Enfortumab vedotin plus pembrolizumab in treatment‐naïve metastatic urothelial carcinoma patients: An Austrian real‐world analysis

Antibody-drug conjugates (ADCs) and immunotherapy have changed the treatment landscape for locally advanced and metastatic urothelial carcinoma (la/mUC). Clinical trials have demonstrated the superiority of enfortumab vedotin (EV) combined with pembrolizumab (P) over chemotherapy. This retrospective, multicentre Austrian registry analysis evaluated the effectiveness and safety of EV + P in treatment-naïve la/mUC patients in a real-world setting. This study included 203 first-line EV + P treated patients from 20 Austrian centres. The majority were male (77.3%), with a median age of 70 years (range, 26-92), while 33.5% were ≥75 years. Comorbidities were common, with 25.1% having a Charlson Comorbidity Index (CCI) ≥ 5, and 46.3% moderate to severe renal impairment. Among 195 evaluable patients, the objective response rate (ORR) was 63.6% (95% CI, 56.6-70.0), including 21.5% complete responses and 42.1% partial responses. Disease control was achieved in 75.4% (95% CI, 68.9-80.9). Median progression-free survival (PFS) and overall survival (OS) were not reached after a median follow-up of 5.8 months. Poor outcomes were associated with ECOG PS >2 (PFS, p = .003; OS, p< .001) and CCI ≥5 (PFS, p = .011; OS, p = .08). EV + P was generally well tolerated; grade ≥3 treatment-related adverse events occurred in 38.4% of patients and immune-related adverse events in 19.2%. Limitations of this study include its retrospective design and short follow-up. These findings support the clinical use of EV + P as first-line treatment for la/mUC, demonstrating substantial effectiveness and manageable toxicity in a large real-world population, including elderly and comorbid patients. Extended follow-up is warranted to determine long-term survival and predictive markers of response.

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Journal
International Journal of Cancer
Published
2025-10-22
DOI
https://doi.org/10.1002/ijc.70203
Citations
1
Primary Topic
Bladder and Urothelial Cancer Treatments
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article
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2.01
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article

Enfortumab vedotin plus pembrolizumab in treatment‐naïve metastatic urothelial carcinoma patients: An Austrian real‐world analysis

Haleh Andalibi, Martin Pichler, Franz Stoiber, Hossein Taghizadeh et al.
1 citations
International Journal of Cancer
Bladder and Urothelial Cancer Treatments
2.01
article

Enfortumab vedotin plus pembrolizumab in treatment‐naïve metastatic urothelial carcinoma patients: An Austrian real‐world analysis

Haleh Andalibi, Martin Pichler, Franz Stoiber, Hossein Taghizadeh, Daniel Heintel, J. Pfuner, Jan Miechowiecki, David Kiesl, Andreas Banner, Simon Peter Gampenrieder, Maximillian Pallauf, Dora Niedersuess‐Beke, Karl Mayrhofer, Johannes Franke, Angelika Terbuch, Thomas Bauernhofer, Stefan Aufderklamm, Susanne Schnabel, Ferdinand Luger, Harun Fajković, Renate Pichler, Sabine Weibrecht, Josef Mühlmann, Johanna Krauter, Wolfgang Hilbe, Clemens Wiesinger, Sonia Vallet, Shahrokh F Shariat, Jasmin Spielgelberg, Roman Taedcke, Dominic Vais
article en
1 citations

Abstract

Antibody-drug conjugates (ADCs) and immunotherapy have changed the treatment landscape for locally advanced and metastatic urothelial carcinoma (la/mUC). Clinical trials have demonstrated the superiority of enfortumab vedotin (EV) combined with pembrolizumab (P) over chemotherapy. This retrospective, multicentre Austrian registry analysis evaluated the effectiveness and safety of EV + P in treatment-naïve la/mUC patients in a real-world setting. This study included 203 first-line EV + P treated patients from 20 Austrian centres. The majority were male (77.3%), with a median age of 70 years (range, 26-92), while 33.5% were ≥75 years. Comorbidities were common, with 25.1% having a Charlson Comorbidity Index (CCI) ≥ 5, and 46.3% moderate to severe renal impairment. Among 195 evaluable patients, the objective response rate (ORR) was 63.6% (95% CI, 56.6-70.0), including 21.5% complete responses and 42.1% partial responses. Disease control was achieved in 75.4% (95% CI, 68.9-80.9). Median progression-free survival (PFS) and overall survival (OS) were not reached after a median follow-up of 5.8 months. Poor outcomes were associated with ECOG PS >2 (PFS, p = .003; OS, p< .001) and CCI ≥5 (PFS, p = .011; OS, p = .08). EV + P was generally well tolerated; grade ≥3 treatment-related adverse events occurred in 38.4% of patients and immune-related adverse events in 19.2%. Limitations of this study include its retrospective design and short follow-up. These findings support the clinical use of EV + P as first-line treatment for la/mUC, demonstrating substantial effectiveness and manageable toxicity in a large real-world population, including elderly and comorbid patients. Extended follow-up is warranted to determine long-term survival and predictive markers of response.

International Journal of CancerVol. 158(6)
St. John's Hospital (US), Innsbruck Medical University (AT), Medical University of Graz (AT), Paracelsus Medical University (AT), State Hospital (GB), Donauspital (AT), Barmherzige Schwestern Krankenhaus Wien (AT), Klinikum Klagenfurt (AT), Hanusch Hospital (AT), Universitätsklinikum St. Pölten (AT), Ordensklinikum Linz Barmherzige Schwestern (AT), IVF Centers Prof. Zech (AT), Kepler Universitätsklinikum (AT), Krankenhaus Oberndorf (AT), Klinikum Wels-Grieskirchen (AT), Hospital of the Brothers of St. John of God (AT), Krankenhaus der Elisabethinen (AT), Klinik Donaustauf (DE), AGO Austria (AT), Karl Landsteiner University of Health Sciences (AT), Karl Landsteiner Society (AT), SBA Research (AT), Medical University of Vienna (AT)
Openalex Percentile: Top 11%
Bladder and Urothelial Cancer Treatments
2.01
DOIOpen Access PDFOpenAlex
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