Basilea reports pooled efficacy data for derazantinib in iCCA patients with FGFR2 gene mutations and amplifications presented at ESMO MAP Virtual Congress 2020
Basel, Switzerland, October 12, 2020
Basilea Pharmaceutica Ltd. (SIX: BSLN) today reported that its fibroblast growth factor receptor (FGFR) inhibitor, derazantinib, demonstrated antitumor efficacy in intrahepatic cholangiocarcinoma (iCCA) patients with FGFR2 gene mutations or amplifications. The analysis was presented at the Molecular Analysis for Precision Oncology (MAP) Virtual Congress 2020, organized by the European Society for Medical Oncology (ESMO), which took place from 9-10 October, 2020. It is based on pooled data from 23 patients treated with derazantinib in two clinical studies1, 2 as well as from the early access3 and compassionate use programs.
The median progression free survival was 7.2 months and patients received treatment for a median of 8.2 months. This is consistent with results previously reported for derazantinib-treated iCCA patients with FGFR2 gene fusions.4, 5 Derazantinib showed a manageable safety profile with a low incidence of nail toxicity, retinal events, hand-foot syndrome and stomatitis (inflammation of the mouth).
Dr. Marc Engelhardt, Chief Medical Officer, said: “Our development strategy for derazantinib is focused on strengthening the clinical evidence on its differentiation versus other FGFR inhibitors based on its unique kinase inhibition spectrum and safety and tolerability profile. FGFR inhibitors, including derazantinib, have demonstrated clinical antitumor activity in patients with FGFR2 gene fusion-positive iCCA. However, to date there is limited clinical evidence for the benefit of FGFR inhibitors in iCCA patients with FGFR2 gene mutations and amplifications. The data presented at the MAP congress show that derazantinib is active in this group of patients and underscore the broad therapeutic potential of derazantinib in FGFR2-positive iCCA.“
ICCA is a cancer originating from the biliary system. Patients are often diagnosed with advanced or metastatic disease, that cannot be surgically removed and the prognosis for these patients is poor.
Apart from iCCA, Basilea is also exploring derazantinib in two phase 1/2 studies, as monotherapy and in combinations with other cancer treatments, in patients with advanced urothelial cancer (FIDES-02), or advanced gastric cancer (FIDES-03), with FGFR genetic aberrations.
For further information, please visit www.esmo.org/meetings/map-virtual-2020/programme/u>
Derazantinib is an investigational orally administered small-molecule FGFR inhibitor with strong activity against FGFR1, 2, and 3.6 FGFR kinases are key drivers of cell proliferation, differentiation and migration. FGFR genetic aberrations, e.g. gene fusions, mutations or amplifications, have been identified as potentially important therapeutic targets for various cancers, including intrahepatic cholangiocarcinoma (iCCA), urothelial, breast, gastric and lung cancers.7 In these cancers, FGFR genetic aberrations are found in a range of 5% to 30%.8
Basilea Pharmaceutica Ltd. is a commercial-stage biopharmaceutical company, focused on the development of products that address the medical challenges in the therapeutic areas of oncology and infectious diseases. With two commercialized drugs, the company is committed to discovering, developing and commercializing innovative pharmaceutical products to meet the medical needs of patients with serious and life-threatening conditions. Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland and listed on the SIX Swiss Exchange (SIX: BSLN). Additional information can be found at Basilea's website www.basilea.com.
This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd. and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. Derazantinib and its uses are investigational and have not been approved by a regulatory authority for any use. Efficacy and safety have not been established. The information presented should not be construed as a recommendation for use. The relevance of findings in nonclinical/preclinical studies to humans is currently being evaluated.
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