Nuvation Bio Inc. (<NYSE: NUVB>) announced updated results from its Phase 2 TRUST-I and TRUST-II clinical trials evaluating IBTROZI (taletrectinib) for treating adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (<NSCLC>). The data were presented at the IASLC 2025 World Conference on Lung Cancer (<WCLC>) in Barcelona, Spain.
The studies revealed sustained, durable responses to IBTROZI treatment. Researchers observed significant progression-free survival times, particularly among patients not previously treated with a tyrosine kinase inhibitor (TKI-naïve).
In the TRUST-II study, TKI-naïve patients showed an 85.2% confirmed objective response rate and a median progression-free survival that had not yet been reached, indicating a substantial portion of patients remained progression-free at the data cutoff. The longest progression-free survival observed was over 31 months. Results were similarly positive for TKI-pretreated patients, though with a shorter median progression-free survival. A high percentage of patients with brain metastases also experienced intracranial responses.
TRUST-I study results showed comparable efficacy. TKI-naïve patients achieved a median progression-free survival of 44.6 months, with a confirmed objective response rate of 90.3%. The longest duration of response observed exceeded 46 months. Again, a high proportion of patients with brain metastases had intracranial responses. TKI-pretreated patients also showed positive results, although with a shorter median progression-free survival.
Across both studies, IBTROZI demonstrated a favorable safety profile. Adverse events were generally manageable, transient, and resolved quickly. The most frequent side effects included diarrhea, nausea, vomiting, and dizziness. While liver enzyme elevations were common, these rarely led to treatment discontinuation.
Dr. Geoffrey Liu of the Princess Margaret Cancer Centre highlighted the significance of these findings, emphasizing the drug’s durable responses and manageable side effects. He noted that the results further supported the recent U.S. Food and Drug Administration (<FDA>) approval of IBTROZI.
Dr. David Hung, Founder, President, and CEO of Nuvation Bio, stated that the long-term data underscore the impressive progression-free survival and durability of response, coupled with a tolerable safety profile. He expressed continued enthusiasm for IBTROZI‘s potential.
The TRUST program, encompassing both TRUST-I and TRUST-II, involved over 300 patients, making it one of the largest global clinical trial programs for ROS1-positive NSCLC to date. The studies’ primary endpoint was confirmed objective response rate, with secondary endpoints including intracranial response rate, duration of response, progression-free survival, and safety.
IBTROZI is an oral, potent, and CNS-active selective next-generation ROS1 inhibitor. The <FDA> approved IBTROZI for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC in June. The approval followed Priority Review and Breakthrough Therapy Designations.
Nuvation Bio continues to monitor patients enrolled in the TRUST studies for long-term outcomes and safety data. Further analysis and potential future studies are anticipated to further elucidate IBTROZI‘s role in ROS1-positive NSCLC treatment.
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