The ROS1 tyrosine kinase inhibitor (TKI) taletrectinib demonstrated high overall and intracranial responses, and a favourable safety profile with low incidence of neurologic adverse events in TKI-naive and TKI-pretreated patients with ROS1+ non-small cell lung cancer (NSCLC).

These results were presented today at the International Association for the Study of Lung Cancer 2024 World Conference on Lung Cancer by Dr. Geoffrey Liu, from Princess Margaret Cancer Centre, Temerty School of Medicine, University of Toronto, Canada.

ROS1 fusions occur in approximately 2 percent of all non-small cell lung cancers and occur when the ROS1 gene attaches to another gene that results in uncontrolled cell growth and tumours.

In the pivotal Phase II TRUST-I study, taletrectinib demonstrated high overall and intracranial response rates, durable responses, and activity against the G2032R acquired resistance mutation, combined with favourable safety and tolerability.

Dr. Liu today presented updated Phase II results in TKI-naive and TKI-pretreated patients from the global, pivotal TRUST-II study, evaluating the efficacy and safety of taletrectinib in patients with advanced ROS1+ NSCLC.

The results included in the presentation are as of June 7, 2024.

TRUST-II is a global, multicenter, single-arm study of taletrectinib, in which all patients received 600 mg of taletrectinib orally once daily.

At the time of analysis, 105 patients with advanced ROS1+ NSCLC were treated with taletrectinib in two cohorts: Cohort 1 consisted of patients who were TKI naive with ≤1 line of chemotherapy while Cohort 2 consisted of patients who were pretreated with 1 prior ROS1 TKI (crizotinib or entrectinib) and ≤1 line of chemotherapy.

Dr. Liu presented the efficacy results from 101 of the 105 patients in these two cohorts who were response evaluable.

The primary endpoint is confirmed objective response rate and key secondary endpoints include duration of response, progression-free survival, and safety.

“Taletrectinib continues to demonstrate encouraging overall responses, robust IC activity, and a favourable safety profile with low incidence of neurologic AEs in both TKI-naive and TKI-pretreated patients with ROS1+ NSCLC,” said Dr. Liu.

"The efficacy and safety of taletrectinib in TRUST-II remains highly consistent with TRUST-I." 

Source: International Association for the Study of Lung Cancer