Multinational phase 3 trial of erdafitinib versus chemotherapy for metastatic urothelial carcinoma after progression on anti-PD-(L)1

Erdafitinib is a pan-FGFR inhibitor approved for the treatment of metastatic urothelial carcinoma (mUC) in adults with susceptible FGFR3/2 alterations who have progression after platinum-containing chemotherapy. The multinational phase 3 THOR Cohort 1 trial compared erdafitinib versus chemotherapy for mUC with susceptible FGFR3/2 alterations with progression after one or two previous treatments that included anti-PD-(L)1. The primary end point was overall survival. The median overall survival was significantly longer with erdafitinib than with chemotherapy 12.1 months versus 7.8 months; HR 0.64; p=0.005), as was the progression-free survival (5.6 months versus 2.7 months; HR 0.58; p<0.001). Treatment related adverse events that led to death were less common with erdafitinib than with chemotherapy (0.7% versus 5.4% of patients).