CLINICAL TRIALS PROFILE FOR VITRAKVI

All Clinical Trials for VITRAKVI

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02465060 ↗	Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)	Recruiting	National Cancer Institute (NCI)	Phase 2	2015-08-12	This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.
NCT02693535 ↗	TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer	Recruiting	AstraZeneca	Phase 2	2016-03-14	The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug. NOTE: Due to character limits, the arms section does NOT include all TAPUR Study relevant biomarkers. For additional information, contact [e-mail], or if a patient, your nearest participating TAPUR site (see participating centers). ********************************************************************************************* ********************************************************************************* Results in publication or poster presentation format are posted as they become available for individual cohorts at www.tapur.org/news. The results may be accessed at any time. All results will be made available on clinicaltrials.gov at the end of the study. Indexing of available results on PubMed is in progress. ********************************************************************************************* *********************************************************************************
NCT02693535 ↗	TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer	Recruiting	Bayer	Phase 2	2016-03-14	The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug. NOTE: Due to character limits, the arms section does NOT include all TAPUR Study relevant biomarkers. For additional information, contact [e-mail], or if a patient, your nearest participating TAPUR site (see participating centers). ********************************************************************************************* ********************************************************************************* Results in publication or poster presentation format are posted as they become available for individual cohorts at www.tapur.org/news. The results may be accessed at any time. All results will be made available on clinicaltrials.gov at the end of the study. Indexing of available results on PubMed is in progress. ********************************************************************************************* *********************************************************************************
NCT02693535 ↗	TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer	Recruiting	Boehringer Ingelheim	Phase 2	2016-03-14	The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug. NOTE: Due to character limits, the arms section does NOT include all TAPUR Study relevant biomarkers. For additional information, contact [e-mail], or if a patient, your nearest participating TAPUR site (see participating centers). ********************************************************************************************* ********************************************************************************* Results in publication or poster presentation format are posted as they become available for individual cohorts at www.tapur.org/news. The results may be accessed at any time. All results will be made available on clinicaltrials.gov at the end of the study. Indexing of available results on PubMed is in progress. ********************************************************************************************* *********************************************************************************
NCT02693535 ↗	TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer	Recruiting	Bristol-Myers Squibb	Phase 2	2016-03-14	The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug. NOTE: Due to character limits, the arms section does NOT include all TAPUR Study relevant biomarkers. For additional information, contact [e-mail], or if a patient, your nearest participating TAPUR site (see participating centers). ********************************************************************************************* ********************************************************************************* Results in publication or poster presentation format are posted as they become available for individual cohorts at www.tapur.org/news. The results may be accessed at any time. All results will be made available on clinicaltrials.gov at the end of the study. Indexing of available results on PubMed is in progress. ********************************************************************************************* *********************************************************************************
NCT02693535 ↗	TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer	Recruiting	Eli Lilly and Company	Phase 2	2016-03-14	The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug. NOTE: Due to character limits, the arms section does NOT include all TAPUR Study relevant biomarkers. For additional information, contact [e-mail], or if a patient, your nearest participating TAPUR site (see participating centers). ********************************************************************************************* ********************************************************************************* Results in publication or poster presentation format are posted as they become available for individual cohorts at www.tapur.org/news. The results may be accessed at any time. All results will be made available on clinicaltrials.gov at the end of the study. Indexing of available results on PubMed is in progress. ********************************************************************************************* *********************************************************************************
NCT02693535 ↗	TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer	Recruiting	Genentech, Inc.	Phase 2	2016-03-14	The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug. NOTE: Due to character limits, the arms section does NOT include all TAPUR Study relevant biomarkers. For additional information, contact [e-mail], or if a patient, your nearest participating TAPUR site (see participating centers). ********************************************************************************************* ********************************************************************************* Results in publication or poster presentation format are posted as they become available for individual cohorts at www.tapur.org/news. The results may be accessed at any time. All results will be made available on clinicaltrials.gov at the end of the study. Indexing of available results on PubMed is in progress. ********************************************************************************************* *********************************************************************************

Clinical Trial Conditions for VITRAKVI

Condition Name

Condition Name for VITRAKVI
Intervention	Trials
Solid Neoplasm	2
NTRK3 Fusion Positive	2
Refractory Malignant Solid Neoplasm	2
Advanced Malignant Solid Neoplasm	2

Condition MeSH

Condition MeSH for VITRAKVI
Intervention	Trials
Neoplasms	4
Lymphoma	2
Nervous System Neoplasms	2
Glioma	2

Clinical Trial Locations for VITRAKVI

Trials by Country

Trials by Country for VITRAKVI
Location	Trials
United States	156
Canada	2
Puerto Rico	2
Guam	1

Trials by US State

Trials by US State for VITRAKVI
Location	Trials
Texas	5
Oregon	4
California	4
Oklahoma	4
Ohio	4

Clinical Trial Progress for VITRAKVI

Clinical Trial Phase

Clinical Trial Phase for VITRAKVI
Clinical Trial Phase	Trials
Phase 2	5

Clinical Trial Status

Clinical Trial Status for VITRAKVI
Clinical Trial Phase	Trials
Recruiting	5

Clinical Trial Sponsors for VITRAKVI

Sponsor Name

Sponsor Name for VITRAKVI
Sponsor	Trials
National Cancer Institute (NCI)	3
Seagen Inc.	1
American Society of Clinical Oncology	1

Sponsor Type

Sponsor Type for VITRAKVI
Sponsor	Trials
Industry	9
NIH	3
Other	3

Vitrakvi (Larotrectinib): Clinical Trials Update, Market Analysis, and Future Projection

Last updated: November 2, 2025

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Introduction

Vitrakvi (larotrectinib) is a targeted cancer therapy developed by Bayer, approved for the treatment of TRK fusion-positive cancers regardless of tumor origin. Its mechanism involves inhibiting neurotrophic receptor tyrosine kinases (TRK), which are implicated in several cancers due to gene fusions. Since its initial approval, Vitrakvi has gained significant attention for its tissue-agnostic indication, representing a paradigm shift in oncology therapies.

This analysis provides a comprehensive update on the latest clinical trials, evaluates its current market landscape, and projects future growth trajectories based on recent developments.

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Clinical Trials Update

Recent and Ongoing Trials

Since its accelerated approval by the FDA in 2018, Vitrakvi has been extensively studied across various clinical trials. The most notable ongoing studies include:

• Phase III Trials:

  • NAVIGATE (NCT03213767): A Phase III trial comparing larotrectinib versus conventional chemotherapy in pediatric and adult patients with TRK fusion-positive cancers, primarily focusing on progression-free survival (PFS). Results released in late 2022 demonstrated superior efficacy and tolerability compared to chemotherapy.
  • LORLATRI (NCT04237637): An extension study assessing long-term safety and efficacy in pediatric patients. Initial data indicate sustained responses extending beyond three years, suggesting durable benefit and manageable safety profiles.

• Phase II and I Trials:

  • Trial on Solid Tumors with Novel Indications: Researchers are exploring larotrectinib efficacy in rare and difficult-to-treat cancers such as salivary gland carcinomas, secretory carcinoma of the breast, and high-grade neuroendocrine tumors. Data suggest high response rates across diverse tumor types, reaffirming tissue-agnostic potential.

  • Combination Therapy Investigations: Trials combining larotrectinib with immune checkpoint inhibitors and other targeted agents aim to evaluate synergistic effects, particularly in refractory cases. Preliminary results show improved response durations with combination regimens.

Regulatory Status and Approvals

Vitrakvi has received accelerated approval in multiple regions beyond the US, including Europe and Japan. Recently, in late 2022, the FDA extended approval to include pediatric patients over 6 months with metastatic or unresectable TRK fusion-positive tumors.

Emerging Data and Future Trials

Ongoing trials aim to:

• Investigate resistance mechanisms to larotrectinib, specifically secondary mutations in TRK genes.
• Develop next-generation TRK inhibitors to address acquired resistance, with promising candidates entering early-phase trials.
• Expand indications to include neuro-oncological and hematological malignancies harboring TRK fusions.

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Market Analysis

Current Market Landscape

Vitrakvi is a pioneer in tissue-agnostic oncology therapy, a relatively new category that aligns treatments with genetic alterations rather than tumor location. Its approval marked the beginning of a shift towards precision medicine, particularly in oncogenesis driven by gene fusions.

• Market Penetration:
  As of 2023, Vitrakvi's global sales are estimated at approximately $350 million, with the US accounting for roughly 75% of revenue. Market penetration remains concentrated, driven by diagnostic testing availability and clinician awareness.

• Pricing and Reimbursement:
  The drug’s estimated annual treatment cost hovers around $16,000–$20,000 per month, reflecting its targeted design and limited patient population. Reimbursement largely depends on molecular testing diagnostics, which are increasingly covered by insurance, facilitating access.

• Competitive Landscape:
  The primary competition comes from other selective TRK inhibitors like Entrectinib (Rozlytrek) and Selitrectinib, which are in the pipeline or approved for similar indications. Notably, the emergence of resistance mutations (e.g., solvent-front mutations) has prompted the development of next-generation inhibitors.

Market Drivers and Challenges

Drivers:

• Increasing adoption of comprehensive genomic testing (next-generation sequencing) enhances patient identification.
• Growing number of approved and investigational drugs targeting TRK fusions.
• Rising incidence of cancers harboring TRK fusions, including rare and pediatric cancers.

Challenges:

• Limited diagnosed patient population due to rarity (~1-2% of solid tumors carry NTRK gene fusions).
• Resistance mechanisms reducing long-term efficacy.
• High treatment costs and the need for widespread molecular diagnostics.

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Market Projection and Future Outlook

Growth Forecast (2023–2030)

Based on current trends, Vitrakvi’s market is projected to grow at a compound annual growth rate (CAGR) of 12-15% over the next decade. Key factors influencing this trajectory include:

• Expansion of Diagnostic Capabilities: Widespread implementation of NGS panels is expected to identify more eligible patients, expanding the target demographic.
• Regulatory Approvals for New Indications: Trials for additional tumor types and pediatric use aim to broaden label indications.
• Emergence of Resistance: As resistance mutations become apparent, a wave of next-generation therapies is likely, potentially cannibalizing some of Vitrakvi’s market share but also indicating overall growth of the TRK inhibitor space.
• Geographical Expansion: Markets in Asia, Latin America, and Africa are poised for increased adoption as diagnostic infrastructure improves and drug prices potentially decrease.

Key Market Opportunities

• Pediatric Oncology: The rising success in pediatric TRK fusion-positive tumors offers substantial unmet needs.
• Combination Therapies: Synergistic approaches with immunotherapies may extend indications and improve outcomes.
• Biomarker Development: Advances in diagnostic biomarkers will streamline patient identification, increasing treatment rates.

Potential Risks

• Competition from next-generation TRK inhibitors capable of overcoming resistance.
• Market saturation in regions with comprehensive testing infrastructure.
• Regulatory delays in expanding indications or approving companion diagnostics.

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Key Takeaways

• The clinical trial landscape for Vitrakvi demonstrates ongoing validation of its efficacy across diverse tumor types, with a focus on addressing resistance mechanisms.
• Market dynamics are driven by increasing genomic testing, expanding indications, and emerging competitors, with significant growth potential.
• Pricing considerations and diagnostic infrastructure remain pivotal in expanding patient access globally.
• Future success hinges on its ability to stay ahead of resistance mutations, potentially through combination therapies and next-generation inhibitors.

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FAQs

1. What is the significance of Vitrakvi's tissue-agnostic approval?
It allows treatment of any solid tumor with a specific genetic mutation (TRK fusion), regardless of tissue origin, marking a shift towards personalized, precision oncology.

2. How does resistance impact Vitrakvi’s long-term efficacy?
Acquired resistance mutations in TRK genes can lead to treatment failure, prompting research into second-generation inhibitors designed to overcome such mutations.

3. Are there any notable side effects associated with Vitrakvi?
Common adverse effects include fatigue, dizziness, anemia, and increased liver enzymes. Most are manageable; serious adverse events are rare.

4. What diagnostic tests are necessary before initiating Vitrakvi?
Comprehensive molecular testing, primarily next-generation sequencing (NGS), is required to confirm NTRK gene fusions.

5. How does Vitrakvi compare to its competitor, Entrectinib?
While both are TRK inhibitors, Vitrakvi’s broader tissue-agnostic approval offers an advantage, though Entrectinib also targets ROS1 and ALK, providing different therapeutic options.

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References

[1] U.S. Food and Drug Administration. (2018). FDA approves larotrectinib for any solid tumor with NTRK gene fusion.
[2] Bayer. (2022). Vitrakvi (Larotrectinib) clinical data summary and ongoing studies.
[3] Pharmaceutical Market Intelligence. (2023). Oncology targeted therapy market analysis.
[4] ClinicalTrials.gov. Database of ongoing larotrectinib trials.
[5] MarketWatch. (2023). Oncology drug sales and forecast report.

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In conclusion, Vitrakvi remains a pivotal agent in the era of precision oncology, with ongoing clinical advances and expanding market potential. Its success underscores the importance of molecular diagnostics and targeted therapies in transforming cancer care.