Erdafitinib or Erdafitinib Plus Cetrelimab for Patients With Metastatic Urothelial Carcinoma and FGFR Alterations: Final Results From the Phase II NORSE Study
Abstract
PURPOSE: -altered mUC. METHODS: alterations who are ineligible for cisplatin were randomly assigned 1:1 in a noncomparative design to once-daily erdafitinib 8 mg (with pharmacodynamically guided uptitration to 9 mg) or erdafitinib 8 mg plus intravenous cetrelimab 240 mg once every 2 weeks at cycles 1-4 and 480 mg once every 4 weeks thereafter. Primary end points were investigator-assessed confirmed overall response rate (ORR) and safety; secondary end points included duration of response (DOR), progression-free survival, and overall survival (OS). No statistical hypotheses were tested. RESULTS: At data cutoff, 87 patients were randomly assigned and treated (erdafitinib, n = 43; erdafitinib plus cetrelimab, n = 44). Of 64 patients with PD-L1 expression data, 56 (87.5%) had low levels of PD-L1 expression (combined positive score
Fields of Study & Subjects
Bladder and Urothelial Cancer Treatments
Fibroblast Growth Factor Research
Urinary and Genital Oncology Studies
Publication details
- Journal / source
- Journal of Clinical Oncology
- Publisher
- American Society of Clinical Oncology (ASCO)
- Volume
- 44
- Issue
- 8
- Pages
- 676–684
- Publication date
- 15 January 2026
- Language
- EN