IBTROZI Shows 49.7-Month Duration and 89.8% Response in ROS1+ NSCLC Trials
Nuvation Bio's pooled TRUST-I/II data showed IBTROZI delivered an 89.8% response rate, 49.7-month median duration of response and 46.1-month progression-free survival in TKI-naive ROS1+ NSCLC patients, with a 76.5% intracranial response rate. TKI-pretreated patients had a 55.8% ORR, 16.6-month DOR, 9.7-month PFS, an 8.5% discontinuation rate and no safety signals.
1. Efficacy in TKI-Naïve and TKI-Pretreated Patients
Long-term pooled data from TRUST-I and TRUST-II demonstrated that TKI-naïve ROS1+ NSCLC patients (n=157) achieved an 89.8% confirmed ORR, a median DOR of 49.7 months, 46.1-month median PFS and a 76.5% intracranial response rate. In TKI-pretreated patients (n=113), IBTROZI produced a 55.8% ORR, 16.6-month DOR, 9.7-month PFS and a 65.6% intracranial response rate, with median overall survival of 29.8 months.
2. Safety and Tolerability
A pooled safety analysis reported low-grade adverse events such as diarrhea, nausea and dizziness that resolved quickly. Treatment discontinuation due to adverse events was 8.5%, and no new safety signals emerged over the longer follow-up period.
3. CNS Activity and Preclinical Findings
IBTROZI demonstrated robust central nervous system activity, maintaining a 76.5% intracranial response rate in TKI-naïve patients and 65.6% in pretreated patients with brain metastases. Preclinical studies showed taletrectinib inhibits TRKB-mediated lung cancer cell migration and key epithelial-to-mesenchymal transition markers.
4. Global Regulatory Status
IBTROZI received FDA approval in June 2025 for advanced ROS1+ NSCLC and holds approvals in Japan and China. In March 2026, the European Medicines Agency validated the Marketing Authorisation Application for taletrectinib, initiating a standard review timeline.