LBA27 Erdafitinib (ERDA) or ERDA plus cetrelimab (CET) for patients with metastatic or locally advanced urothelial carcinoma (mUC) and Fibroblast Growth Factor Receptor alterations (FGFRa): First phase (Ph) II results from the NORSE study

Abstract

First-line (1L) therapy for cisplatin (cis)-ineligible patients (pts) with mUC includes alternative chemotherapy or anti-PD-(L)1 monotherapy for PD-L1 positive tumors. The pan-FGFR inhibitor ERDA has established clinical benefit in 2L mUC for pts with targetable FGFRa. ERDA combined with the anti-PD-1 CET could expand 1L options for pts with FGFRa. The Ph 1b part of NORSE (NCT03473743) determined a tolerable dose of ERDA + CET in pts with 2L mUC. We report early results from the Ph 2 part of NORSE evaluating ERDA or ERDA + CET in cis-ineligible pts with 1L mUC and FGFRa.