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Immune checkpoint inhibitors in urothelial carcinoma: a practical framework for patient selection, toxicity

Abdul Rahman Al Armashi1, Jenny Gong1, Pedro Barata1

  • 1Seidman Cancer Center, University Hospitals Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, USA.

Expert Review of Anticancer Therapy
|February 9, 2026
PubMed
Abstract

Insights

Immune checkpoint inhibitors for urothelial carcinoma face implementation challenges, limited biomarkers, and toxicity issues. Optimizing immunotherapy requires better management of adverse events, response assessment, and equitable access to care.

Area of Science:

  • Oncology
  • Immunotherapy
  • Urothelial Carcinoma

Background:

  • Immune checkpoint inhibitors (ICIs) are crucial for urothelial carcinoma but present significant implementation challenges.
  • Limited utility of predictive biomarkers like programmed death-ligand 1 (PD-L1) and tumor mutational burden (TMB) complicates treatment selection.
  • Treatment discontinuation due to toxicity and difficulties in assessing clinical responses remain problematic.

Purpose of the Study:

  • To provide a comprehensive overview of current challenges and future directions in managing urothelial carcinoma with ICIs.
  • To integrate evidence from clinical trials, systematic reviews, and health-system evaluations from 2016 to 2025.
  • To offer expert opinions on optimizing immunotherapy care delivery and patient outcomes.

Main Methods:

  • Systematic review of clinical trials, health-system evaluations, and guidelines (2016-2025).
  • Analysis of limitations in predictive biomarkers (PD-L1, TMB) and response criteria (iRECIST).
  • Evaluation of toxicity management, pseudoprogression, hyperprogression, and post-ICI sequencing strategies.

Main Results:

  • Identified limitations in PD-L1 expression and TMB utility.
  • Detailed challenges in managing immune-related adverse events and interpreting clinical responses (pseudoprogression, hyperprogression).
  • Highlighted the need for improved delivery models, including navigation, patient-reported outcomes, and telemedicine.

Conclusions:

  • Optimizing immunotherapy requires robust frameworks for managing adverse events, standardizing response assessments, and ensuring equitable access.
  • Emerging technologies like ctDNA and AI-assisted radiomics show promise but need further validation.
  • Systemic improvements are essential for effective and accessible urothelial carcinoma treatment with ICIs.
Keywords:
Biomarkersglobal equityimmune checkpoint inhibitorsmanagement algorithmsreal-world evidencetoxicity predictionurothelial carcinoma

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