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Intravesical Nadofaragene Firadenovec in Non–Muscle Invasive Bladder Cancer

By: Kayci Reyer
Posted: Tuesday, January 26, 2021

According to results of a single-arm, open-label repeat-dose phase III study published in The Lancet Oncology, intravesical nadofaragene firadenovec, also known as rAd-IFNa/Syn3, may be a safe and effective gene therapy for some patients with high-risk non–muscle invasive bladder cancer. Stephen A. Boorjian, MD, of the Mayo Clinic, and colleagues evaluated the effects of the replication-deficient recombinant adenovirus in patients who had previously been unresponsive to Bacillus Calmette-Guérin (BCG) immunotherapy.

Moreover, intravesical nadofaragene firadenovec treatment has a favorable dosing schedule (one intravesical treatment once every 3 months) that can be managed easily by both patient and clinician,” the authors noted.

The study assessed 198 patients between September 2016 and May 2019, initially accepting 157 patients before excluding 6 who did not meet the definition of BCG-unresponsive non–muscle invasive bladder cancer. The remaining 151 patients received 75 mL of intravesical nadofaragene firadenovec (3 × 1011 viral particles per mL). Patients who did not experience a high-grade recurrence received additional doses at 3, 6, and 9 months following the initial dose.

Among the 103 patients with carcinoma in situ, regardless of high-grade Ta or T1 tumor status, 55 patients (53.4%) achieved a complete response within 3 months of receiving the initial dose. Almost half of those patients (45.5%; n = 25) maintained a complete response at a follow-up of 12 months.

The most common grade 3 or 4 treatment-related adverse event was micturition urgency, occurring in two patients. No deaths related to treatment occurred.

“Future research should include analyses to help to identify early treatment responders and provide insights into the potential mechanisms of treatment nonresponse,” the authors proposed.

Disclosure: For full disclosures of the study authors, visit thelancet.com.



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