ABLE-32: A randomized, controlled, phase 3b clinical trial of nadofaragene firadenovec-vncg versus observation in patients with intermediate-risk non–muscle-invasive bladder cancer.

• DOI: 10.1200/jco.2025.43.5_suppl.tps888
• Publication Date: 2025-02-18T14:32:56Z
• Authors: Neal D. Shore; Rian J. Dickstein; Mark Tyson; Vikram M. Narayan; Gautum Agarwal; Evan R. Goldfischer; Michael Brandon W...; Corine Baayen; Kristian Juul; Per Sandstrom; Trinity Bivalacqua

TPS888 Background: There is currently no Food and Drug Administration (FDA)-approved treatment for intermediate-risk non–muscle-invasive bladder cancer (IR NMIBC), defined by the AUA as recurrence of low-grade (LG) Ta within 1 year, solitary LG >3 cm, multifocal Ta, high-grade (HG) (≤3 cm), and/or T1. Nadofaragene firadenovec-vncg first FDA-approved intravesical nonreplicating gene therapy adult patients with high-risk Bacillus Calmette Guérin (BCG)-unresponsive NMIBC carcinoma in situ (CIS) or without papillary tumors. In a nonrandomized, multicenter, open-label, repeat-dose, phase 3 study, 53.4% participants (55/103) CIS ± HG Ta/T1 achieved complete response months after instillation. firadenovec was well tolerated, grade 4/5 study drug-related AEs. Because maintenance nadofaragene following tumor resection may improve clinical outcomes IR NMIBC, ABLE-32 open-label randomized being conducted to evaluate efficacy administered every versus observation NMIBC. Methods: This includes approximately 100 global sites 454 anticipated participants. Adults diagnosed new recurrent having undergone transurethral 60 days prior randomization are eligible. Participants will be randomly assigned 1:1 receive continue observation. The group quarterly doses unless disease recurs progresses. followed if 24 months. All evaluated progression using cytology, cystoscopy, for-cause biopsy up 5 years. primary endpoint recurrence-free survival (RFS), from documented recurrence, progression, death. Secondary endpoints include RFS at 12 safety. Exploratory effect on potential biomarkers health-related quality life. Final results expected 2031. Clinical trial information: NCT06510374 .