Dr. Stephen A. Boorjian on the safety and tolerability of nadofaragene firadenovec in BCG-unresponsive NMIBC

February 15, 2021
Urology Times staff

“One of the things that distinguishes this treatment is its patient and provider ease of delivery,” says Boorjian.

Stephen A. Boorjian, MD, professor of urology at Mayo Clinic, Rochester, MN, discusses the safety and tolerability of nadofaragene firadenovec in a pivotal phase 3 trial of patients with BCG-unresponsive non-muscle invasive bladder cancer

Efficacy data from the trial showed that nadofaragene firadenovec achieved a complete response (CR) rate of 53.4% at 3 months in a subgroup of patients with carcinoma in situ with or without concomitant high-grade Ta or T1 disease. The 12-month CR rate was 24.3% and the median duration of CR was 9.69 months in these patients.

The safety analysis included all 157 patients enrolled on the trial who received at least 1 dose of nadofaragene firadenovec. The most common grade 3 treatment-related adverse event (TRAE) was micturition urgency, which occurred in 2 patients. There were four other grade 3 TRAEs occurring in 1 patient each: bladder spasm, syncope, hypertension, and urinary incontinence. No grade 4 TRAEs were reported and there were no treatment-related deaths.