Dr Li on Unmet Needs in High-Risk MIBC

Roger Li, MD, genitourinary oncologist, Moffitt Cancer Center, discusses persisting unmet needs and potential avenues of research for patients with high-risk, muscle-invasive bladder cancer (MIBC).

Li begins by explaining that patients with Bacillus Calmette­–Guérin (BCG)–unresponsive, high-risk, non–muscle-invasive bladder cancer (NMIBC) have historically been a difficult population to treat. However, FDA-approved agents have entered this treatment space to give this patient population additional options, he says.

For example, in April 2024, the FDA approved nogapendekin alfa inbakicept-pmln (Anktiva; N-803) in combination with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with carcinoma in situ with or without papillary tumors. As agents such as nogapendekin alfa inbakicept enter the BCG-unresponsive NMIBC space, Li ponders if therapies used in this setting could also have an application for patients with MIBC.

Currently, the standard of care for MIBC centers around surgical removal of the bladder via radical cystectomy combined with pelvic lymph node dissection, Li says. Although this surgical approach is effective, it represents a highly invasive technique that significantly impacts a patient's quality of life due to the removal of the bladder, Li emphasizes. A persisting unmet need in this patient population is the development of efficacious and safe therapeutic regimens that could offer bladder preservation as a viable alternative to surgery, he says.

Li notes the possibility and challenge of adapting these treatments to a more aggressive disease setting such as MIBC; however, he underscores the importance of conducting robust clinical trials to evaluate the efficacy and safety of these regimens in patients with MIBC. Such trials are essential to determine whether these therapies could provide disease control comparable with radical cystectomy and offer potential bladder preservation.

Furthermore, bladder-preserving strategies would represent a significant paradigm shift in the management of MIBC, as such strategies could potentially improve survival outcomes and enhance QOL for patients by avoiding the removal of the bladder, Li concludes.