Taletrectinib - (TRUST-I) (China)

Sept. 15, 2026: Nuvation Bio (NYSE: NUVB) reported new subgroup analyses from the pivotal Phase 2 TRUST-I and TRUST-II studies of IBTROZI (taletrectinib) in advanced ROS1-positive NSCLC at the IASLC 2026 World Conference on Lung Cancer.

In TKI-naïve patients, efficacy was similar whether patients had prior chemotherapy or not: ORR was 90.0% (n=30) vs 89.8% (n=127), with median duration of response of 48.3 vs 54.3 months. By ROS1 fusion partner, outcomes were also similar: among TKI-naïve patients, ORR was 89.5% in CD74 fusions (n=19) and 88.9% in non-CD74 fusions (n=18), with median DOR 44.8 vs 43.3 months and median PFS 46.1 vs 44.6 months. The company said TKI-pretreated patients also showed consistent benefit regardless of fusion partner, though detailed figures were not included here.

Safety with long-term follow-up was described as manageable and consistent with prior reports, with no new safety signals; common adverse events were increased AST/ALT, diarrhea, nausea, and vomiting, mostly low grade.

The release also notes FDA approval of taletrectinib on June 11, 2025, for adults with locally advanced or metastatic ROS1+ NSCLC, and highlights ongoing Phase 3 studies TRUST-III and adjuvant TRUST-IV (primary completion estimated in 2030).