On October 28, 2025 Ferring Pharmaceuticals reported that three abstracts featuring ADSTILADRIN (nadofaragene firadenovec-vncg) will be presented at the 101st Annual Meeting of the Western Section of the American Urological Association (AUA) being held November 2-6 in Napa, CA. ADSTILADRIN is the first and only intravesical non-replicating gene therapy approved by the U.S. Food and Drug Administration (FDA) for patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors (±Ta/T1).
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A Ferring-sponsored study will present baseline characteristics and demographics from the initial patient cohort enrolled in ABLE (ADSTILADRIN in BLadder CancEr)-41, a Phase 4 multicenter non-interventional study examining the use of ADSTILADRIN in a real-world setting. In addition, two independent real-world studies will be presented. This includes a study analyzing electronic billing records for 101 patients from 19 U.S. medical centers who received ADSTILADRIN and is exploring durability of remaining on ADSTILADRIN, and lack of progression to radical cystectomy. A third abstract is a case series evaluating re-induction with ADSTILADRIN among 17 patients across 8 academic and community settings, the findings of which were published recently in The Journal of Urology.
"Real-world evidence provides an important view of how a treatment like ADSTILADRIN is being used in routine practice," said Sia Daneshmand, MD, Professor of Urology and Medicine (Oncology) and Director of Urologic Oncology at Keck School of Medicine of University of Southern California. "The ABLE-41 study will add to this evidence by capturing early insights from a broader, more diverse patient population than prior trials, helping us understand patient experiences and inform care for those with BCG-unresponsive NMIBC."
"ADSTILADRIN is an important option for uro-oncologists, offering an effective and convenient quarterly dosing schedule administered in the urologist’s office, and a non-chemotherapy alternative to radical cystectomy," said Daniel A. Shoskes, MD, FRCS(C), Vice President, Global Medical Director- Uro-Oncology, Ferring Pharmaceuticals. "The ongoing research exploring the real-world use of ADSTILADRIN adds to the body of evidence in NMIBC patients who no longer respond to BCG. I am thrilled that this research is also exploring treatment re-induction, helping to build on the strong foundation of our Phase 3 program and further inform care for NMIBC patients."
About ADSTILADRIN Presentations at the Western Section AUA
ADSTILADRIN poster titles and presentation times at 101st Annual Meeting of the Western Section AUA, November 2-6, 2025, are:
ABLE-41, a real-world evidence study for bladder cancer patients treated with nadofaragene firadenovec: baseline patient characteristics and demographics. Abstract #257 (Poster #23), November 2, 2025, 7:00-9:00 a.m. PST
Real-world utilization of ADSTILADRIN in patients with BCG-unresponsive non-muscle invasive bladder cancer. Abstract #242 (Poster #18), November 2, 2025, 7:00-9:00 a.m. PST
Re-induction with nadofaragene firadenovec for BCG-unresponsive NMIBC: real-world data from a multicenter cohort. Abstract #301 (Poster #11), November 2, 2025, 7:00-9:00 a.m. PST
About ABLE-41
ABLE-41 is a non-interventional study following NMIBC patients aged 18 years or older who are being treated with ADSTILADRIN in a clinical setting and had not previously received this therapy in a clinical trial. In September 2023, Ferring announced the first patient enrolled in ABLE-41. Eligible patients include those who were prescribed and scheduled to receive treatment, per their physician’s discretion, or patients who received their first instillation (per physician discretion) after September 5, 2023, but before the site was activated in the trial.
The primary objective is to assess whether patients achieve a complete response (CR) at three months and/or at any time within a year of their first instillation.
Participants in ABLE-41 will be followed for 24 months, or until study discontinuation or withdrawal. Key secondary outcomes include the following: treatment patterns of use; duration of CR; recurrence-free survival, cystectomy-free survival, progression-free survival, overall survival, and bladder cancer–specific mortality; patient, caregiver, and physician experiences; adjunctive use of molecular markers; and safety. Patient experiences will be assessed with a commonly used quality of life questionnaire (EuroQol 5 Dimension 5 Level), measuring mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Caregiver experiences will be measured with the Work Productivity and Activity Impairment questionnaire, adapted for caregiving, which assesses the impact of health problems on paid and unpaid work.
Results from this prospective, multi-institutional study are expected at the end of 2026. Learn more at www.clinicaltrials.gov/study/NCT06026332.
About ADSTILADRIN
ADSTILADRIN (nadofaragene firadenovec-vncg) is the first and only FDA-approved intravesical non-replicating gene-therapy for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. It is a non-replicating adenovirus vector-based therapy containing the gene interferon alfa-2b, administered locally as a monotherapy by catheter directly into the bladder once every three months. The vector enters the cells of the bladder wall, releasing the active gene and causing the bladder’s cell walls to secrete high and transient local expression of interferon alfa-2b protein, a naturally occurring protein the body uses to fight cancer. This approach essentially turns the bladder wall cells into interferon microfactories, enhancing the body’s own natural defenses against the cancer.
ADSTILADRIN has been studied in a clinical trial program that includes 157 patients with high-risk, BCG-unresponsive NMIBC who had been treated with adequate BCG previously and did not see benefit from additional BCG treatment (full inclusion criteria published on clinicaltrials.gov: NCT02773849 and final five-year follow-up analysis published in The Journal of Urology).
(Press release, Ferring Pharmaceuticals, OCT 28, 2025, View Source [SID1234657086])