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Non-muscle invasive bladder cancer (NMIBC) represents 75% of bladder cancer. It commonly recurs and may progress to muscle invasive (MIBC). BCG immunotherapy is an adjuvant treatment recommended in intermediate and high-risk NMIBC.
Treatment failure with intravesical BCG immunotherapy is defined as any high-grade recurrence during or after BCG treatment.
BCG-unresponsive is defined as all BCG-refractory (recurrence during BCG treatment) and some BCG-relapsing (recurrence after completion of treatment) papillary recurrence after 6 months and for Cis recurrence after 12 months.
BCG-unresponsive bladder cancer is unlikely to respond to further BCG treatment: therefore BCG is not useful.
Radical cystectomy is the standard and preferred treatment option; however, it is associated with significant morbidity and mortality. Therefore, many patients are unwilling or unable to undergo the procedure.
Until 2020, valrubicin was the only drug approved by the FDA, with disappointing results on its trial.
Pembrolizumab was approved by the FDA in 2020 based on KEYNOTE 057 results, making it the second drug approved in this setting.
Many other treatments, such as sequential intravesical gemcitabine and docetaxel instillations, hyperthermic intravesical chemotherapy, radiofrequency-induced thermo-chemotherapy effect (RITE), intravesical nadofaragene firadenovec gene therapy, oportuzumab monatox have been studied on this setting. These last two treatments are the most promising and are awaiting FDA review for approval.
