The majority of patients with high-risk non-muscle invasive bladder cancer, or NMIBC, demonstrate an initial response to the most effective therapy currently available: Bacillus Calmette-Guérin, or BCG. The intravesical immunotherapy, in which a weakened bacterium is distributed to the bladder via catheter, has been the treatment of choice for slowing tumor growth since the mid-’80s.
Unfortunately, 40-50% of NMBIC patients experience tumor recurrence or persistence following treatment. In addition, many develop BCG-unresponsive disease, a failure to achieve a disease-free state within six months of initial treatment and maintenance or retreatment three months following treatment.
While radical cystectomy is considered the standard of care for NMIBC patients with BCG-unresponsive disease, the surgery is associated with high complication rates, particularly in populations vulnerable to NMIBC in the first place — smokers and the elderly.
Still, due to the limited efficacy of current FDA-approved alternatives, radical cystectomy remains the best option for many patients. For example, Paul Crispen, M.D., a urologic oncologist and an associate professor at the University of Florida Department of Urology said the one-year cancer-free survival rate for patients treated with the immunotherapy drug pembrolizumab — approved for BCG-unresponsive, high-risk NMIBC in 2020 — is only 19%.
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