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) 31 | 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 |
|---|---|---|---|---|---|---|---|
| NTRK2 fusion | pancreatic adenocarcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is in guidelines as second-line therapy for patients with advanced or metastatic pancreatic adenocarcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | differentiated thyroid gland carcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for adult or pediatric patients 12 years or older with metastatic differentiated thyroid gland carcinoma harboring NTRK fusions that have progressed on prior therapies (PMID: 31549998, PMID: 35491008; ESMO.org). | detail... 35491008 31549998 |
| NTRK2 fusion | colorectal cancer | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with metastatic colorectal cancer harboring an NTRK fusion (PMID: 36307056; ESMO.org). | 36307056 detail... |
| NTRK1 fusion | intrahepatic cholangiocarcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as primary and subsequent-line therapy for patients with unresectable or metastatic biliary tract cancer harboring an NTRK fusion, including intrahepatic cholangiocarcinoma (NCCN.org). | detail... |
| NTRK1 fusion | small intestine adenocarcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with metastatic small bowel adenocarcinoma with an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | esophagus adenocarcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as second-line or subsequent therapy for patients with unresectable locally advanced, recurrent, or metastatic esophageal adenocarcinoma with an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | biliary tract cancer | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as second or later-line therapy for patients with biliary tract cancer harboring an NTRK fusion (PMID: 36372281; ESMO.org). | 36372281 detail... |
| NTRK2 fusion | stomach cancer | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as second-line or subsequent therapy for patients with unresectable locally advanced, recurrent, or metastatic gastric cancer harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | gastrointestinal stromal tumor | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with advanced/metastatic gastrointestinal stromal tumor (GIST) harboring NTRK fusions (PMID: 34560242; ESMO.org). | detail... 34560242 |
| NTRK2 fusion | gastrointestinal stromal tumor | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as neoadjuvant therapy for patients with resectable disease and as first-line systemic therapy for patients with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring NTRK fusions (NCCN.org). | detail... |
| NTRK1 fusion | pancreatic cancer | sensitive | Larotrectinib | Case Reports/Case Series | Actionable | In a Phase I trial, Vitrakvi (larotrectinib) treatment resulted in partial response in a patient with pancreatic cancer harboring NTRK1 fusions (PMID: 29466156, Annals of Oncology, Volume 29, Issue suppl_5; NCT02122913, NCT02637687, and NCT02576431). | 29466156 detail... |
| NTRK1 fusion | pancreatic cancer | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with metastatic pancreatic cancer harboring an NTRK fusion (PMID: 37678671; ESMO.org). | detail... 37678671 |
| NTRK2 fusion | ampulla of Vater adenocarcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as first-line therapy when the performance status is poor or as subsequent therapy for metastatic ampullary adenocarcinoma patients harboring NTRK fusions (NCCN.org). | detail... |
| NTRK1 fusion | glioblastoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with recurrent glioblastoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | lung cancer | predicted - sensitive | Larotrectinib | Phase II | Actionable | In a combined analysis of two clinical trials, Vitrakvi (larotrectinib) treatment demonstrated safety and resulted in an objective response rate (ORR) of 73% (11/15, 1 complete response, 10 partial responses) in 15 evaluable lung cancer patients of 20 harboring NTRK1 (n=16) or NTRK3 (n=4) fusions, with median progression-free survival (PFS) of 35.4 mo, a 12-mo PFS rate of 65%, and 33.9 mo duration of response, and ORR in patients with CNS metastasis was 63% (5/8) (PMID: 35085007; NCT02122913, NCT02576431). | 35085007 |
| NTRK2 fusion | high grade glioma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as adjuvant therapy for pediatric patients with diffuse high-grade gliomas harboring NTRK fusions, or as a preferred regimen for patients with recurrent or progressive disease (NCCN.org). | detail... |
| NTRK1 fusion | cholangiocarcinoma | sensitive | Larotrectinib | Case Reports/Case Series | Actionable | In a Phase I trial, Vitrakvi (larotrectinib) treatment resulted in partial response in a patient with cholangiocarcinoma harboring NTRK1 fusion (Annals of Oncology, Volume 29, Issue suppl_5; NCT02122913, NCT02637687, and NCT02576431). | detail... |
| NTRK2 fusion | neuroendocrine tumor | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with unresectable or metastatic extrapulmonary poorly differentiated neuroendocrine carcinoma, large or small cell carcinoma, or mixed neuroendocrine/non-neuroendocrine neoplasms harboring an NTRK fusion who have progressed on or following prior treatment (NCCN.org). | detail... |
| NTRK1 fusion | ovary epithelial cancer | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as systemic therapy for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 rearrange | sarcoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as a standard treatment for patients with advanced sarcomas harboring NTRK rearrangement (PMID: 34303806; ESMO.org). | detail... 34303806 |
| NTRK1 fusion | Cancer of Unknown Primary | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with cancer of unknown primary harboring NTRK fusions (PMID: 36563965; ESMO.org). | 36563965 detail... |
| NTRK1 fusion | gastroesophageal junction adenocarcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as second-line or subsequent therapy for patients with unresectable locally advanced, recurrent, or metastatic gastroesophageal junction adenocarcinoma with an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | differentiated thyroid gland carcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for adult or pediatric patients 12 years or older with metastatic differentiated thyroid gland carcinoma harboring NTRK fusions that have progressed on prior therapies (PMID: 31549998, PMID: 35491008; ESMO.org). | 35491008 31549998 detail... |
| NTRK1 fusion | mammary analogue secretory carcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with recurrent or metastatic salivary gland secretory carcinoma harboring NTRK fusions (PMID: 36567082; ESMO.org). | 36567082 |
| NTRK1 fusion | colorectal cancer | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with metastatic colorectal cancer harboring an NTRK fusion (PMID: 36307056; ESMO.org). | 36307056 detail... |
| NTRK2 fusion | cervical cancer | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as second-line therapy for patients with recurrent or metastatic cervical cancer harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | extrahepatic bile duct carcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as primary and subsequent-line therapy for patients with unresectable or metastatic biliary tract cancer harboring an NTRK fusion, including extrahepatic cholangiocarcinoma (NCCN.org). | detail... |
| NTRK1 fusion | pancreatic adenocarcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is in guidelines as second-line therapy for patients with advanced or metastatic pancreatic adenocarcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | rectum cancer | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for advanced or metastatic rectal cancer patients with an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | endometrial carcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as a second-line or subsequent-line therapy (category 2B) for patients with recurrent endometrial carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | low grade glioma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with recurrent or progressive low grade glioma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | pancreatic cancer | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with metastatic pancreatic cancer harboring an NTRK fusion (PMID: 37678671; ESMO.org). | 37678671 detail... |
| NTRK1 fusion | salivary gland cancer | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with NTRK1 fusion-positive salivary gland tumors with distant metastases (NCCN.org). | detail... |
| NTRK2 fusion | gallbladder cancer | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as primary and subsequent-line therapy for patients with unresectable or metastatic biliary tract cancer harboring an NTRK fusion, including gallbladder cancer (NCCN.org). | detail... |
| NTRK2 fusion | mammary analogue secretory carcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with recurrent or metastatic salivary gland secretory carcinoma harboring NTRK fusions (PMID: 36567082; ESMO.org). | 36567082 |
| NTRK1 G595R NTRK1 act mut | Advanced Solid Tumor | decreased response | Larotrectinib | Preclinical | Actionable | In a preclinical study, a cell line oncogenic mouse model expressing an NTRK1 activating mutation and a secondary resistance mutation, NTRK1 G595R, demonstrated a decreased response when treated with Vitrakvi (larotrectinib) (PMID: 28578312). | 28578312 |
| NTRK1 fusion | breast cancer | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) therapy is included in guidelines for patients with recurrent or metastatic breast cancer harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | colon cancer | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for advanced or metastatic colon cancer patients with an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | colon cancer | sensitive | Larotrectinib | Case Reports/Case Series | Actionable | In a Phase I trial, Vitrakvi (larotrectinib) treatment resulted in partial response in 50% (2/4) and stable disease in 50% (2/4) of patients with colon cancer harboring NTRK1 fusions (PMID: 29466156, Annals of Oncology, Volume 29, Issue suppl_5; NCT02122913, NCT02637687, and NCT02576431). | 29466156 detail... |
| NTRK2 fusion | extrahepatic bile duct carcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as primary and subsequent-line therapy for patients with unresectable or metastatic biliary tract cancer harboring an NTRK fusion, including extrahepatic cholangiocarcinoma (NCCN.org). | detail... |
| NTRK1 fusion | ampulla of Vater adenocarcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as first-line therapy when the performance status is poor or as subsequent therapy for metastatic ampullary adenocarcinoma patients harboring NTRK fusions (NCCN.org). | detail... |
| NTRK2 fusion | colon cancer | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for advanced or metastatic colon cancer patients with an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | high grade glioma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as adjuvant therapy for pediatric patients with diffuse high-grade gliomas harboring NTRK fusions, or as a preferred regimen for patients with recurrent or progressive disease (NCCN.org). | detail... |
| NTRK2 fusion | breast cancer | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) therapy is included in guidelines for patients with recurrent or metastatic breast cancer harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | hepatocellular carcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as subsequent-line therapy for patients with hepatocellular carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | low grade glioma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with recurrent or progressive low grade glioma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 A203T | hematologic cancer | sensitive | Larotrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, Vitrakvi (larotrectinib) inhibited viability of transformed cells expressing NTRK2 A203T in culture (PMID: 32315394). | 32315394 |
| NTRK1 fusion | appendix cancer | predicted - sensitive | Larotrectinib | Case Reports/Case Series | Actionable | In a Phase I trial, Vitrakvi (larotrectinib) treatment resulted in stable disease in a patient with appendix cancer harboring NTRK1 fusions (PMID: 29466156, Annals of Oncology, Volume 29, Issue suppl_5; NCT02122913, NCT02637687, and NCT02576431). | 29466156 detail... |
| NTRK2 fusion | small intestine adenocarcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with metastatic small bowel adenocarcinoma with an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | thyroid gland papillary carcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with papillary thyroid carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | central nervous system cancer | sensitive | Larotrectinib | Phase II | Actionable | In two Phase II trials, Vitrakvi (larotrectinib) treatment resulted in an objective response rate of 30% (10/33, 3 complete responses, 7 partial responses) in pediatric and adult patients with primary central nervous system tumors harboring NTRK fusions including high grade (n=19) and low grade (n=8) gliomas, with a 24-week disease control rate of 73% and a 12-month progression-free survival rate of 56% (PMID: 34850167; NCT02637687, NCT02576431). | 34850167 |
| NTRK2 fusion | skin melanoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) therapy is included in guidelines for patients with metastatic or unresectable cutaneous melanoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion NTRK1 G595R | Advanced Solid Tumor | resistant | Larotrectinib | FDA contraindicated | Actionable | Vitrakvi (larotrectinib) is contraindicated for solid tumors with an NTRK1 fusion harboring a known NTRK1 resistance mutation, including G595R (FDA.gov). | detail... |
| NTRK1 fusion | gallbladder cancer | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as primary and subsequent-line therapy for patients with unresectable or metastatic biliary tract cancer harboring an NTRK fusion, including gallbladder cancer (NCCN.org). | detail... |
| NTRK1 fusion | thyroid gland anaplastic carcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with metastatic thyroid gland anaplastic carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | thyroid gland papillary carcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with papillary thyroid carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | cervical cancer | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as second-line therapy for patients with recurrent or metastatic cervical cancer harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | biliary tract cancer | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as second or later-line therapy for patients with biliary tract cancer harboring an NTRK fusion (PMID: 36372281; ESMO.org). | 36372281 detail... |
| NTRK1 G667C NTRK1 act mut | Advanced Solid Tumor | decreased response | Larotrectinib | Preclinical | Actionable | In a preclinical study, a cell line oncogenic mouse model expressing an NTRK1 activating mutation and a secondary resistance mutation, NTRK1 G667C, demonstrated a decrease response when treated with Vitrakvi (larotrectinib) (PMID: 28578312). | 28578312 |
| NTRK2 fusion | anaplastic oligodendroglioma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with recurrent anaplastic gliomas harboring an NTRK fusion, including anaplastic oligodendroglioma (NCCN.org). | detail... |
| NTRK2 fusion | esophagus squamous cell carcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as second-line or subsequent therapy for patients with unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma with an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | esophagus adenocarcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as second-line or subsequent therapy for patients with unresectable locally advanced, recurrent, or metastatic esophageal adenocarcinoma with an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | vulva squamous cell carcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with advanced or metastatic vulva squamous cell carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | Erdheim-Chester disease | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as first-line or subsequent-line therapy for patients with Erdheim-Chester disease harboring NTRK2 fusions (NCCN.org). | detail... |
| NTRK1 amp | esophagus squamous cell carcinoma | predicted - sensitive | Larotrectinib | Case Reports/Case Series | Actionable | In a clinical case study, Vitrakvi (larotrectinib) resulted in a partial response with regression of both the primary tumor and metastatic lesions within 6 weeks from the start of treatment in a patient with squamous cell esophageal carcinoma with NTRK1 amplification (PMID: 32323889). | 32323889 |
| NTRK1 fusion | thyroid gland cancer | predicted - sensitive | Larotrectinib | Phase II | Actionable | In a combined analysis of two clinical trials, Vitrakvi (larotrectinib) treatment demonstrated a favorable safety profile, resulted in an objective response rate of 75% (21/28, 2 complete responses, 19 partial responses) in patients with non-medullary, advanced thyroid cancer harboring NTRK1 (n=12) or NTRK3 (n=16) fusions, with median progression-free survival (PFS) not reached and a 12-month PFS rate of 81% (Annals of Oncology (2020) 31 (suppl_4): S1086; NCT02122913, NCT02576431). | detail... |
| NTRK2 fusion | uterine corpus sarcoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as first-line therapy for patients with advanced, recurrent, metastatic, or inoperable uterine sarcoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | gastrointestinal stromal tumor | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as neoadjuvant therapy for patients with resectable disease and as first-line systemic therapy for patients with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring NTRK fusions (NCCN.org). | detail... |
| NTRK1 fusion | gastrointestinal stromal tumor | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with advanced/metastatic gastrointestinal stromal tumor (GIST) harboring NTRK fusions (PMID: 34560242; ESMO.org). | detail... 34560242 |
| NTRK2 fusion | thyroid gland Hurthle cell carcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with thyroid Hurthle cell carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | hepatocellular carcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as subsequent-line therapy for patients with hepatocellular carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | thyroid gland anaplastic carcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with metastatic thyroid gland anaplastic carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | anaplastic oligodendroglioma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with recurrent anaplastic gliomas harboring an NTRK fusion, including anaplastic oligodendroglioma (NCCN.org). | detail... |
| NTRK2 fusion | lung non-small cell carcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with metastatic non-small cell lung cancer harboring an NTRK fusion with no satisfactory treatment options (PMID: 36872130; ESMO.org). | detail... 36872130 |
| NTRK2 fusion | lung non-small cell carcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is in guidelines as first-line therapy for patients with metastatic non-small cell lung cancer harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | Erdheim-Chester disease | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as first-line or subsequent-line therapy for patients with Erdheim-Chester disease harboring NTRK1 fusions (NCCN.org). | detail... |
| NTRK2 rearrange | sarcoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as a standard treatment for patients with advanced sarcomas harboring NTRK rearrangement (PMID: 34303806; ESMO.org). | detail... 34303806 |
| NTRK1 fusion | anaplastic astrocytoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with recurrent anaplastic gliomas harboring an NTRK fusion, including anaplastic astrocytoma (NCCN.org). | detail... |
| NTRK2 fusion | intrahepatic cholangiocarcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as primary and subsequent-line therapy for patients with unresectable or metastatic biliary tract cancer harboring an NTRK fusion, including intrahepatic cholangiocarcinoma (NCCN.org). | detail... |
| NTRK2 fusion | anaplastic astrocytoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with recurrent anaplastic gliomas harboring an NTRK fusion, including anaplastic astrocytoma (NCCN.org). | detail... |
| NTRK1 fusion | stomach cancer | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as second-line or subsequent therapy for patients with unresectable locally advanced, recurrent, or metastatic gastric cancer harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | gastrointestinal system cancer | predicted - sensitive | Larotrectinib | Phase I | Actionable | In a Phase I trial, Vitrakvi (larotrectinib) treatment resulted in an objective response rate of 75% (8/12, 1 complete response, 7 partial responses) in patients with gastrointestinal system malignancies harboring NTRK fusions, including colon cancer, pancreatic carcinoma, cholangiocarcinoma and GIST, and stable disease in 3 patients, with duration of response ranging from 3.5 to 22.9 months (Annals of Oncology, Volume 29, Issue suppl_5; NCT02122913, NCT02637687, and NCT02576431). | detail... |
| NTRK2 fusion | thyroid gland follicular carcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with follicular thyroid carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | thyroid gland follicular carcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with follicular thyroid carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | vulva squamous cell carcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with advanced or metastatic vulva squamous cell carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | central nervous system cancer | sensitive | Larotrectinib | Phase II | Actionable | In two Phase II trials, Vitrakvi (larotrectinib) treatment resulted in an objective response rate of 30% (10/33, 3 complete responses, 7 partial responses) in pediatric and adult patients with primary central nervous system tumors harboring NTRK fusions including high grade (n=19) and low grade (n=8) gliomas, with a 24-week disease control rate of 73% and a 12-month progression-free survival rate of 56% (PMID: 34850167; NCT02637687, NCT02576431). | 34850167 |
| NTRK2 fusion | glioblastoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with recurrent glioblastoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | Advanced Solid Tumor | sensitive | Larotrectinib | FDA approved | Actionable | In three trials that supported FDA approval, Vitrakvi (larotrectinib) treatment resulted in an overall response rate of 75% (41/55) in adult and pediatric patients with advanced solid tumors harboring either an NTRK1, NTRK2, or NTRK3 fusion, including 7 patients achieving a complete response and 34 patients achieving a partial response (PMID: 29466156; NCT02122913, NCT02637687, NCT02576431). | detail... 29466156 detail... |
| NTRK1 fusion | Advanced Solid Tumor | sensitive | Larotrectinib | Clinical Study - Cohort | Actionable | In a combined analysis of three trials, Vitrakvi (larotrectinib) resulted in improved median overall survival (39.7 vs 10.2 months) and a 78% lower risk of death (HR=0.22, P=0.001) compared to standard of care treatment in patients with advanced solid tumors harboring NTRK fusions (PMID: 36689698; NCT02122913, NCT02637687, and NCT02576431). | 36689698 |
| NTRK1 fusion | Advanced Solid Tumor | sensitive | Larotrectinib | Phase Ib/II | Actionable | In a Phase I/II trial (SCOUT), Vitrakvi (larotrectinib) treatment resulted in complete response in 26.7% (4/15), partial response in 66.7% (10/15), and stable disease in 6.7% (1/15) of pediatric patients with advanced solid tumors harboring NTRK fusions, and progressive diseases in all 7 patients without NTRK fusions (PMID: 29606586; NCT02637687). | 29606586 |
| NTRK1 fusion | skin melanoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) therapy is included in guidelines for patients with metastatic or unresectable cutaneous melanoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | thyroid gland Hurthle cell carcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with thyroid Hurthle cell carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | lung non-small cell carcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with metastatic non-small cell lung cancer harboring an NTRK fusion with no satisfactory treatment options (PMID: 36872130; ESMO.org). | detail... 36872130 |
| NTRK1 fusion | lung non-small cell carcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is in guidelines as first-line therapy for patients with metastatic non-small cell lung cancer harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | sarcoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is in guidelines for patients with soft tissue sarcoma with non-specific histology and an NTRK fusion (NCCN.org). | detail... |
| NTRK2 R458G | hematologic cancer | sensitive | Larotrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, Vitrakvi (larotrectinib) inhibited viability of transformed cells expressing NTRK2 R458G in culture (PMID: 32315394). | 32315394 |
| NTRK1 fusion | neuroendocrine tumor | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with unresectable or metastatic extrapulmonary poorly differentiated neuroendocrine carcinoma, large or small cell carcinoma, or mixed neuroendocrine/non-neuroendocrine neoplasms harboring an NTRK fusion who have progressed on or following prior treatment (NCCN.org). | detail... |
| NTRK1 act mut | Advanced Solid Tumor | predicted - sensitive | Larotrectinib | Preclinical | Actionable | In a preclinical study, a cell line oncogenic mouse model expressing a constitutively active NTRK1 mutation demonstrated decreased phosphorylation of Ntrk1 and inhibition of tumor growth when treated with Vitrakvi (larotrectinib) (PMID: 28578312). | 28578312 |
| NTRK2 fusion | Advanced Solid Tumor | sensitive | Larotrectinib | Phase Ib/II | Actionable | In a Phase I/II trial, Vitrakvi (larotrectinib) treatment resulted in complete response in 26.7% (4/15), partial response in 66.7% (10/15), and stable disease in 6.7% (1/15) of pediatric patients with advanced solid tumors harboring NTRK fusions, and progressive diseases in all 7 patients without NTRK fusions (PMID: 29606586; NCT02637687). | 29606586 |
| NTRK2 fusion | Advanced Solid Tumor | sensitive | Larotrectinib | FDA approved | Actionable | In three trials that supported FDA approval, Vitrakvi (larotrectinib) treatment resulted in an overall response rate of 75% (41/55) in adult and pediatric patients with advanced solid tumors harboring either an NTRK1, NTRK2, or NTRK3 fusion, including 7 patients achieving a complete response and 34 patients achieving a partial response (PMID: 29466156; NCT02122913, NCT02637687, NCT02576431). | detail... 29466156 |
| NTRK2 fusion | Advanced Solid Tumor | sensitive | Larotrectinib | Clinical Study - Cohort | Actionable | In a combined analysis of three trials, Vitrakvi (larotrectinib) resulted in improved median overall survival (39.7 vs 10.2 months) and a 78% lower risk of death (HR=0.22, P=0.001) compared to standard of care treatment in patients with advanced solid tumors harboring NTRK fusions (PMID: 36689698; NCT02122913, NCT02637687, and NCT02576431). | 36689698 |
| NTRK2 fusion | salivary gland cancer | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with NTRK2 fusion-positive salivary gland tumors with distant metastases (NCCN.org). | detail... |
| NTRK1 fusion | uterine corpus sarcoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as first-line therapy for patients with advanced, recurrent, metastatic, or inoperable uterine sarcoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | rectum cancer | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for advanced or metastatic rectal cancer patients with an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | gastroesophageal junction adenocarcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as second-line or subsequent therapy for patients with unresectable locally advanced, recurrent, or metastatic gastroesophageal junction adenocarcinoma with an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | endometrial carcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as a second-line or subsequent-line therapy (category 2B) for patients with recurrent endometrial carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | Cancer of Unknown Primary | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines for patients with cancer of unknown primary harboring NTRK fusions (PMID: 36563965; ESMO.org). | 36563965 detail... |
| NTRK2 fusion | ovary epithelial cancer | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as systemic therapy for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | esophagus squamous cell carcinoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is included in guidelines as second-line or subsequent therapy for patients with unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma with an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | sarcoma | sensitive | Larotrectinib | Guideline | Actionable | Vitrakvi (larotrectinib) is in guidelines for patients with soft tissue sarcoma with non-specific histology and an NTRK fusion (NCCN.org). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT04655404 | Phase I | Larotrectinib | A Pilot Study of Larotrectinib for Newly-Diagnosed High-Grade Glioma With NTRK Fusion | Recruiting | USA | GBR | DEU | CAN | AUS | 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 |
| NCT02693535 | Phase II | Cobimetinib + Vemurafenib Atezolizumab + Talazoparib Regorafenib Larotrectinib Trastuzumab + Tucatinib Ipilimumab + Nivolumab Palbociclib Afatinib Entrectinib Talazoparib Pembrolizumab Temsirolimus Pertuzumab + Trastuzumab Atezolizumab + Pertuzumab/trastuzumab/hyaluronidase-zzxf Crizotinib Abemaciclib Sunitinib Olaparib | 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 (TAPUR) | Recruiting | USA | 0 |
| 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 | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 22 |
| 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) | Active, not recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | AUS | 13 |
| 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 |
| NCT03834961 | Phase II | Larotrectinib | Larotrectinib in Treating Patients With Previously Untreated TRK Fusion Solid Tumors and TRK Fusion Relapsed Acute Leukemia | Active, not recruiting | USA | CAN | 0 |
| NCT02122913 | Phase I | Larotrectinib | A Study to Test the Safety of the Investigational Drug Larotrectinib in Adults That May Treat Cancer | Completed | USA | 0 |
| NCT04879121 | Phase II | Larotrectinib | Larotrectinib for the Treatment of NTRK Amplification Positive, Locally Advanced or Metastatic Solid Tumors | Recruiting | USA | 0 |
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