Therapy Detail
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| Therapy Name | Entrectinib |
| Synonyms | |
| Therapy Description |
Rozlytrek (entrectinib) inhibits the activity of TrkA/B/C, Ros1 fusion proteins, and Alk, which leads to induction of apoptosis and inhibition of proliferation in cells expressing these kinases (PMID: 27003761). Rozlytrek (entrectinib) is FDA approved for use in patients with ROS1 positive non-small cell lung cancer and in adult and pediatric (1 year and older) patients with solid tumors harboring NTRK fusions without known acquired resistance mutations (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Entrectinib | Rozlytrek | RXDX-101 | ALK Inhibitor 32 ROS1 Inhibitor 20 Trk Receptor Inhibitor (Pan) 31 | Rozlytrek (entrectinib) inhibits the activity of TrkA/B/C, Ros1 fusion proteins, and Alk, which leads to induction of apoptosis and inhibition of proliferation in cells expressing these kinases (PMID: 27003761). Rozlytrek (entrectinib) is FDA approved for use in patients with ROS1 positive non-small cell lung cancer and in adult and pediatric (1 year and older) patients with solid tumors harboring NTRK fusions without known 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 |
|---|---|---|---|---|---|---|---|
| NTRK1 fusion | endometrial carcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines as a second-line or subsequent-line therapy (category 2A) for patients with recurrent endometrial carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | anaplastic oligodendroglioma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with recurrent anaplastic gliomas harboring an NTRK fusion, including anaplastic oligodendroglioma (NCCN.org). | detail... |
| NTRK1 fusion | sarcoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is in guidelines for patients with soft tissue sarcoma with non-specific histology and an NTRK fusion (NCCN.org). | detail... |
| EML4 - ALK | Advanced Solid Tumor | sensitive | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, Rozlytrek (entrectinib) inhibited viability of transformed cells expressing EML4-ALK in culture (PMID: 33627640). | 33627640 |
| EML4 - ALK ALK F1174I | Advanced Solid Tumor | resistant | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing EML4-ALK with ALK F1174I were resistant to Rozlytrek (entrectinib) in culture (PMID: 33627640). | 33627640 |
| NTRK2 fusion | ovary epithelial cancer | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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... |
| EML4 - ALK ALK I1171T | Advanced Solid Tumor | resistant | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing EML4-ALK with ALK I1171T were resistant to Rozlytrek (entrectinib) in culture (PMID: 33627640). | 33627640 |
| NTRK2 fusion | sarcoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is in guidelines for patients with soft tissue sarcoma with non-specific histology and an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | Squamous Cell Carcinoma of Unknown Primary | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with squamous cell carcinoma of unknown primary harboring NTRK1 fusions (NCCN.org). | detail... |
| NTRK1 fusion | anaplastic oligodendroglioma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with recurrent anaplastic gliomas harboring an NTRK fusion, including anaplastic oligodendroglioma (NCCN.org). | detail... |
| EML4 - ALK ALK L1196M | Advanced Solid Tumor | conflicting | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing EML4-ALK with ALK L1196M were resistant to Rozlytrek (entrectinib) in culture (PMID: 33627640). | 33627640 |
| EML4 - ALK ALK L1196M | Advanced Solid Tumor | conflicting | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing EML4-ALK with ALK L1196M were sensitive to Rozlytrek (entrectinib), resulting in anti-proliferative activity in culture (PMID: 26939704). | 26939704 |
| NTRK2 rearrange | sarcoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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 | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with recurrent anaplastic gliomas harboring an NTRK fusion, including anaplastic astrocytoma (NCCN.org). | detail... |
| NTRK1 fusion | gallbladder cancer | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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... |
| EML4 - ALK ALK I1171N ALK L1196M | Advanced Solid Tumor | resistant | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing EML4-ALK with ALK I1171N and L1196M were resistant to treatment with Rozlytrek (entrectinib) in culture (PMID: 33627640). | 33627640 |
| NTRK2 fusion | salivary gland cancer | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with NTRK2 fusion-positive salivary gland tumors with distant metastases (NCCN.org). | detail... |
| NTRK2 fusion | high grade glioma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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... |
| EML4 - ALK ALK C1156Y | Advanced Solid Tumor | sensitive | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, Rozlytrek (entrectinib) inhibited viability of transformed cells expressing EML4-ALK with ALK C1156Y in culture (PMID: 33627640). | 33627640 |
| EML4 - ALK ALK C1156Y | Advanced Solid Tumor | sensitive | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing EML4-ALK with ALK C1156Y were sensitive to Rozlytrek (entrectinib), resulting in anti-proliferative activity (PMID: 26939704). | 26939704 |
| NTRK1 fusion | ampulla of Vater adenocarcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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 | vaginal carcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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 (NCCN.org). | detail... |
| ROS1 fusion | lung non-small cell carcinoma | sensitive | Entrectinib | FDA approved | Actionable | In a combined analysis of 3 clinical trials (ALKA-372-001, STARTRK-1, STARTRK-2) that supported FDA approval, Rozlytrek (entrectinib) treatment resulted in an objective response rate of 77% (41/53), a median duration of response of 25 months in patients with ROS1 fusion positive non-small cell lung cancer, with median progression-free survival of 26 and 14 months for patients without (n=30) and with (n=23) CNS disease, respectively (PMID: 31838015; NCT02097810; NCT02568267). | detail... 31838015 |
| NTRK2 fusion | vulva cancer | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with advanced or metastatic vulvar cancer harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | high grade glioma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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... |
| EML4 - ALK ALK L1196M ALK G1202R | Advanced Solid Tumor | resistant | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing EML4-ALK with ALK L1196M and G1202R were resistant to treatment with Rozlytrek (entrectinib) in culture (PMID: 33627640). | 33627640 |
| NTRK1 fusion | thyroid gland Hurthle cell carcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with thyroid Hurthle cell carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | Advanced Solid Tumor | sensitive | Entrectinib | Case Reports/Case Series | Actionable | In a Phase I/II trial (STARTRK-NG), Rozlytrek (entrectinib) treatment was safe and resulted in an overall response rate (ORR) of 57.7% (15/26, 7 complete responses) with median duration of response and progression-free survival no reached in pediatric patients with CNS or extracranial solid tumors harboring fusions in NTRK1, NTRK2, NTRK3, ROS1, or ALK, ORR was 60% (9/15) in patients harboring fusions in NTRK1/2/3 (PMID: 35395680; NCT02650401). | 35395680 |
| NTRK2 fusion | Advanced Solid Tumor | sensitive | Entrectinib | FDA approved | Actionable | In a combined analysis of 3 clinical trials (ALKA-372-001, STARTRK-1, STARTRK-2) that supported FDA approval, Rozlytrek (entrectinib) treatment resulted in an objective response rate of 57% (31/54, 4 complete response, 27 partial response) in patients with NTRK1/2/3 fusion-positive advanced solid tumors, with a median duration of response of 10 months (PMID: 31838007; 2012-000148-88, NCT02097810, NCT02568267). | detail... 31838007 |
| EML4 - ALK ALK I1171S | Advanced Solid Tumor | resistant | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing EML4-ALK with ALK I1171S were resistant to Rozlytrek (entrectinib) in culture (PMID: 33627640). | 33627640 |
| NTRK2 fusion | biliary tract cancer | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines as second or later-line therapy for patients with biliary tract cancer harboring an NTRK fusion (PMID: 36372281; ESMO.org). | detail... 36372281 |
| NTRK1 fusion | low grade glioma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with recurrent or progressive low grade glioma harboring an NTRK fusion (NCCN.org). | detail... |
| EML4 - ALK ALK D1203N | Advanced Solid Tumor | resistant | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing EML4-ALK with ALK D1203N were resistant to treatment with Rozlytrek (entrectinib) in culture (PMID: 33627640). | 33627640 |
| NTRK2 A203T | hematologic cancer | sensitive | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, Rozlytrek (entrectinib) decreased Ntrk2 phosphorylation and viability and increased apoptosis in a transformed cell line expressing NTRK2 A203T in culture (PMID: 32315394). | 32315394 |
| NTRK2 fusion | neuroendocrine tumor | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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... |
| NTRK2 fusion | extrahepatic bile duct carcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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 | gastroesophageal junction adenocarcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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 | cervical cancer | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines as second-line therapy for patients with recurrent or metastatic cervical cancer harboring an NTRK fusion (NCCN.org). | detail... |
| ROS1 fusion | skin melanoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines as second-line therapy for metastatic or unresectable cutaneous melanoma patients with ROS1 fusions (NCCN.org). | detail... |
| NTRK1 fusion | gastrointestinal stromal tumor | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with advanced/metastatic gastrointestinal stromal tumor (GIST) harboring NTRK fusions (PMID: 34560242; ESMO.org). | detail... 34560242 |
| NTRK1 fusion | gastrointestinal stromal tumor | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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... |
| EML4 - ALK ALK G1269A | Advanced Solid Tumor | predicted - resistant | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing EML4-ALK with ALK G1269A demonstrated resistance to treatment with Rozlytrek (entrectinib) in culture (PMID: 33627640). | 33627640 |
| EML4 - ALK ALK G1269A | Advanced Solid Tumor | predicted - resistant | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing EML4-ALK with ALK G1269A demonstrated a decreased response when treated with Rozlytrek (entrectinib) compared to cells expressing wild-type EML4-ALK (PMID: 26939704). | 26939704 |
| NTRK2 rearrange | Advanced Solid Tumor | predicted - sensitive | Entrectinib | Clinical Study | Actionable | In a clinical study, Rozlytrek (entrectinib) treatment resulted in objective response in 75% (3/4) of patients with advanced solid tumors harboring rearrangement in NTRK1, NTRK2, or NTRK3 genes (AACR Apr 2016, Abstract # CT007). | detail... |
| NTRK2 fusion | colorectal cancer | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with metastatic colorectal cancer harboring an NTRK fusion (PMID: 36307056; ESMO.org). | detail... 36307056 |
| NTRK2 fusion | thyroid gland anaplastic carcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with metastatic thyroid gland anaplastic carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | skin melanoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) therapy is included in guidelines for patients with metastatic or unresectable cutaneous melanoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | Cancer of Unknown Primary | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with cancer of unknown primary harboring NTRK fusions (PMID: 36563965; ESMO.org). | 36563965 detail... |
| ALK F1174V | neuroblastoma | sensitive | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, Rozlytrek (entrectinib) treatment inhibited ALK phosphorylation, downstream signaling, and viability of a neuroblastoma cell line harboring ALK F1174V in culture (PMID: 35085006). | 35085006 |
| NTRK1 fusion | Erdheim-Chester disease | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines as first-line or subsequent-line therapy for patients with Erdheim-Chester disease harboring NTRK1 fusions (NCCN.org). | detail... |
| NTRK2 fusion | mammary analogue secretory carcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with recurrent or metastatic salivary gland secretory carcinoma harboring NTRK fusions (PMID: 36567082; ESMO.org). | 36567082 |
| NTRK2 fusion | glioblastoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with recurrent glioblastoma harboring an NTRK fusion (NCCN.org). | detail... |
| EML4 - ALK ALK V1180L | Advanced Solid Tumor | sensitive | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, Rozlytrek (entrectinib) inhibited viability of transformed cells expressing EML4-ALK with ALK V1180L in culture (PMID: 33627640). | 33627640 |
| EML4 - ALK ALK L1196Q | Advanced Solid Tumor | resistant | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing EML4-ALK with ALK L1196Q were resistant to Rozlytrek (entrectinib) in culture (PMID: 33627640). | 33627640 |
| NTRK1 fusion | ovary epithelial cancer | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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... |
| EML4 - ALK ALK I1171N ALK L1198F | Advanced Solid Tumor | predicted - resistant | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing EML4-ALK with ALK I1171N and L1198F demonstrated resistance to treatment with Rozlytrek (entrectinib) in culture (PMID: 33627640). | 33627640 |
| ROS1 fusion | Advanced Solid Tumor | predicted - sensitive | Entrectinib | Case Reports/Case Series | Actionable | In a Phase I/II trial (STARTRK-NG), Rozlytrek (entrectinib) treatment was safe and resulted in an overall response rate (ORR) of 57.7% (15/26, 7 complete responses) with median duration of response and progression-free survival no reached in pediatric patients with CNS or extracranial solid tumors harboring fusions in NTRK1, NTRK2, NTRK3, ROS1, or ALK, ORR was 62.5% (5/8) in patients harboring ROS1 fusions (PMID: 35395680; NCT02650401). | 35395680 |
| NTRK1 fusion | Adenocarcinoma of Unknown Primary | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with adenocarcinoma of unknown primary harboring NTRK1 fusions (NCCN.org). | detail... |
| ROS1 rearrange | lung non-small cell carcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines as a first-line or subsequent therapy for patients with advanced or metastatic ROS1 rearrangement-positive non-small cell lung cancer (NCCN.org). | detail... |
| ROS1 rearrange | lung non-small cell carcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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). | 30285222 detail... |
| ROS1 rearrange | lung non-small cell carcinoma | sensitive | Entrectinib | Clinical Study | Actionable | In a combined analysis of 2 Phase I trials (ALKA-372-001, STARTRK-1), Rozlytrek (entrectinib) treatment resulted in a complete response in 15% (2/13) and partial response in 77% (10/13) patients with ROS-1 rearranged non-small cell lung carcinoma that were treatment-naive (PMID: 28183697; NCT02097810). | 28183697 |
| ALK del exon4-11 | neuroblastoma | sensitive | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, Rozlytrek (entrectinib) treatment inhibited ALK phosphorylation, downstream signaling, and viability of a neuroblastoma cell line harboring a deletion of ALK exons 4-11 in culture (PMID: 35085006). | 35085006 |
| NTRK2 fusion | endometrial carcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines as a second-line or subsequent-line therapy (category 2A) for patients with recurrent endometrial carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | glioblastoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with recurrent glioblastoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | cervical cancer | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines as second-line therapy for patients with recurrent or metastatic cervical cancer harboring an NTRK fusion (NCCN.org). | detail... |
| EML4 - ALK ALK I1171N ALK F1174L | Advanced Solid Tumor | resistant | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing EML4-ALK with ALK I1171N and F1174L were resistant to treatment with Rozlytrek (entrectinib) in culture (PMID: 33627640). | 33627640 |
| NTRK2 fusion | Adenocarcinoma of Unknown Primary | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with adenocarcinoma of unknown primary harboring NTRK2 fusions (NCCN.org). | detail... |
| ALK F1245V | neuroblastoma | predicted - sensitive | Entrectinib | Case Reports/Case Series | Actionable | In a combined analysis of 2 Phase I trials (ALKA-372-001, STARTRK-1), Rozlytrek (entrectinib) treatment resulted in a partial response that lasted 8.3 months in a patient with neuroblastoma harboring ALK F1245V, who remained on treatment for over 3.5 years due to clinical benefit (PMID: 28183697; NCT02097810). | 28183697 |
| NTRK2 fusion | rectum cancer | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for advanced or metastatic rectal cancer patients with an NTRK fusion (NCCN.org). | detail... |
| NTRK1 rearrange | Advanced Solid Tumor | predicted - sensitive | Entrectinib | Clinical Study | Actionable | In a clinical study, Rozlytrek (entrectinib) treatment resulted in objective response in 75% (3/4) of patients with advanced solid tumors harboring rearrangement in NTRK1, NTRK2, or NTRK3 genes (AACR Apr 2016, Abstract # CT007). | detail... |
| NTRK2 fusion | thyroid gland papillary carcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with papillary thyroid carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| EML4 - ALK ALK I1171S ALK G1269A | Advanced Solid Tumor | resistant | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing EML4-ALK with ALK I1171S and G1269A were resistant to treatment with Rozlytrek (entrectinib) in culture (PMID: 33627640). | 33627640 |
| EML4 - ALK ALK I1171N ALK G1269A | Advanced Solid Tumor | resistant | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing EML4-ALK with ALK I1171N and G1269A were resistant to treatment with Rozlytrek (entrectinib) in culture (PMID: 33627640). | 33627640 |
| NTRK1 fusion | uterine corpus sarcoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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 | thyroid gland follicular carcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with follicular thyroid carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | rectum cancer | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for advanced or metastatic rectal cancer patients with an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | small intestine adenocarcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with metastatic small bowel adenocarcinoma with an NTRK fusion (NCCN.org). | detail... |
| EML4 - ALK ALK G1202R | Advanced Solid Tumor | resistant | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing EML4-ALK with ALK G1202R were resistant to Rozlytrek (entrectinib) in culture (PMID: 26939704). | 26939704 |
| EML4 - ALK ALK G1202R | Advanced Solid Tumor | resistant | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing EML4-ALK with ALK G1202R were resistant to treatment with Rozlytrek (entrectinib) in culture (PMID: 33627640). | 33627640 |
| NTRK1 fusion | intrahepatic cholangiocarcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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 | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with recurrent anaplastic gliomas harboring an NTRK fusion, including anaplastic astrocytoma (NCCN.org). | detail... |
| NTRK2 fusion | uterine corpus sarcoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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... |
| ALK positive | lung non-small cell carcinoma | sensitive | Entrectinib | Case Reports/Case Series | Actionable | In a Phase I trial, Rozlytrek (entrectinib) treatment resulted in stable disease in a patient with ALK-positive non-small cell lung carcinoma (J Clin Oncol 32:5s, 2014 (suppl; abstr 2502)). | detail... |
| NTRK2 fusion | gallbladder cancer | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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 | Advanced Solid Tumor | sensitive | Entrectinib | FDA approved | Actionable | In a combined analysis of 3 clinical trials (ALKA-372-001, STARTRK-1, STARTRK-2) that supported FDA approval, Rozlytrek (entrectinib) treatment resulted in an objective response rate of 57% (31/54, 4 complete response, 27 partial response) in patients with NTRK1/2/3 fusion-positive advanced solid tumors, with a median duration of response of 10 months (PMID: 31838007; 2012-000148-88, NCT02097810, NCT02568267). | detail... 31838007 |
| NTRK1 fusion | Advanced Solid Tumor | sensitive | Entrectinib | Case Reports/Case Series | Actionable | In a Phase I/II trial (STARTRK-NG), Rozlytrek (entrectinib) treatment was safe and resulted in an overall response rate (ORR) of 57.7% (15/26, 7 complete responses) with median duration of response and progression-free survival no reached in pediatric patients with CNS or extracranial solid tumors harboring fusions in NTRK1, NTRK2, NTRK3, ROS1, or ALK, ORR was 60% (9/15) in patients harboring fusions in NTRK1/2/3 (PMID: 35395680; NCT02650401). | 35395680 |
| NTRK1 fusion | colon cancer | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for advanced or metastatic colon cancer patients with an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | gastrointestinal stromal tumor | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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... |
| NTRK2 fusion | gastrointestinal stromal tumor | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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 follicular carcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with follicular thyroid carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| ROS1 rearrange | Advanced Solid Tumor | predicted - sensitive | Entrectinib | Clinical Study | Actionable | In a combined analysis of 2 Phase I trials (ALKA-372-001, STARTRK-1), Rozlytrek (entrectinib) treatment resulted in an objective response rate of 86% (12/14) in patients with ROS-1 rearranged advanced solid tumors that were treatment-naive, but no response (0/6) in patients who received prior Xalkori (crizotinib) (PMID: 28183697; NCT02097810). | 28183697 |
| NTRK2 fusion | lung non-small cell carcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines as first-line or subsequent therapy for patients with advanced or metastatic non-small cell lung cancer harboring an NTRK2 fusion (NCCN.org). | detail... |
| NTRK2 fusion | lung non-small cell carcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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). | 36872130 detail... |
| ALK F1174L | neuroblastoma | predicted - sensitive | Entrectinib | Case Reports/Case Series | Actionable | In a Phase I/II trial, Rozlytrek (entrectinib) treatment resulted in a complete response in a patient with neuroblastoma harboring ALK F1174L (PMID: 35395680; NCT02650401). | 35395680 |
| EML4 - ALK ALK F1174V | Advanced Solid Tumor | resistant | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing EML4-ALK with ALK F1174V were resistant to Rozlytrek (entrectinib) in culture (PMID: 33627640). | 33627640 |
| NTRK2 R458G | hematologic cancer | sensitive | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, Rozlytrek (entrectinib) decreased Ntrk2 phosphorylation and viability and increased apoptosis in a transformed cell line expressing NTRK2 R458G in culture (PMID: 32315394). | 32315394 |
| NTRK2 fusion | Cancer of Unknown Primary | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with cancer of unknown primary harboring NTRK fusions (PMID: 36563965; ESMO.org). | detail... 36563965 |
| NTRK2 fusion | ampulla of Vater adenocarcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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 | esophagus squamous cell carcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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 | esophagus adenocarcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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 | vaginal carcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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 (NCCN.org). | detail... |
| NTRK2 fusion | gastroesophageal junction adenocarcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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 | esophagus adenocarcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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... |
| NTRK2 fusion | stomach cancer | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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 | pancreatic cancer | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with metastatic pancreatic cancer harboring an NTRK fusion (PMID: 37678671; ESMO.org). | 37678671 detail... |
| NTRK2 fusion | thyroid gland Hurthle cell carcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with thyroid Hurthle cell carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| EML4 - ALK ALK L1198F | Advanced Solid Tumor | sensitive | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, Rozlytrek (entrectinib) inhibited viability of transformed cells expressing EML4-ALK with ALK L1198F in culture (PMID: 33627640). | 33627640 |
| EML4 - ALK ALK I1171N ALK L1198H | Advanced Solid Tumor | resistant | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing EML4-ALK with ALK I1171N and L1198H were resistant to treatment with Rozlytrek (entrectinib) in culture (PMID: 33627640). | 33627640 |
| EML4 - ALK | mucosal melanoma | sensitive | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, Rozlytrek (entrectinib) decreased viability of a mucosal melanoma cell line harboring EML4-ALK in culture (PMID: 29054983). | 29054983 |
| EML4 - ALK ALK F1245V | Advanced Solid Tumor | resistant | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing EML4-ALK with ALK F1245V were resistant to treatment with Rozlytrek (entrectinib) in culture (PMID: 33627640). | 33627640 |
| EML4 - ALK ALK I1171N ALK L1256F | Advanced Solid Tumor | resistant | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing EML4-ALK with ALK I1171N and L1256F were resistant to treatment with Rozlytrek (entrectinib) in culture (PMID: 33627640). | 33627640 |
| EML4 - ALK ALK L1198F ALK G1202R | Advanced Solid Tumor | resistant | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing EML4-ALK with ALK L1198F and G1202R were resistant to treatment with Rozlytrek (entrectinib) in culture (PMID: 33627640). | 33627640 |
| NTRK1 fusion | stomach cancer | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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 | lung non-small cell carcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines as first-line or subsequent therapy for patients with advanced or metastatic non-small cell lung cancer harboring an NTRK1 fusion (NCCN.org). | detail... |
| NTRK1 fusion | lung non-small cell carcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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). | 36872130 detail... |
| EML4 - ALK ALK I1171N | lung non-small cell carcinoma | resistant | Entrectinib | Preclinical - Patient cell culture | Actionable | In a preclinical study, patient-derived non-small cell lung cancer cells harboring EML4-ALK with ALK I1171N were resistant to treatment with Rozlytrek (entrectinib) in culture (PMID: 33627640). | 33627640 |
| NTRK2 fusion | pancreatic adenocarcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines as first-line or subsequent therapy for patients with locally advanced, metastatic, or recurrent pancreatic adenocarcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | extrahepatic bile duct carcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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... |
| ROS1 positive | pancreatic cancer | predicted - sensitive | Entrectinib | Case Reports/Case Series | Actionable | In a Phase I trial, Rozlytrek (entrectinib) treatment resulted in stable disease in a patient with ROS1-positive pancreatic cancer (J Clin Oncol 32:5s, 2014 (suppl; abstr 2502)). | detail... |
| NTRK1 fusion | differentiated thyroid gland carcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for adult or pediatric patients 12 years or older with metastatic or unresectable differentiated thyroid gland carcinoma harboring NTRK fusions that have progressed on prior therapies (PMID: 31549998, PMID: 35491008; ESMO.org). | detail... 35491008 31549998 |
| ALK rearrange | Advanced Solid Tumor | predicted - sensitive | Entrectinib | Clinical Study | Actionable | In a combined analysis of 2 Phase I trials (ALKA-372-001, STARTRK-1), Rozlytrek (entrectinib) treatment resulted in an objective response rate of 57% (4/7) in patients with ALK-rearranged advanced solid tumors that were treatment-naive, but no response (0/19) in patients who received prior Alk inhibitor treatments (PMID: 28183697; NCT02097810). | 28183697 |
| NTRK2 fusion | pancreatic cancer | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with metastatic pancreatic cancer harboring an NTRK fusion (PMID: 37678671; ESMO.org). | 37678671 detail... |
| NTRK2 fusion | esophagus squamous cell carcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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 | Squamous Cell Carcinoma of Unknown Primary | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with squamous cell carcinoma of unknown primary harboring NTRK2 fusions (NCCN.org). | detail... |
| NTRK1 fusion | breast cancer | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) therapy is included in guidelines for patients with recurrent or metastatic breast cancer harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | biliary tract cancer | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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 | low grade glioma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with recurrent or progressive low grade glioma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | pancreatic adenocarcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines as first-line or subsequent therapy for patients with locally advanced, metastatic, or recurrent pancreatic adenocarcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | colorectal cancer | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with metastatic colorectal cancer harboring an NTRK fusion (PMID: 36307056; ESMO.org). | 36307056 detail... |
| EML4 - ALK ALK I1171N | Advanced Solid Tumor | resistant | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing EML4-ALK with ALK I1171N were resistant to Rozlytrek (entrectinib) in culture (PMID: 33627640). | 33627640 |
| NTRK2 fusion | intrahepatic cholangiocarcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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... |
| ROS1 positive | lung non-small cell carcinoma | sensitive | Entrectinib | FDA approved | Actionable | In a combined analysis of 3 clinical trials (ALKA-372-001, STARTRK-1, STARTRK-2) that supported FDA approval, Rozlytrek (entrectinib) treatment resulted in an objective response rate of 77% (41/53), a median duration of response of 25 months in patients with ROS1 fusion positive non-small cell lung cancer, with median progression-free survival of 26 and 14 months for patients without (n=30) and with (n=23) CNS disease, respectively (Cancer Res 2019;79(13 Suppl):Abstract nr CT192; NCT02097810; NCT02568267). | detail... detail... |
| EML4 - ALK ALK T1151K | Advanced Solid Tumor | sensitive | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, Rozlytrek (entrectinib) inhibited viability of transformed cells expressing EML4-ALK with ALK T1151K in culture (PMID: 33627640). | 33627640 |
| EML4 - ALK ALK C1156Y ALK G1269A | Advanced Solid Tumor | resistant | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing ALK C1156Y and G1269A compound mutation in the context of EML4-ALK were resistant to Rozlytrek (entrectinib) in culture (PMID: 31585938). | 31585938 |
| NTRK2 fusion | Erdheim-Chester disease | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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 | skin melanoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) therapy is included in guidelines for patients with metastatic or unresectable cutaneous melanoma harboring an NTRK fusion (NCCN.org). | detail... |
| EML4 - ALK ALK I1171N ALK F1174I | Advanced Solid Tumor | resistant | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing EML4-ALK with ALK I1171N and F1174I were resistant to treatment with Rozlytrek (entrectinib) in culture (PMID: 33627640). | 33627640 |
| NTRK2 fusion | small intestine adenocarcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with metastatic small bowel adenocarcinoma with an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | neuroendocrine tumor | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) 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 | salivary gland cancer | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with NTRK1 fusion-positive salivary gland tumors with distant metastasis (NCCN.org). | detail... |
| NTRK1 fusion | thyroid gland papillary carcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with papillary thyroid carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| EML4 - ALK ALK L1256F | Advanced Solid Tumor | resistant | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing EML4-ALK with ALK L1256F were resistant to treatment with Rozlytrek (entrectinib) in culture (PMID: 33627640). | 33627640 |
| NTRK1 fusion | mammary analogue secretory carcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with recurrent or metastatic salivary gland secretory carcinoma harboring NTRK fusions (PMID: 36567082; ESMO.org). | 36567082 |
| NTRK2 fusion | hepatocellular carcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines as subsequent-line therapy for patients with hepatocellular carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| ALK positive | neuroblastoma | sensitive | Entrectinib | Case Reports/Case Series | Actionable | In a Phase I trial, Rozlytrek (entrectinib) treatment resulted in partial response in a patient with ALK-positive neuroblastoma (J Clin Oncol 32:5s, 2014 (suppl; abstr 2502)). | detail... |
| NTRK1 rearrange | sarcoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines as a standard treatment for patients with advanced sarcomas harboring NTRK rearrangement (PMID: 34303806; ESMO.org). | detail... 34303806 |
| NTRK1 fusion | thyroid gland anaplastic carcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with metastatic thyroid gland anaplastic carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | vulva cancer | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for patients with advanced or metastatic vulvar cancer harboring an NTRK fusion (NCCN.org). | detail... |
| NTRK2 fusion | colon cancer | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for advanced or metastatic colon cancer patients with an NTRK fusion (NCCN.org). | detail... |
| NTRK1 fusion | hepatocellular carcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines as subsequent-line therapy for patients with hepatocellular carcinoma harboring an NTRK fusion (NCCN.org). | detail... |
| EML4 - ALK | lung non-small cell carcinoma | sensitive | Entrectinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, non-small cell lung carcinoma cells harboring EML4-ALK were sensitive to Rozlytrek (entrectinib), resulting in inhibition of cell proliferation and complete tumor regression in cell line xenograft models (PMID: 26939704). | 26939704 |
| ALK fusion | Advanced Solid Tumor | sensitive | Entrectinib | Case Reports/Case Series | Actionable | In a Phase I/II trial (STARTRK-NG), Rozlytrek (entrectinib) treatment was safe and resulted in an overall response rate (ORR) of 57.7% (15/26, 7 complete responses) with median duration of response and progression-free survival not reached in pediatric patients with CNS or extracranial solid tumors harboring fusions in NTRK1, NTRK2, NTRK3, ROS1, or ALK, ORR was 33.3% (1/3) in patients harboring ALK fusions (PMID: 35395680; NCT02650401). | 35395680 |
| NTRK2 fusion | breast cancer | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) therapy is included in guidelines for patients with recurrent or metastatic breast cancer harboring an NTRK fusion (NCCN.org). | detail... |
| EML4 - ALK ALK L1196M ALK D1203N | Advanced Solid Tumor | resistant | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing EML4-ALK with ALK L1196M and D1203N were resistant to treatment with Rozlytrek (entrectinib) in culture (PMID: 33627640). | 33627640 |
| EML4 - ALK ALK D1203N ALK F1245V | Advanced Solid Tumor | resistant | Entrectinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing EML4-ALK with ALK D1203N and F1245V were resistant to treatment with Rozlytrek (entrectinib) in culture (PMID: 33627640). | 33627640 |
| NTRK2 fusion | differentiated thyroid gland carcinoma | sensitive | Entrectinib | Guideline | Actionable | Rozlytrek (entrectinib) is included in guidelines for adult or pediatric patients 12 years or older with metastatic or unresectable differentiated thyroid gland carcinoma harboring NTRK fusions that have progressed on prior therapies (PMID: 31549998, PMID: 35491008; ESMO.org). | detail... 35491008 31549998 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03498521 | Phase II | Atezolizumab + Paclitaxel Carboplatin Carboplatin + Paclitaxel Olaparib Vismodegib Alectinib Bevacizumab + Erlotinib Cisplatin + Gemcitabine Cobimetinib + Vemurafenib Ipatasertib + Paclitaxel Cisplatin + Paclitaxel Gemcitabine Atezolizumab Entrectinib Pertuzumab + Trastuzumab Paclitaxel + Pertuzumab + Trastuzumab Ipatasertib Carboplatin + Gemcitabine | A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site (CUPISCO) | Active, not recruiting | NLD | ITA | GBR | FRA | ESP | DEU | AUT | AUS | 25 |
| NCT02097810 | Phase I | Entrectinib | Study of Oral RXDX-101 in Adult Patients With Locally Advanced or Metastatic Cancer Targeting NTRK1, NTRK2, NTRK3, ROS1, or ALK Molecular Alterations. (STARTRK-1) | Completed | USA | 1 |
| NCT04302025 | Phase II | Cobimetinib + Vemurafenib Entrectinib Atezolizumab Alectinib Pralsetinib | A Study of Multiple Therapies in Biomarker-Selected Patients With Resectable Stages IB-III Non-Small Cell Lung Cancer | Recruiting | USA | 0 |
| 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 |
| NCT02650401 | Phase I | Entrectinib | Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options (STARTRK-NG) | Active, not recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | 4 |
| NCT05770544 | Phase II | Entrectinib | DETERMINE Trial Treatment Arm 03: Entrectinib in Adult, Teenage/Young Adults and Paediatric Patients With ROS1 Gene Fusion-positive Cancers. (DETERMINE) | Recruiting | GBR | 0 |
| NCT05722886 | Phase II | Cobimetinib + Vemurafenib Alectinib Pertuzumab + Trastuzumab Entrectinib Atezolizumab | DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial) - Master Screening Protocol (DETERMINE) | Recruiting | GBR | 0 |
| NCT03994796 | Phase II | Abemaciclib GDC-0084 Entrectinib | Genetic Testing in Guiding Treatment for Patients With Brain Metastases | Recruiting | USA | 0 |
| NCT04632992 | Phase II | Ipatasertib Atezolizumab + Capecitabine Entrectinib Atezolizumab + Docetaxel Ado-trastuzumab emtansine + Atezolizumab Capecitabine + Pertuzumab/trastuzumab/hyaluronidase-zzxf Paclitaxel + Pertuzumab/trastuzumab/hyaluronidase-zzxf Alectinib Inavolisib Pertuzumab/trastuzumab/hyaluronidase-zzxf Docetaxel + Pertuzumab/trastuzumab/hyaluronidase-zzxf Atezolizumab + Paclitaxel Ado-trastuzumab emtansine + Tucatinib | A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response (MyTACTIC) | Completed | USA | 0 |
| NCT04591431 | Phase II | Everolimus Nivolumab Itacitinib Erlotinib Ponatinib Pemigatinib Ipatasertib Ipilimumab Cobimetinib Atezolizumab Palbociclib Entrectinib Vemurafenib Lapatinib Trastuzumab Brigatinib Alectinib Ado-trastuzumab emtansine Pertuzumab Vismodegib | The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy (ROME) | Active, not recruiting | ITA | 0 |
| NCT05170204 | Phase III | Durvalumab Alectinib Pralsetinib Entrectinib | A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC) | Recruiting | USA | NZL | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 17 |
| NCT03066661 | Expanded access | Entrectinib | Expanded Access to Entrectinib for Cancers With NTRK1/2/3, ROS1, or ALK Gene Fusions | No longer available | USA | 0 |
| NCT03178552 | Phase II | Entrectinib Carboplatin + Cisplatin + Gemcitabine Atezolizumab Carboplatin + Cisplatin + Pemetrexed Disodium Atezolizumab + Cobimetinib + Vemurafenib Alectinib | A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) (B-FAST) | Recruiting | USA | NZL | NLD | ITA | FRA | ESP | DEU | CAN | BEL | AUS | 21 |
| NCT04603807 | Phase III | Entrectinib Crizotinib | A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases | Recruiting | NLD | ITA | FRA | ESP | DEU | 14 |
| NCT02568267 | Phase II | Entrectinib | Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions) (STARTRK-2) | Active, not recruiting | USA | NLD | ITA | GBR | FRA | ESP | DEU | BEL | AUS | 7 |
| NCT02587650 | Phase II | Ceritinib Capmatinib Regorafenib Entrectinib | Capmatinib, Ceritinib, Regorafenib, or Entrectinib in Treating Patients With BRAF/NRAS Wild-Type Stage III-IV Melanoma | Terminated | USA | 0 |
| NCT03330990 | Phase I | Entrectinib | Evaluate the Effect of Entrectinib on the Pharmacokinetics of Midazolam in Cancer Patients | Completed | USA | 0 |
| NCT04589845 | Phase II | Alectinib Ado-trastuzumab emtansine Ipatasertib Inavolisib Entrectinib Atezolizumab Idasanutlin | Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study | Recruiting | USA | NZL | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 14 |
| NCT05238831 | Phase II | Vemurafenib Vinorelbine Palbociclib Irinotecan Alpelisib Capecitabine Atezolizumab Paclitaxel Entrectinib Cobimetinib Nab-paclitaxel Fulvestrant Carboplatin Olaparib Pertuzumab/trastuzumab/hyaluronidase-zzxf Niraparib Vismodegib Alectinib Letrozole Ado-trastuzumab emtansine Bevacizumab Eribulin Anastrozole | SMMART Adaptive Clinical Treatment (ACT) Trial | Withdrawn | 0 |
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