(Press-News.org) (San Diego, Calif.--September 10, 2024, 10:35 a.m. PCT) – The ROS1 tyrosine kinase inhibitor (TKI) taletrectinib demonstrated high overall and intracranial responses, and a favorable 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 tumors.
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 favorable 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.
Cohort 1: TKI naive, ≤1 line of chemotherapy (54/55 patients were response evaluable)
Cohort 2: TKI pretreated, 1 prior ROS1 TKI and ≤1 line of chemotherapy (47/50 patients were response evaluable)
Baseline Brain Metastases
35%
56%
Prior Chemotherapy
20%
38%
Prior Crizotinib
NA
80%
Prior Entrectinib
NA
20%
Confirmed ORR
85% (95% CI: 73-93)
62% (95% CI: 46-75)
Intracranial ORR
67% (95% CI: 30-93)
56% (95% CI: 30-80)
Common Adverse Effects (all grades)
Increased ALT (68%), Increased AST (67%), Diarrhea (57%)
“Taletrectinib continues to demonstrate encouraging overall responses, robust IC activity, and a favorable 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."
About the IASLC:
The International Association for the Study of Lung Cancer (IASLC) is the only global organization dedicated solely to the study of lung cancer and other thoracic malignancies. Founded in 1974, the association's membership includes more than 10,000 lung cancer specialists across all disciplines in over 100 countries, forming a global network working together to conquer lung and thoracic cancers worldwide. The association also publishes the Journal of Thoracic Oncology, the primary educational and informational publication for topics relevant to the prevention, detection, diagnosis, and treatment of all thoracic malignancies. Visit www.iaslc.org for more information.
About the WCLC:
The World Conference on Lung Cancer (WCLC) is the world’s largest meeting dedicated to lung cancer and other thoracic malignancies, attracting nearly 7,000 researchers, physicians and specialists from more than 100 countries. The goal is to increase awareness, collaboration and understanding of lung cancer, and to help participants implement the latest developments across the globe. The conference will cover a wide range of disciplines and unveil several research studies and clinical trial results. For more information, visit https://wclc2024.iaslc.org.
END
Phase II study of taletrectinib shows clinically meaningful overall response and favorable safety in patients with ROS1+ non-small cell lung cancer
2024-09-10
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