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Immune checkpoint inhibitors for BCG-resistant NMIBC: the dawn of a new era

Simone Albisinni1, Nieves Martinez Chanza2, Fouad Aoun3,4

  • 1Department of Urology, University Hospital of Brussels, Erasme Hospital, Université Libre de Bruxelles (ULB), Brussels, Belgium - simone.albisinni@erasme.ulb.ac.be.

Minerva Urology and Nephrology
|March 30, 2021
PubMed
Abstract

Insights

Immune checkpoint inhibitors (ICI) show promise for high-risk non-muscle invasive bladder cancer (NMIBC) resistant to BCG therapy. Pembrolizumab is FDA-approved, and other ICI agents are under investigation, potentially revolutionizing NMIBC treatment.

Area of Science:

  • Uro-oncology
  • Immunotherapy
  • Bladder Cancer Treatment

Background:

  • High-risk non-muscle invasive bladder cancer (NMIBC) is a significant clinical challenge due to its recurrence and potential lethality.
  • Current treatment options for BCG-resistant NMIBC are limited, with radical surgery being the primary alternative.
  • Immune checkpoint inhibitors (ICI) are emerging as a potential therapeutic strategy for patients unresponsive to intravesical BCG therapy.

Purpose of the Study:

  • To review current data on the efficacy and safety of immune checkpoint inhibitors (ICI) in BCG-resistant non-muscle invasive bladder cancer (NMIBC).
  • To summarize ongoing clinical trials investigating ICI in the management of BCG-unresponsive NMIBC.

Main Methods:

  • A narrative literature search was conducted using keywords related to immunotherapy, BCG resistance, and bladder cancer.
  • Databases searched included PubMed, Embase, and Web of Science up to November 1, 2020.
  • Ongoing clinical trials were identified through clinicaltrials.gov.

Main Results:

  • Pembrolizumab showed a 40.6% complete response rate in the KEYNOTE-057 trial for BCG-resistant NMIBC.
  • Preliminary data for atezolizumab indicated a 41.1% complete response rate at 3 months in the SWOG S1605 trial.
  • Several other ICI agents (avelumab, nivolumab, durvalumab) are under investigation in various clinical trials, some in combination with radiotherapy or BCG.

Conclusions:

  • Pembrolizumab has gained FDA approval for treating BCG-resistant NMIBC, marking a significant advancement.
  • Multiple other ICI therapies are actively being evaluated in ongoing clinical trials.
  • The results from these trials are highly anticipated and are expected to usher in a new treatment paradigm for BCG-resistant NMIBC.

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