Therapy Detail

Therapy Name BGJ398
Therapy Description

Infigratinib (BGJ398) is pan-FGFR inhibitor, which inhibits tumor angiogenesis and tumor cell proliferation (NCI Drug Dictionary).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
BGJ398 Infigratinib FGFR Inhibitor (Pan) 17 Infigratinib (BGJ398) is pan-FGFR inhibitor, which inhibits tumor angiogenesis and tumor cell proliferation (NCI Drug Dictionary).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
FGFR2 amp stomach cancer sensitive BGJ398 Preclinical Actionable In a preclinical study, BGJ398 inhibited proliferation of gastric cancer cell lines harboring FGFR2 amplification in culture (PMID: 26036639). 26036639
FGFR3 V555M Advanced Solid Tumor resistant BGJ398 Preclinical - Cell culture Actionable In a preclinical study, transformed cells over expressing FGFR3 V555M were resistant to BGJ398 in culture (PMID: 28034880). 28034880
FGFR3 V555L transitional cell carcinoma resistant BGJ398 Clinical Study Actionable In a clinical study, two patients with metastatic urothelial carcinoma progressed while being treated with BGJ398 and subsequent cell-free DNA testing revealed FGFR3 V555L (also corresponds to V443M) (PMID: 29848605). 29848605
FGFR3 D764H head and neck squamous cell carcinoma no benefit BGJ398 Preclinical - Cell culture Actionable In a preclinical study, BGJ398 inhibited proliferation of a head and neck squamous cell carcinoma cell line expressing FGFR3 D764H in culture, however, cells expressing FGFR3 D764H did not demonstrate increased sensitivity to BGJ398 compared to cells expressing wild-type FGFR3 (PMID: 27053219). 27053219
FGR2 E565A FGFR2 K641R FGFR2 L617V FGFR2 N549H FGFR2 V564F FGFR2-OPTN cholangiocarcinoma predicted - resistant BGJ398 Clinical Study Actionable In a clinical study, FGFR2 mutations E565A, K641R, L617V, N549H and V564F were identified in the cell-free DNA of a cholangiocarcinoma patient harboring FGFR2-OPTN fusion after the patient progressed while on BGJ398 treatment (PMID: 28034880). 28034880
FGFR3 S131L head and neck squamous cell carcinoma decreased response BGJ398 Preclinical - Cell culture Actionable In a preclinical study, a head and neck squamous cell carcinoma cell line expressing FGFR3 S131L demonstrated decreased sensitivity to BGJ398 compared to cells expressing wild-type FGFR3 in culture (PMID: 27053219). 27053219
FGFR3 amp Advanced Solid Tumor predicted - sensitive BGJ398 Phase I Actionable In a Phase I trial, BGJ398 demonstrated safety and preliminary efficacy in patients with select solid tumors harboring FGFR alterations (Cancer Res October 1, 2014 74:CT326). detail...
FGFR2-FAM76A ovarian cancer sensitive BGJ398 Preclinical - Patient cell culture Actionable In a preclincal study, BGJ398 demonstrated enhanced inhibition of the survival in patient-derived ovarian cancer cells harboring FGFR2 - FAM76A in culture (PMID: 24563622). 24563622
FGFR3 S249C urinary system cancer sensitive BGJ398 Preclinical - Cell culture Actionable In a preclinical study, BGJ398 decreased Myc expression, induced cell cycle arrest, and inhibited growth of a urinary tract cancer cell line harboring FGFR3 S249C in culture (PMID: 27401245). 27401245
FGFR2 S267_D273dup Advanced Solid Tumor sensitive BGJ398 Preclinical Actionable In a preclinical study, BGJ398 prevented oncogenic transformation of cells expressing FGFR2 S267_D273dup (PMID: 26048680). 26048680
FGFR2 V564F Advanced Solid Tumor resistant BGJ398 Preclinical - Cell culture Actionable In a preclinical study, transformed cells over expressing FGFR2 V564F were resistant to BGJ398 in culture (PMID: 28034880). 28034880
FGFR2-AHCYL1 Advanced Solid Tumor sensitive BGJ398 Preclinical Actionable In a preclinical study, treatment with BGJ398 prevented transformation of cells expressing FGFR2-AHCYL1 in culture (PMID: 24122810). 24122810
FGFR2 K660N Advanced Solid Tumor sensitive BGJ398 Preclinical - Cell line xenograft Actionable In a preclinical study, BGJ398 inhibited growth of transformed cells expressing FGFR2 K660N in culture and inhibited tumor growth in xenograft models (PMID: 23786770). 23786770
FGFR2 amp breast cancer sensitive BGJ398 Phase I Actionable In a Phase I trial, a breast cancer patient harboring an FGFR2 amplification demonstrated stable disease when treated with BGJ398 (PMID: 27870574). 27870574
FGFR1 positive uterus leiomyosarcoma decreased response BGJ398 Preclinical - Cell culture Actionable In a preclinical study, uterine leiomyosarcoma cells with moderate Fgfr1 expression level demonstrated decreased response to BGJ398 in culture (PMID: 27535980). 27535980
FGFR2 amp myxoid liposarcoma sensitive BGJ398 Preclinical Actionable In a preclinical study, BGJ398 increased apoptosis, and inhibited cell proliferation and migration of myxoid liposarcoma cell lines harboring FGFR2 amplification in culture (PMID: 26036639). 26036639
FGFR3-BAIAP2L1 urinary bladder cancer sensitive BGJ398 Preclinical - Cell culture Actionable In a preclinical study, BGJ398 inhibited proliferation of a bladder cancer cell line harboring FGFR3-BAIAP2L1 in culture (PMID: 25589496). 25589496
FGFR2 W290C Advanced Solid Tumor sensitive BGJ398 Preclinical - Cell line xenograft Actionable In a preclinical study, BGJ398 inhibited growth of transformed cells expressing FGFR2 W290C in culture and inhibited tumor growth in xenograft models (PMID: 23786770). 23786770
FGFR1 positive leiomyosarcoma decreased response BGJ398 Preclinical - Cell culture Actionable In a preclinical study, leiomyosarcoma cells with moderate Fgfr1 expression level demonstrated decreased response to BGJ398 in culture (PMID: 27535980). 27535980
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
FGFR3 V555M transitional cell carcinoma resistant BGJ398 Clinical Study Actionable In a clinical study, a patient with metastatic urothelial carcinoma progressed while being treated with BGJ398 and subsequent cell-free DNA testing revealed FGFR3 V555M (also corresponds to V443M) (PMID: 29848605). 29848605
FGFR3 mutant Advanced Solid Tumor sensitive BGJ398 Preclinical Actionable In a preclinical study, tumor cell lines with FGFR3 mutations demonstrated sensitivity to BGJ398 in culture (PMID: 23002168). 23002168
FGFR3 V555L Advanced Solid Tumor decreased response BGJ398 Preclinical - Cell culture Actionable In a preclinical study, transformed cells over expressing FGFR3 V555L demonstrated reduced sensitivity to BGJ398 in culture (PMID: 28034880). 28034880
FGFR3 over exp urinary bladder cancer sensitive BGJ398 Preclinical - Pdx Actionable In a preclinical study, treatment with BGJ398 led to improved progression-free survival in a patient-derived xenograft (PDX) model of bladder cancer with FGFR3 over expression (PMID: 26270481). 26270481
FGFR1 amp non-small cell lung carcinoma sensitive BGJ398 Preclinical - Cell culture Actionable In a preclinical study, BGJ398 inhibited Erk signaling and growth of FGFR1-amplified non-small cell lung carcinoma cells in culture (PMID: 28630215). 28630215
FGFR3-TACC3 lung adenocarcinoma sensitive BGJ398 Preclinical Actionable In a preclinical study, BGJ398 inhibited growth and FGFR3 phosphorylation in cells expressing FGFR3-TACC3 fusion in culture (PMID: 25294908). 25294908
FGFR3 L608V Advanced Solid Tumor decreased response BGJ398 Preclinical - Cell culture Actionable In a preclinical study, transformed cells over expressing FGFR3 L608V demonstrated reduced sensitivity to BGJ398 in culture (PMID: 28034880). 28034880
FGFR2-BICC1 Advanced Solid Tumor sensitive BGJ398 Preclinical Actionable In a preclinical study, treatment with BGJ398 prevented transformation of cells expressing FGFR2-BICC1 in culture (PMID: 24122810). 24122810
FGFR1 amp MET amp lung squamous cell carcinoma predicted - resistant BGJ398 Phase I Actionable In a Phase I trial, MET amplification was detected in a squamous cell lung cancer patient harboring FGFR1 amplification whose disease relapsed after 17 months of BGJ398 treatment, supporting a role of MET amplification in drug resistance in FGFR1-amplified lung cancer (PMID: 28630215). 28630215
FGFR3 mutant bladder urothelial carcinoma sensitive BGJ398 Phase I Actionable In a Phase I trial, patients with bladder urothelial carcinoma harboring an FGFR3 mutation demonstrated a disease control rate of 75% (6/8) when treated with BGJ398, including 3 patients with a partial response and 3 with stable disease (PMID: 27870574; NCT01004224). 27870574
FGFR2 E565A FGFR2 K659M FGFR2 N549H FGFR2 N549K FGFR2 V564F FGFR2-ZMYM4 cholangiocarcinoma predicted - resistant BGJ398 Clinical Study Actionable In a clinical study, FGFR2 mutations E565A, K659M, N549H, N549K and V564F were identified in the cell-free DNA of a cholangiocarcinoma patient harboring FGFR2-ZMYM4 fusion after the patient progressed while on BGJ398 treatment (PMID: 28034880). 28034880
FGFR1 amp NRAS over exp non-small cell lung carcinoma decreased response BGJ398 Preclinical - Cell culture Actionable In a preclinical study, overexpression of Nras in FGFR1-amplified non-small cell lung carcinoma cells resulted in decreased response to BGJ398 in culture (PMID: 28630215). 28630215
FGFR1 amp MET over exp lung small cell carcinoma resistant BGJ398 Preclinical - Cell culture Actionable In a preclinical study, overexpression and activation of Met was identified in a small cell lung cancer cell line harboring FGFR1 amplification that acquired resistance to BGJ398 in culture (PMID: 28630215). 28630215
FGFR2 - TACC3 Advanced Solid Tumor sensitive BGJ398 Preclinical Actionable In a preclinical study, BGJ398 prevented oncogenic transformation of cells expressing FGFR2 - TACC3 (PMID: 26048680). 26048680
FGFR1 amp lung squamous cell carcinoma sensitive BGJ398 Phase I Actionable In a Phase I trial, patients with lung squamous cell carcinoma harboring an FGFR1 amplification demonstrated a disease control rate of 50% (18/36) when treated with BGJ398, resulting in 14 patients with stable disease and 4 patients with a partial response (PMID: 27870574). 27870574
FGFR1 amp NRAS amp non-small cell lung carcinoma resistant BGJ398 Preclinical - Cell culture Actionable In a preclinical study, amplification of NRAS was identified in a non-small cell lung cancer cell line harboring FGFR1 amplification that acquired resistance to BGJ398 in culture (PMID: 28630215). 28630215
FGFR3 K650E Advanced Solid Tumor decreased response BGJ398 Preclinical - Cell culture Actionable In a preclinical study, transformed cells over expressing FGFR3 K650E demonstrated reduced sensitivity to BGJ398 in culture (PMID: 28034880). 28034880
FGFR2 fusion FGFR2 V564F cholangiocarcinoma predicted - resistant BGJ398 Clinical Study Actionable In a clinical study, FGFR2 V564F was identified in the cell-free DNA of 3 cholangiocarcinoma patients harboring FGFR2 fusion after the patients progressed while on BGJ398 treatment (PMID: 28034880). 28034880
FGFR2-TNS1 triple-receptor negative breast cancer sensitive BGJ398 Preclinical - Cell line xenograft Actionable In a preclinical study, triple-receptor negative breast cancer xenograft models harboring FGFR2-TNS1 demonstrated tumor regression when treated with BGJ398 (PMID: 29203461). 29203461
FGFR1 amp breast cancer sensitive BGJ398 Phase I Actionable In a Phase I trial, 28% (9/32) of breast cancer patients harboring FGFR1 amplification demonstrated stable disease when treated with BGJ398 (PMID: 27870574). 27870574
FGFR1 positive synovial sarcoma decreased response BGJ398 Preclinical - Cell culture Actionable In a preclinical study, synovial sarcoma cells with moderate Fgfr1 expression level demonstrated decreased response to BGJ398 in culture (PMID: 27535980). 27535980
FGFR2 W290_I291delinsC Advanced Solid Tumor sensitive BGJ398 Preclinical Actionable In a preclinical study, BGJ398 prevented oncogenic transformation of cells expressing FGFR2 W290_I291delinsC (PMID: 26048680). 26048680
FGFR3 L608V FGFR3 V555M transitional cell carcinoma resistant BGJ398 Clinical Study Actionable In a clinical study, a patient with metastatic urothelial carcinoma progressed while being treated with BGJ398 and subsequent cell-free DNA testing revealed FGFR3 V555M (also corresponds to V443M) and FGFR3 L608V (also corresponds to L496V) (PMID: 29848605). 29848605
Unknown unknown alveolar rhabdomyosarcoma not applicable BGJ398 Preclinical - Pdx Actionable In a preclinical study, BGJ398 resulted in antitumor activity in an alveolar rhabdomyosarcoma patient derived xenograft model (PMID: 24687871). 24687871
FGFR3 D788N head and neck squamous cell carcinoma no benefit BGJ398 Preclinical - Cell culture Actionable In a preclinical study, BGJ398 inhibited proliferation of a head and neck squamous cell carcinoma cell line expressing FGFR3 D788N in culture, however, cells expressing FGFR3 D788N did not demonstrate increased sensitivity to BGJ398 compared to cells expressing wild-type FGFR3 (PMID: 27053219). 27053219
FGFR1 amp KRAS G12V non-small cell lung carcinoma decreased response BGJ398 Preclinical - Cell culture Actionable In a preclinical study, overexpression of KRAS G12V in FGFR1-amplified non-small cell lung carcinoma cells resulted in decreased response to BGJ398 in culture (PMID: 28630215). 28630215
FGFR3 mutant transitional cell carcinoma sensitive BGJ398 Phase I Actionable In a Phase I trial, BGJ398 treatment resulted in complete response in 4% (1/25) and partial response in 32% (8/25) of urothelial carcinoma patients harboring FGFR3 mutations or fusions (J Clin Oncol 34, 2016 (suppl; abstr 4517)). detail...
FGFR3 mutant transitional cell carcinoma sensitive BGJ398 Clinical Study Actionable In a clinical study, BGJ398 treatment led to 25.4% (17/67) confirmed responses and a disease control rate of 64% (43/67), which included complete responses, partial responses, and stable disease, and resulted in a median progression-free survival of 3.75 months and a median overall survival of 7.75 months (PMID: 29848605). 29848605
FGFR2 amp colon cancer sensitive BGJ398 Preclinical - Cell culture Actionable In a preclinical study, BGJ398 reduced Myc expression, induced cell-cycle arrest, and inhibited growth of a colon cancer cell line with FGFR2 amplification in culture (PMID: 27401245). 27401245
FGFR3 fusion transitional cell carcinoma sensitive BGJ398 Phase I Actionable In a Phase I trial, BGJ398 treatment resulted in complete response in 4% (1/25) and partial response in 32% (8/25) of urothelial carcinoma patients harboring FGFR3 mutations or fusions (J Clin Oncol 34, 2016 (suppl; abstr 4517)). detail...
FGFR1 over exp uterus leiomyosarcoma sensitive BGJ398 Preclinical - Cell culture Actionable In a preclinical study, PD173074 inhibited survival of FGFR1 over expressing uterus leiomyosarcoma cells in culture (PMID: 27535980). 27535980
FGFR2 K660E Advanced Solid Tumor sensitive BGJ398 Preclinical - Cell culture Actionable In a preclinical study, BGJ398 inhibited growth of transformed cells expressing FGFR2 K660E in culture (PMID: 23786770). 23786770
FGFR3 S249C Advanced Solid Tumor sensitive BGJ398 Preclinical - Cell culture Actionable In a preclinical study, BGJ398 inhibited growth of transformed cells expressing FGFR3 S249C in culture (PMID: 23786770). 23786770
FGFR2 F276C intrahepatic cholangiocarcinoma predicted - sensitive BGJ398 Phase I Actionable In a Phase II trial, BGJ398 treatment resulted in partial response after 2 month of therapy and maintained the response for 4 months in a patient with advanced intrahepatic cholangiocarcinoma harboring a FGFR2 F276C mutation, which is consistent with inhibition of Erk signaling in cholangiocarcinoma cells expressing FGFR2 F274C in culture (JCO Precis Oncol 2017:1, 1-13; NCT02150967). detail...
FGFR3 N540K Advanced Solid Tumor resistant BGJ398 Preclinical - Cell culture Actionable In a preclinical study, transformed cells over expressing FGFR3 N540K were resistant to BGJ398 in culture (PMID: 28034880). 28034880
FGFR1 over exp head and neck squamous cell carcinoma sensitive BGJ398 Preclinical Actionable In a preclinical study, BGJ398 inhibited cell growth and induced apoptosis in HNSCC cells over expressing Fgfr1 in culture and in xenograft models (PMID: 26015511). 26015511
FGFR2 amp FGFR2 over exp stomach cancer sensitive BGJ398 Preclinical - Pdx Actionable In a preclinical study, BGJ398 decreased Myc expression and inhibited tumor growth in patient-derived xenograft (PDX) models of gastric cancer with FGFR2 amplification and over expression (PMID: 27401245). 27401245
BRCA1 loss FGFR2-DNM3 triple-receptor negative breast cancer predicted - sensitive BGJ398 Preclinical - Cell line xenograft Actionable In a preclinical study, BRCA1-deficient triple-receptor negative breast cancer xenograft models harboring FGFR2-DNM3 were sensitive to treatment with BGJ398, demonstrating tumor regression, however, after 43 days on average, three out of six models developed resistance (PMID: 29203461). 29203461
FGFR3 R248C Advanced Solid Tumor sensitive BGJ398 Preclinical - Cell culture Actionable In a preclinical study, BGJ398 inhibited growth of transformed cells expressing FGFR3 R248C in culture (PMID: 23786770). 23786770
FGFR3 amp urinary system cancer sensitive BGJ398 Preclinical - Cell culture Actionable In a preclinical study, BGJ398 decreased Myc expression, induced cell cycle arrest, and inhibited growth of a urinary tract cancer cell line harboring FGFR3 amplification in culture (PMID: 27401245). 27401245
FGFR2 mutant cholangiocarcinoma sensitive BGJ398 Phase I Actionable In a Phase I trial, a patient with cholangiocarcinoma harboring an FGFR2 mutation demonstrated a decreased tumor burden when treated with BGJ398 (PMID: 27870574). 27870574
FGFR2 mutant endometrial cancer sensitive BGJ398 Preclinical Actionable In a preclinical study, BGJ398 inhibited the growth of FGFR2-mutated endometrial cancer cells in vitro and in xenograft models (PMID: 23443805). 23443805
FGFR1 amp synovial sarcoma sensitive BGJ398 Preclinical - Cell culture Actionable In a preclinical study, BGJ398 inhibited survival of FGFR1 amplified synovial sarcoma cells in culture (PMID: 27535980). 27535980
FGFR3-TACC3 malignant glioma sensitive BGJ398 Preclinical - Cell culture Actionable In a preclinical study, BJG398 inhibited Fgfr3 kinase activity in transformed astrocytes expressing the FGFR3-TACC3 fusion in culture (PMID: 22837387). 22837387
FGFR2 V564F FGFR2-BICC1 cholangiocarcinoma predicted - resistant BGJ398 Clinical Study Actionable In a clinical study, FGFR2 V564F was identified in the cell-free DNA of a cholangiocarcinoma patient harboring FGFR2-BICC1 fusion after the patient progressed while on BGJ398 treatment (PMID: 28034880). 28034880
FGFR1-TACC1 malignant glioma sensitive BGJ398 Preclinical - Cell culture Actionable In a preclinical study, BJG398 inhibited Fgfr1 kinase activity and cell growth in transformed cells expressing the FGFR1-TACC1 fusion in culture (PMID: 22837387). 22837387
Clinical Trial Phase Therapies Title Recruitment Status
NCT02706691 Phase II BGJ398 Pan FGFR Kinase Inhibitor BGJ398 in Treating Patients With FGFR1-3 Translocated, Mutated, or Amplified Recurrent Head and Neck Cancer Recruiting
NCT02150967 Phase II BGJ398 A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma Recruiting
NCT01975701 Phase II BGJ398 A Phase 2 Study of BGJ398 in Patients With Recurrent GBM Active, not recruiting
NCT02657486 Phase I BGJ398 BGJ398 in Non-Muscle-Invasive Urothelial Carcinoma of the Bladder Recruiting
NCT02312804 Phase I Paclitaxel Carboplatin BGJ398 Ph Ib/BGJ398/Cervix and Other Solid Tumors Withdrawn
NCT01004224 Phase I BGJ398 A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies Completed
NCT02160041 Phase II BGJ398 BGJ398 for Patients With Tumors With FGFR Genetic Alterations Completed