Non-muscle-invasive bladder cancer (NMIBC), also known as superficial bladder cancer, is the most common form of bladder cancer, comprising roughly 75% of all newly diagnosed bladder cancer in the USA and includes carcinoma in situ (CIS), Ta and T1 lesions. Together Ta and T1 lesions are termed papillary cancers.
Non-muscle-invasive bladder cancer types have a low metastatic potential. They are resected and treated with adjuvant intravesical therapy. BC-819 is an experimental intravesical therapy.
Muscle-invasive bladder cancers that are diagnosed de novo or originate from the progression of NMIBC signify a greater risk of metastatic disease and are treated with complete bladder resection. Prevention of progression is a key goal.
BC-819 is designed to be included in early treatment for patients diagnosed with NMIBC. The treatment is being tested in two settings: in patients who have been treated with BCG and for whom a single course of treatment has failed; and in patients who have been treated with BCG and for whom two courses of treatment have failed. Disease in the latter population is termed BCG-unresponsive, and there are no standard approaches to therapy for this group. The intravesical approach is well suited for BC-819 treatment, with instillation into the bladder allowing direct contact of high drug concentration without systemic exposure.