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Dr Narayan on Long-Term Results With Nadofaragene Firadenovec in NMIBC

Vikram M. Narayan, MD, discusses the final 5-year analysis of a phase 3 trial of nadofaragene firadenovec in patients with BCG-unresponsive NMIBC.

Vikram M. Narayan, MD, assistant professor, Department of Urology, Emory University School of Medicine, Winship Cancer Institute; director, Urologic Oncology, Grady Memorial Hospital, discusses results from the final 5-year analysis of a phase 3 trial (NCT02773849) investigating nadofaragene firadenovec-vncg (Adstiladrin) in patients with BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC).

These 5-year follow-up data are important because they represent the longest follow-up to date of any intravesical gene therapy, a novel class of drugs for the treatment of patients with BCG-unresponsive NMIBC, Narayan says. Regarding safety, investigators observed no new safety signals at 5 years of follow-up, and only 2% of patients discontinued nadofaragene firadenovec because of an adverse effect (AE), Narayan explains. Furthermore, no grade 4 or 5 treatment-related AEs were noted, Narayan emphasizes.

Regarding efficacy, among the patients with carcinoma in situ (CIS) who achieved a complete response (CR) at 3 months, 10.9% remained high-grade recurrence free (HGRF) at 57 months. Among the patients with only high-grade Ta/T1 disease who were HGRF at 3 months, 20.0% maintained their CR at 57 months. A total of 25% of patients with CIS and 49% of those with Ta/T1 disease had an ongoing response. This was defined as the absence of disease recurrence at their last disease assessment, although some patients were lost to follow-up, Narayan adds.

Regarding the bladder preservation rates observed in this study, Narayan provides the caveat that bladder preservation often cannot be attributed to 1 specific cause and that many patients in the study who progressed on nadofaragene firadenovec could have received subsequent treatments that helped to preserve their bladder. However, among the patients with CIS, 43.2% (95% CI, 32.3%-53.7%) had a cystectomy-free survival (CFS) at month 60. Moreover, the 60-month CFS rate was 76.3% (95% CI, 64.6%-84.5%) among patients with only high-grade Ta/T1 disease. The 5-year follow-up data from this study indicate that nadofaragene firadenovec is a safe alternative to cystectomy, which is welcome news for patients, Narayan concludes.

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