Real-world data support durable benefit of nadofaragene in NMIBC

In this interview, Gabriela M. Diáz, MD, a research assistant at Cleveland Clinic in Cleveland, Ohio, discusses a real-world study evaluating the use of nadofaragene firadenovec (Adstiladrin) in patients with BCG-unresponsive non–muscle invasive bladder cancer (NMIBC).

Investigators examined 108 patients to characterize treatment patterns, durability of response, and the need for subsequent therapies following nadofaragene. The cohort was predominantly male and White, and the most common treatment administered after nadofaragene was transurethral resection of the bladder tumor (TURBT), typically occurring around 85 days later. Although most patients did not require further intervention, those who did showed varied patterns, reinforcing the need to better understand long-term management strategies.

A key finding was that 86% of patients required no additional therapy after receiving nadofaragene. Diáz suggests that both biological and clinical factors likely contribute to this durability. Evidence from prior long-term follow-up studies indicates that patients with papillary disease tend to achieve higher complete response rates and longer recurrence-free survival than those with carcinoma in situ, implying that tumor phenotype and underlying disease biology may influence sustained responsiveness.

The study also identified a subset of patients who underwent cyclical treatment—receiving nadofaragene, then TURBT, then nadofaragene again. Diáz interprets this pattern as potentially reflecting effective and practical retreatment in real-world practice, though she notes that residual clinical uncertainty still exists around how best to manage recurrences.

When comparing these findings with pivotal clinical trials, Diáz reports that the real-world results appear broadly consistent, demonstrating meaningful durability and indications of successful retreatment, albeit with more limited follow-up in this analysis. Notably, no patients in the cohort underwent radical cystectomy within the roughly 12-month observation period, suggesting that nadofaragene may delay—but not necessarily eliminate—the need for surgery.

Looking ahead, Diáz said she envisions nadofaragene fitting into NMIBC management through combination or sequencing strategies alongside emerging gene and immunotherapies, while emphasizing the ongoing need for research to determine its optimal long-term role.