- Independent experience at three Mayo Clinic sites and real-world outcomes data with ADSTILADRIN in patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) to be presented at ASCO GU 2025
- Protocols for two ongoing studies from the ADSTILADRIN in BLadder CancEr (ABLE) clinical trial program to be presented at ASCO GU 2025
- Real-world data and ABLE clinical trial program highlight potentially practice-changing evidence and Ferring’s ongoing commitment to advance the standard of care in BCG-unresponsive NMIBC
Reno, Nevada (UroToday.com) -- Ferring Pharmaceuticals announced three abstracts featuring ADSTILADRIN® (nadofaragene firadenovec-vncg) will be presented at the 2025 American Society of Clinical Oncologists Genitourinary Cancers (ASCO GU) Symposium held February 13-15 in San Francisco. 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).
Mayo Clinic will present additional updated early results in a poster presentation of an independent, retrospective real-world outcomes study conducted at three of their sites. The study is evaluating complete response rates, high-grade recurrence-free survival, cystectomy-free survival, overall survival, and adverse events among patients treated with ADSTILADRIN for high-risk BCG-unresponsive NMIBC.
“Understanding real-world outcomes in patients with BCG-unresponsive NMIBC is essential for informing how we approach treatment and deliver care,” said Mark D. Tyson, M.D., urologic oncologist and associate professor, Mayo Clinic, Scottsdale, Ariz., and principal investigator of this independent study. “These initial encouraging post-marketing results provide valuable insights into the benefits of using ADSTILADRIN in everyday clinical practice, allowing providers to make more informed decisions and deliver the best possible care for patients.”Additional abstracts to be presented include the study protocols for two studies in the ABLE (ADSTILADRIN in BLadder CancEr) clinical trial program – the three-arm ABLE-22 study and the two-arm ABLE-32 study. Clinical sites were recently activated for both studies which are investigating the efficacy and safety of ADSTILADRIN in high-risk and intermediate-risk NMIBC.
“These real-world data extend the body of evidence for efficacy, safety, and low treatment burden of ADSTILADRIN in NMIBC patients who no longer respond to BCG, building on the positive five-year results from our pivotal Phase 3 trial announced last year,” said Bipin Dalmia, Global Head of Uro-Oncology & Urology Franchise, Ferring Pharmaceuticals. “As the first and only FDA approved intravesical bladder-sparing monotherapy for BCG-unresponsive NMIBC patients, ADSTILADRIN is fully available throughout the United States, offering a convenient quarterly dosing schedule that may help encourage treatment adherence. The continuation of our clinical trial program further highlights our commitment to advancing the science in our journey to establish ADSTILADRIN as the new standard of care and backbone therapy across the urothelial cancer disease spectrum.”
About ADSTILADRIN Presentations at ASCO GU
ADSTILADRIN poster titles and presentation times at ASCO GU, February 13-15, 2025, are:
- Real-world outcomes of nadofaragene firadenovec in BCG-unresponsive non-muscle invasive bladder cancer. Abstract #716 (Poster #D13), Friday, February 14, 11:30 a.m. PST
- ABLE-22: Safety and efficacy evaluation of nadofaragene firadenovec alone or in combination with chemotherapy or immunotherapy—a randomized, open-label, phase 2 study. Abstract #TPS891 (Poster #J19), Friday, February 14, 11:30 a.m. PST
- 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. Abstract #TPS888 (Poster #J16), Friday, February 14, 11:30 a.m. PST