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Updated: Jul 14, 2026

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New Intravesical Agents for BCG-Unresponsive High-Risk Non-Muscle Invasive Bladder Cancer

Anastasios D Asimakopoulos1, Maxim Kochergin2, Gaia Colalillo1

  • 1Urology Unit, Fondazione PTV Policlinico Tor Vergata, Rome, Italy.

Bladder Cancer (Amsterdam, Netherlands)
|July 12, 2024
PubMed
Abstract

Insights

Novel intravesical therapies show promise for BCG-unresponsive bladder cancer. Nadofaragene firadenovec and other agents offer new salvage treatment options for high-risk non-muscle invasive bladder cancer (NMIBC).

Area of Science:

  • Urology
  • Oncology
  • Pharmacology

Background:

  • High-risk non-muscle invasive bladder cancer (NMIBC) lacks standard second-line treatments beyond valrubicin and pembrolizumab.
  • Bacillus Calmette-Guérin (BCG) unresponsive NMIBC presents a significant unmet clinical need for effective salvage therapies.

Purpose of the Study:

  • To systematically review novel intravesical therapeutic agents for the salvage treatment of BCG-unresponsive NMIBC.
  • To evaluate the efficacy, durability, survival outcomes, and toxicity profiles of these emerging treatments.

Main Methods:

  • A comprehensive literature search was conducted across PubMed, EMBASE, and Web of Science databases.
  • Efficacy endpoints included complete response rates (CR), durability of CR, overall survival, recurrence-free survival, and cancer-specific survival.
  • Clinicaltrials.gov was searched to identify ongoing investigations.

Main Results:

  • Intravesical gene therapy, particularly nadofaragene firadenovec, shows potential as a significant advancement for high-risk NMIBC.
  • Combination therapy with N-803/BCG and innovative drug delivery systems are also yielding promising results.
  • 14 studies were included, highlighting the active development in this field.

Conclusions:

  • New intravesical agents and treatment strategies for BCG-unresponsive NMIBC are expected to become available soon.
  • Urologists will need to select the optimal agent based on individual patient profiles, considering safety, efficacy, and cost-effectiveness.
Keywords:
BCGbladder cancerbladder instillationsintravesical instillationsnon-muscle invasive bladder cancer

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