Erdafitinib may show clinical activity in urothelial cancer with FGFR alterations


Former treatment strategies for urothelial cancer is confined to surgery and chemotherapy. Though several immune checkpoint inhibitors have been approved in this cancer type recently, these treatments remain relatively ineffective. Therefore, additional treatment options are necessary. FGFR alterations account for about 20-30 % of the urothelial cancer patients, but no approved FGFR inhibitors exists for urothelial cancer. Therefore, researchers conducted a phase II study to assess the efficacy and safety of erdafitinib, a pan-FGFR inhibitor, in urothelial cancer patients with FGFR2/FGFR3 mutations or fusions who experienced treatment failure after standard chemotherapy. The results showed that the objective response rate (ORR) was 42% on continuous dosing of 8mg/day with dosage up titrated to 9mg/day by day 14 if patients did not undergo treatment-related adverse effect (TRAEs). Among responders, those who experience complete response is 5% and partial response is 37%. The safety profile showed that the most common grade ≧3 TRAEs were stomatitis, asthenia and diarrhea. These findings indicate that erdafitinib may be effective in urothelial cancer patients with FGFR alterations for future use.



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