Vikram M Narayan, Stephen A Boorjian, Mehrdad Alemozaffar, Badrinath R Konety, Neal D Shore, Leonard G Gomella, Ashish M Kamat, Trinity J Bivalacqua, Jeffrey S Montgomery, Seth P Lerner, Joseph E Busby, Michael Poch, Paul L Crispen, Gary D Steinberg, Anne K Schuckman, Tracy M Downs, Joseph Mashni, Brian R Lane, Gennady Bratslavsky, Lawrence I Karsh, Michael E Woods, Gordon Brown, Daniel Canter, Adam Luchey, Yair Lotan, Brant A Inman, Michael B Williams, Michael S Cookson, Sam S Chang, Alexander I Sankin, Michael A O'Donnell, David Sawutz, Richard Philipson, Nigel R Parker, Seppo Yla-Herttuala, Dorte Rehm, Jørn S Jakobsen, Kristian Juul, Colin P N Dinney
BACKGROUND: Nadofaragene firadenovec-vncg is a non-replicating adenoviral vector-based gene therapy for BCG-unresponsive carcinoma in situ (CIS) with/without HG Ta/T1). We report outcomes following 5 years of planned follow-up. METHODS: This open-label phase 3 trial (NCT02773849) enrolled patients with BCG-unresponsive NMIBC in 2 cohorts: CIS ± Ta/T1 (CIS; n = 107) and Ta/T1 without CIS (Ta/T1 cohort; n = 50). Patients received 75 mL (3 × 1011 vp/mL) of Nadofaragene firadenovec intravesically once every 3 months with cystoscopy and cytology assessments, with continued treatment offered to those remaining high-grade recurrence free (HGRF)...
May 5, 2024: Journal of Urology