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    DRUG CLASS:

    Trk inhibitor

    Related drugs:
    11d
    Effectiveness and cost-effectiveness of first-line versus second-line use of repotrectinib in the treatment of ROS1 fusion-positive advanced NSCLC. (PubMed, Expert Rev Anticancer Ther)
    Repotrectinib is not cost-effective at current prices, but first-line use is consistently more economically favorable than second-line therapy. Price reductions or shorter treatment durations could improve its cost-effectiveness.
    Journal • HEOR • Cost-effectiveness
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    ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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    ROS1 fusion • ROS1 positive
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    Augtyro (repotrectinib)
    1m
    Phase II Study of REPotrectinib With or Without Fulvestrant in Patients With Hormone Receptor-positive Human Epidermal Growth Factor 2-negative Metastatic Invasive LObular Carcinoma Who Received a Prior Endocrine Therapy in Combination With Cyclin-dependent Kinase 4 and 6 Inhibitor (REPLOT Trial) (clinicaltrials.gov)
    P2, N=6, Terminated, M.D. Anderson Cancer Center | N=58 --> 6 | Trial completion date: Dec 2027 --> Dec 2025 | Recruiting --> Terminated | Trial primary completion date: Dec 2027 --> Dec 2025; <75% Participation
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
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    fulvestrant • Augtyro (repotrectinib)
    2ms
    A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3) (clinicaltrials.gov)
    P3, N=190, Active, not recruiting, Bristol-Myers Squibb | Trial primary completion date: Mar 2027 --> Mar 2026
    Trial primary completion date
    |
    Xalkori (crizotinib) • Augtyro (repotrectinib)
    3ms
    Study to Evaluate the Effect of Repotrectinib on the Drug Levels of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants (clinicaltrials.gov)
    P1, N=32, Not yet recruiting, Bristol-Myers Squibb
    New P1 trial
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    Augtyro (repotrectinib) • metformin • omeprazole
    3ms
    Larotrectinib for the Treatment of NTRK Amplification Positive, Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P2, N=13, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Nov 2025 --> Nov 2027 | Trial primary completion date: Nov 2025 --> Nov 2027
    Trial completion date • Trial primary completion date • Pan tumor
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    NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2)
    |
    Vitrakvi (larotrectinib)
    4ms
    A Study to Assess the Drug Levels of Repotrectinib in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment (clinicaltrials.gov)
    P1, N=18, Completed, Bristol-Myers Squibb | Recruiting --> Completed
    Trial completion
    |
    Augtyro (repotrectinib)
    4ms
    A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3) (clinicaltrials.gov)
    P3, N=190, Active, not recruiting, Bristol-Myers Squibb | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Xalkori (crizotinib) • Augtyro (repotrectinib)
    4ms
    Phase II Study of REPotrectinib With or Without Fulvestrant in Patients With Hormone Receptor-positive Human Epidermal Growth Factor 2-negative Metastatic Invasive LObular Carcinoma Who Received a Prior Endocrine Therapy in Combination With Cyclin-dependent Kinase 4 and 6 Inhibitor (REPLOT Trial) (clinicaltrials.gov)
    P2, N=58, Recruiting, M.D. Anderson Cancer Center | Trial primary completion date: Dec 2025 --> Dec 2027
    Trial primary completion date
    |
    fulvestrant • Augtyro (repotrectinib)
    5ms
    CA127-1072: A Study to Assess the Effect of Voriconazole and Quinidine on the Pharmacokinetics of a Single Dose of Repotrectinib in Healthy Participants (clinicaltrials.gov)
    P1, N=32, Completed, Bristol-Myers Squibb | Trial completion date: Jul 2025 --> Dec 2024 | Trial primary completion date: Jul 2025 --> Dec 2024 | Recruiting --> Completed
    Trial completion • Trial completion date • Trial primary completion date
    |
    Augtyro (repotrectinib)
    5ms
    Exposure-Response Analysis of Repotrectinib to Support the Dose Recommendation for Patients With ROS1-Positive NSCLC or NTRK-Positive Solid Tumors. (PubMed, CPT Pharmacometrics Syst Pharmacol)
    This work highlighted the importance of selecting appropriate exposure measures in exposure-response analyses, particularly when dose or dose frequencies change throughout treatment. The integrated exposure-response analyses provided a robust framework to support the repotrectinib dosing strategy.
    Journal
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    ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    ROS1 positive • NTRK positive
    |
    Augtyro (repotrectinib)
    6ms
    A Study to Evaluate the Efficacy and Safety of TL118 in Solid Tumors Patients (clinicaltrials.gov)
    P2, N=60, Recruiting, Teligene US | Trial completion date: Apr 2026 --> Apr 2027 | Trial primary completion date: Aug 2025 --> Aug 2026
    Trial completion date • Trial primary completion date
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    NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2)
    |
    TL118