FGFR-altered metastatic urothelial carcinoma whose disease progressed after one or two previous treatments that included an anti–PD-1 or anti–PD-L1 agent
Erdafitinib (n=136) vs. SOC (Docetaxel; Vinflunine) (n=130)
Efficacy
mPFS: 5.6 vs. 2.7 mos, HR:0.58, p<0.001
mOS: 12.1 vs. 7.8 mos, HR:0.64, p=0.005
ORR: 45.6% vs. 11.5%
Safety
Grade3: Palmar–plantar erythrodysesthesia syndrome (9.6% vs.0), stomatitis (8.1% vs. 1.8%), anemia (7.4% vs. 8.0%), hyperphosphatemia (5.25 vs. 0), neutropenia (0 vs. 14.3%)