{"id":"padcev","rwe":[{"pmid":"41551852","year":"2025","title":"A zirconium-89-labeled antibody-drug conjugate PET probe for noninvasive monitoring of Nectin4 expression in breast cancer and lung cancer.","finding":"","journal":"Cell reports. Physical science","studyType":"Clinical Study"},{"pmid":"41183712","year":"2026","title":"Post-market surveillance data demonstrate high mortality associated with enfortumab vedotin skin toxicity, not worsened by immune checkpoint inhibitors or corticosteroids.","finding":"","journal":"Journal of the American Academy of Dermatology","studyType":"Clinical Study"},{"pmid":"41001717","year":"2025","title":"Advanced Antibody-Drug Conjugates Design: Innovation in Linker Chemistry and Site-Specific Conjugation Technologies.","finding":"","journal":"Chembiochem : a European journal of chemical biology","studyType":"Clinical Study"},{"pmid":"40907809","year":"2025","title":"Aligning organ-specific toxicities with formulation strategies: a rational design approach to chemotherapy optimization.","finding":"","journal":"International journal of pharmaceutics","studyType":"Clinical Study"},{"pmid":"40507807","year":"2025","title":"Mechanistic Insights into Anti-Nectin4-VcMMAE-Induced Ocular Toxicity: From Cellular Uptake Pathways to Molecular Modification.","finding":"","journal":"International journal of molecular sciences","studyType":"Clinical Study"}],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Nectin-4","category":"target"},{"label":"NECTIN4","category":"gene"},{"label":"TUBB","category":"gene"},{"label":"TUBB1","category":"gene"},{"label":"L01FX13","category":"atc"},{"label":"Intravenous","category":"route"},{"label":"Injection","category":"form"},{"label":"Active","category":"status"},{"label":"Metastatic urothelial carcinoma","category":"indication"},{"label":"Astellas","category":"company"},{"label":"Approved 2010s","category":"decade"}],"phase":"marketed","safety":{"safetySignals":[{"llr":301.576,"date":"","count":137,"signal":"Malignant neoplasm progression","source":"DrugCentral FAERS","actionTaken":"Reported 137 times (LLR=302)"},{"llr":240.957,"date":"","count":68,"signal":"Taste disorder","source":"DrugCentral FAERS","actionTaken":"Reported 68 times (LLR=241)"},{"llr":206.693,"date":"","count":112,"signal":"Neuropathy peripheral","source":"DrugCentral FAERS","actionTaken":"Reported 112 times (LLR=207)"},{"llr":186.732,"date":"","count":67,"signal":"Myelosuppression","source":"DrugCentral FAERS","actionTaken":"Reported 67 times (LLR=187)"},{"llr":167.899,"date":"","count":170,"signal":"Rash","source":"DrugCentral FAERS","actionTaken":"Reported 170 times (LLR=168)"},{"llr":144.049,"date":"","count":66,"signal":"Hyperglycaemia","source":"DrugCentral FAERS","actionTaken":"Reported 66 times (LLR=144)"},{"llr":122.214,"date":"","count":49,"signal":"Skin disorder","source":"DrugCentral FAERS","actionTaken":"Reported 49 times (LLR=122)"},{"llr":97.83,"date":"","count":95,"signal":"Decreased appetite","source":"DrugCentral FAERS","actionTaken":"Reported 95 times (LLR=98)"},{"llr":59.385,"date":"","count":20,"signal":"Skin toxicity","source":"DrugCentral FAERS","actionTaken":"Reported 20 times (LLR=59)"},{"llr":58.32,"date":"","count":30,"signal":"Toxic epidermal necrolysis","source":"DrugCentral FAERS","actionTaken":"Reported 30 times (LLR=58)"},{"llr":57.567,"date":"","count":29,"signal":"Stevens-Johnson syndrome","source":"DrugCentral FAERS","actionTaken":"Reported 29 times (LLR=58)"},{"llr":49.636,"date":"","count":64,"signal":"Alopecia","source":"DrugCentral FAERS","actionTaken":"Reported 64 times (LLR=50)"},{"llr":47.8,"date":"","count":80,"signal":"Malaise","source":"DrugCentral FAERS","actionTaken":"Reported 80 times (LLR=48)"},{"llr":45.97,"date":"","count":31,"signal":"Hepatic function abnormal","source":"DrugCentral FAERS","actionTaken":"Reported 31 times (LLR=46)"},{"llr":43.71,"date":"","count":70,"signal":"Pruritus","source":"DrugCentral FAERS","actionTaken":"Reported 70 times (LLR=44)"}],"commonSideEffects":[{"type":"common","effect":"Alopecia","drugRate":"44.9%","organSystem":"Skin and subcutaneous tissue disorders","placeboRate":"","totalAtRisk":336,"totalAffected":151,"trialsReporting":2},{"type":"common","effect":"Decreased appetite","drugRate":"43.2%","organSystem":"Metabolism and nutrition disorders","placeboRate":"","totalAtRisk":336,"totalAffected":145,"trialsReporting":2},{"type":"common","effect":"Diarrhoea","drugRate":"34.8%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":336,"totalAffected":117,"trialsReporting":2},{"type":"common","effect":"Fatigue","drugRate":"34.8%","organSystem":"General disorders","placeboRate":"","totalAtRisk":336,"totalAffected":117,"trialsReporting":2},{"type":"common","effect":"Pruritus","drugRate":"34.5%","organSystem":"Skin and subcutaneous tissue disorders","placeboRate":"","totalAtRisk":336,"totalAffected":116,"trialsReporting":2},{"type":"common","effect":"Nausea","drugRate":"32.4%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":336,"totalAffected":109,"trialsReporting":2},{"type":"common","effect":"Peripheral sensory neuropathy","drugRate":"31.0%","organSystem":"Nervous system disorders","placeboRate":"","totalAtRisk":336,"totalAffected":104,"trialsReporting":2},{"type":"common","effect":"Constipation","drugRate":"29.8%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":336,"totalAffected":100,"trialsReporting":2},{"type":"common","effect":"Anaemia","drugRate":"25.3%","organSystem":"Blood and lymphatic system disorders","placeboRate":"","totalAtRisk":336,"totalAffected":85,"trialsReporting":2},{"type":"common","effect":"Dysgeusia","drugRate":"25.0%","organSystem":"Nervous system disorders","placeboRate":"","totalAtRisk":336,"totalAffected":84,"trialsReporting":2},{"type":"common","effect":"Pyrexia","drugRate":"22.0%","organSystem":"General disorders","placeboRate":"","totalAtRisk":336,"totalAffected":74,"trialsReporting":2},{"type":"common","effect":"Rash","drugRate":"19.6%","organSystem":"Skin and subcutaneous tissue disorders","placeboRate":"","totalAtRisk":336,"totalAffected":66,"trialsReporting":2},{"type":"common","effect":"Aspartate aminotransferase increased","drugRate":"18.5%","organSystem":"Investigations","placeboRate":"","totalAtRisk":336,"totalAffected":62,"trialsReporting":2},{"type":"common","effect":"Weight decreased","drugRate":"17.0%","organSystem":"Investigations","placeboRate":"","totalAtRisk":336,"totalAffected":57,"trialsReporting":2},{"type":"common","effect":"Rash maculo-papular","drugRate":"16.4%","organSystem":"Skin and subcutaneous tissue disorders","placeboRate":"","totalAtRisk":336,"totalAffected":55,"trialsReporting":2},{"type":"common","effect":"Neutrophil count decreased","drugRate":"15.2%","organSystem":"Investigations","placeboRate":"","totalAtRisk":336,"totalAffected":51,"trialsReporting":2},{"type":"common","effect":"Vomiting","drugRate":"14.9%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":336,"totalAffected":50,"trialsReporting":2},{"type":"common","effect":"Dry skin","drugRate":"16.9%","organSystem":"Skin and subcutaneous tissue disorders","placeboRate":"","totalAtRisk":296,"totalAffected":50,"trialsReporting":1},{"type":"common","effect":"Hyperglycaemia","drugRate":"14.3%","organSystem":"Metabolism and nutrition disorders","placeboRate":"","totalAtRisk":336,"totalAffected":48,"trialsReporting":2},{"type":"common","effect":"Asthenia","drugRate":"14.0%","organSystem":"General disorders","placeboRate":"","totalAtRisk":336,"totalAffected":47,"trialsReporting":2},{"type":"common","effect":"Alanine aminotransferase increased","drugRate":"13.4%","organSystem":"Investigations","placeboRate":"","totalAtRisk":336,"totalAffected":45,"trialsReporting":2},{"type":"common","effect":"Abdominal pain","drugRate":"12.2%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":336,"totalAffected":41,"trialsReporting":2},{"type":"common","effect":"Insomnia","drugRate":"11.6%","organSystem":"Psychiatric disorders","placeboRate":"","totalAtRisk":336,"totalAffected":39,"trialsReporting":2},{"type":"common","effect":"Hypokalaemia","drugRate":"10.1%","organSystem":"Metabolism and nutrition disorders","placeboRate":"","totalAtRisk":336,"totalAffected":34,"trialsReporting":2},{"type":"common","effect":"Haematuria","drugRate":"10.1%","organSystem":"Renal and urinary disorders","placeboRate":"","totalAtRisk":336,"totalAffected":34,"trialsReporting":2},{"type":"common","effect":"Oedema peripheral","drugRate":"9.5%","organSystem":"General disorders","placeboRate":"","totalAtRisk":336,"totalAffected":32,"trialsReporting":2},{"type":"common","effect":"White blood cell count decreased","drugRate":"9.5%","organSystem":"Investigations","placeboRate":"","totalAtRisk":336,"totalAffected":32,"trialsReporting":2},{"type":"common","effect":"Hyponatraemia","drugRate":"9.5%","organSystem":"Metabolism and nutrition disorders","placeboRate":"","totalAtRisk":336,"totalAffected":32,"trialsReporting":2},{"type":"common","effect":"Cough","drugRate":"9.5%","organSystem":"Respiratory, thoracic and mediastinal disorders","placeboRate":"","totalAtRisk":336,"totalAffected":32,"trialsReporting":2},{"type":"common","effect":"Blood creatinine increased","drugRate":"9.2%","organSystem":"Investigations","placeboRate":"","totalAtRisk":336,"totalAffected":31,"trialsReporting":2},{"type":"common","effect":"Lacrimation increased","drugRate":"10.1%","organSystem":"Eye disorders","placeboRate":"","totalAtRisk":296,"totalAffected":30,"trialsReporting":1},{"type":"common","effect":"Drug eruption","drugRate":"8.9%","organSystem":"Skin and subcutaneous tissue disorders","placeboRate":"","totalAtRisk":336,"totalAffected":30,"trialsReporting":2},{"type":"common","effect":"Stomatitis","drugRate":"8.6%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":336,"totalAffected":29,"trialsReporting":2},{"type":"common","effect":"Back pain","drugRate":"8.6%","organSystem":"Musculoskeletal and connective tissue disorders","placeboRate":"","totalAtRisk":336,"totalAffected":29,"trialsReporting":2},{"type":"common","effect":"Dizziness","drugRate":"8.6%","organSystem":"Nervous system disorders","placeboRate":"","totalAtRisk":336,"totalAffected":29,"trialsReporting":2},{"type":"common","effect":"Neuropathy peripheral","drugRate":"8.3%","organSystem":"Nervous system disorders","placeboRate":"","totalAtRisk":336,"totalAffected":28,"trialsReporting":2},{"type":"common","effect":"Dyspepsia","drugRate":"7.7%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":336,"totalAffected":26,"trialsReporting":2},{"type":"common","effect":"Dyspnoea","drugRate":"8.4%","organSystem":"Respiratory, thoracic and mediastinal disorders","placeboRate":"","totalAtRisk":296,"totalAffected":25,"trialsReporting":1},{"type":"common","effect":"Dry mouth","drugRate":"8.1%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":296,"totalAffected":24,"trialsReporting":1},{"type":"common","effect":"Urinary tract infection","drugRate":"7.1%","organSystem":"Infections and infestations","placeboRate":"","totalAtRisk":336,"totalAffected":24,"trialsReporting":2},{"type":"common","effect":"Dry eye","drugRate":"6.5%","organSystem":"Eye disorders","placeboRate":"","totalAtRisk":336,"totalAffected":22,"trialsReporting":2},{"type":"common","effect":"Arthralgia","drugRate":"6.4%","organSystem":"Musculoskeletal and connective tissue disorders","placeboRate":"","totalAtRisk":296,"totalAffected":19,"trialsReporting":1},{"type":"common","effect":"Muscular weakness","drugRate":"5.7%","organSystem":"Musculoskeletal and connective tissue disorders","placeboRate":"","totalAtRisk":336,"totalAffected":19,"trialsReporting":2},{"type":"common","effect":"Skin hyperpigmentation","drugRate":"6.4%","organSystem":"Skin and subcutaneous tissue disorders","placeboRate":"","totalAtRisk":296,"totalAffected":19,"trialsReporting":1},{"type":"common","effect":"Vision blurred","drugRate":"5.4%","organSystem":"Eye disorders","placeboRate":"","totalAtRisk":336,"totalAffected":18,"trialsReporting":2},{"type":"common","effect":"Malaise","drugRate":"5.4%","organSystem":"General disorders","placeboRate":"","totalAtRisk":336,"totalAffected":18,"trialsReporting":2},{"type":"common","effect":"Conjunctivitis","drugRate":"6.1%","organSystem":"Infections and infestations","placeboRate":"","totalAtRisk":296,"totalAffected":18,"trialsReporting":1},{"type":"common","effect":"Hypomagnesaemia","drugRate":"6.1%","organSystem":"Metabolism and nutrition disorders","placeboRate":"","totalAtRisk":296,"totalAffected":18,"trialsReporting":1},{"type":"common","effect":"Pain in extremity","drugRate":"5.4%","organSystem":"Musculoskeletal and connective tissue disorders","placeboRate":"","totalAtRisk":336,"totalAffected":18,"trialsReporting":2},{"type":"common","effect":"Myalgia","drugRate":"5.1%","organSystem":"Musculoskeletal and connective tissue disorders","placeboRate":"","totalAtRisk":336,"totalAffected":17,"trialsReporting":2}],"specialPopulations":{"Lactation":"There are no data on the presence of enfortumab vedotin-ejfv in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in breastfed child, advise lactating women not to breastfeed during treatment with PADCEV and for at least 4 weeks after the last dose.","Pregnancy":"Based on the mechanism of action and findings in animals, PADCEV can cause fetal harm when administered to pregnant woman. There are no available human data on PADCEV use in pregnant women to inform drug-associated risk. In an animal reproduction study, administration of enfortumab vedotin-ejfv to pregnant rats during organogenesis caused maternal toxicity, embryo-fetal lethality, structural malformations and skeletal anomalies at maternal exposures similar to the exposures at the recommended human dose of 1.25 mg/kg. Advise patients of the potential risk to the fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively.","Geriatric use":"Of the 680 patients treated with PADCEV in clinical trials, 440 (65%) were 65 years or older and 168 (25%) were 75 years or older. No overall differences in safety or effectiveness were observed between these patients and younger patients.","Paediatric use":"Safety and effectiveness of PADCEV in pediatric patients have not been established."},"seriousAdverseEvents":[{"event":"Acute kidney injury","detail":"MedDRA: Renal and urinary disorders. Reported in 1 trial(s).","severity":"serious","incidence":"6.4%"},{"event":"Pneumonia","detail":"MedDRA: Infections and infestations. Reported in 2 trial(s).","severity":"serious","incidence":"5.1%"},{"event":"Malignant neoplasm progression","detail":"MedDRA: Neoplasms benign, malignant and unspecified (incl cysts and polyps). Reported in 2 trial(s).","severity":"serious","incidence":"4.2%"},{"event":"Urinary tract infection bacterial","detail":"MedDRA: Infections and infestations. Reported in 1 trial(s).","severity":"serious","incidence":"3.0%"},{"event":"Urinary tract infection","detail":"MedDRA: Infections and infestations. Reported in 2 trial(s).","severity":"serious","incidence":"2.4%"},{"event":"Diarrhoea","detail":"MedDRA: Gastrointestinal disorders. Reported in 1 trial(s).","severity":"serious","incidence":"2.4%"},{"event":"Pyrexia","detail":"MedDRA: General disorders. Reported in 2 trial(s).","severity":"serious","incidence":"2.1%"},{"event":"Rash","detail":"MedDRA: Skin and subcutaneous tissue disorders. Reported in 2 trial(s).","severity":"serious","incidence":"1.8%"},{"event":"Atrial fibrillation","detail":"MedDRA: Cardiac disorders. Reported in 1 trial(s).","severity":"serious","incidence":"1.7%"},{"event":"Vomiting","detail":"MedDRA: Gastrointestinal disorders. Reported in 1 trial(s).","severity":"serious","incidence":"1.7%"},{"event":"Sepsis","detail":"MedDRA: Infections and infestations. Reported in 1 trial(s).","severity":"serious","incidence":"1.7%"},{"event":"Decreased appetite","detail":"MedDRA: Metabolism and nutrition disorders. Reported in 1 trial(s).","severity":"serious","incidence":"1.7%"},{"event":"Hyperglycaemia","detail":"MedDRA: Metabolism and nutrition disorders. Reported in 2 trial(s).","severity":"serious","incidence":"1.5%"},{"event":"Haematuria","detail":"MedDRA: Renal and urinary disorders. Reported in 1 trial(s).","severity":"serious","incidence":"1.7%"},{"event":"Anaemia","detail":"MedDRA: Blood and lymphatic system disorders. Reported in 1 trial(s).","severity":"serious","incidence":"1.4%"},{"event":"Febrile neutropenia","detail":"MedDRA: Blood and lymphatic system disorders. Reported in 1 trial(s).","severity":"serious","incidence":"1.4%"},{"event":"Neutropenia","detail":"MedDRA: Blood and lymphatic system disorders. Reported in 1 trial(s).","severity":"serious","incidence":"1.4%"},{"event":"Septic shock","detail":"MedDRA: Infections and infestations. Reported in 1 trial(s).","severity":"serious","incidence":"1.4%"},{"event":"Neutrophil count decreased","detail":"MedDRA: Investigations. Reported in 2 trial(s).","severity":"serious","incidence":"1.2%"},{"event":"Dyspnoea","detail":"MedDRA: Respiratory, thoracic and mediastinal disorders. Reported in 1 trial(s).","severity":"serious","incidence":"1.4%"},{"event":"Drug eruption","detail":"MedDRA: Skin and subcutaneous tissue disorders. Reported in 2 trial(s).","severity":"serious","incidence":"1.2%"},{"event":"Rash maculo-papular","detail":"MedDRA: Skin and subcutaneous tissue disorders. Reported in 1 trial(s).","severity":"serious","incidence":"1.4%"},{"event":"Cataract","detail":"MedDRA: Eye disorders. Reported in 2 trial(s).","severity":"serious","incidence":"0.9%"},{"event":"Abdominal pain","detail":"MedDRA: Gastrointestinal disorders. Reported in 1 trial(s).","severity":"serious","incidence":"1.0%"},{"event":"Asthenia","detail":"MedDRA: General disorders. Reported in 1 trial(s).","severity":"serious","incidence":"1.0%"},{"event":"Fatigue","detail":"MedDRA: General disorders. Reported in 1 trial(s).","severity":"serious","incidence":"1.0%"},{"event":"Multiple organ dysfunction syndrome","detail":"MedDRA: General disorders. Reported in 1 trial(s).","severity":"serious","incidence":"1.0%"},{"event":"Cellulitis","detail":"MedDRA: Infections and infestations. Reported in 1 trial(s).","severity":"serious","incidence":"1.0%"},{"event":"Escherichia urinary tract infection","detail":"MedDRA: Infections and infestations. Reported in 1 trial(s).","severity":"serious","incidence":"1.0%"},{"event":"Hyponatraemia","detail":"MedDRA: Metabolism and nutrition disorders. Reported in 2 trial(s).","severity":"serious","incidence":"0.9%"}]},"trials":[],"aliases":[],"company":"Astellas Pharma","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=padcev","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:37:14.404288+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book + Purple Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T07:30:09.396758+00:00"},"dailyMed":{"url":"","method":"api_direct","source":"DailyMed (NIH/NLM)","rawText":"","confidence":1,"sourceType":"dailymed","retrievedAt":"2026-04-20T07:29:57.090839+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Padcev","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-19T23:37:21.746128+00:00"},"chemblData":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3301589/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T07:30:03.087832+00:00"},"trialDetails":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (2 trials with endpoints)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-20T07:30:11.726417+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:37:20.311844+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:37:14.471563+00:00"},"publicationCount":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T07:30:01.796922+00:00"},"recentPublications":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T07:30:02.724851+00:00"},"rxnormFormulations":{"url":"https://rxnav.nlm.nih.gov/REST/drugs.json?name=padcev","method":"api_direct","source":"RxNorm (NIH)","rawText":"","confidence":1,"sourceType":"rxnorm","retrievedAt":"2026-04-20T07:29:56.003677+00:00"},"participantFlowData":{"url":"","method":"deterministic","source":"ClinicalTrials.gov participantFlowModule","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-20T07:30:11.726394+00:00"},"structuredTrialResults":{"url":"","method":"deterministic","source":"ClinicalTrials.gov resultsSection (2 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-20T07:30:11.726386+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Tubulin inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:37:21.746088+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3301589/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:37:21.404276+00:00"},"safety.commonSideEffects":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (2 trials with results)","rawText":"Aggregated from 2 trials. Top AE: Alopecia (44.9%)","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-20T07:30:11.726139+00:00"},"safety.seriousAdverseEvents":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (2 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-20T07:30:11.726155+00:00"}},"allNames":"enfortumab","dailyMed":[{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b5631d3e-4604-4363-8f20-11dfc5a4a8ed","setid":"b5631d3e-4604-4363-8f20-11dfc5a4a8ed","title":"PADCEV EJFV (ENFORTUMAB VEDOTIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SEAGEN INC.]"}],"offLabel":[],"synonyms":["enfortumab","enfortumab vedotin","enfortumab-vedotin-ejfv","padcev","AGS-22CE","AGS-22ME","AGS-22M6E","enfortumab vedotin (genetical recombination)"],"timeline":[{"date":"2019-12-18","type":"positive","source":"DrugCentral","milestone":"FDA approval (Astellas)"},{"date":"2021-09-27","type":"positive","source":"DrugCentral","milestone":"PMDA approval (Astellas Pharma Inc.)"},{"date":"2022-04-13","type":"positive","source":"DrugCentral","milestone":"EMA approval (Astellas Pharma Europe B.V.)"}],"aiSummary":"Enfortumab (padcev) is a small molecule drug developed by Astellas, targeting Nectin-4. It was FDA-approved in 2019 for the treatment of metastatic urothelial carcinoma. Enfortumab is a patented medication with a half-life of approximately 3.6 days. Key safety considerations include potential side effects such as fatigue, nausea, and skin reactions. As a relatively new medication, its long-term safety profile is still being evaluated.","brandName":"Enfortumab","ecosystem":[{"indication":"Metastatic urothelial carcinoma","otherDrugs":[{"name":"erdafitinib","slug":"erdafitinib","company":"Janssen Biotech"}],"globalPrevalence":null}],"mechanism":{"target":"Nectin-4","novelty":"Follow-on","targets":[{"gene":"NECTIN4","source":"DrugCentral","target":"Nectin-4","protein":"Nectin-4"},{"gene":"TUBB","source":"DrugCentral","target":"Tubulin beta","protein":"Tubulin beta chain"},{"gene":"TUBB1","source":"DrugCentral","target":"Tubulin beta","protein":"Tubulin beta-1 chain"},{"gene":"TUBB2A","source":"DrugCentral","target":"Tubulin beta","protein":"Tubulin beta-2A chain"},{"gene":"TUBB2B","source":"DrugCentral","target":"Tubulin beta","protein":"Tubulin beta-2B chain"},{"gene":"TUBB3","source":"DrugCentral","target":"Tubulin beta","protein":"Tubulin beta-3 chain"},{"gene":"TUBB4A","source":"DrugCentral","target":"Tubulin beta","protein":"Tubulin beta-4A chain"},{"gene":"TUBB4B","source":"DrugCentral","target":"Tubulin beta","protein":"Tubulin beta-4B chain"},{"gene":"TUBB6","source":"DrugCentral","target":"Tubulin beta","protein":"Tubulin beta-6 chain"},{"gene":"TUBB8","source":"DrugCentral","target":"Tubulin beta","protein":"Tubulin beta-8 chain"}],"modality":"Small Molecule","explanation":"","oneSentence":"","technicalDetail":"Enfortumab is a small molecule inhibitor that selectively binds to Nectin-4, a transmembrane protein expressed on the surface of urothelial carcinoma cells, thereby preventing its interaction with its ligand, nectin-1, and inhibiting cell growth and survival."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Enfortumab_vedotin","title":"Enfortumab vedotin","extract":"Enfortumab vedotin, sold under the brand name Padcev, is an antibody-drug conjugate used for the treatment of urothelial cancer. It is a nectin-4-directed antibody and microtubule inhibitor conjugate. Enfortumab refers to the monoclonal antibody part, and vedotin refers to the payload drug (MMAE) and the linker.","wiki_history":"==History==\nResults of a Phase I clinical trial were reported in 2016.\n\nIn December 2019, enfortumab vedotin was approved in the United States for the treatment of adult patients with locally advanced or metastatic urothelial cancer who had previously received a programmed cell death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor and a platinum-containing chemotherapy. The approval was based on the results of a clinical trial of 125 such patients.","wiki_society_and_culture":"== Society and culture ==\n\n=== Legal status ===\nOn 16 December 2021, and on 24 February 2022, the Committee for Medicinal Products for Human Use (CHMP)  of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Padcev, intended for the treatment of adults with urothelial cancer. Enfortumab vedotin was approved for medical use in the European Union in April 2022.\n\n=== Names ===\nEnfortumab vedotin is the international nonproprietary name (INN), and the United States Adopted Name (USAN)."},"chemblData":{"prodrug":0,"chemblId":"CHEMBL3301589","maxPhase":"4.0","chirality":1,"parenteral":true,"availability":1,"moleculeType":"Antibody drug 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govitecan","drugSlug":"sacituzumab-govitecan","fdaApproval":"2020-04-04","relationship":"same-class"},{"drugName":"amivantamab","drugSlug":"amivantamab","fdaApproval":"2021-05-21","relationship":"same-class"},{"drugName":"tremelimumab","drugSlug":"tremelimumab","fdaApproval":"2022-10-21","relationship":"same-class"},{"drugName":"naxitamab","drugSlug":"naxitamab","fdaApproval":"2020-11-25","relationship":"same-class"},{"drugName":"loncastuximab tesirine","drugSlug":"loncastuximab-tesirine","fdaApproval":"2021-04-23","relationship":"same-class"},{"drugName":"tisotumab vedotin","drugSlug":"tisotumab-vedotin","fdaApproval":"2021-09-20","relationship":"same-class"}],"genericName":"padcev","indications":{"approved":[{"name":"Metastatic urothelial carcinoma","source":"DrugCentral","snomedId":"","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"gemtuzumab-ozogamicin","brandName":"gemtuzumab ozogamicin","genericName":"gemtuzumab ozogamicin","approvalYear":"2000","relationship":"same-class"},{"drugId":"ipilimumab","brandName":"ipilimumab","genericName":"ipilimumab","approvalYear":"2011","relationship":"same-class"},{"drugId":"brentuximab-vedotin","brandName":"brentuximab vedotin","genericName":"brentuximab 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mafodotin","approvalYear":"2020","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT03474107","phase":"PHASE3","title":"A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)","status":"","acronym":null,"sponsor":"Astellas Pharma Global Development, Inc.","isPivotal":true,"primaryCI":"[0.556, 0.886]","primaryHR":"0.702","enrollment":608,"indication":"Ureteral Cancer, Urothelial Cancer","endpointCount":9,"primaryPValue":"0.00142","completionDate":"","primaryEndpoint":"Overall Survival (OS)"},{"nctId":"NCT04995419","phase":"PHASE2","title":"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","status":"","acronym":null,"sponsor":"Astellas Pharma China, Inc.","isPivotal":false,"primaryCI":"","primaryHR":"","enrollment":40,"indication":"Metastatic Urothelial Cancer","endpointCount":33,"primaryPValue":"","completionDate":"","primaryEndpoint":"Objective Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors V1.1 (RECIST V1.1)"}],"_emaApprovals":[{"date":"2022-04-13","status":"Authorised","company":"ASTELLAS PHARMA EUROPE B.V."}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"pivotalTrials":["NCT03474107"],"administration":{"route":"Intravenous","formulation":"Injection","formulations":[{"form":"INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","route":"INTRAVENOUS","productName":"PADCEVEJFV"}]},"crossReferences":{"MMSL":"328359","NDDF":"018235","UNII":"DLE8519RWM","VANDF":"4039044","INN_ID":"9821","RXNORM":"2268093","UMLSCUI":"C4519740","chemblId":"CHEMBL3301589","ChEMBL_ID":"CHEMBL3301589","KEGG_DRUG":"D11525","DRUGBANK_ID":"DB13007","SNOMEDCT_US":"836465002","IUPHAR_LIGAND_ID":"10738","SECONDARY_CAS_RN":"1448664-46-7","MESH_SUPPLEMENTAL_RECORD_UI":"C000632577"},"formularyStatus":[],"_enricherVersion":"v2","chemblMechanisms":[{"actionType":"BINDING AGENT","targetChemblId":"CHEMBL3712928","mechanismComment":null,"mechanismOfAction":"Nectin-4 binding agent"},{"actionType":"INHIBITOR","targetChemblId":"CHEMBL2095182","mechanismComment":null,"mechanismOfAction":"Tubulin inhibitor"}],"developmentCodes":[],"ownershipHistory":[{"period":"2019-","companyName":"Astellas","relationship":"Original Developer"},{"period":"2021","companyName":"Astellas Pharma Inc.","relationship":"PMDA 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Injection"}],"_revenueClearedDupe":"ags-22m6e","participantFlowData":[{"nctId":"NCT03474107","groups":[{"id":"FG000","title":"Enfortumab Vedotin 1.25mg/kg","description":"Participants received 1.25 milligrams per kilogram (mg/kg) of body weight enfortumab vedotin by intravenous (IV) infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Parti"},{"id":"FG001","title":"Chemotherapy","description":"Participants received either 75 milligram per square meter (mg/m\\^2) docetaxel by IV infusion over approximately 1 hour or 320 mg/m\\^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg"}],"acronym":null,"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","counts":{"FG000":"301","FG001":"307"}},{"type":"Treated","counts":{"FG000":"296","FG001":"291"}},{"type":"COMPLETED","counts":{"FG000":"56","FG001":"22"}},{"type":"NOT COMPLETED","counts":{"FG000":"245","FG001":"285"}}],"dropWithdraws":[{"type":"Adverse Event","counts":{"FG000":"42","FG001":"46"}},{"type":"Death","counts":{"FG000":"2","FG001":"2"}},{"type":"Lost to Follow-up","counts":{"FG000":"0","FG001":"1"}},{"type":"Progressive Disease","counts":{"FG000":"177","FG001":"180"}},{"type":"Protocol Violation","counts":{"FG000":"1","FG001":"1"}},{"type":"Withdrawal by Subject","counts":{"FG000":"15","FG001":"27"}},{"type":"Physician Decision","counts":{"FG000":"7","FG001":"22"}},{"type":"Miscellaneous","counts":{"FG000":"1","FG001":"6"}}]}],"recruitment":"Adult participants with locally advanced or metastatic urothelial cancer (mUC) who had received a platinum-containing chemotherapy and had experienced disease progression or relapse during or following treatment with programmed cell death protein-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitors.","preAssignment":"Participants were stratified by Eastern Cooperative Oncology Group Performance Status (ECOG PS) (0 vs 1), regions of the world Western EU vs US vs Rest of World) and liver metastasis (Yes vs No)."},{"nctId":"NCT04995419","groups":[{"id":"FG000","title":"Enfortumab Vedotin 1.25 mg/kg","description":"Participants received 1.25 milligrams per kilogram (mg/kg) of body weight enfortumab vedotin by intravenous (IV) infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Parti"}],"acronym":null,"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","counts":{"FG000":"40"}},{"type":"COMPLETED","counts":{"FG000":"0"}},{"type":"NOT COMPLETED","counts":{"FG000":"40"}}],"dropWithdraws":[{"type":"Withdrawal by Subject","counts":{"FG000":"3"}},{"type":"Progressive Disease","counts":{"FG000":"19"}},{"type":"Adverse Event","counts":{"FG000":"2"}},{"type":"Ongoing","counts":{"FG000":"16"}}]}],"recruitment":"Adult Chinese participants with locally advanced or metastatic urothelial cancer (mUC) who had received a platinum-containing chemotherapy and programmed cell death protein-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitors.","preAssignment":"Participants who met inclusion criteria and none of the exclusion criteria were enrolled."}],"companionDiagnostics":[],"structuredTrialResults":[{"nctId":"NCT03474107","phase":"PHASE3","title":"A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)","acronym":null,"sponsor":"Astellas Pharma Global Development, Inc.","isPivotal":true,"conditions":["Ureteral Cancer","Urothelial Cancer","Bladder Cancer"],"enrollment":608,"otherEndpoints":[],"primaryEndpoints":[{"type":"PRIMARY","title":"Overall Survival (OS)","results":[{"value":"12.88","spread":"","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"10.58","upperLimit":"15.21"},{"value":"8.97","spread":"","groupId":"OG001","groupTitle":"Chemotherapy","lowerLimit":"8.05","upperLimit":"10.74"}],"analyses":[{"ciPct":"95","pValue":"0.00142","ciLower":"0.556","ciUpper":"0.886","groupIds":["OG000","OG001"],"estimateType":"Stratified Hazard Ratio","estimateValue":"0.702","pValueComment":"Stratification factors were ECOG PS, geographic region and liver metastasis. P-value was based on log-rank test. P-value of overall survival is ≤ the predetermined 1-sided significance level of 0.00679 based on the number of observed deaths.","dispersionType":"","dispersionValue":"","groupDescription":"","statisticalMethod":"Stratified Log rank","statisticalComment":"","testedNonInferiority":"SUPERIORITY"}],"paramType":"MEDIAN","timeFrame":"From randomization until the analysis cut-off date of 15-Jul-2020 (median OS follow-up was 11.10 months)","description":"OS was defined as the time from the date of randomization until the documented date of death from any cause. OS was analyzed using Kaplan-Meier estimates. Participants who were still alive at the time of data cutoff date were to be censored at the last known alive date or at the data cutoff date, whichever was earlier.","unitOfMeasure":"months","reportingStatus":"POSTED"}],"secondaryEndpoints":[{"type":"SECONDARY","title":"Progression Free Survival on Study Therapy (PFS1) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)","results":[{"value":"5.55","spread":"","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"5.32","upperLimit":"5.82"},{"value":"3.71","spread":"","groupId":"OG001","groupTitle":"Chemotherapy","lowerLimit":"3.52","upperLimit":"3.94"}],"analyses":[{"ciPct":"95","pValue":"<0.00001","ciLower":"0.505","ciUpper":"0.748","groupIds":["OG000","OG001"],"estimateType":"Stratified Hazard Ratio","estimateValue":"0.615","pValueComment":"Stratification factors were ECOG PS, geographic region and liver metastasis. P-value was based on log-rank test. P value of PFS is ≤ the predetermined 1-sided significance level of 0.02189 based on the number of observed PFS events.","dispersionType":"","dispersionValue":"","groupDescription":"","statisticalMethod":"Stratified Log Rank","statisticalComment":"","testedNonInferiority":"SUPERIORITY"}],"paramType":"MEDIAN","timeFrame":"From randomization until the analysis cut-off date of 15-Jul-2020 (median OS follow-up was 11.10 months)","description":"PFS: time from date of randomization until date of documented radiological disease progression (PD) per investigator based on RECIST V1.1, or until death due to any cause, whichever occurred first. PD: \\>= 20% increase in sum of diameters of target lesions taking as reference the smallest sum, and sum must also demonstrate an absolute increase of \\>= 5 mm. Appearance of 1 or more new lesions is also considered progression. A participant who neither progressed nor died was censored at date of last radiological assessment (RA)/ date of randomization if no post-baseline RA was available. Participants who received any further anticancer therapy (ACT) for disease before radiological progression was censored at date of last RA before ACT started and participants who had PD/death after \\>=2 missed RAs were censored at last RA prior to 2 or more missed RAs. Kaplan-Meier estimates was used. Median time of follow-up for PFS was based on data cut-off \\& is same as median follow-up time for OS.","unitOfMeasure":"months","reportingStatus":"POSTED"},{"type":"SECONDARY","title":"Overall Response Rate (ORR) as Per RECIST V1.1","results":[{"value":"40.6","spread":"","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"34.90","upperLimit":"46.54"},{"value":"17.9","spread":"","groupId":"OG001","groupTitle":"Chemotherapy","lowerLimit":"13.71","upperLimit":"22.76"}],"analyses":[{"ciPct":"","pValue":"<0.001","ciLower":"","ciUpper":"","groupIds":["OG000","OG001"],"estimateType":"","estimateValue":"","pValueComment":"\"Stratification factors were ECOG PS, Region and Liver Metastasis.","dispersionType":"","dispersionValue":"","groupDescription":"","statisticalMethod":"Stratified Cochran-Mantel-Haenszel","statisticalComment":"","testedNonInferiority":"SUPERIORITY"}],"paramType":"NUMBER","timeFrame":"From randomization until the analysis cut-off date of 15-Jul-2020 (median OS follow-up was 11.10 months)","description":"ORR was defined as the percentage of participants with complete response (CR) or partial response (PR) based on the RECIST v1.1. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \\< 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters. ORR was analysed using exact method based on binomial distribution (Clopper-Pearson). Median time of follow up for ORR was based on data cut-off and is same as median follow-up time for OS.","unitOfMeasure":"percentage of participants","reportingStatus":"POSTED"},{"type":"SECONDARY","title":"Disease Control Rate (DCR) as Per RECIST V1.1","results":[{"value":"71.9","spread":"","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"66.30","upperLimit":"76.99"},{"value":"53.4","spread":"","groupId":"OG001","groupTitle":"Chemotherapy","lowerLimit":"47.52","upperLimit":"59.17"}],"analyses":[{"ciPct":"","pValue":"<0.001","ciLower":"","ciUpper":"","groupIds":["OG000","OG001"],"estimateType":"","estimateValue":"","pValueComment":"Stratification factors were ECOG PS, Region and Liver Metastasis.","dispersionType":"","dispersionValue":"","groupDescription":"","statisticalMethod":"Stratified Cochran-Mantel-Haenszel","statisticalComment":"","testedNonInferiority":"SUPERIORITY"}],"paramType":"NUMBER","timeFrame":"From randomization until the analysis cut-off date of 15-Jul-2020 (median OS follow-up was 11.10 months)","description":"DCR was defined as the percentage of participants with a CR, PR or a stable disease (SD) based on RECIST v1.1. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \\< 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters. SD was defined as neither sufficient decrease to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference the smallest sum of diameters while on study drug. Progressive disease is defined in PFS1 endpoint. DCR was analysed using exact method based on binomial distribution (Clopper-Pearson). Median time of follow up for DCR was based on data cut-off and is same as median follow-up time for OS.","unitOfMeasure":"percentage of participants","reportingStatus":"POSTED"},{"type":"SECONDARY","title":"Duration of Response (DOR) as Per RECIST V1.1","results":[{"value":"7.39","spread":"","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"5.59","upperLimit":"9.46"},{"value":"8.11","spread":"","groupId":"OG001","groupTitle":"Chemotherapy","lowerLimit":"5.65","upperLimit":"9.56"}],"analyses":[],"paramType":"MEDIAN","timeFrame":"From date of first objective response until the analysis cut-off date of 15-Jul-2020 (median OS follow-up was 11.10 months)","description":"DOR: time from the date of the first CR/PR (whichever is first recorded) that was subsequently confirmed as assessed by investigator to the date of documented PD or death due to any cause whichever occurred first. If a participant has neither progressed nor died, the participant was censored at the date of last RA or at the date of first CR/PR if no subsequent post-baseline RA was available. Participants who received any further ACT for the disease before radiological progression were censored at the date of the last RA before the ACT started. In addition, participants who had PD/death after \\>= 2 missed RAs were censored at the last RA prior to the 2 or more missed RAs. Kaplan-Meier estimates was used. Median time of follow up for DOR was based on data cut-off and is same as median follow-up time for OS. CR/PR and PD were defined in ORR and PFS1 endpoints, respectively.","unitOfMeasure":"months","reportingStatus":"POSTED"},{"type":"SECONDARY","title":"Change From Baseline to Week 12 in European Organisation for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire Global Health Status (QL2 Score)","results":[{"value":"-2.30","spread":"18.02","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"","upperLimit":""},{"value":"-5.72","spread":"16.04","groupId":"OG001","groupTitle":"Chemotherapy","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"MEAN","timeFrame":"Baseline and week 12","description":"EORTC QLQ-C30 is a generic questionnaire consisting of 30 items. The instrument yields functional scales (physical, role, emotional, cognitive, social), symptom scales/items (fatigue, Nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea), global health status, and financial impact score. Most items are scored 1 (\"not at all\") to 4 (\"very much\") except for the items contributing to the global health status/QoL, which are scored 1 (\"very poor\") to 7 (\"excellent\"). The recall period for each question is \"during the past week\". All raw domain scores are linearly transformed to a 0-100 scale with higher scores on symptoms indicate a worse health state. Higher scores on the global health status and functioning scales indicate better health status/function.","unitOfMeasure":"score on a scale","reportingStatus":"POSTED"},{"type":"SECONDARY","title":"Change From Baseline to Week 12 in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS)","results":[{"value":"-1.8","spread":"16.6","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"","upperLimit":""},{"value":"-5.3","spread":"14.5","groupId":"OG001","groupTitle":"Chemotherapy","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"MEAN","timeFrame":"Baseline and week 12","description":"EQ-5D-5L is a health status instrument for self-reported assessment of 5 domains of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each domain is rated by selecting 1 of 5 standardized categorizations ranging from no problem to extreme problem. The final question is a visual analogue scale (VAS) to rank health status from 0 (best health imaginable) to 100 (worst health imaginable).","unitOfMeasure":"score on a scale","reportingStatus":"POSTED"},{"type":"SECONDARY","title":"Number of Participants With Treatment Emergent Adverse Events","results":[{"value":"290","spread":"","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"","upperLimit":""},{"value":"288","spread":"","groupId":"OG001","groupTitle":"Chemotherapy","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"NUMBER","timeFrame":"From first dose up to 30 days after last dose (Median (range) time on study drug was 4.99 (0.5, 19.4) months in enfortumab vedotin and 3.45 (0.2, 15.0) months in chemotherapy group)","description":"An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A TEAE is defined as an AE observed or worsened after starting administration of the study drug.","unitOfMeasure":"participants","reportingStatus":"POSTED"},{"type":"SECONDARY","title":"Number of Participants With ECOG Performance Status","results":[{"value":"40","spread":"","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"","upperLimit":""},{"value":"44","spread":"","groupId":"OG001","groupTitle":"Chemotherapy","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"NUMBER","timeFrame":"End of treatment (EOT) (Median (range) time on study drug was 4.99 (0.5, 19.4) months in enfortumab vedotin and 3.45 (0.2, 15.0) months in chemotherapy group)","description":"ECOG performance status was measured on an 6 point scale. 0-Fully active, able to carry on all pre-disease performance without restriction.\n\n1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.\n2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.\n3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.\n4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.\n5. Dead. Number of participants with ECOG PS was reported.","unitOfMeasure":"participants","reportingStatus":"POSTED"}]},{"nctId":"NCT04995419","phase":"PHASE2","title":"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","acronym":null,"sponsor":"Astellas Pharma China, Inc.","isPivotal":false,"conditions":["Metastatic Urothelial Cancer"],"enrollment":40,"otherEndpoints":[],"primaryEndpoints":[{"type":"PRIMARY","title":"Objective Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors V1.1 (RECIST V1.1)","results":[{"value":"37.5","spread":"","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"22.7","upperLimit":"54.2"}],"analyses":[],"paramType":"NUMBER","timeFrame":"From first dose up to progressive disease or death (maximum duration: 9.33 months)","description":"ORR was defined as the percentage of participants with best overall response (BOR) as complete response (CR) or partial response (PR) based on the RECIST v1.1. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \\< 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters.","unitOfMeasure":"percentage of participants","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"Pharmacokinetics (PK) of Antibody-Drug Conjugate (ADC), Total Antibody (TAb), in Serum: Maximum Concentration (Cmax) at Cycle 1 Day 1","results":[{"value":"31.7","spread":"5.73","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"MEAN","timeFrame":"Cycle 1 Day 1: pre-dose, end of infusion (EOI), 2 hour, 4 hour post-dose (each cycle = 28 days)","description":"Cmax was derived from the PK blood samples collected.","unitOfMeasure":"micrograms per milliliter (ug/mL)","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"PK of Monomethyl Auristatin E (MMAE) in Serum: Maximum Concentration (Cmax) at Cycle 1 Day 1","results":[{"value":"3.33","spread":"1.74","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"MEAN","timeFrame":"Cycle 1 Day 1: pre-dose, end of infusion (EOI), 2 hour, 4 hour post-dose (each cycle = 28 days)","description":"Cmax was derived from the PK blood samples collected.","unitOfMeasure":"nanograms per milliliter (ng/mL)","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"PK of ADC, TAb in Serum: Maximum Concentration (Cmax) at Cycle 1 Day 15","results":[{"value":"34.4","spread":"4.64","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"MEAN","timeFrame":"Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)","description":"Cmax was derived from the PK blood samples collected.","unitOfMeasure":"ug/mL","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"PK of MMAE in Serum: Maximum Concentration (Cmax) at Cycle 1 Day 15","results":[{"value":"4.49","spread":"3.58","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"MEAN","timeFrame":"Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)","description":"Cmax was derived from the PK blood samples collected.","unitOfMeasure":"ng/mL","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"PK of ADC , TAb in Serum: Trough Concentration (Ctrough) at Cycle 1 Day 1","results":[{"value":"0","spread":"NA","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"MEAN","timeFrame":"Cycle 1 Day 1: pre-dose","description":"As per planned analysis, if more than 50% of PK concentrations were below the limit of quantification (i.e 0) at a given time point, standard deviation was not reported.","unitOfMeasure":"ug/mL","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"PK of MMAE in Serum: Trough Concentration (Ctrough) at Cycle 1 Day 1","results":[{"value":"0","spread":"NA","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"MEAN","timeFrame":"Cycle 1 Day 1: pre-dose","description":"As per planned analysis, if more than 50% of PK concentrations were below the limit of quantification (i.e 0) at a given time point, standard deviation was not reported.","unitOfMeasure":"ng/mL","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"PK of ADC, TAb in Serum: Trough Concentration (Ctrough) at Cycle 1 Day 15","results":[{"value":"4620","spread":"1590","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"MEAN","timeFrame":"Cycle 1 Day 15: pre-dose","description":"Ctrough was derived from the PK blood samples collected.","unitOfMeasure":"ug/mL","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"PK of MMAE in Serum: Trough Concentration (Ctrough) at Cycle 1 Day 15","results":[{"value":"1880","spread":"1680","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"MEAN","timeFrame":"Cycle 1 Day 15: pre-dose","description":"Ctrough was derived from the PK blood samples collected.","unitOfMeasure":"picograms per milliliter (pg/mL)","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"PK of ADC, TAb, MMAE in Serum: Time to Maximum Concentration (Tmax) at Cycle 1 Day 1","results":[{"value":"2.00","spread":"","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"1.87","upperLimit":"2.93"}],"analyses":[],"paramType":"MEDIAN","timeFrame":"Cycle 1 Day 1: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)","description":"Tmax was derived from the PK blood samples collected.","unitOfMeasure":"days","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"PK of ADC, TAb, MMAE in Serum: Time to Maximum Concentration (Tmax) at Cycle 1 Day 15","results":[{"value":"1.93","spread":"","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"0.858","upperLimit":"2.92"}],"analyses":[],"paramType":"MEDIAN","timeFrame":"Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)","description":"Tmax was derived from the PK blood samples collected.","unitOfMeasure":"days","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"PK of ADC, TAb, MMAE in Serum: Area Under Concentration-time Curve From 0 to Day 28 (AUC0-28d) at Cycle 1 Day 1","results":[],"analyses":[],"paramType":"","timeFrame":"Cycle 1 Day 1: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)","description":"AUC0-28d was derived from the PK blood samples collected.","unitOfMeasure":"","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"PK of ADC, TAb, MMAE in Serum: Area Under Concentration-time Curve From 0 to Day 28 (AUC0-28d) at Cycle 1 Day 15","results":[],"analyses":[],"paramType":"","timeFrame":"Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)","description":"AUC0-28d was derived from the PK blood samples collected.","unitOfMeasure":"","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"PK of ADC, TAb in Serum: Area Under Concentration-time Curve From 0 to Day 7 (AUC0-7d) at Cycle 1 Day 1","results":[{"value":"77.4","spread":"17.3","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"MEAN","timeFrame":"Cycle 1 Day 1 : pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)","description":"AUC0-7d was derived from the PK blood samples collected.","unitOfMeasure":"day*ug/mL","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"PK of MMAE in Serum: Area Under Concentration-time Curve From 0 to Day 7 (AUC0-7d) at Cycle 1 Day 1","results":[{"value":"16.9","spread":"9.21","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"MEAN","timeFrame":"Cycle 1 Day 1 : pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)","description":"AUC0-7d was derived from the PK blood samples collected.","unitOfMeasure":"day*ng/mL","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"PK of ADC, TAb in Serum: Area Under Concentration-time Curve From 0 to Day 7 (AUC0-7d) at Cycle 1 Day 15","results":[{"value":"94.7","spread":"15.7","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"MEAN","timeFrame":"Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)","description":"AUC0-7d was derived from the PK blood samples collected.","unitOfMeasure":"day*ug/mL","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"PK of MMAE in Serum: Area Under Concentration-time Curve From 0 to Day 7 (AUC0-7d) at Cycle 1 Day 15","results":[{"value":"23.3","spread":"16.4","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"MEAN","timeFrame":"Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)","description":"AUC0-7d was derived from the PK blood samples collected.","unitOfMeasure":"day*ng/mL","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"PK of ADC, TAb, MMAE in Plasma: Accumulation Ratio of Cmax (RacCmax)","results":[{"value":"1.28","spread":"0.499","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"MEAN","timeFrame":"Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)","description":"Accumulation ratio is the ratio of Cmax after the dosing interval (Cycle 1 Day 15) divided by Cmax after the first dosing interval (Cycle 1 Day 1).","unitOfMeasure":"ratio","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"PK of ADC, TAb, MMAE in Serum: Accumulation Ratio of AUC0-7d ( RacAUC0-7d)","results":[{"value":"1.32","spread":"0.486","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"MEAN","timeFrame":"Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)","description":"RacAUC0-7d was calculated using AUC0-7d and derived from the PK blood samples collected.","unitOfMeasure":"ratio","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"PK of ADC, TAb, MMAE in Serum: Terminal Elimination Half-life (t1/2)","results":[{"value":"3.12","spread":"","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"2.83","upperLimit":"3.82"}],"analyses":[],"paramType":"MEDIAN","timeFrame":"Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)","description":"t1/2 was derived from the PK blood samples collected.","unitOfMeasure":"days","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"PK of ADC, TAb, MMAE in Serum: Systemic Clearance (CL)","results":[{"value":"196","spread":"76.2","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"MEAN","timeFrame":"Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)","description":"CL was derived from the PK blood samples collected.","unitOfMeasure":"Liters/hour (L/hr)","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"PK of ADC, TAb, MMAE in Serum: Volume of Distribution at Steady State (Vss)","results":[{"value":"28900","spread":"10800","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"MEAN","timeFrame":"Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)","description":"Vss was derived from the PK blood samples collected.","unitOfMeasure":"Liters","reportingStatus":"POSTED"}],"secondaryEndpoints":[{"type":"SECONDARY","title":"Duration of Response (DOR) as Per RECIST V1.1 Per IRC","results":[{"value":"NA","spread":"","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"2.04","upperLimit":"NA"}],"analyses":[],"paramType":"MEDIAN","timeFrame":"From date of the first CR/PR up to progressive disease or death (maximum duration: 9.33 months)","description":"DOR: time from the date of the first CR/PR (whichever is first recorded) that was subsequently confirmed as assessed by IRC to the date of documented progressive disease. or death due to any cause whichever occurred first. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \\< 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters. Progressive Disease:\\>= 20% increase in sum of diameters of target lesions taking as reference the smallest sum, and sum must also demonstrate an absolute increase of \\>= 5 mm. Appearance of 1 or more new lesions is also considered progression.","unitOfMeasure":"months","reportingStatus":"POSTED"},{"type":"SECONDARY","title":"Duration of Response (DOR) as Per RECIST V1.1 Per Investigator's Assessment","results":[{"value":"NA","spread":"","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"2.04","upperLimit":"NA"}],"analyses":[],"paramType":"MEDIAN","timeFrame":"From date of the first CR/PR up to progressive disease or death (maximum duration: 9.33 months)","description":"DOR: time from the date of the first CR/PR (whichever is first recorded) that was subsequently confirmed as assessed by Investigator's Assesment to the date of documented progressive disease or death due to any cause whichever occurred first. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \\< 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters. Progressive disease:\\>= 20% increase in sum of diameters of target lesions taking as reference the smallest sum, and sum must also demonstrate an absolute increase of \\>= 5 mm. Appearance of 1 or more new lesions is also considered progression.","unitOfMeasure":"months","reportingStatus":"POSTED"},{"type":"SECONDARY","title":"Objective Response Rate (ORR) as Per Investigator Assessment","results":[{"value":"42.5","spread":"","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"27.0","upperLimit":"59.1"}],"analyses":[],"paramType":"NUMBER","timeFrame":"From first dose up to progressive disease or death (maximum duration: 9.33 months)","description":"ORR was defined as the percentage of participants with BOR as CR or PR based on the RECIST v1.1 as per investigator's assesment. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \\< 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters.","unitOfMeasure":"percentage of participants","reportingStatus":"POSTED"},{"type":"SECONDARY","title":"Disease Control Rate (DCR) as Per RECIST V1.1 Per IRC","results":[{"value":"72.5","spread":"","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"56.1","upperLimit":"85.4"}],"analyses":[],"paramType":"NUMBER","timeFrame":"From first dose up to progressive disease or death (maximum duration: 9.33 months)","description":"DCR: percentage of participants with a CR, PR or SD based on RECIST v1.1 as assessed by IRC. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \\< 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters. SD was defined as neither sufficient decrease to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference the smallest sum of diameters while on study drug. Progressive disease:\\>= 20% increase in sum of diameters of target lesions taking as reference the smallest sum, and sum must also demonstrate an absolute increase of \\>= 5 mm. Appearance of 1 or more new lesions is also considered progression.","unitOfMeasure":"percentage of participants","reportingStatus":"POSTED"},{"type":"SECONDARY","title":"Disease Control Rate (DCR) as Per RECIST V1.1 Per Investigator's Assesment","results":[{"value":"82.5","spread":"","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"67.2","upperLimit":"92.7"}],"analyses":[],"paramType":"NUMBER","timeFrame":"From first dose up to progressive disease or death (maximum duration: 9.33 months)","description":"DCR: percentage of participants with a CR, PR or SD based on RECIST v1.1 as assessed by investigator's assessment. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \\< 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters. SD was defined as neither sufficient decrease to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference the smallest sum of diameters while on study drug. Progressive disease:\\>= 20% increase in sum of diameters of target lesions taking as reference the smallest sum, and sum must also demonstrate an absolute increase of \\>= 5 mm. Appearance of 1 or more new lesions is also considered progression.","unitOfMeasure":"percentage of participants","reportingStatus":"POSTED"},{"type":"SECONDARY","title":"Progression Free-Survival Per RECIST V1.1 Per IRC","results":[{"value":"4.67","spread":"","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"3.65","upperLimit":"5.62"}],"analyses":[],"paramType":"MEDIAN","timeFrame":"From first dose up to progressive disease or death (maximum duration: 9.33 months)","description":"PFS: time from first dose of the study drug until date of documented radiological disease progression per IRC based on RECIST V1.1, or until death due to any cause, whichever occurred first. Progressive disease: \\>= 20% increase in sum of diameters of target lesions taking as reference the smallest sum, and sum must also demonstrate an absolute increase of \\>= 5 mm. Appearance of 1 or more new lesions is also considered progression. A participant who neither progressed nor died was censored at date of last radiological assessment (RA)/ date of randomization if no post-baseline RA was available. Participants who received any further anticancer therapy (ACT) for disease before radiological progression was censored at date of last RA before ACT started and participants who had PD/death after \\>=2 missed RAs were censored at last RA prior to 2 or more missed RAs. Kaplan-Meier estimates was used.","unitOfMeasure":"months","reportingStatus":"POSTED"},{"type":"SECONDARY","title":"Progression Free-Survival Per RECIST V1.1 Per Investigator's Assessment","results":[{"value":"4.24","spread":"","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"3.75","upperLimit":"7.20"}],"analyses":[],"paramType":"MEDIAN","timeFrame":"From first dose up to progressive disease or death (maximum duration: 9.33 months)","description":"PFS: time from first dose of the study drug until date of documented radiological disease progression per investigator based on RECIST V1.1, or until death due to any cause, whichever occurred first. Progressive disease: \\>= 20% increase in sum of diameters of target lesions taking as reference the smallest sum, and sum must also demonstrate an absolute increase of \\>= 5 mm. Appearance of 1 or more new lesions is also considered progression. A participant who neither progressed nor died was censored at date of last RA/ date of randomization if no post-baseline RA was available. Participants who received any further ACT for disease before radiological progression was censored at date of last RA before ACT started and participants who had progressive disease/death after \\>=2 missed RAs were censored at last RA prior to 2 or more missed RAs. Kaplan-Meier estimates was used.","unitOfMeasure":"months","reportingStatus":"POSTED"},{"type":"SECONDARY","title":"Overall Survival (OS)","results":[{"value":"NA","spread":"","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"6.74","upperLimit":"NA"}],"analyses":[],"paramType":"MEDIAN","timeFrame":"From first dose up to death (maximum duration: 9.33 months)","description":"OS was defined as the time from first dose of the study drug until the documented date of death from any cause. OS was analyzed using Kaplan-Meier estimates. Participants who were still alive at the time of data cutoff date were to be censored at the last known alive date or at the data cutoff date, whichever was earlier.","unitOfMeasure":"months","reportingStatus":"POSTED"},{"type":"SECONDARY","title":"Number of Participants With Antitherapeutic Antibodies (ATA)","results":[{"value":"0","spread":"","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"COUNT_OF_PARTICIPANTS","timeFrame":"From first dose until 9.33 months","description":"Number of participants with ATA were reported.","unitOfMeasure":"Participants","reportingStatus":"POSTED"},{"type":"SECONDARY","title":"Number of Participants With Treatment Emergent Adverse Events","results":[{"value":"40","spread":"","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"COUNT_OF_PARTICIPANTS","timeFrame":"Baseline up to 9.33 months","description":"An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. TEAE is defined as an adverse event observed after starting administration of the study drug and within 30 days after taking the last dose of study drug.","unitOfMeasure":"Participants","reportingStatus":"POSTED"},{"type":"SECONDARY","title":"Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)","results":[{"value":"0","spread":"","groupId":"OG000","groupTitle":"Enfortumab Vedotin 1.25 mg/kg","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"COUNT_OF_PARTICIPANTS","timeFrame":"End of Treatment (Baseline up to 9.33 months)","description":"ECOG performance status was measured on an 6 point scale. 0-Fully active, able to carry on all pre-disease performance without restriction.\n\n1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.\n2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.\n3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.\n4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.\n5. Dead. Number of participants with ECOG PS was reported.\"","unitOfMeasure":"Participants","reportingStatus":"POSTED"}]}],"genericManufacturerList":[],"status":"approved","companyName":"Astellas Pharma","companyId":"astellas","modality":"ADC","firstApprovalDate":"2019","enrichmentLevel":5,"visitCount":8,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"EU","regulator":"EMA","status":"pending","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":30,"withResults":2},"validation":{"fieldsValidated":3,"lastValidatedAt":"2026-04-20T07:30:09.533079+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}