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DRUG:

Padcev (enfortumab vedotin-ejfv)

i
Other names: ASG-22ME, AGS-22C3, AGS-22CE, AGS-22M6E, AGS-M6, ASG-22CE, ASG-22M6E, AGS22CE, AGS 22CE, AGS22M6E, AGS 22M6E, AGSM6, AGS M6, ASG 22ME, ASG-22ME, AGS 22C3, AGS 22ME, AGS22C3, AGS22ME, ASG 22CE, ASG22M6E, ASG 22M6E, ASG22ME
Company:
Astellas, Pfizer
Drug class:
Microtubule inhibitor, Nectin-4-targeted antibody-drug conjugate
Related drugs:
4d
Redefining standards: a comprehensive systematic review of practice changing advances in GU oncology from ASCO and ESMO 2025. (PubMed, Front Endocrinol (Lausanne))
Key advances include: (1) In bladder cancer, perioperative durvalumab (NIAGARA) and enfortumab vedotin plus pembrolizumab (KEYNOTE-905/EV-303) set new standards, while HER2-targeted disitamab vedotin plus toripalimab (RC48-C016) improved metastatic survival...(3) In prostate cancer, enzalutamide plus leuprolide improved survival in high-risk biochemical recurrence (EMBARK). Capivasertib plus abiraterone benefited PTEN-deficient metastatic hormone-sensitive disease (CAPItello-281). The PSMAddition trial demonstrated that adding [177Lu]Lu-PSMA-617 to standard therapy significantly improved radiographic PFS in PSMA-positive mHSPC. Docetaxel scheduling was optimized (ARASAFE), and an AI model (STAMPEDE) identified patients for AR inhibitor benefit. Novel agents like saruparib and pasritamig showed promise...The 2025 evidence establishes multiple new standards of care across GU cancers, emphasizing biomarker-driven strategies, immunotherapy integration, novel resistance mechanisms, and treatment optimization. This synthesis provides an evidence-based framework for updating guidelines and highlights the move toward more personalized management, while noting persistent challenges and future research needs.
Review • Journal • PD(L)-1 Biomarker • IO biomarker
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HER-2 (Human epidermal growth factor receptor 2) • PTEN (Phosphatase and tensin homolog)
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FOLH1 positive
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Keytruda (pembrolizumab) • Imfinzi (durvalumab) • docetaxel • Loqtorzi (toripalimab-tpzi) • Xtandi (enzalutamide) • abiraterone acetate • Truqap (capivasertib) • Aidixi (disitamab vedotin) • Padcev (enfortumab vedotin-ejfv) • saruparib (AZD5305) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • leuprolide acetate for depot suspension • pasritamig (JNJ-8343)
6d
Trial initiation date
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PD-L1 (Programmed death ligand 1)
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Bavencio (avelumab) • Padcev (enfortumab vedotin-ejfv)
7d
Enrollment open
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Keytruda (pembrolizumab) • Padcev (enfortumab vedotin-ejfv)
7d
Journal • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
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HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • NECTIN4 (Nectin Cell Adhesion Molecule 4) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
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HER-2 expression
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Padcev (enfortumab vedotin-ejfv)
9d
Port-Site Seeding of Urothelial Carcinoma After Robotic-Assisted Radical Prostatectomy Accompanied With Elevated Serum Levels of Carbohydrate Antigen 19-9: A Case Report. (PubMed, Case Rep Urol)
Cancer progression with the elevation of serum CA19-9 was observed during subsequent avelumab therapy, and enfortumab vedotin therapy was initiated. RARP for patients with a past history of bladder tumor presents a risk of dissemination of UC due to urine leakage. Thorough examination for UC before RARP is recommended.
Journal
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CA 19-9 (Cancer antigen 19-9)
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Bavencio (avelumab) • Padcev (enfortumab vedotin-ejfv)
13d
New and Emerging Drug Reactions. (PubMed, Dermatol Clin)
In this article, we discuss the clinical and histopathologic findings of cutaneous adverse reactions to newer medications, including those recently approved to treat inflammatory skin diseases, such as dupilumab for atopic dermatitis and IL-12/-23 and IL-23 specific inhibitors for psoriasis, as well as those with oncologic indications, including immune checkpoint inhibitors, mogamulizumab, and enfortumab vedotin.
Review • Journal
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IL23A (Interleukin 23 Subunit Alpha)
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Padcev (enfortumab vedotin-ejfv) • Poteligeo (mogamulizumab-kpkc) • Dupixent (dupilumab)
14d
Enrollment open
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Padcev (enfortumab vedotin-ejfv)
15d
Study of GB-4362 With Enfortumab Vedotin and Pembrolizumab for Advanced Urothelial Cancer (clinicaltrials.gov)
P1, N=37, Recruiting, Generate Biomedicines | Not yet recruiting --> Recruiting
Enrollment open
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Keytruda (pembrolizumab) • Padcev (enfortumab vedotin-ejfv)
20d
Trial initiation date
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Keytruda (pembrolizumab) • Padcev (enfortumab vedotin-ejfv) • MK-3120
20d
Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing (clinicaltrials.gov)
P2, N=39, Recruiting, Peking Union Medical College | Trial primary completion date: Jul 2026 --> Jul 2028
Trial primary completion date
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HER-2 (Human epidermal growth factor receptor 2) • NTRK (Neurotrophic receptor tyrosine kinase)
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carboplatin • Perjeta (pertuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Lenvima (lenvatinib) • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • Piqray (alpelisib) • Irene (pyrotinib) • albumin-bound paclitaxel • abiraterone acetate • fulvestrant • Aidixi (disitamab vedotin) • exemestane • Padcev (enfortumab vedotin-ejfv) • bicalutamide • Kaitanni (cadonilimab) • goserelin acetate • Qibeian (iparomlimab/tuvonralimab) • Yidafan (ivonescimab) • iparomlimab (QL1604) • leuprolide acetate for depot suspension • Entyvio (vedolizumab)
25d
Urothelial Carcinoma of the Bladder with a Single Pancreatic Metastasis: A Case Report. (PubMed, Reports (MDPI))
The patient was referred for systemic therapy with immune checkpoint inhibitors and Enfortumab Vedotin...EUS-guided biopsy with immunohistochemistry is essential to distinguish secondary lesions from primary pancreatic tumors. Accurate diagnosis is crucial to guide systemic therapy, particularly with emerging immunotherapy and antibody-drug conjugates.
Journal
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GATA3 (GATA binding protein 3)
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Padcev (enfortumab vedotin-ejfv)
26d
Nectin-4 expression in vulvar squamous cell carcinoma. (PubMed, Virchows Arch)
One potential target for the ADC Enfortumab Vedotin (EV) is Nectin-4...Nectin-4 could be a potential target in the therapy of women with VSCC. Further (pre-)clinical data is needed to evaluate the use of EV in therapy of women with VSCC.
Journal • IO biomarker
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NECTIN4 (Nectin Cell Adhesion Molecule 4)
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Padcev (enfortumab vedotin-ejfv)