On September 11, 2018 Incyte Corporation (NASDAQ:INCY) and Foundation Medicine, Inc., reported that the companies have entered into an agreement for the development, regulatory support and commercialization of companion diagnostics (CDx), with an initial focus on CDx development for pemigatinib (INCB54828), Incyte’s selective FGFR1/2/3 inhibitor, in patients with cholangiocarcinoma (Press release, Incyte, SEP 11, 2018, View Source [SID1234529610]). The initial CDx, which will include detection of activating FGFR2 translocations, is expected to be incorporated into FoundationOneCDx, Foundation Medicine’s FDA-approved comprehensive genomic profiling (CGP) assay and broad CDx platform.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"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 patients," said Steven Stein, M.D., Chief Medical Officer, Incyte. "Incyte is evaluating pemigatinib in patients with cholangiocarcinoma as part of the FIGHT clinical development program; initial data have been accepted for presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) meeting in Munich this October."
"We’re committed to helping our biopharma partners bring biomarker-driven therapies to cancer patients. Partnerships with innovative biopharma companies, such as Incyte, who leverage our FDA-approved platform to help accelerate companion diagnostics development, are essential to achieving this mission," said Melanie Nallicheri, Chief Business Officer and Head of Biopharma at Foundation Medicine. "We’re proud to partner with Incyte to advance development of a potential new precision oncology treatment option for cholangiocarcinoma."
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.