marked.bio

ROS1 TKI (next generation) · small molecule

taletrectinib

4 active trials across 2 of our biomarkers, targeting ROS1/TRK. 1 active approval for a biomarker on marked.bio.

Also known as DS-6051b, AB-106, Ibtrozi.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

TherapyBiomarkerTumourUnited StatesEuropean Union
taletrectinib
FDA, 2025
locally advanced or metastatic, ROS1-positive FDA approval 11/06/2025; label revised 9/2026. Source
EU (EMA)
ROS1-positive advanced NSCLC EMA validated the marketing authorisation application (Eisai/Nuvation Bio announcement 26/03/2026). No CHMP opinion found as of 28/10/2026, so still under review. Company source; EMA does not publish named applications. Source
Ibtrozi 		ROS1 fusion NSCLC Approved 2025 Under review

TRUST-I and TRUST-II single-arm, 157 TKI-naive; 113 TKI-pretreated
Response 90% and 87% (TKI-naive); 52% and 62% (TKI-pretreated) (TRUST-I 83-95 (TKI-naive))Lasting 49.7 months (TRUST-I, TKI-naive)

Serious side effects 31%Stopped for side effects 7%Fatal 5%

Trial details and side effects
Patients
ROS1-positive NSCLC (NCT04395677)
Most common side effects
diarrhoea 64%, nausea 47%, vomiting 43%, dizziness 22%, rash 22%, constipation 21% (352 patients)
Notes
Response rates given separately for TRUST-I and TRUST-II. US label rev. 09/2026.
Source
US label

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
ROS1 fusion 4 5 Phase 3
NTRK1/2/3 fusion 0 3 –

Sponsors

Industry sponsors leading active biomarker-selected trials of taletrectinib.

  1. Nuvation Bio 4

Trials

4 of 7 trials shown

  1. Phase 3 Study of Taletrectinib vs Placebo as an Adjuvant Therapy in ROS1 Positive NSCLC (TRUST-IV)

    Recruiting Phase 3 Nuvation Bio Started 2025Primary completion 2030-08 NCT07154706

    taletrectinib FDA

    Documented ROS1 rearrangement in primary tumor by a validated local assay performed in CLIA-certified or locally equiva…

    ROS1 fusionNon-small Cell Lung Cancer (NSCLC)

  2. A Phase III Study Comparing Taletrectinib With Standard Therapy in ROS1 Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients

    Recruiting Phase 3 Nuvation Bio Started 2024Primary completion 2029-01 NCT06564324

    taletrectinib FDAcrizotinib FDA EU

    Have documentation of ROS1 rearrangement by a positive result

    ROS1 fusionNon Small Cell Lung Cancer

  3. Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC

    Active, not recruiting Phase 2 Nuvation Bio Started 2021Primary completion 2025-06 NCT04919811

    taletrectinib FDA

    Evidence of ROS1 fusion by a validated assay as performed in Clinical Laboratory Improvement Amendments (CLIA)-ce…

    ROS1 fusionNon Small Cell Lung Cancer

  4. A Study of AB-106 in Subjects With Advanced NSCLC Harboring ROS1 Fusion Gene

    Active, not recruiting Phase 2 Nuvation Bio Started 2020Primary completion 2024-06 NCT04395677

    taletrectinib FDA

    Positivity of ROS1 fusion is determined by the local qualified laboratories by using the FISH, RT-PCR or NGS assay,…

    ROS1 fusionNon Small Cell Lung Cancer