Ferring Adds Three New Studies to Non-Muscle Invasive Bladder Cancer Clinical Trial Program With ADSTILADRIN (nadofaragene firadenovec-vncg) - Seite 2

The ADSTILADRIN clinical trial program includes two additional studies, the first being ABLE–41, a U.S. Real-World Evidence (RWE) Study announced in September 2023 and the second being a bridging study in Japan. The ABLE-22, ABLE-32 and ABLE-42 clinical trials announced today are yet another milestone for this comprehensive research program.

Additional ongoing studies in the ADSTILADRIN clinical trial program include:

• ABLE-41 (NCT06026332): An ongoing, non-interventional RWE study following NMIBC patients aged 18 years or older with high-risk, BCG-unresponsive NMIBC who are being treated with ADSTILADRIN in a clinical setting and had not previously received this therapy in a clinical trial. The study is exploring early utilization, experiences, and outcomes of ADSTILADRIN in the routine care setting in these patients. The first patient was enrolled in September 2023.

• Japan Phase 3B Study (000381): Single arm bridging study of high grade, BCG-unresponsive NMIBC patients.

Healthcare providers in the U.S. can learn more about the ADSTILADRIN clinical trial program by calling 1-888-FERRING (888-337-7464) and selecting option number one or emailing [e-mail].

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 quantities 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-grade, 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).¹

About Non-Muscle Invasive Bladder Cancer (NMIBC)

NMIBC is a form of bladder cancer which is present in the superficial layer of the bladder and has not invaded deeper into the bladder or spread to other parts of the body.² In the United States, bladder cancer is the seventh most common cancer, fourth among men^3-4, and it is estimated that there will be approximately 83,190 new cases of bladder cancer in the U.S. in 2024.⁵ Historically, 75% of bladder cancer presents as NMIBC.⁶ In patients with high-risk NMIBC, intravesical BCG remains the first-line standard-of-care. However, more than 50% of patients who receive initial treatment with BCG will experience disease recurrence and progression within one year, with many developing BCG-unresponsive disease.⁵ Current treatment options for BCG-unresponsive patients are very limited, and National Comprehensive Cancer Network (NCCN) guidelines recommend cystectomy (partial or complete removal of the bladder).⁷