[{"orgOrder":0,"company":"Basilea Pharmaceutica","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Basilea announces clinical supply agreement for its planned study FIDES-03 with derazantinib in gastric cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"January 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Basilea Pharmaceutica","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Basilea Announces Completion of Patient Enrolment into First Cohort of Phase 2 Study FIDES-01 With Derazantinib","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 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Urothelial Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Basilea Pharmaceutica","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Basilea Presents Preclinical Data on Anti-Angiogenic Activity of Derazantinib at ENA 2020","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Basilea Pharmaceutica","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Basilea Reports +Ve Topline Results from P2 Study FIDES-01 for Derazantinib in FGFR2 Gene Fusion +ve Patients with Bile Duct Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Basilea Pharmaceutica","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Basilea Reports Derazantinib\/PD-L1 Checkpoint Inhibitor Combination Results from Dose-Finding part of FIDES-02 Study in Solid Tumors","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Basilea Pharmaceutica","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Basilea Presents Full Safety and Efficacy Data Set on Derazantinib in Patients with Fgfr2 Fusion-Positive iCCA at ESMO Congress","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Basilea Pharmaceutica","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Basilea Presents Preclinical Data on Synergy Between Derazantinib and Paclitaxel in Gastric Tumor Models At ANE Conference","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Basilea Pharmaceutica","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Basilea Reports Updated Interim Results for iCCA patients with FGFR2 Mutations and Amplifications from phase 2 study FIDES-01 at ASCO GI Cancers Symposium","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"}]
Find Clinical Drug Pipeline Developments & Deals for Derazantinib
BAL087 (derazantinib), an orally administered small-molecule FGFR inhibitor has demonstrated clinically meaningful efficacy with 74% disease control rate and median progression-free survival was 7.3 months in FIDES-01 study in patients iCCA.
The synergistic effect between derazantinib and paclitaxel is particularly encouraging as we are exploring derazantinib alone and in combination settings, including paclitaxel, in our clinical phase 1/2 study FIDES-03 in patients with gastric cancer.
Derazantinib is investigational orally administered small-molecule FGFR inhibitor with strong activity against FGFR1, 2, and 3. FIDES-01 study evaluated derazantinib, in patients with FGFR2 fusion-positive advanced or metastatic intrahepatic cholangiocarcinoma.
The derazantinib-atezolizumab combination was well tolerated and no dose-limiting toxicities were observed. Finding from the cohort in the FIDES-02 study were presented at the virtual American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU 2021).
Clinical proof of concept achieved for derazantinib monotherapy in FGFR2 gene fusion-positive iCCA. Derazantinib has shown a well manageable safety profile.
The FIDES-03 study will assess the efficacy and safety of derazantinib as monotherapy and combination therapy with ramucirumab and paclitaxel or with Roche’s PD-L1 checkpoint inhibitor atezolizumab.
The presented data from several preclinical models demonstrate that derazantinib has an anti-angiogenic effect, which may contribute to its overall anti-tumor activity in FGFR-driven cancers.
Successful completion of phase 1b part of FIDES-02 exploring the safety and tolerability of combining derazantinib with PD-L1 checkpoint inhibitor atezolizumab.
FGFR inhibitors, including derazantinib, have showed clinical antitumor activity in patients with FGFR2 gene fusion-positive iCCA. To date there is limited clinical evidence for the benefit of FGFR inhibitors in iCCA patients with FGFR2 gene mutations and amplifications.
The preclinical derazantinib data may provide an explanation for differences in reported adverse event profiles between various FGFR kinase inhibitors. Furthermore, derazantinib shows promising efficacy in patient-derived tumor models with gene aberrations in FGFR1-3.
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