# Enfortumab vedotin

Source: https://onco.cc/drugs/enfortumab-vedotin/  
OnCo record `enfortumab-vedotin` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Enfortumab vedotin is an ADC against Nectin-4 that, combined with pembrolizumab, nearly doubled survival in advanced bladder cancer.

## Summary

EV-302 (2023): enfortumab vedotin plus pembrolizumab versus platinum chemotherapy in first-line advanced urothelial cancer, OS 31.5 vs 16.1 months (HR 0.47). Now the global standard. Being tested in muscle-invasive bladder cancer (EV-303/304, positive in 2025). Rash, neuropathy, and hyperglycaemia are class effects.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-04
- Brand: Padcev
- Modality: ADC
- Mechanism: Fully human anti-Nectin-4 IgG1; MMAE released by cathepsin B; bystander killing.
- Payload: MMAE (tubulin inhibitor), DAR ~3.8
- Linker: mc-vc-PABC, protease-cleavable
- Approvals: US 2019: Advanced urothelial cancer after platinum and PD-1/PD-L1 (accelerated); US 2023: First-line advanced urothelial cancer with pembrolizumab; EU 2022: mUC after platinum + PD-1; 1L with pembrolizumab 2024
- Dosing: IV infusion over 30 min; 1.25 mg/kg (max 125 mg) days 1, 8, 15 of 28-day cycle (monotherapy) or days 1 and 8 of 21-day cycle with pembrolizumab
- Toxicity (grade 3+): Rash 15%; Peripheral neuropathy 8%; Fatigue 6%; Pruritus 1.1%; Diarrhoea 4.5%; Alopecia 0.5%; Decreased appetite 1.8%; Weight decrease 3.6%; Dry eye 0%; Hyperglycaemia (grade 3-4 glucose elevation) 14%

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Enfortumab_vedotin
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Enfortumab%20vedotin

## Connected records

- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/), [Muscle-invasive and advanced bladder cancer](https://onco.cc/cancers/muscle-invasive-bladder-cancer/), [Urethral cancer](https://onco.cc/cancers/urethral/), [Urothelial carcinoma of the urethra](https://onco.cc/cancers/urethral-urothelial-carcinoma/)
- technologies: [ADC payload neutralisers](https://onco.cc/technologies/adc-payload-neutralizer/), [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/), [The ADC supply chain (antibody, payload-linker, conjugation, fill)](https://onco.cc/technologies/adc-supply-chain/)
- targets: [Nectin-4](https://onco.cc/targets/nectin4/)
- companies: [Astellas](https://onco.cc/companies/astellas/), [Generate:Biomedicines](https://onco.cc/companies/generate-biomedicines/), [Pfizer (incl. Seagen)](https://onco.cc/companies/pfizer/)
- terms: [mc-Val-Cit-PABC](https://onco.cc/terms/mc-vc-pabc/), [MMAE](https://onco.cc/terms/mmae/), [Rash and skin toxicity (acneiform rash, paronychia)](https://onco.cc/terms/rash-skin-toxicity/), [Tubulin inhibitor payloads](https://onco.cc/terms/tubulin-inhibitor-payloads/)
- trials: [A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005)](https://onco.cc/trials/nct06305767/), [A Study of ASP2998 Given by Itself and Given With Standard Therapies in People With Solid Tumors](https://onco.cc/trials/nct07287995/), [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)](https://onco.cc/trials/nct06483334/), [A Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Metastatic Urothelial Carcinoma](https://onco.cc/trials/nct07815665/), [A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)](https://onco.cc/trials/nct04225117/), [A Study to Find Out if Enfortumab Vedotin Given With Pembrolizumab Helps People With Muscle-invasive Bladder Cancer Keep Their Bladder](https://onco.cc/trials/nct07475806/), [An Open-label Study to Investigate the Efficacy and Safety of Dato-DXd + Rilvegostomig vs SoC in Adult Participants With High-risk MIUC](https://onco.cc/trials/nct07720284/), [Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309)](https://onco.cc/trials/nct07566156/), [EV-302 / KEYNOTE-A39](https://onco.cc/trials/ev-302/), [EV-303 / KEYNOTE-905](https://onco.cc/trials/ev-303/), [EV-304 / KEYNOTE-B15](https://onco.cc/trials/ev-304/), [Modular Trial of sEphB4-HSA in EphrinB2-High Solid Tumors](https://onco.cc/trials/nct06493552/), [Ph II Study of Enfortumab Vedotin in Patients With Advanced or Metastatic CRC or HCC](https://onco.cc/trials/nct06553885/), [Protein-Matched ADC or PDC Umbrella Trial in Advanced Pancreatic and Breast Cancer](https://onco.cc/trials/nct07825753/), [Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer](https://onco.cc/trials/nct07421700/), [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](https://onco.cc/trials/nct04960709/)
- pairings: [ADC + checkpoint inhibitor](https://onco.cc/pairings/adc-plus-io/), [Enfortumab vedotin + pembrolizumab across the bladder cancer continuum](https://onco.cc/pairings/ev-pembro-continuum/)
- ideas: [Bladder preservation for MIBC after perioperative EV + pembrolizumab complete response](https://onco.cc/ideas/idea-bladder-preservation-mibc/), [Continuous-flow synthesis of ultra-potent ADC payloads to ease the capacity squeeze](https://onco.cc/ideas/idea-reg-hpapi-continuous-flow/), [Dose and schedule optimisation trials specific to antibody-drug conjugates](https://onco.cc/ideas/idea-tr1-adc-dose-and-schedule-optimisation/)
- roadmaps: [ADC roadmap: from Mylotarg to bispecific and dual-payload ADCs](https://onco.cc/roadmaps/adc-generations/), [Chemotherapy roadmap: mustard gas → curative combinations → the warhead inside smarter drugs](https://onco.cc/roadmaps/chemotherapy-roadmap/)
- people: [Jae Lyun Lee](https://onco.cc/people/lee-jae-lyun/), [Jonathan E. Rosenberg](https://onco.cc/people/jonathan-rosenberg/), [Shilpa Gupta](https://onco.cc/people/shilpa-gupta/), [Thomas Powles](https://onco.cc/people/thomas-powles/)
- key papers: [EV-302: enfortumab vedotin plus pembrolizumab replaces chemotherapy as first treatment for advanced bladder cancer](https://onco.cc/key-papers/paper-ev-302-nejm-2024/)
- pathways: [Bladder cancer (KEGG map)](https://onco.cc/pathways/bladder-cancer-signalling/), [Drug efflux pumps (ABC transporters)](https://onco.cc/pathways/drug-efflux-pumps/), [Mitosis & the spindle assembly checkpoint](https://onco.cc/pathways/mitotic-spindle-checkpoint/)
- biomarkers: [Nectin-4 expression](https://onco.cc/biomarkers/nectin-4-expression/)

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