Long-Term Efficacy and Safety of Taletrectinib in Patients With ROS1+ Non–Small Cell Lung Cancer: Results From the Phase II TRUST-I Study
Mené sur 103 patients atteints d'un cancer du poumon non à petites cellules ROS1+ de stade avancé (durée médiane de suivi : 51 mois), cet essai de phase II évalue l'efficacité, du point de vue du taux de réponse objective, de la durée de la réponse, de la survie sans progression et de la survie globale, et la toxicité du talétrectinib (un inhibiteur de tyrosine kinase ciblant ROS1)
Taletrectinib is a next-generation, CNS-active, selective ROS1 tyrosine kinase inhibitor (TKI) with activity against the ROS1 G2032R resistance mutation. Initial data from the TRUST-I study (ClinicalTrials.gov identifier: NCT04395677) demonstrated high response rates and intracranial (IC) activity, with promising durability, in Chinese patients with advanced ROS1+ non–small cell lung cancer (NSCLC). With longer follow-up, taletrectinib continued to demonstrate high and durable response rates in both TKI-naïve and crizotinib-pretreated patients, including IC activity and promising overall survival (OS). Among 103 TKI-naïve patients who started taletrectinib at 600 mg once daily (median follow-up, 51.0 months), the objective response rate (ORR) was 90.3% (95% CI, 82.9 to 95.3), the median duration of response (DOR) and median progression-free survival (PFS) exceeded 4 years (49.7 months and 49.6 months, respectively), and median OS was not reached. Among 66 crizotinib-pretreated patients (median follow-up, 45.2 months), the ORR was 51.5%, the median DOR was 13.2 months, the median PFS was 7.6 months, and the median OS was 25.6 months. The safety profile remained consistent with prior reports, and no new safety signals were identified. Overall, taletrectinib demonstrated durable long-term efficacy and a manageable safety profile in patients with advanced ROS1+ NSCLC.
Journal of Clinical Oncology , article en libre accès, 2026