Academic Journal
EV-103 dose escalation/cohort A: 5-year follow-up of enfortumab vedotin plus pembrolizumab in previously untreated locally advanced/metastatic urothelial carcinoma.
| Τίτλος: | EV-103 dose escalation/cohort A: 5-year follow-up of enfortumab vedotin plus pembrolizumab in previously untreated locally advanced/metastatic urothelial carcinoma. |
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| Συγγραφείς: | Rosenberg JE; Memorial Sloan Kettering Cancer Center, New York, USA. Electronic address: rosenbj1@mskcc.org., O'Donnell PH; University of Chicago, Chicago, USA., Petrylak DP; Yale Cancer Center, New Haven, USA., Flaig TW; Division of Medical Oncology, CU School of Medicine, Aurora, USA., Hoimes CJ; Duke Cancer Institute, Durham, USA., Gupta S; Cleveland Clinic Taussig Cancer Institute, Cleveland, USA., Mar N; University of California Irvine, Irvine, USA., Friedlander TW; University of California San Francisco Medical Center, San Francisco, USA., Tagawa ST; Weill Cornell Medical Center, New York, USA., Bilen MA; Winship Cancer Institute of Emory University, Atlanta, USA., Brown JR; University Hospitals Cleveland Medical Center, Case Western Reserve University School of Medicine, Cleveland, USA., McKay RR; University of California San Diego, San Diego, USA., Merchan JR; University of Miami, Miami, USA., Srinivas S; Stanford University Medical Center, Stanford, USA., Gorla S; Astellas Pharma, Inc., Northbrook, USA., Moreno BH; Merck & Co., Inc., Rahway, USA., Davis G; Pfizer Inc., Bothell, USA., Wirtz HS; Pfizer Inc., Bothell, USA., Zhu Y; Pfizer Inc., Bothell, USA., Milowsky MI; University of North Carolina, Chapel Hill, USA. |
| Πηγή: | ESMO open [ESMO Open] 2026 Jun; Vol. 11 (6), pp. 107700. Date of Electronic Publication: 2026 May 19. |
| Τύπος έκδοσης: | Journal Article; Clinical Trial, Phase I; Clinical Trial, Phase II |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: Elsevier Country of Publication: England NLM ID: 101690685 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2059-7029 (Electronic) Linking ISSN: 20597029 NLM ISO Abbreviation: ESMO Open Subsets: MEDLINE |
| Imprint Name(s): | Publication: 2021 : [London] : Elsevier Original Publication: London : BMJ, [2016]- |
| Ιατρικοί όροι (MeSH): | Antibodies, Monoclonal, Humanized*/administration & dosage , Antibodies, Monoclonal, Humanized*/therapeutic use , Antibodies, Monoclonal, Humanized*/pharmacology , Antibodies, Monoclonal, Humanized*/adverse effects , Antineoplastic Combined Chemotherapy Protocols*/therapeutic use , Antineoplastic Combined Chemotherapy Protocols*/administration & dosage , Antineoplastic Combined Chemotherapy Protocols*/adverse effects , Antibodies, Monoclonal*/administration & dosage , Antibodies, Monoclonal*/therapeutic use , Carcinoma, Transitional Cell*/drug therapy , Urologic Neoplasms*/drug therapy , Urologic Neoplasms*/pathology , Urinary Bladder Neoplasms*/drug therapy , Urinary Bladder Neoplasms*/pathology, Humans ; Female ; Male ; Follow-Up Studies ; Aged ; Middle Aged ; Aged, 80 and over |
| Περίληψη: | Background: Dose escalation/cohort A of the phase Ib/II EV-103/KEYNOTE-869 study (NCT03288545) assessed safety and efficacy of enfortumab vedotin (EV) plus pembrolizumab (P) in cisplatin-ineligible patients with previously untreated locally advanced/metastatic urothelial carcinoma (la/mUC). Here we report updated results after 5 years of follow-up. Methods: Patients received EV 1.25 mg/kg intravenously on days 1 and 8, and pembrolizumab 200 mg on day 1 of every 3-week cycle. The primary endpoint was safety. Select secondary endpoints included objective response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Results: Forty-five patients were enrolled. Baseline characteristics were representative of a cisplatin-ineligible population; 84.4% had visceral disease and 55.6% had reduced renal function (creatine clearance <60 ml/min). The median follow-up time was 62.1 months [95% confidence interval (CI) 59.4-63.1]. There were no new safety signals, and safety was consistent with EV+P in other la/mUC studies. Confirmed ORR was 73.3%, median DOR was 22.1 months [95% CI 8.4-not estimable (NE)], median PFS was 12.7 months (95% CI 6.1-NE), and median OS was 26.1 months (95% CI 15.5-NE). The estimated 5-year survival rate was 41.5% (95% CI 26.5-56.0). Conclusion: Along with results from EV-302/KEYNOTE-A39 (NCT04223856), the 5-year results further support the sustained benefit from EV+P and establish the combination as the standard of care for previously untreated la/mUC. (Copyright © 2026 The Author(s). Published by Elsevier Ltd.. All rights reserved.) |
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| Grant Information: | P30 CA008748 United States CA NCI NIH HHS |
| Contributed Indexing: | Keywords: EV-103; enfortumab vedotin; first line; pembrolizumab; urothelial cancer |
| Substance Nomenclature: | 0 (Antibodies, Monoclonal, Humanized) DPT0O3T46P (pembrolizumab) DLE8519RWM (enfortumab vedotin) 0 (Antibodies, Monoclonal) |
| Entry Date(s): | Date Created: 20260519 Date Completed: 20260620 Latest Revision: 20260813 |
| Update Code: | 20260813 |
| PubMed Central ID: | PMC13213747 |
| DOI: | 10.1016/j.esmoop.2026.107700 |
| PMID: | 42155320 |
| Βάση Δεδομένων: | MEDLINE |
| ISSN: | 2059-7029 |
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| DOI: | 10.1016/j.esmoop.2026.107700 |