Incyte and Foundation Medicine Announce Agreement to Develop Companion Diagnostic for Pemigatinib (INCB54828), a Selective FGFR Inhibitor, in Patients with Cholangiocarcinoma
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“There is an urgent need for a novel, biomarker-based, targeted
therapeutic approach for patients with cholangiocarcinoma. The initial
goal of this collaboration is to develop a companion diagnostic to
enable testing at diagnosis of stage IV disease, with the aim of helping
to reduce morbidity and mortality, and we are very pleased to be working
with Foundation Medicine as we seek to improve outcomes for these
“We’re committed to helping our biopharma partners bring
biomarker-driven therapies to cancer patients. Partnerships with
innovative biopharma companies, such as
About FGFR and Pemigatinib (INCB54828)
Fibroblast growth factor receptors (FGFRs) play an important role in tumor cell proliferation and survival, migration and angiogenesis (the formation of new blood vessels). Activating mutations, translocations and gene amplifications in FGFRs are closely correlated with the development of various cancers.
Pemigatinib is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations. Phase 2 studies investigating the safety and efficacy of pemigatinib monotherapy across several FGFR-driven malignancies are ongoing—the FIGHT (FIbroblast Growth factor receptor in oncology and Hematology Trials) clinical trial program currently comprises FIGHT-201 in patients with metastatic or surgically unresectable bladder cancer, including with activating FGFR3 alterations; FIGHT-202 in patients with metastatic or surgically unresectable cholangiocarcinoma who have failed previous therapy, including with activating FGFR2 translocations; and FIGHT-203 in patients with myeloproliferative neoplasms with activating FGFR1 translocations.
FoundationOne®CDx is a next generation, sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens. FoundationOne CDx is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms.
For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit http://www.foundationmedicine.com/genomic-testing/foundation-one-cdx.
Follow @Incyte on Twitter at https://twitter.com/Incyte.
About Foundation Medicine
Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company offers a full suite of comprehensive genomic profiling tests to identify the molecular alterations in a patient's cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicine’s molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer.
For more information, please visit http://www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).
Foundation Medicine® and FoundationOne® are
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Forward-Looking Statement of
Except for the historical information set forth herein, the matters set
forth in this release contain predictions, estimates and other
forward-looking statements, including without limitation statements
regarding a collaboration between
Catalina Loveman, +1-302-498-6171
Michael Booth, DPhil, +1-302-498-5914
Lee-Ann Murphy, +1-617-245-3077