Nuvation Bio announces new data from Phase 2 studies of IBTROZI

Nuvation Bio (NUVB) announced new and updated results from the Phase 2 TRUST-I and TRUST-II studies evaluating IBTROZI for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer, NSCLC. For patients in TRUST-II who had not previously been treated with a ROS1 tyrosine kinase inhibitor, confirmed objective response rate was 85.2% at a median follow-up of 20.5 months. Median progression-free survival was not yet reached, meaning more than half of patients had not progressed, and the longest PFS was observed at 31.6 months and ongoing. Median duration of response was also not yet reached; the longest DOR was observed at 30.4 months and ongoing. A DOR of at least 12 months was achieved by 74.0% of patients and of at least 18 months by 68% of patients based on Kaplan-Meier estimates. An intracranial response was achieved by 66.7% of patients with brain metastases. In TKI-pretreated patients, cORR was 61.7% at a median follow-up of 20.4 months. Updated efficacy data as of October 28, 2024, from the TRUST-I study will be presented in a poster session on September 9. For TKI-naive patients in TRUST-I, cORR was 90.3% at a median follow-up of 40.9 months. Median PFS was 44.6 months. Median DOR was not yet reached; the longest DOR was observed at 46.9 months and ongoing. An intracranial response was achieved by 87.5% of patients with brain metastases. In TKI-pretreated patients, cORR was 51.5% at a median follow-up of 35.1 months. Median PFS was 7.6 months, and median DOR was 13.2 months. An intracranial response was achieved by 75.0% of patients with brain metastases.