Study
| Pooled, international, open-label, single-arm, phase II studies (TRUST-I and TRUST-II) |
| Advanced or metastatic ROS1+ NSCLC, TKI-naïve or previously treated (crizotinib/entrectinib) |
| Taletrectinib 600 mg orally once daily until progression or toxicity |
Efficacy
| cORR: 88.8% (TKI-naïve), 55.8% (TKI-pretreated) |
| mDOR: 44.2 mos (TKI-naïve), 16.6 mos (TKI-pretreated) |
| mPFS: 45.6 mos (TKI-naïve), 9.7 mos (TKI-pretreated) |
| G2032R subset ORR: 61.5% |
Safety
| Any Grade AEs: AST ↑ (72%), ALT ↑ (68%), diarrhea (64%), nausea (46%), vomiting (44%) |
| Grade ≥3 AEs: AST ↑ (7.4%), ALT ↑ (9.9%), QT prolongation (3.4%) |
| Neurologic AEs: dizziness (21%), dysgeusia (15%) – mostly Grade 1 |
| Discontinuations due to AEs: 6.5% |
J Clin Oncol 2025;43:1920-29
http://doi.org/10.1200/JCO-25-00275
Reviewed by Ulas D. Bayraktar, MD on Jun 2, 2025
