Therapy Detail
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| Therapy Name | Larotrectinib |
| Synonyms | |
| Therapy Description |
Vitrakvi (larotrectinib) binds to and prevents activation of TRK receptors (NTRK1, -2, -3), resulting in decreased growth and increased apoptosis in Trk-expressing tumor cells (PMID: 29532798). Vitrakvi (larotrectinib) is FDA approved for use in adult and pediatric patients with solid tumors that have progressed, are metastatic, or are not surgically resectable and have an NTRK fusion without acquired resistance mutations (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Larotrectinib | Vitrakvi | LOXO-101|ARRY-470 | Trk Receptor Inhibitor (Pan) 24 | Vitrakvi (larotrectinib) binds to and prevents activation of TRK receptors (NTRK1, -2, -3), resulting in decreased growth and increased apoptosis in Trk-expressing tumor cells (PMID: 29532798). Vitrakvi (larotrectinib) is FDA approved for use in adult and pediatric patients with solid tumors that have progressed, are metastatic, or are not surgically resectable and have an NTRK fusion without acquired resistance mutations (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| ETV6 - NTRK3 | glioblastoma | predicted - sensitive | Larotrectinib | Case Reports/Case Series | Actionable | In a clinical case study, an 18-month-old patient with glioblastoma harboring ETV6-NTRK3 was treated with Viktravi (larotrectinib) and demonstrated tumor regression after 8 weeks and remained clinically stable after 6 months of therapy (PMID: 32923892). | 32923892 |
| ETV6 - NTRK3 | congenital fibrosarcoma | sensitive | Larotrectinib | Phase I | Actionable | In a Phase I clinical trial, treatment with Vitrakvi (larotrectinib) resulted in a partial response in a pediatric patient with infantile fibrosarcoma harboring ETV6-NTRK3 (PMID: 27093299). | 27093299 |
| ETV6 - NTRK3 | congenital fibrosarcoma | sensitive | Larotrectinib | Phase Ib/II | Actionable | In a Phase I/II trial, Vitrakvi (larotrectinib) treatment resulted in complete response in 33.3% (2/6) and partial response in 66.7% (4/6) of pediatric patients with congenital fibrosarcoma harboring ETV6-NTRK3 fusions (PMID: 29606586; NCT02637687). | 29606586 |
| ETV6 - NTRK3 | congenital fibrosarcoma | sensitive | Larotrectinib | Case Reports/Case Series | Actionable | In a clinical case study, a patient with congenital fibrosarcoma harboring ETV6-NTRK3 demonstrated tumor regression by 90% when treated with Vitrakvi (larotrectinib) (PMID: 28578312). | 28578312 |
| ETV6 - NTRK3 | acute myeloid leukemia | sensitive | Larotrectinib | Preclinical | Actionable | In a preclinical study, Vitrakvi (larotrectinib) inhibited cell growth and downstream signaling in acute myeloid leukemia cells harboring ETV6-NTRK3 in culture and xenografts (PMID: 26216294). | 26216294 |
| ETV6 - ALK | glioblastoma | predicted - sensitive | Larotrectinib | Case Reports/Case Series | Actionable | In a clinical case study, an infant patient with glioblastoma harboring ETV6-ALK who achieved a 56% reduction in tumor size after nine months of Xalkori (crizotinib) treatment following chemotherapy and a partial resection was then switched to Vitrakvi (larotrectinib) treatment, resulting in a further reduction to 73% of the original tumor size after three months and ongoing clinical improvement (PMID: 32238360). | 32238360 |
| ETV6 - ALK | pediatric low-grade glioma | predicted - sensitive | Larotrectinib | Case Reports/Case Series | Actionable | In a clinical case study, a pediatric patient with low-grade glioma who responded to initial surgical resection and chemotherapy underwent a subsequent resection upon recurrence and began treatment with Vitrakvi (larotrectinib) following identification of an ETV6-ALK fusion, and remained disease-free over 12 months of treatment (PMID: 32238360). | 32238360 |
| ETV6 - NTRK3 | gastrointestinal stromal tumor | predicted - sensitive | Larotrectinib | Case Reports/Case Series | Actionable | In a Phase I trial, Vitrakvi (larotrectinib) treatment resulted in complete response in 1 and partial response in 2 patients with gastrointestinal stromal tumor harboring ETV6-NTRK3 fusions (PMID: 29466156, Annals of Oncology, Volume 29, Issue suppl_5; NCT02122913, NCT02637687, and NCT02576431). | 29466156 detail... |
| ETV6 - NTRK3 | B-lymphoblastic leukemia/lymphoma with BCR-ABL1 | predicted - sensitive | Larotrectinib | Case Reports/Case Series | Actionable | In a clinical case study, Vitrakvi (larotrectinib) treatment resulted in significant suppression of leukemic cells and clinical benefit in a patient with relapsed Philadelphia chromosome (Ph)-like acute lymphoblastic leukemia associated with an expansion of a subclone harboring ETV6-NTRK3 fusion (PMID: 31905241). | 31905241 |
| ETV6 - NTRK2 | acute myeloid leukemia | sensitive | Larotrectinib | Case Reports/Case Series | Actionable | In a clinical study, a patient with secondary AML achieved a partial remission when treated with Vitrakvi (larotrectinib), showing complete elimination of the cell population harboring ETV6-NTRK2, and the patient-derived xenograft (PDX) model harboring ETV6-NTRK2 showed sensitivity to treatment with Vitrakvi (larotrectinib), demonstrating a decrease in ETV6-NTRK2-expressing cells (PMID: 29920189). | 29920189 |
| ETV6 - NTRK3 | Advanced Solid Tumor | sensitive | Larotrectinib | Phase II | Actionable | In a combined analysis of three trials, Vitrakvi (larotrectinib) treatment resulted in complete response in 21.4% (6/28) and partial response in 67.9% (19/28) of patients with advanced solid tumors harboring an ETV6-NTRK3 fusion (PMID: 29466156; NCT02122913, NCT02637687, NCT02576431). | 29466156 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT02576431 | Phase II | Larotrectinib | A Study to Test the Effect of the Drug Larotrectinib in Adults and Children With NTRK-fusion Positive Solid Tumors (NAVIGATE) | Recruiting | USA | CAN | 28 |
| NCT03834961 | Phase II | Larotrectinib | Larotrectinib in Treating Patients With Previously Untreated TRK Fusion Solid Tumors and TRK Fusion Relapsed Acute Leukemia | Recruiting | USA | CAN | 0 |
| NCT02465060 | Phase II | Erdafitinib Copanlisib Trametinib Crizotinib Sunitinib Sapanisertib Nivolumab AZD4547 Dasatinib Pertuzumab + Trastuzumab Dabrafenib + Trametinib Binimetinib Adavosertib Osimertinib Palbociclib Afatinib Capivasertib Defactinib GSK2636771 Vismodegib Ado-trastuzumab emtansine Larotrectinib Taselisib | Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) | Recruiting | USA | 2 |
| NCT02637687 | Phase I | Larotrectinib | A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in Children (SCOUT) | Recruiting | USA | CAN | 20 |
| NCT03155620 | Phase II | Tazemetostat Larotrectinib LY3023414 Vemurafenib Palbociclib Olaparib Ulixertinib Erdafitinib Selumetinib Ensartinib | Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) | Recruiting | USA | 1 |
| NCT03213704 | Phase II | Larotrectinib | Larotrectinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With NTRK Fusions (A Pediatric MATCH Treatment Trial) | Recruiting | USA | 1 |
| NCT02122913 | Phase I | Larotrectinib | A Study to Test the Safety of the Investigational Drug Larotrectinib in Adults That May Treat Cancer | Active, not recruiting | USA | 0 |
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