Nuvation announces pooled data from pivotal Phase 2 TRUST-I, TRUST-II studies

Nuvation Bio announced pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies evaluating taletrectinib, an investigational next-generation ROS1 TKI. The findings will be highlighted in a poster presentation on September 14, 2024, at the European Society of Medical Oncology Congress 2024 in Barcelona, Spain. The pooled efficacy and safety data from the TRUST-I and TRUST-II studies presented at ESMO are as of June 7, 2024; both studies remain ongoing. The ESMO data set includes 337 patients with advanced ROS1+ NSCLC who received 600mg of taletrectinib orally once daily in 21-day cycles. The primary endpoint of these registrational studies is confirmed objective response rate as assessed by an independent review committee. Key secondary endpoints include intracranial cORR, DOR, PFS, and safety. The pooled efficacy analyses included 160 patients with advanced ROS1+ NSCLC who had not previously been treated with a ROS1 TKI and 113 patients who had previously been treated with crizotinib or entrectinib. Among these two populations, 94% of patients had stage IV NSCLC. In addition, 20% of TKI-naive and 37% of TKI-pretreated patients received prior chemotherapy, while 23% of TKI-naive and 49% of TKI-pretreated patients had brain metastases at baseline. The efficacy results, independently assessed by an IRC, showed in TKI-naive patients: Tumors shrank in 89% of taletrectinib-treated patients. Measurable brain metastases shrank in 77%of taletrectinib-treated patients. After median follow-up of 21 months, the median DOR and the median PFS were 44 months and 46 months, respectively. In TKI-pretreated patients, it showed that: Tumors shrank in 56% of taletrectinib-treated patients. Measurable brain metastases shrank in 66% of taletrectinib-treated patients. Tumors shrank in 62% of taletrectinib-treated patients with G2032R mutations. After median follow-up of 21 months, the median DOR and the median PFS were 17 months and 10 months, respectively. The pooled safety analysis included 337 patients with advanced ROS1+ NSCLC. The results demonstrated a favorable safety and tolerability profile, with a low incidence and a limited spectrum of neurologic TEAEs and a low rate of treatment discontinuation. The incidence of neurologic TEAEs was low. The rate of treatment discontinuation due to TEAEs was 7% and the rate of dose reduction due to TEAEs was 29%.