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Background <p>Non-muscle-invasive bladder cancer (NMIBC) is characterized by high rates of recurrence and progression, particularly in high-risk disease. Despite transurethral resection and adjuvant intravesical Bacillus Calmette–Guérin (BCG) therapy, a&#xa0;need for more effective bladder-preserving treatment strategies remains.</p> Objective <p>The aim of this review is to describe the current therapeutic landscape of NMIBC and to critically evaluate the evidence for novel treatment approaches, particularly in BCG-naïve high-risk NMIBC and in BCG-refractory tumors, as several novel intravesical and systemic therapies have been approved for these entities in the United States.</p> Methods <p>This review summarizes current guideline recommendations, phase&#xa0;III&#xa0;trials investigating combinations of PD-1/PD-L1 immune checkpoint inhibitors with BCG in BCG-naïve patients, and emerging treatment strategies for BCG-refractory NMIBC.</p> Results <p>In BCG-naïve high-risk NMIBC, phase&#xa0;III&#xa0;trials evaluating durvalumab or sasanlimab in combination with BCG have demonstrated a&#xa0;significant improvement in disease- or event-free survival compared to BCG monotherapy. Regulatory approval in Europe is anticipated. For patients with BCG-refractory disease, several novel intravesical and systemic therapies have been approved in the United States, enabling bladder-preserving treatment approaches. However, approval in Europe appears unlikely, and radical cystectomy is therefore expected to remain the standard of care in this disease setting. In parallel, innovative therapeutic approaches, including gene therapies, oncolytic viruses, and novel drug-delivery systems, are currently under clinical investigation.</p> Conclusion <p>The therapeutic landscape of NMIBC is undergoing rapid evolution. Combination strategies and novel intravesical therapies have the potential to expand the role of BCG to reduce recurrence and progression rates and further establish bladder-preserving treatment paradigms.</p>

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Therapie des nicht-muskelinvasiven Blasenkarzinoms

  • 期刊论文

  • 发表日期：

    2026年2月9日

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  • Mirjam Leeder,
  • Katharina Leucht,
  • Maria Marx,
  • Marc-Oliver Grimm

摘要

Background

Non-muscle-invasive bladder cancer (NMIBC) is characterized by high rates of recurrence and progression, particularly in high-risk disease. Despite transurethral resection and adjuvant intravesical Bacillus Calmette–Guérin (BCG) therapy, a need for more effective bladder-preserving treatment strategies remains.

Objective

The aim of this review is to describe the current therapeutic landscape of NMIBC and to critically evaluate the evidence for novel treatment approaches, particularly in BCG-naïve high-risk NMIBC and in BCG-refractory tumors, as several novel intravesical and systemic therapies have been approved for these entities in the United States.

Methods

This review summarizes current guideline recommendations, phase III trials investigating combinations of PD-1/PD-L1 immune checkpoint inhibitors with BCG in BCG-naïve patients, and emerging treatment strategies for BCG-refractory NMIBC.

Results

In BCG-naïve high-risk NMIBC, phase III trials evaluating durvalumab or sasanlimab in combination with BCG have demonstrated a significant improvement in disease- or event-free survival compared to BCG monotherapy. Regulatory approval in Europe is anticipated. For patients with BCG-refractory disease, several novel intravesical and systemic therapies have been approved in the United States, enabling bladder-preserving treatment approaches. However, approval in Europe appears unlikely, and radical cystectomy is therefore expected to remain the standard of care in this disease setting. In parallel, innovative therapeutic approaches, including gene therapies, oncolytic viruses, and novel drug-delivery systems, are currently under clinical investigation.

Conclusion

The therapeutic landscape of NMIBC is undergoing rapid evolution. Combination strategies and novel intravesical therapies have the potential to expand the role of BCG to reduce recurrence and progression rates and further establish bladder-preserving treatment paradigms.