Study
| Phase 3, randomized trial, multicenter ttrial ( THOR) |
| 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%) |
N Engl J Med October 21, 2023
Erdafitinib or Chemotherapy in Advanced or Metastatic Urothelial Carcinoma
http://doi.org/10.1056/NEJMoa2308849
Reviewed by Elvin Chalabiyev, MD on Nov 20, 2023
