New York, New York, U.S., September 15, 2026
Nuvation Bio Inc. has announced new analyses from the pivotal TRUST-I and TRUST-II clinical studies evaluating IBTROZI® (taletrectinib) in patients with advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). The findings, presented at the IASLC 2026 World Conference on Lung Cancer (WCLC) in Seoul, South Korea, showed that IBTROZI maintained consistent and durable efficacy across key patient subgroups, including patients with different ROS1 fusion partners and those who had previously received chemotherapy. The company said the analyses add to the clinical evidence supporting taletrectinib as a targeted treatment option for adults with locally advanced or metastatic ROS1+ NSCLC.
Consistent Responses After Prior Chemotherapy
One analysis examined outcomes according to prior chemotherapy exposure among patients who had not previously received a ROS1 tyrosine kinase inhibitor (TKI). Results from the pooled TRUST-I and TRUST-II population showed that responses to IBTROZI remained consistent whether patients had received chemotherapy before starting taletrectinib or had not. The objective response rate (ORR) was 90.0% among patients with prior chemotherapy and 89.8% among those without prior chemotherapy. Median duration of response (DOR) was also substantial, reaching 48.3 months in the prior-chemotherapy group and 54.3 months in patients without previous chemotherapy. These findings provide additional information about the activity of taletrectinib in patients who may have started treatment before comprehensive biomarker testing identified a ROS1 fusion.
Durable Efficacy Across ROS1 Fusion Partners
Additional analyses evaluated whether the ROS1 fusion partner influenced treatment outcomes. CD74 is one of the most common ROS1 fusion partners in NSCLC, while other patients have tumors driven by different fusion partners. Among TKI-naïve patients, IBTROZI produced an ORR of 89.5% in patients with CD74 fusions and 88.9% in patients with non-CD74 fusions. Median DOR was similarly durable, at 44.8 months and 43.3 months, respectively. Median progression-free survival (PFS) was also comparable between the groups, at 46.1 months for CD74 fusions and 44.6 months for non-CD74 fusions. These subgroup findings indicate that treatment activity was observed across different ROS1 molecular profiles rather than being limited to a single common fusion partner.
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Long-Term Safety and IBTROZI Clinical Development
The new analyses also included longer-term safety follow-up from the TRUST-I and TRUST-II studies. Nuvation Bio reported that the safety profile remained manageable and consistent with previous reports, with no new safety signals identified in the long-term analysis. Common adverse events included increased AST and ALT levels, diarrhea, nausea, and vomiting, which were reported as mostly low grade. IBTROZI is an oral, CNS-active, selective next-generation ROS1 inhibitor. The U.S. FDA approved taletrectinib in June 2025 for adults with locally advanced or metastatic ROS1+ NSCLC.
The ongoing development program includes additional clinical studies intended to evaluate taletrectinib across different treatment settings. TRUST-IV is a Phase 3 study evaluating IBTROZI as adjuvant therapy in patients with resected early-stage ROS1+ NSCLC, while TRUST-III is a randomized Phase 3 study comparing IBTROZI with crizotinib in patients with advanced ROS1+ NSCLC who have not previously received ROS1 TKIs. The latest WCLC analyses add further subgroup information to the broader clinical development program and highlight the importance of molecular testing and targeted treatment in ROS1-driven lung cancer.
Source: Nuvation Bio press release
