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Therapy Name Futibatinib
Synonyms
Therapy Description

Futibatinib (TAS-120) is a third-generation pan-FGFR inhibitor, which result in the inhibition of FGFR-mediated signal transduction pathways and tumor cell proliferation (PMID: 31109923).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Futibatinib TAS-120 FGFR Inhibitor (Pan) 18 Futibatinib (TAS-120) is a third-generation pan-FGFR inhibitor, which result in the inhibition of FGFR-mediated signal transduction pathways and tumor cell proliferation (PMID: 31109923).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown Advanced Solid Tumor not applicable Futibatinib Phase I Actionable In a Phase I trial, TAS-120 treatment resulted in clinical response in 5.5% (2/36) and stable disease over 24 weeks in 5.5% (2/36) of patients with advanced solid tumors (Ann Oncol 2017, Vol 28, Suppl 5, Abstract # 372PD). detail...
FGFR2 - INA FGFR2 M538I FGFR2 N550H FGFR2 N550T FGFR2 L618V FGFR2 H683L intrahepatic cholangiocarcinoma sensitive Futibatinib Case Reports/Case Series Actionable In a Phase I trial, a patient with intrahepatic cholangiocarcinoma, harboring an FGFR2-INA fusion with FGFR2 H683L, L618V, N550H, N550T, M538I mutations, responded to TAS-120 for 5.1 months before progressing due to acquired FGFR2 V565L and E566A mutations, detected in cell-free DNA (PMID: 31109923; NCT02052778). 31109923
Unknown unknown urinary bladder cancer not applicable Futibatinib Phase I Actionable In a Phase I trial, TAS-120 treatment resulted in stable disease over 24 weeks in a bladder cancer patient (Ann Oncol 2017, Vol 28, Suppl 5, Abstract # 372PD). detail...
Unknown unknown esophageal cancer not applicable Futibatinib Phase I Actionable In a Phase I trial, TAS-120 treatment resulted in clinical response in an esophageal cancer patient (Ann Oncol 2017, Vol 28, Suppl 5, Abstract # 372PD). detail...
FGFR2 fusion FGFR2 M538I intrahepatic cholangiocarcinoma sensitive Futibatinib Preclinical - Cell culture Actionable In a preclinical study, TAS-120 treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 M538I were sensitive to treatment as demonstrated by decreased cell viability and decreased activation of downstream signaling (PMID: 31109923). 31109923
FGFR2 - SORBS1 intrahepatic cholangiocarcinoma predicted - sensitive Futibatinib Case Reports/Case Series Actionable In a Phase I trial (FOENIX-101), Futibatinib (TAS-120) treatment resulted in a partial response in a patient with intrahepatic cholangiocarcinoma harboring FGFR2-SOEBS1 fusion (PMID: 32622884; NCT02052778). 32622884
FGFR2 - ZMYM4 FGFR2 V563L intrahepatic cholangiocarcinoma resistant Futibatinib Case Reports/Case Series Actionable In a Phase I trial, a patient with intrahepatic cholangiocarcinoma, harboring an FGFR2-SORBS1 fusion with FGFR2 V565F, K660M E566A, N550H, and N550K mutations, responded to TAS-120 for 7.2 months before progressing due to an acquired FGFR2 V563L mutation, detected in cell-free DNA and tumor biopsy (PMID: 31109923; NCT02052778). 31109923
FGFR2 fusion FGFR2 V565F intrahepatic cholangiocarcinoma resistant Futibatinib Preclinical - Cell culture Actionable In a preclinical study, TAS-120 treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 V565F were resistant to treatment, as demonstrated by cell viability and downstream signaling assays (PMID: 31109923). 31109923
FGFR2 rearrange cholangiocarcinoma predicted - sensitive Futibatinib Phase I Actionable In a Phase I trial, TAS-120 treatment resulted in partial response in 2 patients with cholangiocarcinoma harboring FGFR2 rearrangements (Annals of Oncology, Volume 29, Issue suppl_5). detail...
FGFR2 - KIAA1217 intrahepatic cholangiocarcinoma sensitive Futibatinib Preclinical - Pdx Actionable In a preclinical study, TAS-120 treatment of an intrahepatic cholangiocarcinoma patient-derived xenograft model, harboring an FGFR2-KIAA1217 fusion, decreased tumor growth and suppressed MEK/ERK signaling (PMID: 31109923). 31109923
FGFR2 fusion FGFR2 H683L intrahepatic cholangiocarcinoma sensitive Futibatinib Preclinical - Cell culture Actionable In a preclinical study, TAS-120 treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 H683L were sensitive to treatment as demonstrated by decreased cell viability and decreased activation of downstream signaling (PMID: 31109923). 31109923
FGFR2 - SORBS1 FGFR2 V565F intrahepatic cholangiocarcinoma resistant Futibatinib Case Reports/Case Series Actionable In a Phase I trial, a patient with intrahepatic cholangiocarcinoma, harboring an FGFR2-SORBS1 fusion, responded to TAS-120 for 15.8 months before progressing due to an acquired FGFR2 V565F mutation, detected in cell-free DNA (PMID: 31109923; NCT02052778). 31109923
FGFR2 fusion FGFR2 K715R intrahepatic cholangiocarcinoma sensitive Futibatinib Preclinical - Cell culture Actionable In a preclinical study, TAS-120 treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 K715R were sensitive to treatment as demonstrated by decreased cell viability and decreased activation of downstream signaling (PMID: 31109923). 31109923
FGFR2 - SHTN1 FGFR2 E565A cholangiocarcinoma resistant Futibatinib Preclinical - Cell culture Actionable In a preclinical study, cholangiocarcinoma cells expressing both FGFR2-SHTN1 and FGFR2 E565A demonstrated resistance to treatment with Futibatinib (TAS-120) in culture (PMID: 31911531). 31911531
FGFR2 - SHTN1 Advanced Solid Tumor sensitive Futibatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing FGFR2-SHTN1 were sensitive to treatment with Futibatinib (TAS-120), demonstrating decreased cell viability in culture (PMID: 31911531). 31911531
FGFR2 fusion intrahepatic cholangiocarcinoma predicted - sensitive Futibatinib Phase II Actionable In a Phase II trial (FOENIX-CCA2), Futibatinib (TAS-120) demonstrated manageable toxicity profile, resulted in an objective response rate (ORR) of 37.3% (25/67), a median duration of response of 8.3 months, and a disease control rate of 82% in patients with intrahepatic cholangiocarcinoma harboring FGFR2 fusions (82%) or other rearrangements (18%), ORR was 36.2% (21/58) in patients harboring FGFR2 fusions (Annals of Oncology (2020) 31 (suppl_4): S261-S262; NCT02052778). detail...
FGFR2 fusion FGFR2 E566A intrahepatic cholangiocarcinoma sensitive Futibatinib Preclinical - Cell culture Actionable In a preclinical study, TAS-120 treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 E566A were sensitive to treatment as demonstrated by decreased cell viability and decreased activation of downstream signaling (PMID: 31109923). 31109923
FGFR2 - SHTN1 FGFR2 L617M cholangiocarcinoma resistant Futibatinib Preclinical - Cell culture Actionable In a preclinical study, cholangiocarcinoma cells expressing both FGFR2-SHTN1 and FGFR2 L617M demonstrated resistance to treatment with Futibatinib (TAS-120) in culture (PMID: 31911531). 31911531
FGFR2 amp breast cancer predicted - sensitive Futibatinib Case Reports/Case Series Actionable In a Phase I trial, Futibatinib (TAS-120) treatment resulted in a partial response in a patients with breast cancer harboring FGFR2 amplification, with 37% tumor shrinkage (Annals of Oncology (2020) 31 (suppl_4): S475). detail...
FGFR2 - ZMYM4 FGFR2 N550H FGFR2 N550K FGFR2 V565F FGFR2 E566A FGFR2 K660M intrahepatic cholangiocarcinoma sensitive Futibatinib Case Reports/Case Series Actionable In a Phase I trial, a patient with intrahepatic cholangiocarcinoma, harboring an FGFR2-ZMYM4 fusion with FGFR2 V565F, K660M E566A, N550H, and N550K mutations, responded to TAS-120 for 7.2 months before progressing due to an acquired FGFR2 V563L mutation, detected in cell-free DNA (PMID: 31109923; NCT02052778). 31109923
FGFR2 - SORBS1 FGFR2 K660M FGFR2 K715R intrahepatic cholangiocarcinoma sensitive Futibatinib Case Reports/Case Series Actionable In a Phase I trial, a patient with intrahepatic cholangiocarcinoma, harboring an FGFR2-SORBS1 fusion with FGFR2 K660M and K175R mutations, responded to TAS-120 for 15.8 months before progressing due to an acquired FGFR2 V565F mutation, detected in cell-free DNA (PMID: 31109923; NCT02052778). 31109923
FGFR2 - NRAP intrahepatic cholangiocarcinoma sensitive Futibatinib Case Reports/Case Series Actionable In a Phase I trial, a patient with intrahepatic cholangiocarcinoma, harboring an FGFR2-NRAP fusion responded to TAS-120 for 17.2 months before progressing due to an acquired FGFR2 N550K mutation, detected in cell-free DNA and the tumor biopsy (PMID: 31109923; NCT02052778). 31109923
FGFR2 fusion FGFR2 L618V intrahepatic cholangiocarcinoma sensitive Futibatinib Preclinical - Cell culture Actionable In a preclinical study, TAS-120 treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 L618V were sensitive to treatment as demonstrated by decreased cell viability and decreased activation of downstream signaling (PMID: 31109923). 31109923
FGFR2 - SHTN1 FGFR2 E565A Advanced Solid Tumor resistant Futibatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing both FGFR2-SHTN1 and FGFR2 E565A demonstrated resistance to treatment with Futibatinib (TAS-120) in culture (PMID: 31911531). 31911531
FGFR3 fusion Advanced Solid Tumor predicted - sensitive Futibatinib Preclinical - Cell line xenograft Actionable In a preclinical study, TAS-120 demonstrated growth inhibition and reduced FGFR phosphorylation in human cancer cell lines and xenograft models harboring FGFR mutations (Mol Cancer Ther 2013;12(11 Suppl):A270). detail...
FGFR2 - SHTN1 cholangiocarcinoma sensitive Futibatinib Preclinical - Cell culture Actionable In a preclinical study, cholangiocarcinoma cells expressing FGFR2-SHTN1 were sensitive to treatment with Futibatinib (TAS-120), demonstrating decreased cell viability in culture (PMID: 31911531). 31911531
FGFR2 - BICC1 intrahepatic cholangiocarcinoma predicted - sensitive Futibatinib Case Reports/Case Series Actionable In a Phase II trial (FOENIX-CCA2), Futibatinib (TAS-120) demonstrated manageable toxicity profile, resulted in an objective response rate (ORR) of 37.3% (25/67), a median duration of response of 8.3 months, and a disease control rate of 82% in patients with intrahepatic cholangiocarcinoma harboring FGFR2 fusions (82%) or other rearrangements (18%), ORR was 33.3% (5/15) in patients harboring FGFR2-BICC1 fusion (Annals of Oncology (2020) 31 (suppl_4): S261-S262; NCT02052778). detail...
FGFR2 - BICC1 intrahepatic cholangiocarcinoma predicted - sensitive Futibatinib Case Reports/Case Series Actionable In a Phase I trial (FOENIX-101), Futibatinib (TAS-120) treatment resulted in a partial response in two patients with intrahepatic cholangiocarcinoma harboring FGFR2-BICC1 fusion (PMID: 32622884; NCT02052778). 32622884
FGFR2 - NRAP FGFR2 N550K intrahepatic cholangiocarcinoma resistant Futibatinib Case Reports/Case Series Actionable In a Phase I trial, a patient with intrahepatic cholangiocarcinoma, harboring an FGFR2-NRAP fusion responded to TAS-120 for 17.2 months before progressing due to an acquired FGFR2 N550K mutation, detected in cell-free DNA and the tumor biopsy (PMID: 31109923; NCT02052778). 31109923
FGFR1 M563I FGFR1 K687E oligodendroglioma predicted - sensitive Futibatinib Case Reports/Case Series Actionable In a Phase I trial (FOENIX-101), Futibatinib (TAS-120) treatment resulted in a partial response in a patient with anaplastic oligodendroglioma harboring FGFR1 M563I and FGFR1 K687E (PMID: 32622884; NCT02052778). 32622884 detail... detail...
FGFR2 amp Advanced Solid Tumor predicted - sensitive Futibatinib Phase I Actionable In a Phase I trial (FOENIX-101), Futibatinib (TAS-120) treatment demonstrated manageable safety profile, and resulted in a partial response in 6% (5/86) and stable disease in 48% (41/86) of patients with advanced solid tumors harboring FGF/FGFR aberrations, among whom 5% (4/74) harbored FGFR2 amplification (PMID: 32622884; NCT02052778). 32622884
FGFR2 fusion FGFR2 N550H intrahepatic cholangiocarcinoma sensitive Futibatinib Preclinical - Cell culture Actionable In a preclinical study, TAS-120 treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 N550H were sensitive to treatment as demonstrated by decreased cell viability and decreased activation of downstream signaling (PMID: 31109923). 31109923
FGFR2 rearrange FGFR2 amp cholangiocarcinoma predicted - sensitive Futibatinib Phase I Actionable In a Phase I trial, TAS-120 treatment resulted in partial response in a patient with cholangiocarcinoma harboring FGFR2 rearrangement and FGFR2 amplification (Annals of Oncology, Volume 29, Issue suppl_5). detail...
FGFR2 rearrange intrahepatic cholangiocarcinoma predicted - sensitive Futibatinib Case Reports/Case Series Actionable In a Phase II trial (FOENIX-CCA2), Futibatinib (TAS-120) demonstrated manageable toxicity profile, resulted in an objective response rate (ORR) of 37.3% (25/67), a median duration of response of 8.3 months, and a disease control rate of 82% in patients with intrahepatic cholangiocarcinoma harboring FGFR2 fusions (82%) or other rearrangements (18%), ORR was 44.4% (4/9) in patients harboring FGFR2 rearrangements (Annals of Oncology (2020) 31 (suppl_4): S261-S262; NCT02052778). detail...
FGFR2 fusion FGFR2 K660M intrahepatic cholangiocarcinoma sensitive Futibatinib Preclinical - Cell culture Actionable In a preclinical study, TAS-120 treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 K660M were sensitive to treatment as demonstrated by decreased cell viability and decreased activation of downstream signaling (PMID: 31109923). 31109923
FGFR2 fusion biliary tract cancer predicted - sensitive Futibatinib Phase I Actionable In a Phase I trial, TAS-120 treatment resulted in stable disease over 24 weeks in two biliary tract cancer patients harboring FGFR2 fusions (Ann Oncol 2017, Vol 28, Suppl 5, Abstract # 372PD). detail...
FGFR2 amp stomach cancer predicted - sensitive Futibatinib Phase I Actionable In a Phase I trial, Futibatinib (TAS-120) treatment resulted in clinical response in a gastric cancer patient harboring FGFR2 amplification (Ann Oncol 2017, Vol 28, Suppl 5, Abstract # 372PD). detail...
FGFR2 amp stomach cancer predicted - sensitive Futibatinib Case Reports/Case Series Actionable In a Phase I trial, Futibatinib (TAS-120) treatment resulted in a partial response in 2 patients with gastric cancer harboring FGFR2 amplification, with 59% and 90% tumor shrinkage, respectively (Annals of Oncology (2020) 31 (suppl_4): S475). detail...
FGFR2 fusion cholangiocarcinoma predicted - sensitive Futibatinib Phase I Actionable In a Phase I trial, TAS-120 treatment resulted in an objective response rate of 25% (7/28, 7 partial responses) in patients with cholangiocarcinoma harboring FGFR2 fusions, with 71% of patients experienced tumor shrinkage, 54% (15/28) achieved stable disease (Annals of Oncology, Volume 29, Issue suppl_5). detail...
FGFR2 - INA FGFR2 V565L FGFR2 E566A intrahepatic cholangiocarcinoma resistant Futibatinib Case Reports/Case Series Actionable In a Phase I trial, a patient with intrahepatic cholangiocarcinoma, harboring an FGFR2-INA fusion with FGFR2 H683L, L618V, N550H, N550T, M538I mutations, responded to TAS-120 for 5.1 months before progressing due to acquired FGFR2 V565L and E566A mutations, detected in cell-free DNA (PMID: 31109923; NCT02052778). 31109923
FGFR2 fusion FGFR2 N550K intrahepatic cholangiocarcinoma sensitive Futibatinib Preclinical - Cell culture Actionable In a preclinical study, TAS-120 treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 N550K were sensitive to treatment as demonstrated by decreased cell viability and decreased activation of downstream signaling (PMID: 31109923). 31109923
FGFR1 N546D intrahepatic cholangiocarcinoma predicted - sensitive Futibatinib Case Reports/Case Series Actionable In a Phase I trial (FOENIX-101), Futibatinib (TAS-120) treatment resulted in a partial response in a patient with glioblastoma harboring FGFR1 N546D (PMID: 32622884; NCT02052778). 32622884
FGFR2 fusion Advanced Solid Tumor predicted - sensitive Futibatinib Phase I Actionable In a Phase I trial (FOENIX-101), Futibatinib (TAS-120) treatment demonstrated manageable safety profile, and resulted in a partial response in 6% (5/86) and stable disease in 48% (41/86) of patients with advanced solid tumors harboring FGF/FGFR aberrations, among whom 20% (15/74) harbored FGFR2 fusions (PMID: 32622884; NCT02052778). 32622884
FGFR1 amp Advanced Solid Tumor predicted - sensitive Futibatinib Phase I Actionable In a Phase I trial (FOENIX-101), Futibatinib (TAS-120) treatment demonstrated manageable safety profile, and resulted in a partial response in 6% (5/86) and stable disease in 48% (41/86) of patients with advanced solid tumors harboring FGF/FGFR aberrations, among whom 20% (15/74) harbored FGFR1 amplification (PMID: 32622884; NCT02052778). 32622884

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04189445 Phase II Futibatinib Futibatinib in Patients With Specific FGFR Aberrations Recruiting USA 13
NCT02052778 Phase Ib/II Futibatinib A Study of TAS-120 in Patients With Advanced Solid Tumors Active, not recruiting USA 9
NCT04024436 Phase II Fulvestrant + Futibatinib Futibatinib A Study of TAS-120 in Patients With Metastatic Breast Cancer Recruiting USA 5
NCT04093362 Phase III Futibatinib Cisplatin + Gemcitabine Futibatinib Vs Gemcitabine-Cisplatin Chemotherapy as 1st-Line Treatment of Patients With Advanced Cholangiocarcinoma (CCA) Harboring FGFR2 Gene Rearrangements (FOENIX-CCA3) Not yet recruiting USA 0


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