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Thomas Flaig, MD


Ongoing Trial to Evaluate Erdafitinib in FGFR3-Mutated Non–Muscle-Invasive Bladder Cancer

By: Kayci Reyer
Posted: Tuesday, August 1, 2023

A look into an ongoing phase II trial investigating the safety and efficacy of targeted erdafitinib, an FGFR1-4 inhibitor treatment, for patients with recurrent non–muscle-invasive bladder cancer was presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract TPS4614). The window-of-opportunity trial seeks to determine the treatment’s impact on intermediate- and high-risk FGFR3-altered disease after intravesical therapy.

“This trial is being conducted in parallel with a co-clinical trial of patient-derived organoid/xenograft models…to further refine the understanding of FGFR3 mutational resistance to standard treatment and the effects of targeted immunotherapy on tumor clinicogenomics,” noted Eugene J. Pietzak, MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues.

The study is enrolling patients who have received at least one prior induction course of bacillus Calmette-Guérin (BCG) and/or intravesical chemotherapy. Eligible patients demonstrate clinically staged Ta papillary recurrence and harbor an FGFR3 mutation or fusion. Between office cystoscopy and transurethral resection of the recurrent bladder tumor, patients will receive 6 mg of daily oral erdafinitib for 28 days.

Two trial stages are planned, with estimated enrollments of 16 patients in the first stage and 9 patients in the second stage. The primary outcome is the rate of objective response; safety, patient-reported outcomes, and recurrence-free survival will also be evaluated.

Disclosure: For full disclosures of the study authors, visit

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