Molecular Profile Detail

Profile Name FGFR2 fusion
Gene Variant Detail

FGFR2 fusion (unknown)

Relevant Treatment Approaches

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Molecular Profile Indication/Tumor Type Response Type Relevant Treatment Approaches Therapy Name Approval Status Evidence Type Efficacy Evidence References
FGFR2 fusion Advanced Solid Tumor predicted - sensitive AZD4547 Phase II Actionable In a Phase II (MATCH) trial, AZD4547 treatment resulted in partial response in 22% (2/9) and stable disease in 55% (5/9) of patients with advanced solid tumors harboring FGFR fusions, with a 6-month progression-free survival rate of 42% (J Clin Oncol 36, 2018 (suppl; abstr 2503); NCT02465060). detail...
FGFR2 fusion biliary tract cancer predicted - sensitive TAS-120 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 fusion urinary system cancer sensitive Erdafitinib Phase I Actionable In a Phase I trial, Erdafitinib (JNJ-42756493) treatment resulted in partial response for more than 12 months in a urothelial cancer patient harboring FGFR2 - BICC1 and FGFR2 - CASP7 fusions (PMID: 26324363). 26324363
FGFR2 fusion cholangiocarcinoma sensitive BGJ398 Phase I Actionable In a Phase I trial, two patients with cholangiocarcinoma harboring FGFR2 fusions demonstrated a decreased tumor burden when treated with BGJ398 (PMID: 27870574). 27870574
FGFR2 fusion endometrial cancer sensitive Erdafitinib Phase I Actionable In a Phase I trial, Erdafitinib (JNJ-42756493) treatment resulted in partial response in an endometrial cancer patient harboring FGFR2 - BICC1 and FGFR2 - OFD1 fusions (PMID: 26324363). 26324363
FGFR2 fusion cholangiocarcinoma predicted - sensitive TAS-120 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 fusion intrahepatic cholangiocarcinoma sensitive Derazantinib Phase I Actionable In a Phase I trial, Derazantinib (ARQ 087) treatment resulted in partial response in 2 and stable disease in 1 of the 5 intrahepatic cholangiocarcinoma patients harboring FGFR2 fusions, and progressive disease in 5 patients without FGFR aberrations (PMID: 28972963; NCT01752920). detail... 28972963
Clinical Trial Phase Therapies Title Recruitment Status
NCT02265341 Phase II Ponatinib Ponatinib Hydrochloride in Treating Patients With Advanced Biliary Cancer With FGFR2 Fusions Active, not recruiting
NCT02795156 Phase II Afatinib Regorafenib Study to Assess the Activity of Molecularly Matched Targeted Therapies in Select Tumor Types Based on Genomic Alterations Recruiting
NCT02465060 Phase II Dabrafenib Trametinib Crizotinib Sunitinib Sapanisertib Nivolumab AZD4547 Dasatinib Binimetinib Adavosertib Osimertinib Trastuzumab Palbociclib Afatinib Capivasertib Defactinib GSK2636771 Vismodegib trastuzumab emtansine Larotrectinib Pertuzumab Taselisib Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) Recruiting
NCT02393248 Phase Ib/II Cisplatin + Gemcitabine + Pemigatinib Docetaxel + Pemigatinib Epacadostat + Pembrolizumab Open-Label, Dose-Escalation Study of INCB054828 in Subjects With Advanced Malignancies Recruiting
NCT03834220 Phase II FF-284 Basket Trial in Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3- (FUZE Clinical Trial) Not yet recruiting
NCT02160041 Phase II BGJ398 BGJ398 for Patients With Tumors With FGFR Genetic Alterations Completed
NCT02872714 Phase II Pemigatinib A Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Urothelial Carcinoma Recruiting
NCT02052778 Phase Ib/II TAS-120 A Dose Finding Study Followed by a Safety and Efficacy Study in Patients With Advanced Solid Tumors or Multiple Myeloma With FGF/FGFR-Related Abnormalities Recruiting
NCT03230318 Phase III Derazantinib ARQ 087 in Subjects With FGFR2 Gene Fusion Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma Recruiting
NCT02546661 Phase I AZD4547 Durvalumab Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer Recruiting
NCT01948297 Phase I FF-284 Debio 1347-101 Phase I Trial in Advanced Solid Tumours With Fibroblast Growth Factor Receptor (FGFR) Alterations Recruiting
NCT02608125 Phase I PRN1371 A Dose Escalation and Dose Expansion Study of PRN1371 in Adult Patients With Advanced Solid Tumors Recruiting