A single instillation of a virus carrying the interferon gene into the bladder every three months cleared carcinoma in situ in about half of patients who had failed BCG, and became the first gene therapy approved for bladder cancer.
Single-arm phase 3 study of 157 patients with BCG-unresponsive high-grade non-muscle-invasive bladder cancer treated with intravesical nadofaragene firadenovec, a non-replicating adenovirus vector expressing interferon alfa-2b, every three months.
Among patients with carcinoma in situ, 53.4 percent had a complete response within 12 months and about a quarter remained free of high-grade recurrence at one year. Treatment was well tolerated with mostly transient bladder symptoms.
Bladder-sparing gene therapy is a realistic option for BCG-unresponsive disease, given four times a year in clinic. Durability is limited and cystoscopic follow-up continues.
Shares Nadofaragene firadenovec, Non-muscle-invasive bladder cancer.
Shares Nadofaragene firadenovec, Non-muscle-invasive bladder cancer.
Shares Non-muscle-invasive bladder cancer, The Lancet Oncology.
Shares Nadofaragene firadenovec, Non-muscle-invasive bladder cancer.