Therapy Detail

Therapy Name Larotrectinib
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) 23 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).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
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-NTRK2 acute myeloid leukemia sensitive Larotrectinib Clinical Study Actionable In a clinical study, a patient-derived xenograft model with AML harboring ETV6-NTRK2 showed sensitivity to treatment with Larotrectinib, demonstrating a decrease in ETV6-NTRK2-expressing cells, and the patient with secondary AML, from whom the model was derived from, developed a partial remission when treated with Vitrakvi (larotrectinib), showing complete elimination of the cell population harboring ETV6-NTRK2 (PMID: 29920189). 29920189
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 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 Clinical Study 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 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
ETV6-NTRK3 gastrointestinal stromal tumor predicted - sensitive Larotrectinib Phase I 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...
Clinical Trial Phase Therapies Title Recruitment Status
NCT02576431 Phase II Larotrectinib Study of LOXO-101 in Subjects With NTRK Fusion Positive Solid Tumors Recruiting
NCT03155620 Phase II Tazemetostat Larotrectinib LY3023414 Vemurafenib Olaparib Selumetinib Ensartinib Pediatric MATCH: Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Advanced Refractory Solid Tumors or Lymphomas Recruiting
NCT02122913 Phase I Larotrectinib Oral TRK Inhibitor LOXO-101 for Treatment of Advanced Adult Solid Tumors Active, not recruiting
NCT02637687 Phase I Larotrectinib Oral TRK Inhibitor LOXO-101 for Treatment of Advanced Pediatric Solid or Primary Central Nervous System Tumors Recruiting
NCT02465060 Phase II Dabrafenib Trametinib Crizotinib Sunitinib Sapanisertib Nivolumab AZD4547 Dasatinib Binimetinib Adavosertib Osimertinib Trastuzumab Palbociclib Afatinib Capivasertib Defactinib GSK2636771 Vismodegib trastuzumab emtansine Larotrectinib Pertuzumab Taselisib Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) Recruiting
NCT03213704 Phase II Larotrectinib Pediatric MATCH: Trk Inhibitor LOXO-101 in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With NTRK Fusions Recruiting