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Background <p>Histologic variants (HV) of urothelial carcinoma (UC-V) and non-urothelial carcinomas (NUC) of the bladder and urinary tract are aggressive malignancies with poor prognosis and limited response to platinum-based chemotherapy. Despite their biological particularities and distinct immune microenvironments, these HV subtypes are under-represented in immune checkpoint blockade (ICB) trials.</p> Methods <p>PEMBROBLAD is a French national multicenter retrospective study conducted across 24 centers. We included patients with advanced UC-V or NUC who received second-line anti–PD-(L)1 monotherapy after progression on platinum-based chemotherapy between 2016 and 2022. Primary endpoint was overall survival (OS); secondary endpoints included progression-free survival (PFS), objective response rate (ORR) and safety.</p> Results <p>We included 129 UC-V and 34 NUC. With a median follow-up was 21.9&#xa0;months, the median OS was 8.6 [95% confidence interval (CI), 5.3–11.2] months, with 8.5 [95% CI 5.3–10.9] months for UC-V and 10.5[95% CI 3.5–22.8] months for NUC. The median PFS was 2.6 [95% CI 2.1–3.4] months with 2.5 [95% CI 2.0–3.4] months for the UC-V group and 2.6 [2.0–3.4] months for the NUC group. ORR was 31.4% overall (complete response 15.3%, partial response 16.1%). In multivariable analysis, ECOG performance status ≥ 2 was independently associated with both poorer OS (HR 3.30, 95% CI 1.22–8.92; <i>p</i> = 0.018) and PFS (HR 2.32, 95% CI 1.52–3.54; <i>p</i> &lt; 0.001). Pembrolizumab treatment was associated with improved PFS (HR 0.53, 95% CI 0.31–0.81; <i>p</i> = 0.017). Grade ≥ 3 immune-related adverse events occurred in 10.8% of patients, with no treatment-related deaths.</p> Conclusions <p>Anti–PD-(L)1 monotherapy shows clinical benefit in advanced UC-V and NUC after platinum failure.</p>

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Real-world efficacy and safety of immune checkpoint blockades in advanced urothelial carcinoma with histologic variant subtypes: the pembroblad study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月24日

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  • Karim Amrane,
  • Luca Campedel,
  • Fabien Moinard-Butot,
  • Mathilde Gout,
  • Hakim Mahammedi,
  • Mostefa Bennamoun,
  • Tressie Herrmann,
  • Pierre-Etienne Gabriel,
  • Damien Pouessel,
  • Matthieu Roulleaux-Dugage,
  • Constance Thibault,
  • Mathilde Cancel,
  • Aude Flechon,
  • Olivier Huillard,
  • Baptiste Abbar,
  • Delphine Borchiellini,
  • Louis Doublet,
  • Laëtitia Augusto-Pelegrin,
  • Elouen Boughalem,
  • Pierre Cornillon,
  • Clément Dumont,
  • Philippe Barthélémy

摘要

Background

Histologic variants (HV) of urothelial carcinoma (UC-V) and non-urothelial carcinomas (NUC) of the bladder and urinary tract are aggressive malignancies with poor prognosis and limited response to platinum-based chemotherapy. Despite their biological particularities and distinct immune microenvironments, these HV subtypes are under-represented in immune checkpoint blockade (ICB) trials.

Methods

PEMBROBLAD is a French national multicenter retrospective study conducted across 24 centers. We included patients with advanced UC-V or NUC who received second-line anti–PD-(L)1 monotherapy after progression on platinum-based chemotherapy between 2016 and 2022. Primary endpoint was overall survival (OS); secondary endpoints included progression-free survival (PFS), objective response rate (ORR) and safety.

Results

We included 129 UC-V and 34 NUC. With a median follow-up was 21.9 months, the median OS was 8.6 [95% confidence interval (CI), 5.3–11.2] months, with 8.5 [95% CI 5.3–10.9] months for UC-V and 10.5[95% CI 3.5–22.8] months for NUC. The median PFS was 2.6 [95% CI 2.1–3.4] months with 2.5 [95% CI 2.0–3.4] months for the UC-V group and 2.6 [2.0–3.4] months for the NUC group. ORR was 31.4% overall (complete response 15.3%, partial response 16.1%). In multivariable analysis, ECOG performance status ≥ 2 was independently associated with both poorer OS (HR 3.30, 95% CI 1.22–8.92; p = 0.018) and PFS (HR 2.32, 95% CI 1.52–3.54; p < 0.001). Pembrolizumab treatment was associated with improved PFS (HR 0.53, 95% CI 0.31–0.81; p = 0.017). Grade ≥ 3 immune-related adverse events occurred in 10.8% of patients, with no treatment-related deaths.

Conclusions

Anti–PD-(L)1 monotherapy shows clinical benefit in advanced UC-V and NUC after platinum failure.