Data support safe reinduction of nadofaragene firadenovec in NMIBC

In this video, Bogdana Schmidt, MD, MPH, an assistant professor of urology at the University of Utah Huntsman Cancer Institute in Salt Lake City, discusses a retrospective study examining the outcomes of reinduction therapy with nadofaragene firadenovec (Adstiladrin), the first FDA-approved intravesical gene therapy for non–muscle invasive bladder cancer (NMIBC). The initial clinical trials for this therapy had strict criteria—patients who failed to achieve a complete response after 1 induction course (3 monthly doses) were removed from the study without a chance for reinduction. However, real-world clinical experience suggested that some patients might benefit from additional dosing, similar to what has been observed with BCG therapy and other investigational agents such as nogapendekin alfa inbakicept-pmln (Anktiva) and cretostimogene grenadenorepvec.

Schmidt and colleagues retrospectively analyzed 17 patients across 8 clinical sites who underwent reinduction after not achieving or maintaining a complete response to nadofaragene firadenovec. The cohort included 13 patients with carcinoma in situ (CIS ± papillary disease) and 4 with papillary-only disease. Results showed that 38% of CIS patients responded to reinduction, whereas 75% of those with papillary-only disease achieved a response. Across all patients, the 6-month high-grade recurrence-free survival rate was 53%, with a median recurrence-free interval of 97 days.

Importantly, safety outcomes were favorable: cystectomy-free survival was 94%, overall survival was 100%, and only 1 patient progressed to muscle-invasive disease. No cases of metastatic progression were reported.

Schmidt emphasized that, despite the small sample size and short follow-up period, these findings provide meaningful real-world data supporting the feasibility and safety of reinduction with nadofaragene firadenovec. The results may help clinicians counsel patients who relapse or show incomplete response, potentially allowing for bladder preservation and delaying cystectomy while evaluating additional treatment options.