On June 23, 2016 ArQule, Inc. (Nasdaq:ARQL) reported that preliminary data from the ongoing phase 2 portion of a phase 1/2 trial in intrahepatic cholangiocarcinoma (iCCA) with our proprietary fibroblast growth factor receptor (FGFR) inhibitor, ARQ 087, will be presented on June 30, 2016 at the ESMO (Free ESMO Whitepaper) 18th World Congress on Gastrointestinal Cancer in Barcelona, Spain (Press release, ArQule, JUN 23, 2016, View Source [SID:1234513506]). This is a biomarker driven trial designed to enroll at least 20 patients in iCCA with FGFR2 genetic alterations. The company has been granted orphan drug designation by the U.S. Food and Drug Administration and European Medicine’s Agency for ARQ 087 in this indication.
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!
Presentation Details
Abstract Number: 340 (PD #19)
Poster Title: ARQ 087, an Oral Pan-Fibroblast Growth Factor Receptor (FGFR) Inhibitor, in Patients with Advanced and/or Metastatic Intrahepatic Cholangiocarcinoma (iCCA)
Poster Discussion Time: June 30, 2016 from 11:00 a.m. to 11:30 a.m. CEST
Poster Presentation Time: June 30, 2016 from 5:10 p.m. to 5:40 p.m. CEST
Location: Exhibit Hall
About Intrahepatic Cholangiocarcinoma
Cholangiocarcinoma (CCA) is the most common biliary malignancy and the second most common hepatic malignancy after hepatocellular carcinoma (HCC)1. Depending on the anatomic location, CCA is classified as intrahepatic (iCCA), perihilar (pCCA), and extrahepatic (eCCA). iCCA originates from the intrahepatic biliary ductal system and forms an intrahepatic mass. The average age adjusted incidence rate for iCCA is approximately one in 100,000 per year in the United States and Europe2,3.
About FGFR and ARQ 087
ARQ 087 is a multi-kinase inhibitor designed to preferentially inhibit the fibroblast growth factor receptor ("FGFR") family with demonstrated efficacy in FGFR2 genetic alterations. The FGFR pathway is disrupted in several ways in human cancer, thus providing numerous therapeutic targets for an inhibitor of this pathway. ARQ 087 has demonstrated in vivo inhibition of tumor growth and downstream signaling in tumors whose growth is driven by FGFR targets.
Signals of single agent activity with this drug were observed in phase 1a testing. Phase 1b expansion cohorts with ARQ 087 include patients with cholangiocarcinoma and adrenocortical tumors, as well as those with FGFR translocations, amplifications and mutations. Clinical development of ARQ 087 has advanced into phase 2 for intrahepatic cholangiocarcinoma (iCCA) following the observation of two confirmed responses in this patient population in the phase 1 portion of the program.