Ferring Showcases New Real-World Evidence on ADSTILADRIN® at the 101st Western Section AUA Annual Meeting
Napa, CA — October 29, 2025 — Ferring Pharmaceuticals today announced that three abstracts highlighting new real-world data for ADSTILADRIN® (nadofaragene firadenovec-vncg) will be presented at the 101st Annual Meeting of the Western Section of the American Urological Association (AUA), taking place from November 2–6 in Napa, California. These presentations underscore Ferring’s continued commitment to advancing treatment options for patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC).
ADSTILADRIN is the first and only intravesical non-replicating gene therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with high-risk BCG-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumors (±Ta/T1). This innovative therapy represents a major advancement in uro-oncology by providing a non-chemotherapy, bladder-preserving option for patients who historically have faced limited alternatives following BCG failure.
Advancing Real-World Understanding of ADSTILADRIN
At the upcoming meeting, Ferring will sponsor and support three distinct studies designed to provide a deeper understanding of ADSTILADRIN’s use and outcomes in routine clinical practice. Together, these studies will explore the therapy’s performance in diverse patient populations, real-world treatment patterns, and potential benefits for patients who undergo treatment re-induction.
The centerpiece of Ferring’s data presentation is the ABLE (ADSTILADRIN in BLadder CancEr)-41 study, a Phase 4, multicenter, non-interventional real-world trial. This ongoing study collects and analyzes data from patients receiving ADSTILADRIN under routine care conditions. Researchers will present baseline characteristics and demographic data from the initial patient cohort enrolled in ABLE-41, providing early insight into the types of patients receiving ADSTILADRIN in everyday clinical settings.
Unlike traditional controlled clinical trials, which often have strict inclusion and exclusion criteria, the ABLE-41 study captures real-world experiences from a broader and more diverse patient population—including individuals with comorbidities or clinical profiles that might not fit neatly within earlier trial parameters. This design allows for a more comprehensive understanding of how ADSTILADRIN performs across various clinical contexts and may help guide treatment decisions for urologists treating BCG-unresponsive NMIBC.
Independent Studies Explore Real-World Outcomes and Re-Induction
In addition to ABLE-41, two independent investigator-initiated studies will be featured at the conference.
The first real-world analysis examined electronic billing records from 19 U.S. medical centers, encompassing 101 patients who had received ADSTILADRIN. This study aimed to evaluate treatment durability, defined as how long patients remain on ADSTILADRIN without progressing to radical cystectomy—the surgical removal of the bladder, which remains the standard treatment for many high-risk NMIBC cases after BCG failure. Preliminary findings from this analysis suggest encouraging patterns of continued ADSTILADRIN use and potential delays in progression to more invasive surgical interventions, reinforcing the therapy’s role as a meaningful bladder-sparing option.
A second abstract focuses on a case series of 17 patients across eight academic and community treatment centers, exploring outcomes associated with re-induction using ADSTILADRIN. Re-induction refers to repeating the treatment after an initial course if a patient experiences recurrence or disease persistence. These findings, recently published in The Journal of Urology, provide valuable insights into how clinicians are incorporating ADSTILADRIN into ongoing care strategies, including how re-induction may extend therapeutic benefits for certain patients.
Expert Perspectives on the Expanding Role of ADSTILADRIN
“Real-world evidence provides an essential complement to clinical trial data by showing how therapies perform in day-to-day clinical use,” said Sia Daneshmand, MD, Professor of Urology and Medicine (Oncology) and Director of Urologic Oncology at the Keck School of Medicine of the University of Southern California. “The ABLE-41 study will expand our understanding of ADSTILADRIN by capturing insights from a wider range of patients, offering valuable data that can help refine treatment strategies for those living with BCG-unresponsive NMIBC.”
Dr. Daneshmand, a leading expert in uro-oncology, emphasized the importance of broadening the evidence base for therapies like ADSTILADRIN beyond the confines of controlled trials. “We know that not all patients seen in clinical practice look like those in clinical trials,” he said. “Studies like ABLE-41 provide the opportunity to understand how ADSTILADRIN works in the real world—across diverse patient populations and clinical environments—helping us make more informed, individualized care decisions.”
Daniel A. Shoskes, MD, FRCS(C), Vice President and Global Medical Director of Uro-Oncology at Ferring Pharmaceuticals, highlighted the company’s dedication to supporting ongoing innovation and data generation in NMIBC.
“ADSTILADRIN represents an important therapeutic option for uro-oncologists, offering an effective, convenient, and office-administered therapy with a quarterly dosing schedule,” said Dr. Shoskes. “It provides a non-chemotherapy alternative to radical cystectomy for patients who no longer respond to BCG.”
He added, “We are excited to see the expanding body of evidence that reinforces ADSTILADRIN’s clinical value and informs best practices. The research being presented at the Western Section AUA meeting—particularly the data on treatment re-induction—adds meaningful new insights to our understanding of how to optimize care for NMIBC patients.”
Transforming the Treatment Landscape for NMIBC
Non-muscle invasive bladder cancer represents approximately 75–80% of all newly diagnosed bladder cancer cases. Among these, high-risk NMIBC—especially in patients who do not respond to BCG therapy—presents a persistent therapeutic challenge. For many years, radical cystectomy has remained the primary curative option for BCG-unresponsive disease, yet it is an invasive procedure associated with significant morbidity and impacts on quality of life.
ADSTILADRIN’s approval introduced a first-of-its-kind gene therapy that delivers a copy of the interferon alfa-2b gene directly into the bladder wall using a non-replicating adenovirus vector. This promotes local production of the therapeutic protein, stimulating an anti-tumor immune response within the bladder. The result is a targeted, durable approach that spares patients from systemic toxicity and major surgery.
Through real-world studies such as ABLE-41 and others presented at this year’s AUA meeting, Ferring continues to expand the clinical understanding of how ADSTILADRIN is used and performs across practice settings. These efforts reinforce the company’s commitment to improving outcomes and quality of life for patients facing high-risk NMIBC.
