectinib to treat advanced or metastatic ROS1+ NSCLC patients, who are either ROS1 TKI treatment naïve or who previously received treatment with crizotinib.

Currently, participants are being enrolled at clinical sites in North America, Europe and Asia in a pivotal global Phase II TRUST-II trial of taletrectinib.