Nuvation Bio's IBTROZI Shows 88% Patient Quality-of-Life Improvement in TRUST-II
NUVB•In the TRUST-II study of IBTROZI for ROS1+ NSCLC, 88% of 69 patients reported improved or stable global health quality-of-life at first assessment, with 93% of TKI-pretreated patients and sustained relief from cough and shortness of breath through eight months. Cognitive function scores also improved or remained stable across treatment.
1. Patient-Reported Outcomes
The global Phase 2 TRUST-II study assessed quality-of-life and symptom impact in 69 ROS1+ NSCLC patients treated with IBTROZI. At the first assessment (cycle 2 day 1), 88% of patients reported improved or stable global health, including 93% of TKI-pretreated patients, and 84–96% experienced relief from cough and shortness of breath lasting through eight months. Cognitive function scores also improved or remained stable throughout the treatment period.
2. Regulatory Milestones
IBTROZI received FDA approval for ROS1+ NSCLC in June 2025 and a supplemental NDA was accepted in May 2026 with a target action date of January 4, 2027. In March 2026, the European Medicines Agency validated the Marketing Authorisation Application for taletrectinib, initiating a standard review timeline for full approval consideration.
3. Upcoming Presentations and Trials
New patient-reported outcomes from TRUST-II will be presented at the ASCO Annual Meeting on May 31, 2026. A separate poster will detail the ongoing Phase 3 TRUST-IV trial, a randomized, double-blind study of adjuvant taletrectinib versus placebo in stage IB–IIIA ROS1+ NSCLC, with results expected to guide future regulatory and clinical strategies.
