On January 9, 2019 ArQule, Inc.’s (Nasdaq: ARQL) partner, Basilea Pharmaceutica Ltd. (SIX: BSLN), reported results from the interim analysis of the registrational Phase 2 study with the orally administered pan-fibroblast growth factor receptor (FGFR) kinase inhibitor derazantinib (BAL087) (Press release, ArQule, JAN 9, 2019, View Source [SID1234532595]). The analysis showed promising activity in patients with FGFR2 gene fusion-expressing intrahepatic cholangiocarcinoma (iCCA) and also confirmed the safety profile and tolerability of the drug candidate observed in previous clinical studies.
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The interim analysis in the ongoing registrational Phase 2 study was conducted after 42 patients had been enrolled in the study, with a subset of 29 evaluable patients who had at least one post-baseline imaging assessment. The objective response rate (ORR) in the 29 evaluable patients was 21%. The disease control rate (DCR), reflecting the proportion of patients with a partial response or with stable disease, was 83%. The safety data obtained from all 42 patients enrolled to date was consistent with the results from previous clinical studies with derazantinib.
Peter Lawrence, President and Chief Operating Officer of ArQule, said, "We are pleased with derazantinib’s continued progress since it was licensed to Basilea Pharmaceutica in April 2018 in the US, EU, Japan and rest of world excluding Greater China. Under the terms of the license agreement, ArQule is eligible to receive up to $326 million in regulatory and commercial milestone payments, and we look forward to further progress and updates from Basilea."