Enfortumab Vedotin

Summary

Enfortumab Vedotin (CHEMBL3301589) is an approved antibody drug conjugate (ATC L01FX13) targeting NECTIN4; indicated across 10 conditions including neoplasm and transitional cell carcinoma; with CIViC clinical evidence for 1 variant-indication association (e.g. NECTIN4 D594H in cancer).

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Antibody drug conjugate
• ATC class: L01FX13
• Targets: 1 (NECTIN4)
• Indications: 10 conditions
• Clinical trials: 61
• Precision-oncology evidence (CIViC): 1 variant–indication association

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL3301589
Name	Enfortumab Vedotin
Type	Antibody drug conjugate
Max phase	4
ATC	L01FX13

Also known as: AGS-22CE, AGS-22M6E, AGS-22ME, AGS-22MSE, Asg-22ce, ASG-22ME, Enfortumab vedotin, Enfortumab vedotin ejfv, Enfortumab vedotin-ejfv, Enfortumab vedotina, Enfortumab vedotine, Padcev

Targets

Targets

Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).

Gene	Target	Action	pAffinity	Cancer dependency	UniProt
NECTIN4	nectin cell adhesion molecule 4	Binding		0.5%	Q96NY8

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

Aggregated over 1 target gene(s): NECTIN4.

Top Reactome pathways

5 total, by targets touching each:

Pathway	Targets	Genes
Cell-Cell communication	1	NECTIN4
Adherens junctions interactions	1	NECTIN4
Nectin/Necl trans heterodimerization	1	NECTIN4
Cell-cell junction organization	1	NECTIN4
Cell junction organization	1	NECTIN4

Dominant GO biological processes

GO term	Targets
homophilic cell-cell adhesion	1
heterophilic cell-cell adhesion	1
negative regulation of natural killer cell mediated cytotoxicity	1
cell adhesion	1
signal transduction	1
symbiont entry into host cell	1

Indications & clinical

Indications

4 approved indications. FDA phase 4, plus an anticancer drug’s labelled cancer uses (which ChEMBL often logs at phase 3).

Indication	Phase	MONDO	EFO
neoplasm	4	MONDO:0005070	EFO:0000616
transitional cell carcinoma	4	MONDO:0006474	EFO:1000601
benign urinary system neoplasm	4	MONDO:0004180	MONDO:0004180
urothelial carcinoma	3	MONDO:0040679	EFO:0008528

2 diseases in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.

Disease (in trials)	Phase	MONDO	EFO
exocrine pancreatic carcinoma	2	MONDO:0005192	EFO:0002618
pancreatic ductal adenocarcinoma	2	MONDO:0005184	MONDO:0005184

4 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 61.

Phase distribution

Phase	Trials
PHASE2	33
PHASE1/PHASE2	8
PHASE1	8
PHASE3	6
PHASE4	2
PHASE2/PHASE3	2
Not specified	2

Top trials by phase / activity

NCT	Phase	Status	Title
NCT06764095	PHASE4	RECRUITING	Enfortumab Vedotin and Pembrolizumab With Cystectomy and/or Ureterectomy for Locally Advanced or Metastatic Bladder and Upper Urothelial Tract Cancer, CAST-AI Trial
NCT06862219	PHASE4	RECRUITING	A Safety Study of Enfortumab Vedotin in Indian Adults With Urothelial Cancer
NCT03924895	PHASE3	ACTIVE_NOT_RECRUITING	Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)
NCT04223856	PHASE3	ACTIVE_NOT_RECRUITING	Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer
NCT04960709	PHASE3	ACTIVE_NOT_RECRUITING	Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin or Who Refuse Cisplatin
NCT06493552	PHASE2/PHASE3	RECRUITING	Modular Trial of sEphB4-HSA in EphrinB2-High Solid Tumors
NCT07346053	PHASE3	NOT_YET_RECRUITING	The Impact of Time-of-day Administration of EV/P on Objective Response Rate in Adults With Advanced Bladder Cancer
NCT07566156	PHASE3	RECRUITING	Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer ( EV-309 )
NCT03474107	PHASE3	COMPLETED	A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)
NCT04887870	PHASE2/PHASE3	COMPLETED	Study of Sitravatinib With or Without Other Anticancer Therapies Receiving Clinical Benefit From Parent Study
NCT03547973	PHASE2	RECRUITING	Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread
NCT04225117	PHASE2	ACTIVE_NOT_RECRUITING	A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)
NCT04754191	PHASE2	ACTIVE_NOT_RECRUITING	Enfortumab Vedotin as Monotherapy in Patients With Metastatic Castration-Resistant Prostate Cancer
NCT05239624	PHASE2	RECRUITING	Enfortumab Vedotin and Pembrolizumab in People With Bladder Cancer
NCT05656235	PHASE2	RECRUITING	Renal Retention in High Grade Upper Tract Urothelial Cancer
NCT05756569	PHASE2	RECRUITING	Enfortumab Vedotin Plus Pembrolizumab for the Treatment of Locally Advanced or Metastatic Bladder Cancer of Variant Histology
NCT05775471	PHASE2	RECRUITING	Pembrolizumab and Enfortumab Vedotin With Pembrolizumab Prior to and After Radical Nephroureterectomy for High-Risk Upper Tract Urothelial Cancer
NCT05868265	PHASE2	RECRUITING	A Study of Enfortumab Vedotin in People With Urothelial Carcinoma of the Upper Urinary Tract
NCT05879653	PHASE2	RECRUITING	Pembrolizumab and EV With Radiation Therapy for MIBC Patients (PEVRAD)
NCT05915351	PHASE2	ACTIVE_NOT_RECRUITING	Enfortumab Vedotin in Previously Treated Locally Advanced or Metastatic Pancreatic Cancer (EPIC)
NCT05923190	PHASE2	ACTIVE_NOT_RECRUITING	Enfortumab Vedotin Schedule De-escalation in Metastatic Urothelial Carcinoma
NCT06041503	PHASE2	RECRUITING	Enfortumab Vedotin With or Without Pembrolizumab in Rare Genitourinary Tumors (E-VIRTUE)
NCT06104618	PHASE2	RECRUITING	Enfortumab Vedotin for the Treatment of Patients With Metastatic or Unresectable Squamous Cell Carcinoma of the Penis
NCT06145308	PHASE2	RECRUITING	Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing
NCT06302569	PHASE2	RECRUITING	Pembrolizumab Plus Enfortumab Vedotin in Collecting Duct and Renal Medullary Carcinoma
NCT06305767	PHASE1/PHASE2	ACTIVE_NOT_RECRUITING	A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005)
NCT06311214	PHASE2	RECRUITING	Personalized Antibody-Drug Conjugate Therapy Based on RNA and Protein Testing for the Treatment of Advanced or Metastatic Solid Tumors (The ADC MATCH Screening and Treatment Trial)
NCT06356155	PHASE2	RECRUITING	Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Cisplatin-eligible Upper Tract Urothelial Cancer
NCT06394570	PHASE1/PHASE2	RECRUITING	Enfortumab Vedotin and Stereotactic Radiation for Localized, Cisplatin Ineligible Muscle Invasive Bladder Cancer
NCT06434350	PHASE1/PHASE2	RECRUITING	Enfortumab Vedotin With Radiation for Locally Advanced Bladder Cancer (CONSOLIDATE)
NCT06470282	PHASE1/PHASE2	RECRUITING	Enfortumab Vedotin and Pembrolizumab Combined With Radiotherapy in Muscle Invasive Bladder Cancer
NCT06483334	PHASE1/PHASE2	ACTIVE_NOT_RECRUITING	A Study of Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Plus Enfortumab Vedotin (EV) With and Without Pembrolizumab in Advanced Urothelial Carcinoma (MK-3475-04C/KEYMAKER-U04)
NCT06553885	PHASE2	RECRUITING	Ph II Study of Enfortumab Vedotin in Patients With Advanced or Metastatic CRC or HCC
NCT06809140	PHASE2	RECRUITING	Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Bladder Cancer
NCT06891560	PHASE2	RECRUITING	A Study of Enfortumab Vedotin in People With Adenoid Cystic Carcinoma
NCT06904573	PHASE2	RECRUITING	Probiotics in Advanced Urothelial Carcinoma
NCT06906822	PHASE2	RECRUITING	PLUG-IN: Pembrolizumab Combined With Enfortumab Vedotin for Advanced Melanoma Patients
NCT07087860	PHASE2	RECRUITING	Therapeutic Plasma Exchange With Enfortumab Vedotin and Pembrolizumab for Treatment of Bladder Cancers
NCT07110038	PHASE2	RECRUITING	DEPECA-1 - A Phase II Study to Evaluate a First-line Systemic Therapy With Enfortumab Vedotin Plus Avelumab for Advanced and Metastatic Penile Carcinoma
NCT07139977	PHASE2	NOT_YET_RECRUITING	Study of EV for Recurrent Endometrial Carcinoma
NCT07221942	PHASE2	RECRUITING	Pembrolizumab Maintenance After Enfortumab Vedotin (EV)/Pembro Induction in Front-Line Metastatic Urothelial Carcinoma
NCT07287995	PHASE1/PHASE2	RECRUITING	A Study of ASP2998 Given by Itself and Given With Standard Therapies in People With Solid Tumors
NCT07347314	PHASE2	RECRUITING	Enfortumab Vedotin in Patients With Advanced Small Bowel Adenocarcinoma Refractory or Intolerant to Platinum-based Combination Therapy
NCT07374549	PHASE2	NOT_YET_RECRUITING	SYS6002 vs PADCEV in Patients With Advanced Urothelial Carcinoma
NCT07421700	PHASE1/PHASE2	RECRUITING	Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer
NCT07475806	PHASE2	RECRUITING	A Study to Find Out if Enfortumab Vedotin Given With Pembrolizumab Helps People With Muscle-invasive Bladder Cancer Keep Their Bladder
NCT03219333	PHASE2	COMPLETED	A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
NCT03606174	PHASE2	TERMINATED	A Phase 2 Study of Sitravatinib in Combination With PD-(L)1 Checkpoint Inhibitor Regimens in Patients With Advanced or Metastatic Urothelial Carcinoma
NCT03869190	PHASE1/PHASE2	COMPLETED	Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)
NCT04995419	PHASE2	COMPLETED	A Study to Evaluate Enfortumab Vedotin (ASG-22CE) in Chinese Participants With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Platinum-containing Chemotherapy and Programmed Cell Death Protein-1 ( PD 1) / (Programmed Death Ligand-1 (PD-L1) Inhibitor Therapy
NCT05097599	PHASE2	TERMINATED	StrataPATH™ (Precision Indications for Approved Therapies)
NCT04878029	PHASE1	RECRUITING	Cabozantinib in Combination With Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Cancer
NCT04963153	PHASE1	ACTIVE_NOT_RECRUITING	Testing Combination Erdafitinib and Enfortumab Vedotin in Metastatic Bladder Cancer After Treatment With Chemotherapy and Immunotherapy
NCT05614739	PHASE1	RECRUITING	FORAGER-1: A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3
NCT01409135	PHASE1	COMPLETED	A Study of the Safety and Pharmacokinetics of AGS-22M6E in Subjects With Malignant Solid Tumors That Express Nectin-4
NCT02091999	PHASE1	COMPLETED	A Study of Escalating Doses of ASG-22CE Given as Monotherapy in Subjects With Metastatic Urothelial Cancer and Other Malignant Solid Tumors That Express Nectin-4
NCT03070990	PHASE1	COMPLETED	A Study of Enfortumab Vedotin in Japanese Subjects With Locally Advanced or Metastatic Urothelial Carcinoma
NCT05014139	PHASE1	TERMINATED	A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)
NCT05524545	PHASE1	COMPLETED	A Study of Evorpacept (ALX148) With Enfortumab Vedotin for Subjects With Urothelial Carcinoma (ASPEN-07)
NCT06011954	Not specified	RECRUITING	A Study to Survey Adults in South Korea With Cancer Who Receive PADCEV Injection
NCT06724159	Not specified	RECRUITING	Observational Study of the Effectiveness of Funded Drugs for Genitourinary Tumors.

Clinical evidence (CIViC)

Variant × indication × effect (1 predictive associations from 1 curated evidence items):

Variant	Indication	Effect	Therapy	Level	CIViC
NECTIN4 D594H	Cancer	Sensitivity/Response	Enfortumab Vedotin	CIViC D	EID7656

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).