New Reference: Erdafitinib for Cisplatin-Ineligible FGFR-Altered Metastatic Urothelial Carcinoma

Erdafitinib alone and in combination with cetrelimab demonstrated significant antitumor activity among cisplatin-ineligible patients with metastatic FGFR-altered urothelial carcinoma. The safety profile was consistent with previous findings with manageable adverse events, and there was no additive toxicity observed with the combination treatment.

Study

Phase II noncomparative study [NORSE]

Cisplatin-ineligible patients with metastatic FGFR-altered urothelial carcinoma

Erdafitinib 8 mg (n=43) vs Erdafitinib 8 mg + Cetrelimab (n=44)

Efficacy

ORR: 44.2% vs 54.5%

mDOR: 9.7 mos vs 11.1 mos

mOS: 16.2 mos vs 20.8 mos

mPFS: 5.6 mos vs 11.0 mos

Safety

Grade >=3 AE: stomatitis (16.3% vs 9.1%), hyperphosphatemia (7.0% vs 0%), palmar-plantar erythrodysesthesia syndrome (2.3% vs 6.8%)

Drug-related deaths: 0% vs 2.3% (respiratory failure related to cetrelimab)

J Clin Oncol. Published online January 15, 2026

Loriot Y, Powles T, Moreno V Erdafitinib or Erdafitinib Plus Cetrelimab for Patients With Metastatic Urothelial Carcinoma and FGFR Alterations: Final Results From the Phase II NORSE Study

http://doi.org/10.1200/JCO-25-00826

Reviewed by Ulas D. Bayraktar, MD on Jan 21, 2026

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