Long-Term Efficacy and Safety of Taletrectinib in Patients With ROS1+ Non-Small Cell Lung Cancer: Results From the...

Area of Science:

• Oncology
• Pharmacology

Background:

• Non-small cell lung cancer (NSCLC) harboring ROS1 alterations presents a target for tyrosine kinase inhibitors (TKIs).
• Resistance mutations, such as ROS1 G2032R, can limit the efficacy of existing therapies.
• Taletrectinib is a next-generation TKI designed for CNS activity and selectivity against ROS1.

Purpose of the Study:

• To evaluate the long-term efficacy and safety of taletrectinib in Chinese patients with advanced ROS1+ NSCLC.
• To assess taletrectinib's activity in both TKI-naïve and crizotinib-pretreated patient populations.
• To investigate intracranial activity and overall survival outcomes with extended follow-up.

Main Methods:

• The TRUST-I study (NCT04395677) assessed taletrectinib in patients with advanced ROS1+ NSCLC.
• Patients received taletrectinib at 600 mg once daily.
• Data analysis included objective response rate (ORR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety assessments.

Main Results:

• In TKI-naïve patients (n=103), ORR was 90.3%, with median DOR and PFS exceeding 4 years (49.7 and 49.6 months).
• In crizotinib-pretreated patients (n=66), ORR was 51.5%, with median DOR of 13.2 months, median PFS of 7.6 months, and median OS of 25.6 months.
• Taletrectinib demonstrated significant intracranial activity and a manageable safety profile with no new signals.

Conclusions:

• Taletrectinib demonstrates high and durable efficacy, including intracranial activity, in advanced ROS1+ NSCLC patients.
• The drug shows sustained long-term benefits in both TKI-naïve and crizotinib-pretreated populations.
• Taletrectinib presents a promising therapeutic option with a favorable safety profile for ROS1+ NSCLC.