Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that it extended its clinical supply agreement (CSA) with Roche (SIX: RO, ROG) to explore a combination of Basilea’s panFGFR kinase inhibitor derazantinib and Roche’s atezolizumab (Tecentriq®) in patients with gastric (stomach) cancer. The initial CSA covered urothelial (bladder) cancer and was concluded in January 2019. Basilea expects to start a biomarker-driven multi-cohort phase 1/2 study (FIDES-03) in advanced gastric cancer patients with FGFR genetic aberrations in the third quarter of 2020. The study will assess the efficacy and safety of derazantinib as mono- and combination therapy in the second-line setting. Basilea will be the sponsor of the study and Roche will provide clinical supply of atezolizumab, a PD-L1 checkpoint inhibitor.
Dr. Marc Engelhardt, Chief Medical Officer of Basilea, said: “The unique kinase inhibition profile of derazantinib and convincing pre-clinical in vivo data in gastric cancer models support this phase 1/2 study with derazantinib alone and as a combination therapy in biomarker-defined groups of patients with advanced gastric cancer. Advanced gastric cancer is associated with a very poor prognosis and is an area of high unmet medical need.”
Gastric cancer is the fifth most common cancer worldwide and the third most lethal cancer type. Median survival rarely exceeds twelve months and the five-year-survival is less than 10%. Basilea estimates that there are approximately 190,000 new cases of gastric cancer per year in total across the EU top 5 countries, Japan and the U.S. FGFR genetic aberrations have been observed in about 10% of gastric cancers.