Ferring Advances Clinical Trials for ADSTILADRIN in Bladder and Upper Tract Urothelial Cancers

Ferring Pharmaceuticals has announced significant progress in its nadofaragene firadenovec-vncg (ADSTILADRIN) clinical trial program, expanding its potential applications in bladder cancer and beyond. Nadofaragene, the first FDA-approved gene therapy for high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC), is now the focus of multiple new trials.

The company has activated sites for three major studies:

1. ABLE-22 Trial: A phase 2 study assessing nadofaragene as a monotherapy and in combination with chemotherapy or immune checkpoint inhibitors for high-risk BCG-unresponsive NMIBC.
2. ABLE-32 Trial: A phase 3B trial exploring the safety and efficacy of nadofaragene in intermediate-risk NMIBC, a condition with no current FDA-approved treatments.
3. LUNAR Study: A phase 1/2 trial investigating nadofaragene in low-grade upper tract urothelial cancer (UTUC), evaluating its safety, tolerability, and efficacy in this unique setting.

At the upcoming Society of Urologic Oncology (SUO) 25th Annual Meeting, researchers will present the protocol for the ABLE-32 trial and five-year data from the pivotal phase 3 study, demonstrating clinically meaningful cystectomy-free survival in high-risk BCG-unresponsive NMIBC patients achieving a complete response at three months.

Nadofaragene’s innovative mechanism leverages gene therapy to deliver interferon alfa-2b directly to bladder wall cells, turning them into “interferon microfactories.” This localized approach aims to enhance the body’s natural defenses while sparing patients from radical surgery.

Ferring’s expansion into intermediate-risk NMIBC and UTUC underscores its commitment to addressing unmet needs across the urothelial cancer spectrum. By prioritizing data collection on reinduction strategies for patients with incomplete initial responses, the company is exploring new ways to maximize treatment outcomes and bladder preservation.