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Bending the Curve Trial by Trial
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TRUST-I and TRUST-II (pooled)

Taletrectinib in ROS1+ Non-Small Cell Lung Cancer: TRUST (pooled analysis of the TRUST-I and TRUST-II pivotal cohorts)

Phase 2N = 273NCT04395677NCT04919811

Population
ROS1-positive NSCLC, efficacy-evaluable population of 273 patients: TKI-naive (160) and TKI-pretreated (113)
Design
Pooled efficacy from two phase 2, single-arm, open-label, multicentre trials (TRUST-I and TRUST-II) of taletrectinib 600 mg orally once daily in ROS1-positive NSCLC. Primary endpoint confirmed objective response rate by independent review committee. Data as of 7 June 2024. TRUST-I (NCT04395677) is the China study and TRUST-II (NCT04919811) the global study, per the full text; efficacy is reported in the response-evaluable population (at least one measurable baseline lesion by independent review and at least one dose).
Primary endpoint
ORR
Arms
  • Taletrectinib (experimental, n = 273): Taletrectinib 600 mg orally once daily
People
Pérol M
Show the numbers
Results reported for TRUST-I and TRUST-II (pooled)
EndpointAnalysisTaletrectinibControlEffect
ORRTKI-naive patients (n=160)Confirmed objective response rate by independent review committeeprimaryPérol 202588.8%—Intracranial confirmed ORR 76.5% in TKI-naive patients. The abstract gives no confidence intervals.
DORTKI-naive patients (n=160)primaryPérol 2025median 44.2 months——
PFSTKI-naive patients (n=160)primaryPérol 2025median 45.6 months——
ORRTKI-pretreated patients (n=113)Confirmed objective response rate by independent review committeeprimaryPérol 202555.8%—Intracranial confirmed ORR 65.6% in TKI-pretreated patients. Confirmed ORR 61.5% (8 of 13) in patients with the G2032R mutation. The abstract gives no confidence intervals.
DORTKI-pretreated patients (n=113)primaryPérol 2025median 16.6 months——
PFSTKI-pretreated patients (n=113)primaryPérol 2025median 9.7 months——
Results reported for TRUST-I and TRUST-II (pooled)
EndpointAnalysisTaletrectinibControlEffect
ORRTKI-naive patients (n=160)Confirmed objective response rate by independent review committeeprimaryPérol 202588.8%—Intracranial confirmed ORR 76.5% in TKI-naive patients. The abstract gives no confidence intervals.
DORTKI-naive patients (n=160)primaryPérol 2025median 44.2 months——
PFSTKI-naive patients (n=160)primaryPérol 2025median 45.6 months——
ORRTKI-pretreated patients (n=113)Confirmed objective response rate by independent review committeeprimaryPérol 202555.8%—Intracranial confirmed ORR 65.6% in TKI-pretreated patients. Confirmed ORR 61.5% (8 of 13) in patients with the G2032R mutation. The abstract gives no confidence intervals.
DORTKI-pretreated patients (n=113)primaryPérol 2025median 16.6 months——
PFSTKI-pretreated patients (n=113)primaryPérol 2025median 9.7 months——
Illustrative — modelled from reported values, not trial data. DOR, primary.
0%25%50%75%100%020406080100Months (modelled)
  • Taletrectinib (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsTaletrectinib
0100.0%
2864.5%
5542.2%
8327.2%
11117.5%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%020406080100Months (modelled)
  • Taletrectinib (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsTaletrectinib
0100.0%
2964.4%
5742.0%
8627.1%
11417.7%
Primary publication: Pérol M, Li W, Pennell NA, Liu G, Ohe Y, De Braud F, et al. Taletrectinib in ROS1+ Non-Small Cell Lung Cancer: TRUST. J Clin Oncol. 2025;43(16):1920-1929. PubMedDOI

Appears in

Sources

  1. Pérol M, Li W, Pennell NA, Liu G, Ohe Y, De Braud F, et al. Taletrectinib in ROS1+ Non-Small Cell Lung Cancer: TRUST. J Clin Oncol. 2025;43(16):1920-1929.

    PubMedDOI