New immunotherapies for high-risk non-muscle invasive bladder cancer: Current state and future perspectives

C Gómez Del Cañizo1, M Rodríguez-Izquierdo Jiménez1, E Peña Vallejo1

  • 1Unidad de Uro-Oncología, Servicio de Urología, Hospital Universitario 12 de Octubre, Madrid, España.

Abstract

Insights

Checkpoint inhibitors show promise as a new treatment for non-muscle invasive bladder tumors (NMIBT) when standard Bacillus Calmette-Guerin (BCG) therapy fails. Further research is ongoing to explore their efficacy in BCG-untreated patients.

Area of Science:

  • Uro-oncology
  • Immunotherapy

Background:

  • Standard treatment for high-risk non-muscle invasive bladder tumors (NMIBT) involves transurethral resection and Bacillus Calmette-Guerin (BCG) instillations.
  • Limited response rates and the need for novel therapeutic strategies highlight the importance of exploring new treatments for NMIBT.
  • The success of checkpoint inhibitors in advanced cancers has spurred interest in their application for NMIBT.

Purpose of the Study:

  • To review the current landscape of checkpoint inhibitors in the treatment of non-muscle invasive bladder tumors (NMIBT).
  • To assess the preliminary efficacy and ongoing research of checkpoint inhibitors in BCG-untreated and BCG-refractory NMIBT patients.

Main Methods:

  • A literature search was conducted on PubMed using keywords «bladder cancer» and «check point inhibitors».
  • Clinical trials were identified using clinicaltrials.gov and clinicaltrialsregister.eu.

Main Results:

  • Fifteen ongoing clinical trials are investigating checkpoint inhibitors in BCG non-responder NMIBT patients, with two trials (Keynote 057 and SWOG S1605) showing promising preliminary results with pembrolizumab and atezolizumab, respectively.
  • Pembrolizumab received FDA approval in January 2020 for specific NMIBT cases based on positive trial outcomes.
  • Five trials are currently evaluating checkpoint inhibitors in BCG-untreated NMIBT patients, though results are pending. Intravesical administration is also being explored.

Conclusions:

  • Checkpoint inhibitors represent a significant new therapeutic avenue for NMIBT patients, particularly those who do not respond to BCG therapy.
  • These agents are anticipated to play a future role in the treatment of BCG-untreated NMIBT.
  • Urologist education on these novel agents and the establishment of multidisciplinary teams are essential for optimal patient management and selection of the best therapeutic options.

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