Adstiladrin Now Available for High-Risk, Non-Muscle-Invasive Bladder Cancer – Renal and Urology News

Adstiladrin^® (nadofaragene firadenovec-vncg) is now available for the treatment of adults with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. 

Adstiladrin is a nonreplicating adenoviral vector-based gene therapy that delivers a copy of a gene encoding a human interferon-alfa 2b (IFNα2b) to the bladder urothelium. The treatment, which is administered by intravesical instillation once every 3 months, is expected to produce anti-tumor effects as a result of cell transduction and transient local expression of the IFNα2b protein.

The efficacy and safety of Adstiladrin was based on data from an open-label, multicenter, single-arm phase 3 trial (ClinicalTrials.gov Identifier: NCT02773849), which included 103 adults with BCG-unresponsive, high-risk, NMIBC with CIS with or without papillary tumors following transurethral resection. Results showed a complete response rate of 51% (95% CI, 41-61). Median duration of response was 9.7 months (range, 3 to 52+ months), and 46% of responders continued to remain free of high-grade recurrence at 12 months.

The most common adverse reactions reported were increased glucose, instillation site discharge, increased triglycerides, fatigue, bladder spasm, micturition, increased creatinine, hematuria, decreased phosphate, chills, pyrexia, and dysuria.

Adstiladrin is supplied in a carton containing 4 vials. All vials contain a nominal concentration of 3 x 10¹¹ viral particles per mL, and each vial contains an extractable volume of no less than 20mL. The treatment is administered by intravesical instillation and should be retained in the bladder for 1 hour before voiding.

To evaluate early utilization and outcomes with Adstiladrin in a real world setting, Ferring has initiated the non-interventional ABLE-41 study (ClinicalTrials.gov Identifier: NCT06026332).

This article originally appeared on MPR