Therapy Detail
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| Therapy Name | Repotrectinib |
| Synonyms | |
| Therapy Description |
Augtyro (repotrectinib) is a multi-kinase inhibitor that demonstrates strong activity against Ros1, Ntrk1/2/3, and Alk, and also inhibits Jak2 and Src family kinases, resulting in tumor cell death (PMID: 30093503, PMID: 32269053). Augtyro (repotrectinib) is FDA-approved for use in patients with advanced or metastatic ROS1 fusion-positive non-small cell lung cancer, and in adult and pediatric patients 12 years or older with advanced solid tumors harboring NTRK fusions (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Repotrectinib | Augtyro | TPX-0005 | ALK Inhibitor 33 JAK2 Inhibitor 19 ROS1 Inhibitor 23 SRC Inhibitor 31 Trk Receptor Inhibitor (Pan) 33 | Augtyro (repotrectinib) is a multi-kinase inhibitor that demonstrates strong activity against Ros1, Ntrk1/2/3, and Alk, and also inhibits Jak2 and Src family kinases, resulting in tumor cell death (PMID: 30093503, PMID: 32269053). Augtyro (repotrectinib) is FDA-approved for use in patients with advanced or metastatic ROS1 fusion-positive non-small cell lung cancer, and in adult and pediatric patients 12 years or older with advanced solid tumors harboring NTRK fusions (FDA.gov). |
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Showing 1 to 117 of 117 entries
| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| NTRK1 fusion | Advanced Solid Tumor | sensitive | Repotrectinib | FDA approved | Actionable | In a Phase I/II (TRIDENT-1) trial that supported FDA approval, Augtyro (repotrectinib) treatment resulted in a confirmed objective response rate (cORR) of 58% (23/40), a 12-mo duration of response (DOR) of 86%, and 12-mo progression-free survival (PFS) of 56% in TKI-naive patients with advanced solid tumors harboring NTRK fusions, and a 50% (24/48) cORR, 39% 12-mo DOR, and 22% 12-mo PFS in TKI-pretreated patients (Ann Oncol (2023) 34 (suppl_2): S787-S788; NCT03093116). | detail... detail... |
| NTRK2 fusion | Advanced Solid Tumor | sensitive | Repotrectinib | FDA approved | Actionable | In a Phase I/II (TRIDENT-1) trial that supported FDA approval, Augtyro (repotrectinib) treatment resulted in a confirmed objective response rate (cORR) of 58% (23/40), a 12-mo duration of response (DOR) of 86%, and 12-mo progression-free survival (PFS) of 56% in TKI-naive patients with advanced solid tumors harboring NTRK fusions, and a 50% (24/48) cORR, 39% 12-mo DOR, and 22% 12-mo PFS in TKI-pretreated patients (Ann Oncol (2023) 34 (suppl_2): S787-S788; NCT03093116). | detail... detail... |
| ROS1 fusion | lung non-small cell carcinoma | sensitive | Repotrectinib | FDA approved | Actionable | In a Phase I/II trial (TRIDENT-1) that supported FDA approval, Augtyro (repotrectinib) resulted in an objective response rate of 79% (56/71, 7 complete and 49 partial responses) and 38% (21/56, 3 complete and 18 partial responses), median duration of response of 34.1 and 14.8 months, and a median progression-free survival of 35.7 and 9.0 months in patients with TKI-naive and TKI-treated, ROS1 fusion-positive non-small cell lung cancer, respectively (PMID: 38197815; NCT03093116). | 38197815 detail... |
| NTRK1 fusion | Squamous Cell Carcinoma of Unknown Primary | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines for patients with squamous cell carcinoma of unknown primary harboring NTRK1 fusions (NCCN.org). | detail... |
| NTRK1 fusion | rectum cancer | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as second-line or subsequent therapy (category 2A) for patients with advanced or metastatic rectal cancer harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | stomach cancer | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as second-line or subsequent therapy for patients with unresectable locally advanced, recurrent, or metastatic gastric cancer harboring an NTRK1 fusion (NCCN.org). | detail... |
| NTRK1 fusion | Adenocarcinoma of Unknown Primary | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines for patients with adenocarcinoma of unknown primary harboring NTRK1 fusions (NCCN.org). | detail... |
| NTRK1 fusion | esophagus squamous cell carcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) 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 | vaginal carcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as second-line or subsequent therapy for patients with recurrent or metastatic vaginal squamous cell carcinoma or adenocarcinoma harboring an NTRK fusion who are naive to prior NTRK targeted therapy or have progressed on prior NTRK therapy (NCCN.org). | detail... |
| NTRK1 fusion | pancreatic adenocarcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as first-line therapy for pancreatic adenocarcinoma patients harboring an NTRK fusion with locally advanced disease with good (ECOG 0-1) or intermediate (ECOG 2) performance status (PS), or with metastatic disease with good, intermediate (category 2A), or poor (ECOG 3) (category 2B) PS, and as subsequent therapy for patients with locally advanced, metastatic, or recurrent disease with good (category 2A), intermediate, or poor (category 2B) PS (NCCN.org). | detail... |
| NTRK1 fusion | pilocytic astrocytoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines (category 2B) for patients with recurrent or progressive circumscribed glioma, including pilocytic astrocytoma, harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | gallbladder cancer | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as primary and subsequent-line therapy (category 2A) for patients with unresectable or metastatic biliary tract cancer harboring NTRK fusions, including gallbladder cancer (NCCN.org). | detail... |
| NTRK1 fusion | salivary gland cancer | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines for patients with unresectable locally advanced, recurrent, or metastatic salivary gland tumors harboring an NTRK1 fusion (NCCN.org). | detail... |
| NTRK1 fusion | intrahepatic cholangiocarcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as primary and subsequent-line therapy (category 2A) for patients with unresectable or metastatic biliary tract cancer harboring NTRK fusions, including intrahepatic cholangiocarcinoma (NCCN.org). | detail... |
| NTRK1 fusion | gastrointestinal stromal tumor | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as neoadjuvant therapy (category 2B) for patients with resectable disease and as first-line or second-line systemic therapy (category 2A) for patients with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring NTRK fusions (NCCN.org). | detail... |
| NTRK1 fusion | vulva squamous cell carcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as a second-line or subsequent therapy for patients with advanced or recurrent/metastatic vulvar squamous cell carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | oncocytic carcinoma of the thyroid | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines for patients with advanced or metastatic thyroid Hurthle cell carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | high grade glioma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) 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 | pleomorphic xanthoastrocytoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines (category 2B) for patients with recurrent or progressive circumscribed glioma, including pleomorphic xanthoastrocytoma, harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | glioblastoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines (category 2B) for patients with recurrent glioblastoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | cervical cancer | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as second-line or subsequent therapy for patients with recurrent or metastatic cervical cancer harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | vulva adenocarcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as a second-line or subsequent therapy for patients with advanced or recurrent/metastatic vulvar adenocarcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | sarcoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as a preferred first-line or subsequent therapy for patients with soft tissue sarcoma with non-specific histology harboring an NTRK1 fusion (NCCN.org). | detail... |
| NTRK1 fusion | esophagus adenocarcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) 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 | uterine corpus sarcoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) 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 | hepatocellular carcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines for patients with hepatocellular carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | colon cancer | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as second-line or subsequent therapy (category 2A) for patients with advanced or metastatic colon cancer harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | subependymal giant cell astrocytoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines (category 2B) for patients with recurrent or progressive circumscribed glioma, including subependymal giant cell astrocytoma, harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | ampulla of Vater adenocarcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as first-line or subsequent therapy for patients with metastatic ampullary adenocarcinoma harboring NTRK fusions (NCCN.org). | detail... |
| NTRK1 fusion | small intestine adenocarcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as second-line or subsequent therapy (category 2A) for patients with advanced or metastatic small bowel adenocarcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | biliary tract cancer | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as second or later-line therapy for patients with biliary tract cancer harboring an NTRK fusion (PMID: 39864891; ESMO.org). | 39864891 detail... |
| NTRK1 fusion | endometrial carcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as a second-line or subsequent-line therapy for patients with recurrent endometrial carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | Erdheim-Chester disease | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as first-line or subsequent-line therapy for patients with Erdheim-Chester disease harboring NTRK1 fusions (NCCN.org). | detail... |
| NTRK1 fusion | ovary epithelial cancer | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) 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 | follicular thyroid carcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines for patients with advanced or metastatic follicular thyroid carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | lung non-small cell carcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as first-line or subsequent therapy for patients with non-small cell lung cancer harboring an NTRK1 fusion (NCCN.org). | detail... |
| NTRK1 fusion | anaplastic thyroid carcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as neoadjuvant or systemic therapy for patients with thyroid gland anaplastic carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | papillary thyroid carcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines for patients with advanced or metastatic papillary thyroid carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | extrahepatic bile duct carcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as primary and subsequent-line therapy (category 2A) for patients with unresectable or metastatic biliary tract cancer harboring NTRK fusions, including extrahepatic cholangiocarcinoma (NCCN.org). | detail... |
| NTRK1 fusion | gastroesophageal junction adenocarcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) 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 | breast cancer | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines for patients with recurrent unresectable or stage IV (M1) breast cancer harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | neuroendocrine tumor | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) 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 a prior NTRK-targeted therapy (NCCN.org). | detail... |
| NTRK2 fusion | gastroesophageal junction adenocarcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) 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... |
| NTRK2 fusion | anaplastic thyroid carcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as neoadjuvant or systemic therapy for patients with thyroid gland anaplastic carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | vaginal carcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as second-line or subsequent therapy for patients with recurrent or metastatic vaginal squamous cell carcinoma or adenocarcinoma harboring an NTRK fusion who are naive to prior NTRK targeted therapy or have progressed on prior NTRK therapy (NCCN.org). | detail... |
| NTRK2 fusion | subependymal giant cell astrocytoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines (category 2B) for patients with recurrent or progressive circumscribed glioma, including subependymal giant cell astrocytoma, harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | breast cancer | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines for patients with recurrent unresectable or stage IV (M1) breast cancer harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | glioblastoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines (category 2B) for patients with recurrent glioblastoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | pilocytic astrocytoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines (category 2B) for patients with recurrent or progressive circumscribed glioma, including pilocytic astrocytoma, harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | pleomorphic xanthoastrocytoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines (category 2B) for patients with recurrent or progressive circumscribed glioma, including pleomorphic xanthoastrocytoma, harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | hepatocellular carcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines for patients with hepatocellular carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | papillary thyroid carcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines for patients with advanced or metastatic papillary thyroid carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | gastrointestinal stromal tumor | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as neoadjuvant therapy (category 2B) for patients with resectable disease and as first-line or second-line systemic therapy (category 2A) for patients with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring NTRK fusions (NCCN.org). | detail... |
| NTRK2 fusion | follicular thyroid carcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines for patients with advanced or metastatic follicular thyroid carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | biliary tract cancer | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as second or later-line therapy for patients with biliary tract cancer harboring an NTRK fusion (PMID: 39864891; ESMO.org). | 39864891 detail... |
| NTRK2 fusion | rectum cancer | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as second-line or subsequent therapy (category 2A) for patients with advanced or metastatic rectal cancer harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | small intestine adenocarcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as second-line or subsequent therapy (category 2A) for patients with advanced or metastatic small bowel adenocarcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | pancreatic adenocarcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as first-line therapy for pancreatic adenocarcinoma patients harboring an NTRK fusion with locally advanced disease with good (ECOG 0-1) or intermediate (ECOG 2) performance status (PS), or with metastatic disease with good, intermediate (category 2A), or poor (ECOG 3) (category 2B) PS, and as subsequent therapy for patients with locally advanced, metastatic, or recurrent disease with good (category 2A), intermediate, or poor (category 2B) PS (NCCN.org). | detail... |
| NTRK2 fusion | intrahepatic cholangiocarcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as primary and subsequent-line therapy (category 2A) for patients with unresectable or metastatic biliary tract cancer harboring NTRK fusions, including intrahepatic cholangiocarcinoma (NCCN.org). | detail... |
| NTRK2 fusion | Adenocarcinoma of Unknown Primary | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines for patients with adenocarcinoma of unknown primary harboring NTRK2 fusions (NCCN.org). | detail... |
| NTRK2 fusion | Erdheim-Chester disease | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as first-line or subsequent-line therapy for patients with Erdheim-Chester disease harboring NTRK2 fusions (NCCN.org). | detail... |
| NTRK2 fusion | endometrial carcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as a second-line or subsequent-line therapy for patients with recurrent endometrial carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | cervical cancer | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as second-line or subsequent therapy for patients with recurrent or metastatic cervical cancer harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | lung non-small cell carcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as first-line or subsequent therapy for patients with non-small cell lung cancer harboring an NTRK2 fusion (NCCN.org). | detail... |
| NTRK2 fusion | ovary epithelial cancer | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) 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... |
| NTRK2 fusion | sarcoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as a preferred first-line or subsequent therapy for patients with soft tissue sarcoma with non-specific histology harboring an NTRK2 fusion (NCCN.org). | detail... |
| NTRK2 fusion | colon cancer | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as second-line or subsequent therapy (category 2A) for patients with advanced or metastatic colon cancer harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | salivary gland cancer | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines for patients with unresectable locally advanced, recurrent, or metastatic salivary gland tumors harboring an NTRK2 fusion (NCCN.org). | detail... |
| NTRK2 fusion | vulva squamous cell carcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as a second-line or subsequent therapy for patients with advanced or recurrent/metastatic vulvar squamous cell carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | Squamous Cell Carcinoma of Unknown Primary | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines for patients with squamous cell carcinoma of unknown primary harboring NTRK2 fusions (NCCN.org). | detail... |
| NTRK2 fusion | esophagus squamous cell carcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) 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 | extrahepatic bile duct carcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as primary and subsequent-line therapy (category 2A) for patients with unresectable or metastatic biliary tract cancer harboring NTRK fusions, including extrahepatic cholangiocarcinoma (NCCN.org). | detail... |
| NTRK2 fusion | uterine corpus sarcoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) 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 | vulva adenocarcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as a second-line or subsequent therapy for patients with advanced or recurrent/metastatic vulvar adenocarcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | neuroendocrine tumor | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) 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 a prior NTRK-targeted therapy (NCCN.org). | detail... |
| NTRK2 fusion | oncocytic carcinoma of the thyroid | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines for patients with advanced or metastatic thyroid Hurthle cell carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | ampulla of Vater adenocarcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as first-line or subsequent therapy for patients with metastatic ampullary adenocarcinoma harboring NTRK fusions (NCCN.org). | detail... |
| NTRK2 fusion | high grade glioma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) 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 | gallbladder cancer | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as primary and subsequent-line therapy (category 2A) for patients with unresectable or metastatic biliary tract cancer harboring NTRK fusions, including gallbladder cancer (NCCN.org) | detail... |
| NTRK2 fusion | stomach cancer | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as second-line or subsequent therapy for patients with unresectable locally advanced, recurrent, or metastatic gastric cancer harboring an NTRK2 fusion (NCCN.org). | detail... |
| NTRK2 fusion | esophagus adenocarcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) 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... |
| ROS1 rearrange | lung non-small cell carcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as first-line or subsequent therapy for patients with advanced or metastatic non-small cell lung cancer harboring a ROS1 rearrangement (NCCN.org). | detail... |
| ROS1 rearrange | lung non-small cell carcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in the Pan-Asian Guidelines Adaptation (PAGA) as first-line therapy for advanced and metastatic non-small cell lung cancer patients with ROS1 rearrangements (PMID: 39615406; ESMO.org). | detail... 39615406 |
| ROS1 rearrange | lung non-small cell carcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as first-line therapy for patients with metastatic non-small cell lung cancer harboring a ROS1 rearrangement, or as a next-line therapy in patients with ROS1-rearranged non-small cell lung cancer who have not received prior ROS1 inhibitor therapy (PMID: 30285222, Version Update 15 Sept 2020; ESMO.org). | detail... 30285222 |
| ROS1 rearrange ROS1 G2032R | lung non-small cell carcinoma | sensitive | Repotrectinib | Guideline | Actionable | Augtyro (repotrectinib) is included in guidelines as a subsequent therapy for patients with ROS1 rearranged non-small cell lung cancer harboring ROS1 G2032R (NCCN.org). | detail... |
| NTRK1 fusion | lung non-small cell carcinoma | sensitive | Repotrectinib | Phase Ib/II | Actionable | In a Phase I/II (TRIDENT-1) trial, Augtyro (repotrectinib) treatment resulted in a confirmed objective response rate (cORR) of 62%, a 12-mo duration of response (DOR) of 92%, and 12-mo progression-free survival (PFS) of 64% in TKI-naive (n=21) patients with non-small cell lung cancer harboring NTRK fusions, and a 42% cORR, 44% 12-mo DOR, and 23% 12-mo PFS in TKI-pretreated (n=14) patients (Ann Oncol (2023) 34 (suppl_2): S787-S788; NCT03093116). | detail... |
| NTRK2 fusion | lung non-small cell carcinoma | sensitive | Repotrectinib | Phase Ib/II | Actionable | In a Phase I/II (TRIDENT-1) trial, Augtyro (repotrectinib) treatment resulted in a confirmed objective response rate (cORR) of 62%, a 12-mo duration of response (DOR) of 92%, and 12-mo progression-free survival (PFS) of 64% in TKI-naive (n=21) patients with non-small cell lung cancer harboring NTRK fusions, and a 42% cORR, 44% 12-mo DOR, and 23% 12-mo PFS in TKI-pretreated (n=14) patients (Ann Oncol (2023) 34 (suppl_2): S787-S788; NCT03093116). | detail... |
| ROS1 fusion | lung non-small cell carcinoma | sensitive | Repotrectinib | Phase Ib/II | Actionable | In a Phase I/II trial (TRIDENT-1), Augtyro (repotrectinib) treatment resulted in an intracranial objective response rate (icORR) of 88% (7/8) with intracranial duration of response (DOR) ranging from 1.9-14.8 months in non-small cell lung cancer patients harboring ROS1 fusions who were TKI-naive, and an icORR of 42% (5/12) with intracranial DOR ranging from 3.0-11.1 months in those with 1 prior TKI and no chemo (J Clin Oncol 41, 2023 (suppl 16; abstr 9017); NCT03093116). | detail... |
| ALK fusion | Advanced Solid Tumor | predicted - sensitive | Repotrectinib | Phase I | Actionable | In a Phase I (TRIDENT-1) trial, Augtyro (repotrectinib) treatment resulted in stable disease in 25% (4/16) of patient with advanced solid tumor harboring ALK fusions who completed 2 cycles of treatment (J Clin Oncol 36, 2018 (suppl; abstr 2513); NCT03093116). | detail... |
| ROS1 fusion | Advanced Solid Tumor | predicted - sensitive | Repotrectinib | Phase I | Actionable | In a Phase I (TRIDENT-1) trial, Augtyro (repotrectinib) treatment resulted in partial response in 21.6% (8/37) of patients with advanced solid tumors harboring ROS1 or NTRK fusions (J Clin Oncol 36, 2018 (suppl; abstr 2513); NCT03093116). | detail... |
| ROS1 fusion ROS1 G2032R | Advanced Solid Tumor | predicted - sensitive | Repotrectinib | Phase I | Actionable | In a Phase I (TRIDENT-1) trial, Augtyro (repotrectinib) treatment resulted in partial response in a patient with advanced solid tumor harboring ROS1 G2032R in the context of ROS1 fusion (J Clin Oncol 36, 2018 (suppl; abstr 2513); NCT03093116). | detail... |
| ROS1 fusion ROS1 G2032R | lung non-small cell carcinoma | predicted - sensitive | Repotrectinib | Phase I | Actionable | In a Phase I/II trial (TRIDENT-1), Augtyro (repotrectinib) treatment resulted in a confirmed objective response rate of 59% (10/17) in patients with TKI-pretreated, ROS1 fusion-positive non-small cell lung cancer harboring ROS1 G2032R (PMID: 38197815; NCT03093116). | 38197815 |
| ALK F1174V | neuroblastoma | predicted - resistant | Repotrectinib | Preclinical - Pdx | Actionable | In a preclinical study, a neuroblastoma patient-derived xenograft (PDX) model harboring ALK F1174V was resistant to treatment with Augtyro (repotrectinib) (PMID: 34482287). | 34482287 |
| ALK G1202R | Advanced Solid Tumor | sensitive | Repotrectinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Augtyro (repotrectinib) inhibited ALK G1202R and suppressed tumor growth in cell line xenograft models with ALK G1202R (AACR, Cancer Res: April 2016; Volume 57, Abstract #2132). | detail... |
| ALK wild-type | Advanced Solid Tumor | sensitive | Repotrectinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Augtyro (repotrectinib) inhibited cell proliferation in transformed cell lines over expressing wild-type ALK in culture and suppressed tumor growth in xenograft models (AACR, Cancer Res: April 2016; Volume 57, Abstract #2132). | detail... |
| EML4 - ALK | Advanced Solid Tumor | sensitive | Repotrectinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Augtyro (repotrectinib) inhibited growth of transformed cells expressing EML4-ALK in culture, led to tumor growth inhibition in cell line xenograft models (PMID: 30093503). | 30093503 |
| EML4 - ALK ALK G1202R | Advanced Solid Tumor | sensitive | Repotrectinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Augtyro (repotrectinib) inhibited Alk activity and proliferation of transformed cells expressing ALK G1202R in the context of EML4-ALK in culture, resulted in tumor growth inhibition in cell line xenograft models (PMID: 30093503). | 30093503 |
| ALK amp | neuroblastoma | predicted - sensitive | Repotrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, Augtyro (repotrectinib) treatment resulted in inhibition of cell proliferation in a neuroblastoma cell line harboring ALK amplification in culture (PMID: 34482287). | 34482287 |
| ALK F1174L | Advanced Solid Tumor | sensitive | Repotrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, Augtyro (repotrectinib) decreased Alk phosphorylation and neurite outgrowth in cells expressing ALK F1174L in culture (PMID: 31852910). | 31852910 |
| ALK F1174L | neuroblastoma | sensitive | Repotrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, Augtyro (repotrectinib) inhibited proliferation of a neuroblastoma cell line harboring ALK F1174L in culture (PMID: 31852910). | 31852910 |
| ALK F1174V ALK amp | neuroblastoma | sensitive | Repotrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, Augtyro (repotrectinib) inhibited downstream signaling and proliferation, and induced apoptosis in a neuroblastoma cell line harboring ALK F1174V and ALK amplification in culture (PMID: 31852910). | 31852910 |
| ALK F1245C | Advanced Solid Tumor | sensitive | Repotrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, Augtyro (repotrectinib) decreased Alk phosphorylation and neurite outgrowth in cells expressing ALK F1245C in culture (PMID: 31852910). | 31852910 |
| ALK G1128A | Advanced Solid Tumor | sensitive | Repotrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, Augtyro (repotrectinib) decreased Alk phosphorylation and neurite outgrowth in cells expressing ALK G1128A in culture (PMID: 31852910). | 31852910 |
| ALK I1171N | Advanced Solid Tumor | sensitive | Repotrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, Augtyro (repotrectinib) decreased Alk phosphorylation and neurite outgrowth in cells expressing ALK I1171N in culture (PMID: 31852910). | 31852910 |
| ALK L1196M | Advanced Solid Tumor | sensitive | Repotrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, Augtyro (repotrectinib) inhibited cell proliferation in transformed cell lines over expressing ALK L1196M in culture (AACR, Cancer Res: April 2016; Volume 57, Abstract #2132). | detail... |
| ALK R1192P | Advanced Solid Tumor | sensitive | Repotrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, Augtyro (repotrectinib) decreased Alk phosphorylation and neurite outgrowth in cells expressing ALK R1192P in culture (PMID: 31852910). | 31852910 |
| ALK R1275Q | neuroblastoma | predicted - sensitive | Repotrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, Augtyro (repotrectinib) treatment resulted in inhibition of cell proliferation in a neuroblastoma cell line harboring ALK R1275Q in culture (PMID: 34482287). | 34482287 |
| ALK R1275Q | Advanced Solid Tumor | sensitive | Repotrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, Augtyro (repotrectinib) decreased Alk phosphorylation and neurite outgrowth in cells expressing ALK R1275Q in culture (PMID: 31852910). | 31852910 |
| ALK Y1278S | Advanced Solid Tumor | sensitive | Repotrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, Augtyro (repotrectinib) decreased Alk phosphorylation and neurite outgrowth in cells expressing ALK Y1278S in culture (PMID: 31852910). | 31852910 |
| EML4 - ALK ALK C1237Y | Advanced Solid Tumor | resistant | Repotrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing EML4-ALK and ALK C1237Y were resistant to Augtyro (repotrectinib) in culture (PMID: 38448512). | 38448512 |
| EML4 - ALK ALK G1202R | Advanced Solid Tumor | sensitive | Repotrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, Augtyro (repotrectinib) inhibited Alk phosphorylation and viability of transformed cells expressing EML4-ALK with ALK G1202R in culture (PMID: 36201110). | 36201110 |
| EML4 - ALK ALK I1171N | Advanced Solid Tumor | resistant | Repotrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing EML4-ALK with ALK I1171N were resistant to Augtyro (repotrectinib) in culture (PMID: 36201110). | 36201110 |
| EML4 - ALK ALK L1196M | Advanced Solid Tumor | sensitive | Repotrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, Augtyro (repotrectinib) inhibited Alk activity and proliferation of transformed cells over expressing ALK L1196M in the context of EML4-ALK in culture (European Journal of Cancer , Volume 69, S32). | detail... |
| EML4 - ALK ALK L1196P | Advanced Solid Tumor | resistant | Repotrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing EML4-ALK and ALK L1196P were resistant to Augtyro (repotrectinib) in culture (PMID: 38448512). | 38448512 |
| EML4 - ALK SRC pos | lung cancer | sensitive | Repotrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, Augtyro (repotrectinib) inhibited Alk and Src signaling, and cell proliferation in lung cancer cell lines harboring EML4-ALK and elevated Src activity in culture (AACR, Cancer Res: April 2016; Volume 57, Abstract #2132). | detail... |
| ROS1 D2113G | Advanced Solid Tumor | sensitive | Repotrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, Augtyro (repotrectinib) inhibited proliferation of transformed cells expressing ROS1 D2113G in culture (PMID: 37587872). | 37587872 |
| ROS1 D2113N | Advanced Solid Tumor | sensitive | Repotrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, Augtyro (repotrectinib) inhibited proliferation of transformed cells expressing ROS1 D2113N in culture (PMID: 37587872). | 37587872 |
Showing 1 to 117 of 117 entries
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Showing 1 to 6 of 6 entries
| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03093116 | Phase Ib/II | Repotrectinib | A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1) | Recruiting | USA | POL | NLD | ITA | HUN | GBR | FRA | ESP | DNK | DEU | CAN | BEL | AUS | 6 |
| NCT04094610 | Phase Ib/II | Repotrectinib | A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations | Recruiting | USA | ITA | GBR | FRA | ESP | DNK | CAN | AUS | 3 |
| NCT06140836 | Phase III | Repotrectinib Crizotinib | 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) | Recruiting | USA | TUR | ROU | POL | NLD | ITA | HUN | GRC | FRA | ESP | DEU | CHE | CAN | BRA | AUT | ARG | 6 |
| NCT06315010 | Phase II | Repotrectinib | REPotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain mEtastasis (REPOSE) | Recruiting | ESP | AUT | 0 |
| NCT06408168 | Phase II | Repotrectinib Fulvestrant + Repotrectinib | 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) | Recruiting | USA | 0 |
| NCT06552234 | Phase II | Repotrectinib | Phase II Efficacy Study of Repotrectinib in Frail and/or Elderly Patients With ROS1-rearranged Advanced NSCLC (REPOROS) | Recruiting | FRA | 0 |
Showing 1 to 6 of 6 entries
CKB BOOST