Study
| Phase 2, open-label, single-arm, multicenter trials (TRUST-I and TRUST-II) |
| ROS1-positive advanced or metastatic NSCLC |
| Taletrectinib 600 mg once daily |
Efficacy
| ORR: 88.8% vs. 55.8% (TKI-naïve vs. TKI-pretreated) |
| mDOR: 44.2 mos vs. 16.6 mos (95% CI: 30.4-NR vs. 10.6-27.3) |
| mPFS: 45.6 mos vs. 9.7 mos (95% CI: 29.0-NR vs. 7.4-12.0) |
| 12-mo OS: NR vs. 77.5% (95% CI: 68.1-84.5) |
| IC-mDOR: 14.7 mos vs. 11.9 mos (95% CI: 4.2-30.2 vs. 6.9-23.4) |
| ORR in G2032R mutation: 61.5% |
Safety
| Grade ≥3 AEs: Increased AST (7.4%), ALT (9.9%), anemia (3.4%), QT prolongation (3.4%) |
| Serious AEs: 30% overall, 7.7% treatment-related |
| Discontinuation due to AEs: 6.5% |
| Neurologic AEs (mostly grade 1): dizziness (21%), dysgeusia (15%), headache (11%) |
J Clin Oncol 2025;00:1-10
http://doi.org/10.1200/JCO-25-00275
Reviewed by Ulas D. Bayraktar, MD on Apr 22, 2025
