Phase 2 Study of the Efficacy and Safety of Erdafitinib in Patients With Bacillus Calmette-Guérin (BCG)-Unresponsive, High-Risk Non–Muscle-Invasive Bladder Cancer (HR-NMIBC) With FGFR3/2 Alterations (alt) in THOR-2: Cohort 2 Interim Analysis Results

Abstract

Patients presenting with NMIBC carcinoma in situ (CIS) have a high risk of progression1,2FGFR inhibition may benefit patients with CIS with FGFRalt who are unresponsive to fi rst-line BCG, for whom treatment options, other than radical cystectomy, are limited3-5– Data are limited in patients with CIS only, but in the broader NMIBC population the prevalence of FGFR3alt is up to 80%6Erdafi tinib, an oral selective pan-FGFR tyrosine kinase inhibitor, is approved for locally advanced or metastatic urothelial cancer in adults with susceptible FGFR3/2alt who have progressed during or after ≥1 line of platinum-containing chemotherapy7-9 THOR-2 (NCT04172675) is a multicohort phase 2 study of erdafi tinib in patients with HR-NMIBC.