Real‐Life Impact of Enfortumab Vedotin or Chemotherapy in the Sequential Treatment of Advanced Urothelial Carcinoma: The ARON‐2 Retrospective Experience
ABSTRACT Background Recently, a plethora of novel systemic agents have been incorporated into the therapeutic armamentarium of advanced urothelial carcinoma (aUC). The antibody–drug conjugate (ADC), enfortumab vedotin (EV), has demonstrated relevant clinical benefit in patients with aUC refractory t...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2025-02-01
|
| Series: | Cancer Medicine |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/cam4.70479 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850147158803611648 |
|---|---|
| author | Mimma Rizzo Franco Morelli Yüksel Ürün Sebastiano Buti Se Hoon Park Maria T. Bourlon Enrique Grande Francesco Massari Johannes Landmesser Alexandr Poprach Hideki Takeshita Giandomenico Roviello Zin W. Myint Lazar Popovic Andrey Soares Halima Abahssain Patrizia Giannatempo Javier Molina‐Cerrillo Lorena Incorvaia Samer Salah Annalisa Zeppellini Fernando Sabino Marques Monteiro Camillo Porta Shilpa Gupta Matteo Santoni |
| author_facet | Mimma Rizzo Franco Morelli Yüksel Ürün Sebastiano Buti Se Hoon Park Maria T. Bourlon Enrique Grande Francesco Massari Johannes Landmesser Alexandr Poprach Hideki Takeshita Giandomenico Roviello Zin W. Myint Lazar Popovic Andrey Soares Halima Abahssain Patrizia Giannatempo Javier Molina‐Cerrillo Lorena Incorvaia Samer Salah Annalisa Zeppellini Fernando Sabino Marques Monteiro Camillo Porta Shilpa Gupta Matteo Santoni |
| author_sort | Mimma Rizzo |
| collection | DOAJ |
| description | ABSTRACT Background Recently, a plethora of novel systemic agents have been incorporated into the therapeutic armamentarium of advanced urothelial carcinoma (aUC). The antibody–drug conjugate (ADC), enfortumab vedotin (EV), has demonstrated relevant clinical benefit in patients with aUC refractory to platinum and immune‐checkpoint inhibitor (ICI) therapy. Our study provides a retrospective, international, real‐world analysis comparing the effectiveness of EV to chemotherapy in this setting. Methods The data were extracted from the medical records of patients treated with EV or chemotherapy following pembrolizumab for recurrent or progressive aUC after platinum‐based chemotherapy. Patients were assessed for overall survival (OS), progression‐free survival (PFS), overall response rate (ORR) and duration of response (DoR). Results Our analysis included 247 patients treated with EV (88, 36%) or chemotherapy (159, 64%). Median OS was 9.1 months (95%CI 7.2–10.7) in the overall study population, 13.6 months (95%CI 10.0–31.0) in patients receiving EV and 6.8 months (95%CI 6.0–8.9) in patients receiving chemotherapy (p < 0.001). The OS benefit of EV was not affected by primary tumour site and histology, metastatic sites, type of first platinum‐based chemotherapy or response to pembrolizumab. In the EV cohort, the median PFS was significantly longer (8.8 months [95%CI 6.5–17.0] vs. 3.0 months [95%CI 2.6–3.7]) and the ORR was significantly higher (56% vs. 23%) than in the chemotherapy cohort. Conclusions The results of our international analysis of real‐world data confirm the effectiveness of EV in the sequential strategy of aUC patients who have received prior platinum‐based chemotherapy and anti‐PD‐1 pembrolizumab, regardless of commonly considered prognostic factors. Trial Registration: ClinicalTrials.gov identifier: NCT05290038 |
| format | Article |
| id | doaj-art-329cc815b0194bce9d4bc4fada26ea07 |
| institution | OA Journals |
| issn | 2045-7634 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Wiley |
| record_format | Article |
| series | Cancer Medicine |
| spelling | doaj-art-329cc815b0194bce9d4bc4fada26ea072025-08-20T02:27:39ZengWileyCancer Medicine2045-76342025-02-01144n/an/a10.1002/cam4.70479Real‐Life Impact of Enfortumab Vedotin or Chemotherapy in the Sequential Treatment of Advanced Urothelial Carcinoma: The ARON‐2 Retrospective ExperienceMimma Rizzo0Franco Morelli1Yüksel Ürün2Sebastiano Buti3Se Hoon Park4Maria T. Bourlon5Enrique Grande6Francesco Massari7Johannes Landmesser8Alexandr Poprach9Hideki Takeshita10Giandomenico Roviello11Zin W. Myint12Lazar Popovic13Andrey Soares14Halima Abahssain15Patrizia Giannatempo16Javier Molina‐Cerrillo17Lorena Incorvaia18Samer Salah19Annalisa Zeppellini20Fernando Sabino Marques Monteiro21Camillo Porta22Shilpa Gupta23Matteo Santoni24Medical Oncology Unit Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari Bari ItalyMedical Oncology Unit IRCCS Casa Sollievo della Sofferenza Foggia ItalyDepartment of Medical Oncology, Faculty of Medicine Ankara University Ankara TurkeyDepartment of Medicine and Surgery University of Parma Parma ItalySamsung Medical Center Sungkyunkwan University School of Medicine Seoul KoreaDepartment of Hemato‐Oncology, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Universidad Panamericana Mexico City MexicoDepartment of Medical Oncology MD Anderson Cancer Center Madrid Madrid SpainDepartment of Medical and Surgical Sciences (DIMEC) University of Bologna Bologna ItalyKlinik für Urologie Universitätsklinikum Schleswig‐Holstein Campus Lübeck Lübeck GermanyDepartment of Comprehensive Cancer Care Masaryk Memorial Cancer Institute Brno Czech RepublicDepartment of Urology, Saitama Medical Center Saitama Medical University Saitama JapanDepartment of Health Sciences, Section of Clinical Pharmacology and Oncology University of Florence Florence ItalyDivision of Medical Oncology, Department of Internal Medicine, Markey Cancer Center University of Kentucky Lexington Kentucky USAFaculty of Medicine, Oncology Institute of Vojvodina University of Novi Sad Novi Sad SerbiaHospital Israelita Albert Einstein São Paulo BrazilMedicine and Pharmacy Faculty, National Institute of Oncology, Medical Oncology Unit Mohamed V University Rabat MoroccoMedical Oncology Department Fondazione IRCCS Istituto Nazionale dei Tumori Milan ItalyDepartment of Medical Oncology Hospital Ramón y Cajal Madrid SpainDepartment of Precision Medicine in Medical, Surgical and Critical Care (Me.Pre.C.C.), Section of Medical Oncology University of Palermo Palermo ItalyDepartment of Adult Medical Oncology King Fahad Specialist Hospital‐Dammam Dammam Saudi ArabiaNiguarda Cancer Center Grande Ospedale Metropolitano Niguarda Milan ItalyLatin American Cooperative Oncology Group–LACOG Porto Alegre BrazilChair of Oncology, Interdisciplinary Department of Medicine University of Bari “Aldo Moro” Bari ItalyTaussig Cancer Institute Cleveland Clinic Cleveland Ohio USAMedical Oncology Unit Macerata Hospital Macerata ItalyABSTRACT Background Recently, a plethora of novel systemic agents have been incorporated into the therapeutic armamentarium of advanced urothelial carcinoma (aUC). The antibody–drug conjugate (ADC), enfortumab vedotin (EV), has demonstrated relevant clinical benefit in patients with aUC refractory to platinum and immune‐checkpoint inhibitor (ICI) therapy. Our study provides a retrospective, international, real‐world analysis comparing the effectiveness of EV to chemotherapy in this setting. Methods The data were extracted from the medical records of patients treated with EV or chemotherapy following pembrolizumab for recurrent or progressive aUC after platinum‐based chemotherapy. Patients were assessed for overall survival (OS), progression‐free survival (PFS), overall response rate (ORR) and duration of response (DoR). Results Our analysis included 247 patients treated with EV (88, 36%) or chemotherapy (159, 64%). Median OS was 9.1 months (95%CI 7.2–10.7) in the overall study population, 13.6 months (95%CI 10.0–31.0) in patients receiving EV and 6.8 months (95%CI 6.0–8.9) in patients receiving chemotherapy (p < 0.001). The OS benefit of EV was not affected by primary tumour site and histology, metastatic sites, type of first platinum‐based chemotherapy or response to pembrolizumab. In the EV cohort, the median PFS was significantly longer (8.8 months [95%CI 6.5–17.0] vs. 3.0 months [95%CI 2.6–3.7]) and the ORR was significantly higher (56% vs. 23%) than in the chemotherapy cohort. Conclusions The results of our international analysis of real‐world data confirm the effectiveness of EV in the sequential strategy of aUC patients who have received prior platinum‐based chemotherapy and anti‐PD‐1 pembrolizumab, regardless of commonly considered prognostic factors. Trial Registration: ClinicalTrials.gov identifier: NCT05290038https://doi.org/10.1002/cam4.70479ARON‐2 studychemotherapyenfortumab vedotinNCT05290038pembrolizumabreal‐world data |
| spellingShingle | Mimma Rizzo Franco Morelli Yüksel Ürün Sebastiano Buti Se Hoon Park Maria T. Bourlon Enrique Grande Francesco Massari Johannes Landmesser Alexandr Poprach Hideki Takeshita Giandomenico Roviello Zin W. Myint Lazar Popovic Andrey Soares Halima Abahssain Patrizia Giannatempo Javier Molina‐Cerrillo Lorena Incorvaia Samer Salah Annalisa Zeppellini Fernando Sabino Marques Monteiro Camillo Porta Shilpa Gupta Matteo Santoni Real‐Life Impact of Enfortumab Vedotin or Chemotherapy in the Sequential Treatment of Advanced Urothelial Carcinoma: The ARON‐2 Retrospective Experience Cancer Medicine ARON‐2 study chemotherapy enfortumab vedotin NCT05290038 pembrolizumab real‐world data |
| title | Real‐Life Impact of Enfortumab Vedotin or Chemotherapy in the Sequential Treatment of Advanced Urothelial Carcinoma: The ARON‐2 Retrospective Experience |
| title_full | Real‐Life Impact of Enfortumab Vedotin or Chemotherapy in the Sequential Treatment of Advanced Urothelial Carcinoma: The ARON‐2 Retrospective Experience |
| title_fullStr | Real‐Life Impact of Enfortumab Vedotin or Chemotherapy in the Sequential Treatment of Advanced Urothelial Carcinoma: The ARON‐2 Retrospective Experience |
| title_full_unstemmed | Real‐Life Impact of Enfortumab Vedotin or Chemotherapy in the Sequential Treatment of Advanced Urothelial Carcinoma: The ARON‐2 Retrospective Experience |
| title_short | Real‐Life Impact of Enfortumab Vedotin or Chemotherapy in the Sequential Treatment of Advanced Urothelial Carcinoma: The ARON‐2 Retrospective Experience |
| title_sort | real life impact of enfortumab vedotin or chemotherapy in the sequential treatment of advanced urothelial carcinoma the aron 2 retrospective experience |
| topic | ARON‐2 study chemotherapy enfortumab vedotin NCT05290038 pembrolizumab real‐world data |
| url | https://doi.org/10.1002/cam4.70479 |
| work_keys_str_mv | AT mimmarizzo reallifeimpactofenfortumabvedotinorchemotherapyinthesequentialtreatmentofadvancedurothelialcarcinomathearon2retrospectiveexperience AT francomorelli reallifeimpactofenfortumabvedotinorchemotherapyinthesequentialtreatmentofadvancedurothelialcarcinomathearon2retrospectiveexperience AT yukselurun reallifeimpactofenfortumabvedotinorchemotherapyinthesequentialtreatmentofadvancedurothelialcarcinomathearon2retrospectiveexperience AT sebastianobuti reallifeimpactofenfortumabvedotinorchemotherapyinthesequentialtreatmentofadvancedurothelialcarcinomathearon2retrospectiveexperience AT sehoonpark reallifeimpactofenfortumabvedotinorchemotherapyinthesequentialtreatmentofadvancedurothelialcarcinomathearon2retrospectiveexperience AT mariatbourlon reallifeimpactofenfortumabvedotinorchemotherapyinthesequentialtreatmentofadvancedurothelialcarcinomathearon2retrospectiveexperience AT enriquegrande reallifeimpactofenfortumabvedotinorchemotherapyinthesequentialtreatmentofadvancedurothelialcarcinomathearon2retrospectiveexperience AT francescomassari reallifeimpactofenfortumabvedotinorchemotherapyinthesequentialtreatmentofadvancedurothelialcarcinomathearon2retrospectiveexperience AT johanneslandmesser reallifeimpactofenfortumabvedotinorchemotherapyinthesequentialtreatmentofadvancedurothelialcarcinomathearon2retrospectiveexperience AT alexandrpoprach reallifeimpactofenfortumabvedotinorchemotherapyinthesequentialtreatmentofadvancedurothelialcarcinomathearon2retrospectiveexperience AT hidekitakeshita reallifeimpactofenfortumabvedotinorchemotherapyinthesequentialtreatmentofadvancedurothelialcarcinomathearon2retrospectiveexperience AT giandomenicoroviello reallifeimpactofenfortumabvedotinorchemotherapyinthesequentialtreatmentofadvancedurothelialcarcinomathearon2retrospectiveexperience AT zinwmyint reallifeimpactofenfortumabvedotinorchemotherapyinthesequentialtreatmentofadvancedurothelialcarcinomathearon2retrospectiveexperience AT lazarpopovic reallifeimpactofenfortumabvedotinorchemotherapyinthesequentialtreatmentofadvancedurothelialcarcinomathearon2retrospectiveexperience AT andreysoares reallifeimpactofenfortumabvedotinorchemotherapyinthesequentialtreatmentofadvancedurothelialcarcinomathearon2retrospectiveexperience AT halimaabahssain reallifeimpactofenfortumabvedotinorchemotherapyinthesequentialtreatmentofadvancedurothelialcarcinomathearon2retrospectiveexperience AT patriziagiannatempo reallifeimpactofenfortumabvedotinorchemotherapyinthesequentialtreatmentofadvancedurothelialcarcinomathearon2retrospectiveexperience AT javiermolinacerrillo reallifeimpactofenfortumabvedotinorchemotherapyinthesequentialtreatmentofadvancedurothelialcarcinomathearon2retrospectiveexperience AT lorenaincorvaia reallifeimpactofenfortumabvedotinorchemotherapyinthesequentialtreatmentofadvancedurothelialcarcinomathearon2retrospectiveexperience AT samersalah reallifeimpactofenfortumabvedotinorchemotherapyinthesequentialtreatmentofadvancedurothelialcarcinomathearon2retrospectiveexperience AT annalisazeppellini reallifeimpactofenfortumabvedotinorchemotherapyinthesequentialtreatmentofadvancedurothelialcarcinomathearon2retrospectiveexperience AT fernandosabinomarquesmonteiro reallifeimpactofenfortumabvedotinorchemotherapyinthesequentialtreatmentofadvancedurothelialcarcinomathearon2retrospectiveexperience AT camilloporta reallifeimpactofenfortumabvedotinorchemotherapyinthesequentialtreatmentofadvancedurothelialcarcinomathearon2retrospectiveexperience AT shilpagupta reallifeimpactofenfortumabvedotinorchemotherapyinthesequentialtreatmentofadvancedurothelialcarcinomathearon2retrospectiveexperience AT matteosantoni reallifeimpactofenfortumabvedotinorchemotherapyinthesequentialtreatmentofadvancedurothelialcarcinomathearon2retrospectiveexperience |