Unequal Access to Novel Systemic Therapies for Bladder Cancer: A Global Analysis of Clinical Trials of Immune Checkpoint Inhibitors and Antibody-Drug Conjugates.

PURPOSE OF REVIEW: This narrative review evaluates ongoing clinical trials investigating immune checkpoint inhibitors (ICIs) and antibody–drug conjugates (ADCs) for bladder cancer (BC), with a focus on the global distribution of trial activity and equitable access to participation. We examined whether populations in low- and middle-income countries (LMICs) are proportionally represented in these studies and summarized the most frequently studied agents and emerging combination strategies. The search and inclusion of clinical trials were conducted up to October 2025. RECENT FINDINGS: Pembrolizumab and Enfortumab Vedotin (EV) are the most extensively investigated agents in ongoing BC trials. Pembrolizumab is being evaluated as monotherapy and in combination regimens, with late-phase studies demonstrating improvements in overall survival (OS), progression-free survival (PFS), and disease-free survival (DFS). EV has shown high response rates, particularly among patients with prior treatment failure, and is increasingly studied in combination with checkpoint blockade. However, the majority of these trials are conducted in high-income countries, limiting global access and raising concerns regarding applicability across diverse healthcare settings. These trends reflect a shift toward personalized and targeted therapeutic approaches in advanced BC. ICIs and ADCs have emerged as promising therapeutic strategies for BC, with pembrolizumab and EV demonstrating particular potential. Yet, current clinical trial activity remains heavily concentrated in high-income regions, underscoring a need for expanded research infrastructure and enrollment capacity in LMICs. Broader geographic inclusion and continued evaluation of combination regimens may enhance global relevance and improve equitable access to emerging treatments.