Data from a phase 3 trial indicates that nadofaragene firadenovec-vncg offers a significant benefit for patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC), potentially reducing the need for radical cystectomy. The study, presented at the Society of Urologic Oncology 25th Annual Meeting, followed patients for up to 60 months.
Key Findings on Cystectomy Outcomes
According to Dr. Vikram M. Narayan, assistant professor of urology at Emory University, approximately two-thirds of patients who achieved a complete response at 3 months following nadofaragene firadenovec treatment remained cystectomy-free at the 60-month mark. This suggests a durable response and a significant chance of avoiding surgical removal of the bladder in this patient population.
Among the patients who eventually underwent cystectomy, pathological data revealed that only a small fraction (6 out of 37) had progressed to muscle-invasive bladder cancer. "That's a key take-home as well, because of interest is how many of these patients progress," Dr. Narayan noted. While any progression to muscle-invasive disease is concerning, the low number suggests that nadofaragene firadenovec may play a role in delaying or preventing progression in some patients.
Nadofaragene Firadenovec in NMIBC Treatment
The original phase 3 study, published in Lancet Oncology, led to FDA approval of nadofaragene firadenovec for BCG-unresponsive NMIBC. This analysis focused on understanding the outcomes of patients from that trial who ultimately required cystectomy, their characteristics, and the final pathological data.
"Overall, the take-home message is that in patients with BCG-unresponsive non–muscle-invasive bladder cancer, you can consider nadofaragene as an option among those that are available for treating these patients," Dr. Narayan concluded. The findings support the use of nadofaragene firadenovec as a valuable treatment option in the management of this challenging disease.
