Nuvation Bio Announces IBTROZI Clinical Trial Results

Nuvation Bio announced results from a pooled analysis of long-term follow-up data from the pivotal TRUST-I and TRUST-II trials for IBTROZI, or taletrectinib, in patients with advanced ROS1-positive, or ROS1+, non-small cell lung cancer, or NSCLC. The updated efficacy and safety results for both TKI-naive and TKI-pretreated patients were presented at the American Association for Cancer Research, or AACR, Annual Meeting 2026 in oral and poster presentations. The long-term pooled results in TKI-naive patients demonstrated a confirmed objective response rate, or cORR, of 89.8%, a median duration of response, or mDOR, of 49.7 months and a median progression-free survival, or mPFS, of 46.1 months. Updated results from the TRUST-I study were also simultaneously published in the Journal of Clinical Oncology, demonstrating robust ORR, mDOR and mPFS in TKI-naive patients, with a median follow up of 51 months. The new pooled analysis presented at AACR demonstrated robust efficacy with IBTROZI for both TKI-naive and TKI-pretreated patients in TRUST-I and TRUST-II. For TKI-naive patients: the analysis showed a cORR of 89.8%, a median DOR of 49.7 months, a median PFS of 46.1 months and an intracranial response rate of 76.5% in patients with brain metastases (n=17). Median OS was not yet reached. For TKI-pretreated patients: the analysis showed a cORR of 55.8%, a median DOR of 16.6 months, a median PFS of 9.7 months and an intracranial response rate of 65.6% in patients with brain metastases. Median OS was 29.8 months. Notably, 98% of TKI-pretreated patients enrolled following progressive disease on entrectinib or crizotinib. The remaining two patients were enrolled following intolerance to a prior TKI. A pooled safety analysis demonstrated a favorable and manageable safety profile for IBTROZI, consistent with its prescribing information. Adverse events of clinical interest (diarrhea, nausea, vomiting and dizziness) were generally low-grade and resolved quickly. Treatment discontinuations due to treatment-emergent AEs were low, 8.5%. No new safety signals were identified with the longer follow-up. In another poster session at AACR, new preclinical data showed that taletrectinib inhibited the migration of lung cancer cells, suggesting the ability of taletrectinib to reduce the invasive capacity of lung cancer cells based on its tropomyosin receptor kinase B (TRKB) inhibition profile. In mechanistic studies, taletrectinib reduced the expression of key markers associated with the epithelial to mesenchymal transition pathway. The data also suggested that TRKB-sparing agents may not reduce the migration of TRKB expressing lung cancer cells and may lack the potential CNS-protective effects of TRKB inhibition.