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Non-muscle invasive bladder cancer (NMIBC) accounts for 70–75% of all bladder cancers and is a heterogeneous disease characterized by a wide spectrum of recurrences and progression. Adjuvant treatment for intermediate- and high-risk NMIBC is mainly represented by Bacillus Calmette Guerin (BCG). However, 20%–40% of patients develop disease recurrences or persistence following BCG treatment and are classified as “BCG unresponsive’ (BCGu), thus representing a therapeutic challenge due to their worse prognosis and unavailability of effective intravesical treatments. We provide an overview of completed and ongoing clinical trials assessing the role of innovative immunological and target agents in patients with BCGu and BCG naive (BCGn) NMIBCs. New treatment options are emerging, demonstrating promising clinical activity, namely, pembrolizumab, atezolizumab, oportuzumab monatox, nadofaragene firadenovec, and N-803. The increasing number of newer therapeutic agents for patients with NMIBC poses challenges regarding the choice of the most suited treatment option for each patient and the best treatment sequence, given their diverse mechanisms of action and varying degrees of activity. Tailored treatment approaches are advocated, based on a deeper comprehension of disease features, available therapies, patient’s characteristics, and consequently, on the identification and validation of prognostic and predictive biomarkers.

Emerging treatment landscape of non-muscle invasive bladder cancer