Therapy Detail

Therapy Name Pemigatinib
Synonym
Therapy Description

Pemigatinib (INCB054828) is a fibroblast growth factor receptor (FGFR) inhibitor that blocks FGFR1/2/3 signaling, which results in growth inhibition in tumor cells (Ann Oncol, 29 (suppl 8), October 2018, abstract 756P).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Pemigatinib INCB54828|INCB054828 FGFR1 Inhibitor 21 FGFR2 Inhibitor 15 FGFR3 Inhibitor 12 Pemigatinib (INCB054828) is a fibroblast growth factor receptor (FGFR) inhibitor that blocks FGFR1/2/3 signaling, which results in growth inhibition in tumor cells (Ann Oncol, 29 (suppl 8), October 2018, abstract 756P).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
FGFR2 mutant Advanced Solid Tumor sensitive Pemigatinib Preclinical - Cell culture Actionable In a preclinical study, a variety of cancer cell lines harboring mutations in FGFR1, FGFR2, and/or FGFR3 demonstrated sensitivity to INCB054828 in culture and in cell line xenograft models, resulting in inhibition of tumor growth (Cancer Res 2015;75(15 Suppl):Abstract nr 771). detail...
FGFR3 mutant Advanced Solid Tumor sensitive Pemigatinib Preclinical - Cell line xenograft Actionable In a preclinical study, a variety of cancer cell lines harboring mutations in FGFR1, FGFR2, and/or FGFR3 demonstrated sensitivity to INCB054828 in culture and in cell line xenograft models, resulting in inhibition of tumor growth (Cancer Res 2015;75(15 Suppl):Abstract nr 771). detail...
FGFR2 rearrange cholangiocarcinoma resistant Pemigatinib Phase II Actionable In a Phase II (FIGHT-202) trial, Pemigatinib (INCB054828) treatment resulted in partial response in 18% (8/45, 1 unconfirmed complete response), stable disease in 58% (26/45) of patients with cholangiocarcinoma harboring FGFR2 translocations, with a median progression-free survival of 6.8 months; and no response were observed in cohorts of patients with other FGF/FGFR genetic alterations or wild-type FGF/FGFR (Ann Oncol, Oct 2018, 29 (suppl 8), abstract 756P; NCT02924376). detail...
FGFR1 mutant Advanced Solid Tumor sensitive Pemigatinib Preclinical - Cell line xenograft Actionable In a preclinical study, a variety of cancer cell lines harboring mutations in FGFR1, FGFR2, and/or FGFR3 demonstrated sensitivity to INCB054828 in culture and in cell line xenograft models, resulting in inhibition of tumor growth (Cancer Res 2015;75(15 Suppl):Abstract nr 771). detail...
Clinical Trial Phase Therapies Title Recruitment Status
NCT02872714 Phase II Pemigatinib A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201) Recruiting
NCT02924376 Phase II Pemigatinib Efficacy and Safety of INCB054828 in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy Recruiting
NCT03656536 Phase III Pemigatinib Cisplatin + Gemcitabine A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma - (FIGHT-302) Recruiting
NCT03822117 Phase II Pemigatinib Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations Recruiting
NCT03011372 Phase II Pemigatinib A Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement Recruiting