ADSTILADRIN for Bladder Cancer
(ABLE-41 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to gather real-world data on the use of Adstiladrin, a treatment for patients in the U.S. and Israel. It focuses on understanding how Adstiladrin is used and its outcomes outside a controlled clinical setting. Patients who have been prescribed Adstiladrin by their doctor recently or have received their first dose after September 5, 2023, are eligible to participate. This trial is non-interventional, meaning it will not alter any treatment plans but will observe current practices and results. As a Phase 4 trial, Adstiladrin has already received FDA approval and proven effective, and this research helps determine how it benefits more patients.
Do I have to stop taking my current medications for the ADSTILADRIN trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your doctor.
What is the safety track record for Adstiladrin?
Research has shown that Adstiladrin (nadofaragene firadenovec-vncg) is generally well-tolerated. In a previous study, only 11% of patients experienced serious side effects, and no deaths were linked to the treatment. Additionally, less than 4% of patients encountered severe side effects. Importantly, long-term safety data over five years revealed no new serious issues. This suggests that Adstiladrin is safe for most people, though some may still experience side effects.12345
Why are researchers enthusiastic about this study treatment?
ADSTILADRIN is unique because it uses a non-replicating adenovirus vector to deliver the interferon alfa-2b gene directly to the bladder's cells. This innovative approach is different from traditional treatments like Bacillus Calmette-Guérin (BCG) or chemotherapy, which generally involve systemic administration and can have significant side effects. Researchers are excited about ADSTILADRIN because it offers a targeted therapy with the potential for fewer side effects and a more direct action against bladder cancer cells, which could lead to improved outcomes for patients.
What evidence suggests that Adstiladrin is effective?
Research has shown that Adstiladrin, the treatment under study in this trial, is effective for high-risk bladder cancer unresponsive to BCG treatment. In one study, 51% of patients had no detectable cancer three months after receiving Adstiladrin. Of those patients, 46% continued to show no signs of cancer. Another study found an 80% overall survival rate and a 49% rate of avoiding bladder removal surgery after five years with Adstiladrin. Real-world data indicated a 95% rate of avoiding bladder removal and a 100% overall survival rate at an average follow-up of 8.2 months. These results suggest that Adstiladrin can effectively manage this type of bladder cancer.34678
Who Is on the Research Team?
Global Clinical Compliance
Principal Investigator
Ferring Pharmaceuticals
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Data Collection
Data collected from patients and prescribing physicians in a real-world setting
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ADSTILADRIN
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ferring Pharmaceuticals
Lead Sponsor
Pierre-Yves Berclaz
Ferring Pharmaceuticals
Chief Medical Officer since 2023
MD from the University of Lausanne, PhD in Molecular Biology from the Cincinnati College of Medicine
Jean-Frédéric Paulsen
Ferring Pharmaceuticals
Chief Executive Officer since 2023
Master’s degree in Finance from the London School of Economics and Political Science
Citations
First Real-World Outcomes Data for ADSTILADRIN® ...
The study is evaluating complete response rates, high-grade recurrence-free survival, cystectomy-free survival, overall survival, and adverse events.
Final Five-Year Analysis of Phase 3 Data ...
The study demonstrated an 80% overall survival rate and 49% cystectomy-free survival rate at Month 60 in adult patients with high-risk, Bacillus Calmette-Gué ...
Efficacy: REAL-WORLD evidence
Real-world results · At a median follow-up of 8.2 months, CFS and OS were 95% and 100%, respectively · 3 patients experienced progression: 1 from Ta to T1, 1 from ...
FDA Approval Summary: Nadofaragene Firadenovec-vncg ...
Fifty subjects experienced CR 3 months after the initial treatment (CR = 51%; 95% confidence interval, 40.7; 61.3%), of whom 46% remained in ...
Efficacy & Clinical Trial Data
View efficacy data from clinical trials of ADSTILADRIN® for treating high-risk BCG-unresponsive non-muscle invasive bladder cancer. See Important Safety Info.
Safety & Side Effects
Serious ARs occurred in 11% of patients who received ADSTILADRIN (nadofaragene firadenovec-vncg) · 0 deaths were reported due to treatment-emergent ARs ...
Package Insert - ADSTILADRIN
The safety of ADSTILADRIN was evaluated in Study CS-003, a multicenter, single-arm, open-label study in 157 U.S. patients [see Clinical Studies (14)] with ...
Nadofaragene Firadenovec-vncg (Adstiladrin)
The safety and efficacy of Adstiladrin was evaluated in an open-label, multicenter, single-arm trial that included 157 patients with high-risk BCG-unresponsive ...
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