Nuvation Bio announces data from pivotal Phase 2 TRUST-I study

Nuvation Bio announced that results from the pivotal Phase 2 TRUST-I study conducted in China evaluating taletrectinib, its investigational next-generation ROS1 tyrosine kinase inhibitor, were published today in the Journal of Clinical Oncology and will be highlighted in an oral presentation at the 2024 American Society of Clinical Oncology Annual Meeting, taking place in Chicago, Illinois. Data were reported from 173 patients with advanced ROS1-positive non-small cell lung cancer who were treated with taletrectinib. Results showed tumors shrank in 91% of taletrectinib-treated patients who had not previously been treated with a ROS1 TKI and 52% of taletrectinib-treated patients who had previously been treated with crizotinib. Taletrectinib continued to show robust activity in patients with disease that spread to the brain, as well as in patients with acquired resistance mutations, including G2032R. After median follow-up of 23.5 months in TKI-naive patients, median duration of response and median progression-free survival were not reached. After median follow-up of 9.7 months in TKI-pretreated patients, median duration of response and median progression-free survival were 10.6 months and 7.6 months, respectively. Taletrectinib’s safety profile was consistent with previous reports, with a low incidence of neurologic treatment-emergent adverse events. TRUST-I is a pivotal Phase 2, multicenter, single-arm, open-label study evaluating taletrectinib as a monotherapy in 173 patients with advanced ROS1-positive NSCLC in China who had either not previously been treated with a ROS1 TKI or had previously been treated with crizotinib. Almost all patients received 600 mg of taletrectinib orally once-a-day in 21-day treatment cycles. 21% of TKI-naive patients and 34% of TKI-pretreated patients had received prior chemotherapy. The primary endpoint of this registrational study was cORR as assessed by IRC, and key secondary endpoints included duration of response, progression-free survival, and safety. As of November 29, 2023, results from TRUST-I as assessed by an IRC showed, in TKI-naive patients, 90.6% of patients’ tumors shrank following treatment with taletrectinib. Brain tumors shrank in 87.5% of taletrectinib-treated patients who had measurable central nervous system tumors. After median follow-up of 23.5 months, median duration of response and median progression-free survival were not reached. At two years, 78.6% of patients who responded following treatment with taletrectinib were still responding, and 70.5% of patients were still progression-free. In TKI-pretreated patients, 51.5% of patients’ tumors shrank following treatment with taletrectinib. Brain tumors shrank in 73.3% of taletrectinib-treated patients who had measurable central nervous system tumors. Tumors shrank in 66.7% of taletrectinib-treated patients with G2032R mutations. After median follow-up of 9.7 months, median duration of response was 10.6 months and median progression-free survival was 7.6 months. At nine months, 69.8% of patients who responded following treatment with taletrectinib were still responding, and 47.4% were still progression-free. Taletrectinib’s safety profile was consistent with previous reports. Discontinuations and dose reductions due to TEAEs were low.