biostudies-literatureUnknown13(2)Szabados BEPatients with high-risk non-muscle invasive bladder cancer (NMIBC) are generally treated with transurethral resection of the bladder tumor followed by intravesical bacillus Calmette-Guérin (BCG), the current standard of care. However, recurrence or progression is common and may result in patients requiring radical cystectomy. Additionally, BCG continues to be in short supply worldwide. Therefore, there is an unmet need for new therapies that provide durable disease control and maintain quality of life. In the BCG-naïve high-risk NMIBC setting, potential new treatment options are emerging, with several regimens combining intravesical therapy with systemic PD-1 or PD-L1-directed immune checkpoint inhibitors (ICIs) currently under investigation in several Phase 3 trials. In routine clinical pOncology and therapy275-291https://www.ebi.ac.uk/biostudies/studies/S-EPMC12130421biostudies-literatureOn the Horizon: A Global Multidisciplinary Perspective on Delivering Emerging Therapies for Patients with BCG-Naive High-Risk NMIBC.PMC12130421Shore NDGrande EStrumeier SKulkarni GSSutton JGrivas PSzabados BETodenhofer TGrunwald VBrinkmann JTeresi REHussain SASridhar SSWilson ALGuerrero-Ramos FHoyt MMiguel MCfalseOn the Horizon: A Global Multidisciplinary Perspective on Delivering Emerging Therapies for Patients with BCG-Naive High-Risk NMIBC.Patients with high-risk non-muscle invasive bladder cancer (NMIBC) are generally treated with transurethral resection of the bladder tumor followed by intravesical bacillus Calmette-Guérin (BCG), the current standard of care. However, recurrence or progression is common and may result in patients requiring radical cystectomy. Additionally, BCG continues to be in short supply worldwide. Therefore, there is an unmet need for new therapies that provide durable disease control and maintain quality of life. In the BCG-naïve high-risk NMIBC setting, potential new treatment options are emerging, with several regimens combining intravesical therapy with systemic PD-1 or PD-L1-directed immune checkpoint inhibitors (ICIs) currently under investigation in several Phase 3 trials. In routine clinical p2025-01-01T00:00:00Z2025 Jun2026-06-02T01:08:59.56Z2026-05-24T03:07:40.251ZS-EPMC121304214024679510.1007/s40487-025-00334-6