As reported in the Journal of Clinical Oncology by Li et al, long-term follow-up of a Chinese phase II trial (TRUST-I) showed prolonged activity with taletrectinib in patients with ROS1 mutation–positive non–small cell lung cancer (NSCLC).
Study Details
In the multicenter trial, 173 patients had received taletrectinib at 600 mg once daily by August 2025, including 106 tyrosine kinase inhibitor (TKI)-naive patients and 67 crizotinib-pretreated patients. Initial data from the trial showed high response rates and promising response durability.
Key Findings
Among TKI-naive patients, with a median follow-up of 51.0 months, the objective response rate was 90.3% (95% confidence interval [CI] = 82.9%–95.3%), median duration of response was 49.7 months (95% CI = 41.3 months to not reached), median progression-free survival was 49.6 months (95% CI = 34.5 months to not reached), and median overall survival was not reached (95% CI = 41.6 months to not reached; 3-year overall survival = 65.3%).
Among crizotinib-pretreated patients, with a median follow-up of 45.2 months, the objective response rate was 51.5% (95% CI = 38.9%–64.0%), median duration of response was 13.2 months (95% CI = 7.7–24.8 months), median progression-free survival was 7.6 months (95% CI = 5.5–12.0 months), and median overall survival was 25.6 months (95% CI = 19.2–31.9 months).
Among 8 TKI-naive patients with measurable baseline brain metastases, the intracranial objective response rate was 87.5%. Among 16 crizotinib-pretreated patients with measurable baseline brain metastases, the intracranial objective response rate was 75.0%.
The safety profile was consistent with prior reports, with no new safety signals being identified.
The investigators concluded: “Overall, taletrectinib demonstrated durable long-term efficacy and a manageable safety profile in patients with advanced ROS1[-positive] NSCLC."
Caicun Zhou, MD, PhD, of Shanghai East Hospital and Thoracic Cancer Institute, Tongji University School of Medicine, Shanghai, China, is the corresponding author for the Journal of Clinical Oncology article.
DISCLOSURE: The study was supported by Nuvation Bio Inc. For full disclosures of the study authors, visit ascopubs.org.
