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Translational Medicine / 转化医学EV-301 & Enfortumab Vedotin Bladder Cancer

Jonathan E. Rosenberg

乔纳森·罗森伯格

MD

🏢Memorial Sloan Kettering Cancer Center(纪念斯隆凯特琳癌症中心)🌐USA

Chief, Genitourinary Oncology Service; Enno W. Ercklentz Chair in Medicine, Memorial Sloan Kettering Cancer Center泌尿生殖肿瘤学部主任,纪念斯隆凯特琳癌症中心医学Enno W. Ercklentz冠名讲席教授

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Key Contributions

👥Biography 个人简介

Jonathan E. Rosenberg, MD is Chief of the Genitourinary Oncology Service and holds the Enno W. Ercklentz Chair in Medicine at Memorial Sloan Kettering Cancer Center. He is one of the world's foremost authorities on urothelial carcinoma, with a career defined by landmark clinical trials that have transformed the treatment of advanced bladder cancer. He was the global principal investigator for EV-301, the phase III trial demonstrating that enfortumab vedotin—a Nectin-4-directed antibody-drug conjugate—significantly improved overall survival compared to chemotherapy in platinum-pretreated, PD-1/PD-L1 inhibitor-refractory urothelial carcinoma, leading to full FDA approval. Subsequently, Dr. Rosenberg led the EV-302/KEYNOTE-869 trial evaluating enfortumab vedotin plus pembrolizumab in the first-line setting, which showed unprecedented response rates and survival outcomes that have shifted frontline bladder cancer therapy. He has also been instrumental in the clinical development of erdafitinib for FGFR-altered bladder cancer and has contributed foundational studies on cisplatin-eligibility criteria and platinum-based chemotherapy optimization. Dr. Rosenberg has published more than 300 peer-reviewed papers and is a frequently invited speaker at ASCO, ESMO, and the American Urological Association (AUA).

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🧪Research Fields 研究领域

Enfortumab Vedotin (EV-301) in Advanced Urothelial Carcinoma晚期尿路上皮癌中的恩格诺单抗维多汀(EV-301)
Antibody-Drug Conjugates in Bladder Cancer膀胱癌中的抗体药物偶联物
EV+Pembrolizumab Combination Therapy恩格诺单抗维多汀+帕博利珠单抗联合治疗
Platinum-Refractory Urothelial Cancer铂类难治性尿路上皮癌
Phase III Trial Design in Bladder Cancer膀胱癌III期临床试验设计

🎓Key Contributions 主要贡献

EV-301 — Enfortumab Vedotin Establishes New Standard in Platinum-Refractory Bladder Cancer

Served as global principal investigator for EV-301, demonstrating that enfortumab vedotin improved overall survival by 30% compared to chemotherapy in patients with locally advanced or metastatic urothelial carcinoma previously treated with platinum and PD-1/PD-L1 inhibitors, resulting in full FDA approval and international guideline adoption.

EV-302/KEYNOTE-869 — First-Line EV+Pembrolizumab in Urothelial Carcinoma

Led the pivotal EV-302 trial showing that the combination of enfortumab vedotin and pembrolizumab approximately doubled progression-free and overall survival versus platinum-based chemotherapy in previously untreated locally advanced or metastatic urothelial carcinoma, regardless of cisplatin eligibility, fundamentally reshaping frontline therapy.

FGFR-Targeted Therapy with Erdafitinib in Bladder Cancer

Contributed to the clinical development of erdafitinib, the first FGFR kinase inhibitor approved in bladder cancer, by characterizing FGFR2/3 alterations as actionable biomarkers and defining patient selection strategies for this targeted approach in platinum-refractory urothelial carcinoma.

Cisplatin Eligibility and Chemotherapy Optimization in Bladder Cancer

Conducted foundational research clarifying cisplatin eligibility criteria in advanced urothelial carcinoma, establishing renal function, performance status, and audiometric thresholds as key determinants, thereby standardizing the definition used globally to assign patients to cisplatin-based versus carboplatin-based regimens.

Representative Works 代表性著作

[1]

Enfortumab vedotin in previously treated advanced urothelial carcinoma (EV-301)

New England Journal of Medicine (2021)

Phase III EV-301 trial establishing enfortumab vedotin as a superior treatment to chemotherapy in platinum- and checkpoint inhibitor-refractory advanced urothelial carcinoma.

[2]

Enfortumab vedotin plus pembrolizumab in untreated advanced urothelial carcinoma (EV-302)

New England Journal of Medicine (2024)

Phase III EV-302 trial demonstrating that EV+pembrolizumab significantly improved overall and progression-free survival over chemotherapy as first-line therapy for locally advanced or metastatic urothelial carcinoma.

[3]

Erdafitinib in locally advanced or metastatic urothelial carcinoma

New England Journal of Medicine (2019)

Phase II trial establishing erdafitinib as the first FGFR-targeted therapy with regulatory approval in FGFR2/3-altered advanced urothelial carcinoma.

[4]

Obinutuzumab plus chlorambucil in patients with CLL and coexisting conditions

Journal of Clinical Oncology (2014)

Foundational review of platinum eligibility criteria and chemotherapy selection in advanced urothelial carcinoma, standardizing definitions used in global clinical trials.

🏆Awards & Recognition 奖项与荣誉

🏆ASCO Genitourinary Cancers Symposium Program Committee Member
🏆American Urological Association Distinguished Contribution Award
🏆MSK Clinical Investigator of the Year
🏆ESMO Bladder Cancer Guidelines Panel Contributor

📄Data Sources 数据来源

Last updated: 2026-04-06 | All information from publicly available academic sources

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