Nadofaragene Firadenovec Is Effective With Beneficial Dosing Schedule in Real-World for BCG-Unresponsive NMIBC onclive.com
GROK3 Summary of PR: Nadofaragene Firadenovec Shows Real-World Effectiveness in BCG-Unresponsive NMIBC
Key Findings from the Study
Efficacy: A real-world study by Mayo Clinic researchers demonstrated that nadofaragene firadenovec is effective for BCG-unresponsive NMIBC. At a median follow-up of 8.2 months:
Cystectomy-free survival was 95%, and all patients remained alive.
For patients with carcinoma in situ (CIS), 79% achieved a complete response at 3 months, with high-grade recurrence-free survival rates of 74% at 6 months and 60% at 9 months.
In the papillary-only cohort, recurrence-free survival was 68% at 3 months, 57% at 6 months, and 40% at 9 months.
Safety: The drug was well-tolerated, with most adverse effects being low-grade, transient, and local (e.g., bladder spasms, micturition urgency). Only 9% of patients had grade 3 adverse events (e.g., fatigue, fever, dizziness), aligning with prior phase 3 trial data.
Dosing Schedule: The treatment’s once-every-90-days administration was noted as a significant advantage, especially for patients traveling long distances.
Implications for Patients and Healthcare Providers
Patient Selection: The study underscored the need for careful patient selection to exclude those prone to drug leakage due to bladder spasms or poor bladder compliance, recommending pretreatment with antispasmodics (e.g., rectal diazepam).
Off-Label Use: While approved for BCG-unresponsive NMIBC with CIS, the drug is used off-label for high-grade papillary-only disease (e.g., Ta), though caution is advised for higher-risk cases (e.g., T1 disease).
Competition: Nadofaragene firadenovec competes with nogapendekin alfa inbakicept (Anktiva), which has a higher complete response rate (62% vs. 51%). However, its convenient dosing and real-world results make it a compelling option.
Conclusion
The real-world study confirms nadofaragene firadenovec’s efficacy and safety, solidifying its role as a valuable treatment for BCG-unresponsive NMIBC. Its favorable dosing schedule and tolerability enhance its appeal, though optimal patient selection and cost considerations are key. These findings support its continued use and further research to refine its clinical application.
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