(UroToday.com) At the 2021 American Urologic Association (AUA) annual meeting, the bladder cancer non-invasive session included a presentation by Dr. Sandeep Gurram discussing interim results of a phase 1 trial combining durvalumab and Vicineum in patients with high-grade non-muscle invasive bladder cancer (NMIBC) previously treated with bacillus calmette–guérin (BCG) intravesical therapy. Indeed, radical cystectomy is the gold standard treatment for high-risk NMIBC that fails to respond to intravesical treatment with BCG. However, some patients are unfit or refuse radical cystectomy due to the relatively high complication rates and significant changes in the patient’s lifestyle. Therefore, there is a large unmet need in therapeutic options for NMIBC that recurs or progresses. Vicineum is a recombinant fusion protein comprised of an anti-EpCAM linked to a truncated form of Pseudomonas exotoxin A; of note, 98% of BCG-refractory patients have EpCAM overexpression. Previously the phase III VISTA trial demonstrated efficacy in the BCG failure population with a duration of response in patients with a complete response of 287 days. Dr. Gurram and colleagues presented interim results from the first 12 patients treated thus far with a combination of Vicineum and durvalumab in BCG-unresponsive NMIBC.