The Canadian journal of urology · 2025
Safety of nadofaragene firadenovec-vncg: review of data from phase 2 and phase 3 studies.
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Konety Badrinath R, Lotan Yair, Myers Amanda
Аннотация
INTRODUCTION: Non-muscle-invasive bladder cancer (NMIBC) is a common malignancy worldwide. While Bacillus Calmette-Guérin (BCG) is standard of care for treatment for most patients with high-risk NMIBC, many will either not respond to BCG initially or will eventually develop BCG-unresponsive disease. A treatment option in BCG-unresponsive disease is nadofaragene firadenovec-vncg (Adstiladrin), a nonreplicating adenoviral vector-based gene therapy approved by the US Food and Drug Administration (FDA) for the treatment of adults with high-risk BCG-unresponsive NMIBC with carcinoma in situ with or without papillary tumors.
OBJECTIVE: To review safety outcomes of participants who received the FDA-approved dose of nadofaragene firadenovec (3 × 1011 vp/mL) across phase 2 (NCT01687244) and phase 3 (NCT02773849) studies.
METHODS: Data from the phase 2 and phase 3 studies were collected and analyzed. The findings were reported using descriptive statistics to summarize the key outcomes observed across studies.
RESULTS: Common adverse events (AEs) among nadofaragene firadenovec recipients were leakage of fluid around the urinary catheter, fatigue, bladder spasm, chills, dysuria, and micturition urgency. Most study drug-related AEs were mild and localized, with no grade 4 or 5 study drug-related AEs observed in either study. Study drug-related AEs were generally transient, with most study drug-related AEs having a median duration of ≤2.0 days in the phase 3 study. Discontinuation rates due to study drug-related AEs were low, with none (0%) in the phase 2 study and three (1.9%) in the phase 3 study. No specific postmarketing surveillance was required by the FDA besides routine pharmacovigilance monitoring; no new real-world safety signals have been observed.
CONCLUSION: Nadofaragene firadenovec demonstrated a favorable and tolerable safety profile across its clinical study program, allowing for broad patient selection among those with high-risk BCG-unresponsive NMIBC.
OBJECTIVE: To review safety outcomes of participants who received the FDA-approved dose of nadofaragene firadenovec (3 × 1011 vp/mL) across phase 2 (NCT01687244) and phase 3 (NCT02773849) studies.
METHODS: Data from the phase 2 and phase 3 studies were collected and analyzed. The findings were reported using descriptive statistics to summarize the key outcomes observed across studies.
RESULTS: Common adverse events (AEs) among nadofaragene firadenovec recipients were leakage of fluid around the urinary catheter, fatigue, bladder spasm, chills, dysuria, and micturition urgency. Most study drug-related AEs were mild and localized, with no grade 4 or 5 study drug-related AEs observed in either study. Study drug-related AEs were generally transient, with most study drug-related AEs having a median duration of ≤2.0 days in the phase 3 study. Discontinuation rates due to study drug-related AEs were low, with none (0%) in the phase 2 study and three (1.9%) in the phase 3 study. No specific postmarketing surveillance was required by the FDA besides routine pharmacovigilance monitoring; no new real-world safety signals have been observed.
CONCLUSION: Nadofaragene firadenovec demonstrated a favorable and tolerable safety profile across its clinical study program, allowing for broad patient selection among those with high-risk BCG-unresponsive NMIBC.