Bladder Cancer Coverage from Every Angle
Advertisement
Advertisement

AUA 2021: Trial Update on Novel Gene-Mediated Therapy for High-Grade Bladder Cancer

By: Kayci Reyer
Posted: Wednesday, September 29, 2021

Findings presented during the 2021 American Urological Association (AUA) Annual Meeting (Abstract MP16-02) suggest that treatment with nadofaragene firadenovec, a novel gene-mediated therapy that causes prolonged expression of IFNα2b, appears to be well tolerated and effective in some patients with bacillus Calmette-Guérin (BCG)-unresponsive, high-grade non–muscle-invasive bladder cancer. Yair Lotan, MD, of The University of Texas Southwestern Medical Center, Dallas, and colleagues evaluated the efficacy, safety, and durability of response at a long-term follow-up of 24 months.

The multicenter, phase III trial included two cohorts of patients with BCG-unresponsive non–muscle-invasive bladder cancer: carcinoma in situ (± Ta/T1) and high-grade Ta/T1 alone. Among the high-grade Ta/T1 cohort, 48 patients were included in the efficacy analysis, and 50 patients were in the safety analysis. All patients received 75 mL of nadofaragene firadenovec once every 3 months for a maximum of four doses before undergoing a five-site biopsy at 12 months. Patients without disease recurrence at that time could continue treatment in 3-month intervals.

At data cutoff in September 2020, 9 of the 48 patients in the efficacy analysis (18.8%) had received 24 months of treatment; 33 continued to be followed and underwent restricted-mean follow-up at 23.5 months. At 3, 12, and 24 months, 35 (72.9%), 21 (43.8%), and 16 (33.3%) patients were high-grade disease recurrence-free, respectively. A total of 16 patients (45.7%) who were disease free at 3 months remained so at 24 months.

Instillation-site discharge was the most common treatment-related adverse event (26%), followed by dysuria (16%), bladder spasm (14%), and micturition urgency (14%). Most adverse events were a maximum of grade 2. One patient discontinued treatment due to an adverse event. One grade 4 adverse event occurred, though it was thought not to be related to treatment, and no adverse events resulting in death were reported.

Disclosure: For full disclosures of the study authors, visit auajournals.org.



By continuing to browse this site you permit us and our partners to place identification cookies on your browser and agree to our use of cookies to identify you for marketing. Read our Privacy Policy to learn more.