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 32 JAK2 Inhibitor 19 ROS1 Inhibitor 20 SRC Inhibitor 31 Trk Receptor Inhibitor (Pan) 31 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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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
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
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 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...
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 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
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...
NTRK2 fusion breast cancer sensitive Repotrectinib Guideline Actionable Augtyro (repotrectinib) is included in guidelines as first-line (category 2B) or subsequent-line therapy for patients with recurrent or metastatic breast cancer harboring an NTRK fusion (NCCN.org). 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...
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...
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...
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 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 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
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...
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...
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...
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...
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
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...
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...
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...
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
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 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...
NTRK1 fusion breast cancer sensitive Repotrectinib Guideline Actionable Augtyro (repotrectinib) is included in guidelines as first-line (category 2B) or subsequent-line therapy for patients with recurrent or metastatic breast cancer harboring an NTRK fusion (NCCN.org). detail...
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
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...
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 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
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...
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
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
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...
NTRK1 fusion rectum cancer predicted - 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...
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
NTRK2 fusion lung non-small cell carcinoma predicted - 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 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 hepatocellular carcinoma sensitive Repotrectinib Guideline Actionable Augtyro (repotrectinib) is included in guidelines for patients with hepatocellular carcinoma harboring an NTRK fusion (NCCN.org). 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
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
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...
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 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...
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...
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
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...
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...
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 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
NTRK1 fusion lung non-small cell carcinoma predicted - 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 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 hepatocellular carcinoma sensitive Repotrectinib Guideline Actionable Augtyro (repotrectinib) is included in guidelines for patients with hepatocellular carcinoma harboring an NTRK fusion (NCCN.org). detail...

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  • Filtering will only apply to rows that are already loaded on the page. Filtering has no impact on query parameters.
  • Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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 | CAN | AUS 4
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 | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 9
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) Not yet recruiting USA 0
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 | NLD | ITA | FRA | ESP | DEU | CAN | AUT 13


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