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Padcev

(Enfortumab vedotin)

Phase 3Antibody–drug conjugate

Enfortumab vedotin is used to treat advanced bladder cancer (urothelial carcinoma) in patients who have already received other treatments. It works by delivering a cancer-killing toxin directly to cancer cells.[1] Padcev is currently being investigated across 22 indications[3], with its most advanced program in Phase 3.[1]

Padcev is one of 394 antibody-drug conjugate programs targeting Urinary Bladder Carcinoma. It is currently in Phase 3.

22

Indications

63

Total Trials

49

Active Trials

393

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Urinary Bladder CarcinomaActive, not recruiting

Transitional Cell CarcinomaUnknown

Adenoid Cystic CarcinomaActive, not recruiting

AdenocarcinomaActive, not recruiting

Benign Urinary System NeoplasmUnknown

Endometrial CarcinomaActive, not recruiting

Breast CancerRecruiting

MelanomaActive, not recruiting

Pancreatic CancerActive, not recruiting

Prostate CancerActive, not recruiting

Urinary Bladder CarcinomaPhase 3

Active, not recruiting

Transitional Cell CarcinomaPreclinical

Unknown

Adenoid Cystic CarcinomaPhase 2

Active, not recruiting

AdenocarcinomaPhase 2

Active, not recruiting

Benign Urinary System NeoplasmPreclinical

Unknown

Endometrial CarcinomaPhase 2

Active, not recruiting

Breast CancerPhase 2

Recruiting

MelanomaPhase 2

Active, not recruiting

Pancreatic CancerPhase 2

Active, not recruiting

Prostate CancerPhase 2

Active, not recruiting

Showing 10 of 22 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Padcev

MS Contin

Lexiscan

Adenocard

Zolymbus

MS Contin

HHikma Pharmaceuticals LLC

Effexor

WWyeth-Lederle Vaccines

Chirocaine

PPurdue Pharma LP

Acupan

YYonsei University

Vfend

PPrism Pharmaceuticals

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2Active, not recruiting

Locally Advanced or Metastatic Malignant Solid Tumors

NCT04225117

Q4 2026

Phase 2Recruiting

Squamous Cell Carcinoma

NCT06104618

Phase 1Active, not recruiting

Bladder Cancer

NCT04963153

Phase 1Recruiting

Metastatic Urothelial Cancer

NCT04878029

Q1 2027

Phase 2Active, not recruiting

Prostate Cancer

NCT04754191

Phase 2Recruiting

Adenoid Cystic Carcinoma

NCT06891560

Clinical

Trials by Indication[1]

Bladder Cancer13 trials

A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

Terminated· Astellas logo

Astellas·Phase 1·NCT05014139·37 enrolled

A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 1/2·NCT06305767·230 enrolled

Enfortumab Vedotin Plus Pembrolizumab for the Treatment of Locally Advanced or Metastatic Bladder Cancer of Variant Histology

Recruiting·EEmory University·Phase 2·NCT05756569·25 enrolled

Show 10 more trials

Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Bladder Cancer

Recruiting·MMatthew Galsky·Phase 2·NCT06809140·47 enrolled

Enfortumab Vedotin and Pembrolizumab in People With Bladder Cancer

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT05239624·23 enrolled

Enfortumab Vedotin and Pembrolizumab Combined With Radiotherapy in Muscle Invasive Bladder Cancer

Recruiting·UUniversity of California, San Francisco·Phase 1/2·NCT06470282·47 enrolled

Testing Combination Erdafitinib and Enfortumab Vedotin in Metastatic Bladder Cancer After Treatment With Chemotherapy and Immunotherapy

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT04963153·24 enrolled

Enfortumab Vedotin With Radiation for Locally Advanced Bladder Cancer (CONSOLIDATE)

Recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT06434350·41 enrolled

A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer

Completed· Astellas logo

Astellas·Phase 2·NCT03219333·219 enrolled

Therapeutic Plasma Exchange With Enfortumab Vedotin and Pembrolizumab for Treatment of Bladder Cancers

Recruiting·MMayo Clinic·Phase 2·NCT07087860·70 enrolled

Enfortumab Vedotin and Stereotactic Radiation for Localized, Cisplatin Ineligible Muscle Invasive Bladder Cancer

Recruiting·UUniversity of Texas Southwestern Medical Center·Phase 1/2·NCT06394570·19 enrolled

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

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT04960709·712 enrolled

A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-B15 / EV-304)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT04700124·808 enrolled

Urothelial Carcinoma12 trials

A Phase 2 Study of Sitravatinib in Combination With PD-(L)1 Checkpoint Inhibitor Regimens in Patients With Advanced or Metastatic Urothelial Carcinoma

Terminated·MMirati Therapeutics Inc.·Phase 2·NCT03606174·260 enrolled

Enfortumab Vedotin Schedule De-escalation in Metastatic Urothelial Carcinoma

Active, not recruiting·FFox Chase Cancer Center·Phase 2·NCT05923190·60 enrolled

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)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 1/2·NCT06483334·38 enrolled

Show 9 more trials

A Study of Evorpacept (ALX148) With Enfortumab Vedotin for Subjects With Urothelial Carcinoma (ASPEN-07)

Completed·AALX Oncology Inc.·Phase 1·NCT05524545·36 enrolled

Probiotics in Advanced Urothelial Carcinoma

Recruiting·SSun Yat-sen University·Phase 2·NCT06904573·222 enrolled

A Study of Enfortumab Vedotin in People With Urothelial Carcinoma of the Upper Urinary Tract

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT05868265·24 enrolled

Pembrolizumab Maintenance After Enfortumab Vedotin (EV)/Pembro Induction in Front-Line Metastatic Urothelial Carcinoma

Recruiting·FFox Chase Cancer Center·Phase 2·NCT07221942·97 enrolled

Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)

Completed· Roche logo

Roche·Phase 1/2·NCT03869190·272 enrolled

A Study of Enfortumab Vedotin in Japanese Subjects With Locally Advanced or Metastatic Urothelial Carcinoma

Completed· Astellas logo

Astellas·Phase 1·NCT03070990·19 enrolled

SYS6002 vs PADCEV in Patients With Advanced Urothelial Carcinoma

Not yet recruiting·CCSPC Megalith Biopharmaceutical Co.,Ltd.·Phase 2·NCT07374549·100 enrolled

An Expanded Access Treatment Protocol of Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Urothelial Carcinoma

Approved for marketing· Astellas logo

Astellas··NCT04136808

A Phase II, Open-label, Single-arm, Multi-center Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Cisplatin-eligible Upper Tract Urothelial Cancer (NEPTUNE)

Recruiting·UUniversity of Michigan Rogel Cancer Center·Phase 2·NCT06356155·32 enrolled

Urothelial Cancer9 trials

Pembrolizumab and Enfortumab Vedotin With Pembrolizumab Prior to and After Radical Nephroureterectomy for High-Risk Upper Tract Urothelial Cancer

Recruiting·JJonsson Comprehensive Cancer Center·Phase 2·NCT05775471·21 enrolled

A Safety Study of Enfortumab Vedotin in Indian Adults With Urothelial Cancer

Recruiting· Astellas logo

Astellas·Phase 4·NCT06862219·100 enrolled

A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer

Terminated· Astellas logo

Astellas·Phase 1/2·NCT03288545·348 enrolled

Show 6 more trials

N-803 in Combination With Pembrolizumab and Enfortumab Vedotin for Treatment of Urothelial Cancer

Withdrawn·VVadim S Koshkin·Phase 1·NCT07217496

Renal Retention in High Grade Upper Tract Urothelial Cancer

Recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT05656235·20 enrolled

Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread

Recruiting· Gilead logo

Gilead·Phase 2·NCT03547973·827 enrolled

AN INTERVENTIONAL PHASE 1B/2, OPEN-LABEL STUDY TO INVESTIGATE THE SAFETY, ANTITUMOR ACTIVITY, AND PHARMACOKINETICS OF PF 08634404 MONOTHERAPY OR IN COMBINATION WITH ENFORTUMAB VEDOTIN IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER

Recruiting· Pfizer logo

Pfizer·Preclinical·NCT07421700·132 enrolled

Use-result Surveillance for PADCEV Injection 20 mg and 30 mg (Enfortumab Vedotin) in South Korea

Recruiting· Astellas logo

Astellas··NCT06011954·202 enrolled

A PHASE 3, OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE ENFORTUMAB VEDOTIN IN COMBINATION WITH PEMBROLIZUMAB IN ADULT PARTICIPANTS WITH MUSCLE-INVASIVE BLADDER CANCER WHO ARE INELIGIBLE FOR OR HAVE ELECTED NOT TO UNDERGO CYSTECTOMY

Recruiting· Astellas logo

Astellas·Phase 3·NCT07566156·390 enrolled

Metastatic Urothelial Cancer5 trials

Cabozantinib in Combination With Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Cancer

Recruiting·EEmory University·Phase 1·NCT04878029·32 enrolled

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

Completed· Astellas logo

Astellas·Phase 2·NCT04995419·40 enrolled

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

Completed· Astellas logo

Astellas·Phase 1·NCT02091999·213 enrolled

Show 2 more trials

Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer

Active, not recruiting· Astellas logo

Astellas·Phase 3·NCT04223856·886 enrolled

A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)

Completed· Astellas logo

Astellas·Phase 3·NCT03474107·608 enrolled

Adenocarcinoma2 trials

Enfortumab Vedotin in Patients With Advanced Small Bowel Adenocarcinoma Refractory or Intolerant to Platinum-based Combination Therapy

Recruiting·NNational Cancer Center, Japan·Phase 2·NCT07347314·27 enrolled

A Phase II Multicenter Study of Enfortumab Vedotin With or Without Pembrolizumab in Rare Genitourinary Tumors (E-VIRTUE)

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06041503·68 enrolled

21 more indications

Solid Tumors2 trials

Modular Trial of sEphB4-HSA in EphrinB2-High Solid Tumors

Recruiting·VVasgene Therapeutics, Inc·Phase 2/3·NCT06493552·700 enrolled

A Study of ASP2998 Given by Itself and Given With Standard Therapies in People With Solid Tumors

Recruiting· Astellas logo

Astellas·Phase 1/2·NCT07287995·428 enrolled

Prostate Cancer1 trial

Enfortumab Vedotin as Monotherapy in Patients With Metastatic Castration-Resistant Prostate Cancer

Active, not recruiting·UUniversity of Utah·Phase 2·NCT04754191·34 enrolled

Cancer1 trial

FORAGER-1: A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3

Recruiting· Eli Lilly logo

Eli Lilly·Phase 1·NCT05614739·535 enrolled

Squamous Cell Carcinoma1 trial

Enfortumab Vedotin for the Treatment of Patients With Metastatic or Unresectable Squamous Cell Carcinoma of the Penis

Recruiting·MMayo Clinic·Phase 2·NCT06104618·28 enrolled

Locally Advanced or Metastatic Malignant Solid Tumors1 trial

A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)

Active, not recruiting· Astellas logo

Astellas·Phase 2·NCT04225117·329 enrolled

Salivary Gland Carcinoma1 trial

Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing

Recruiting·PPeking Union Medical College·Phase 2·NCT06145308·39 enrolled

Pancreatic Cancer1 trial

Enfortumab Vedotin in Previously Treated Locally Advanced or Metastatic Pancreatic Cancer (EPIC)

Active, not recruiting·UUniversity of Kansas Medical Center·Phase 2·NCT05915351·28 enrolled

Melanoma1 trial

PLUG-IN: Pembrolizumab Combined With Enfortumab Vedotin for Advanced Melanoma Patients

Recruiting·GGrupo Español Multidisciplinar de Melanoma·Phase 2·NCT06906822·60 enrolled

Metastatic1 trial

Ph II Study of Enfortumab Vedotin in Patients With Advanced or Metastatic CRC or HCC

Recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT06553885·40 enrolled

Advanced or Metastatic Solid Tumors1 trial

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)

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06311214·500 enrolled

Observational Study1 trial

Observational Study of the Effectiveness of Funded Drugs for Genitourinary Tumors.

Recruiting·SSpanish Oncology Genito-Urinary Group··NCT06724159·500 enrolled

Adenoid Cystic Carcinoma1 trial

A Study of Enfortumab Vedotin in People With Adenoid Cystic Carcinoma

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT06891560·34 enrolled

Locally Advanced1 trial

Enfortumab Vedotin and Pembrolizumab With Cystectomy and/or Ureterectomy for Locally Advanced or Metastatic Bladder and Upper Urothelial Tract Cancer, CAST-AI Trial

Recruiting·MMayo Clinic·Phase 4·NCT06764095·75 enrolled

Advanced Urothelial Cancer1 trial

Study of GB-4362 With Enfortumab Vedotin and Pembrolizumab for Advanced Urothelial Cancer

Not yet recruiting·GGenerate Biomedicines·Phase 1·NCT07484022·37 enrolled

Endometrial Cancer1 trial

Open-Label Phase II Trial of Enfortumab Vedotin in Recurrent or Persistent Endometrial Carcinoma

Recruiting·WWilliam Bradley·Phase 2·NCT07139977·12 enrolled

Muscle-Invasive Bladder Cancer1 trial

An Open-label, Single-Arm, Phase 2 Study to Evaluate Enfortumab Vedotin Plus Pembrolizumab for Bladder Preservation in Participants With Muscle-invasive Bladder Cancer (EV-209)

Recruiting· Astellas logo

Astellas·Phase 2·NCT07475806·240 enrolled

Urinary Bladder Cancer, Muscle-invasive1 trial

A Randomized Phase 3 Study Evaluating Cystectomy With Perioperative Pembrolizumab and Cystectomy With Perioperative Enfortumab Vedotin and Pembrolizumab Versus Cystectomy Alone in Participants Who Are Cisplatin-Ineligible or Decline Cisplatin With Muscle-Invasive Bladder Cancer (KEYNOTE-905/EV-303)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT03924895·595 enrolled

Locally Advanced Bladder Urothelial Carcinoma1 trial

A Phase Ib/II Study to Evaluate the Safety and Efficacy of Enfortumab Vedotin Plus Pembrolizumab in Combination With Quemliclustat in Unresectable Locally Advanced and Metastatic Urothelial Carcinoma

Not yet recruiting·FFred Hutchinson Cancer Center·Preclinical·NCT07667335·27 enrolled

Urinary Bladder Cancer1 trial

A Phase 2 Study to Assess Efficacy of Induction Enfortumab Vedotin Plus Pembrolizumab Using a Response-adapted Approach to Spare the Bladder: FIDELIO

Not yet recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT07663747·56 enrolled

Penile Squamous Cell Carcinoma1 trial

DEPECA-1 - DEfeating PEnile Cancer 1 - A Phase II Study to Evaluate a First-line Systemic Therapy With Enfortumab Vedotin Plus Avelumab for Advanced and Metastatic Penile Carcinoma

Recruiting·IInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest·Phase 2·NCT07110038·25 enrolled

Unspecified1 trial

StrataPATH™ (Precision Indications for Approved Therapies)

Terminated·SStrata Oncology·Phase 2·NCT05097599·11 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 18, 2019

PADCEV EJFV

BLA BLA761137

Sources

References

[1]
ClinicalTrials.gov — 63 trial records for Enfortumab vedotin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Enfortumab vedotin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Enfortumab vedotin. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761137). U.S. Food & Drug Administration.
[5]
PubMed — 1 publication indexed for Enfortumab vedotin. U.S. National Library of Medicine.
[6]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Nectin-4 ADC[2]
Modality: Antibody–drug conjugate[2]
Highest Phase: Phase 3[1]
Company: Pfizer

Key Publications[5]

Enfortumab Vedotin Plus Pembrolizumab in Urothelial Cancer: EV-302

N Engl J MedDec 14, 2023DOI: 10.1056/NEJMoa2312117

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