SOUTH SAN FRANCISCO (dpa-AFX) - Basilea Pharmaceutica Ltd. (BPMUF.PK) said that interim results from the phase 1b part of the ongoing phase 1/2 study on advanced urothelial cancer supported the safety of derazantinib in combination with atezolizumab, and the ability to combine the two treatments at full standard doses is particularly encouraging.
The Independent Data Monitoring Committee for the study determined that derazantinib and atezolizumab can be safely combined at doses of 300 mg of daily oral derazantinib and 1200 mg atezolizumab, administered intravenously once every three weeks. The analysis was conducted for 26 patients who received increasing doses of derazantinib and atezolizumab.
The study, dubbed FIDES-02, is evaluating its fibroblast growth factor receptor (FGFR) inhibitor, derazantinib, as single agent and in combination with Roche's PD-L1 checkpoint inhibitor, atezolizumab, in patients with advanced urothelial cancer and FGFR genetic aberrations.
The Recommended Phase 2 Dose (RP2D) for the combination has been determined and phase 2 expansion substudies are open for enrolment, Basilea said in a statement.
The phase 2 substudies include patients with FGFR-positive advanced urothelial cancer being treated with just derazantinib or in combination with atezolizumab as first-line therapy, or after progression on prior FGFR-inhibitor therapy.
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