ReviewClinical pharmacokinetics2024
Clinical Pharmacology of the Antibody-Drug Conjugate Enfortumab Vedotin in Advanced Urothelial Carcinoma and Other Malignant Solid Tumors.
Review in Clinical pharmacokinetics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
26 citing papers in PubMed, 2 syntheses or guidelines pooled it, 36 citations in OpenAlex.
- QT Prolongation Risk of Antibody-Drug Conjugates.Drug safety · 2026Pooled it
- Efficacy and safety of antibody-drug conjugates in the treatment of urothelial cell carcinoma: a systematic review and meta-analysis of prospective clinical trials.Frontiers in pharmacology · 2024Pooled it
- Enfortumab Vedotin plus Pembrolizumab as First-line Treatment in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Results from EV-202 Cohort 9.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Trial
- Phase 2 Study of Zilovertamab Vedotin in Participants with Metastatic Solid Tumors.Cancer research communications · 2025Trial
- Phase 2 Trial of Enfortumab Vedotin in Patients With Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma in China.Cancer medicine · 2024Trial
- Tumor-derived Parathyroid Hormone-Related Protein Is Associated with Suppression of Cytochrome P450 Expression: Evidence From Multimodal Transcriptomics.ACS pharmacology & translational science · 2026Article
- Efficacy and Safety of Enfortumab Vedotin by Trial Eligibility in Advanced Urothelial Carcinoma: A Multicenter Real-World Study.International journal of urology : official journal of the Japanese Urological Association · 2026Article
- Exposure-Response Relationships of Antibody Drug Conjugates in Solid Tumours.Clinical pharmacokinetics · 2026Review
- Clinical Pharmacology and Translational Science Considerations in the Development of Dual-Payload Antibody Drug Conjugates.Clinical and translational science · 2026Review
- Payload Diversification Overcomes Resistance and Guides Sequential Antibody-Drug Conjugate Therapy in Breast Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Article
- Real-world efficacy and safety of disitamab vedotin (RC48) plus PD-1 inhibitors in advanced urothelial carcinoma: a single-center retrospective study.Translational andrology and urology · 2026Article
- Invasive Bladder Cancer With Peritoneal Invasion and Rectal Involvement Causing Rectal, Bilateral Ureteral, and Common Bile Duct Obstruction Without a Retroperitoneal Mass: A Case Report.IJU case reports · 2026Article
- Nectin-4 PET for predicting enfortumab vedotin dose-response in urothelial carcinoma.Science advances · 2026Article
- Antibody-drug conjugates in recurrent or metastatic HNSCC: relevant targets, clinical development, and future prospects.Frontiers in immunology · 2026Review
- The real-world safety profile of enfortumab vedotin with or without pembrolizumab: insights from a comparative analysis of FAERS.Frontiers in immunology · 2026Article
- Cavitation of Pulmonary Metastases During Enfortumab Vedotin for Metastatic Ureteral Urothelial Carcinoma.IJU case reports · 2026Article
- Antibody-drug conjugates in colorectal cancer: advances in targeted delivery and personalized oncology.Frontiers in bioengineering and biotechnology · 2026Review
- Astellas article: UK multidisciplinary recommendations on use of combination first-line enfortumab vedotin▼ and pembrolizumab in advanced urothelial carcinoma.The oncologist · 2025Article
- Lessons learned from QT prolongation risk assessment for antibody-drug conjugates in oncology.Journal of pharmacokinetics and pharmacodynamics · 2025Review
- Enfortumab vedotin and pembrolizumab: redefining the standard of care for previously untreated advanced urothelial cancer.Future oncology (London, England) · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 5 institutions in 2 countries.
Funding
Abstract
Enfortumab vedotin is an antibody-drug conjugate comprised of a human monoclonal antibody directed to Nectin-4 and monomethyl auristatin E (MMAE), a microtubule-disrupting agent. The objectives of this review are to summarize the clinical pharmacology of enfortumab vedotin monotherapy and demonstrate that the appropriate dose has been selected for clinical use. Pharmacokinetics (PK) of enfortumab vedotin (antibody-drug conjugate and total antibody) and free MMAE were evaluated in five clinical trials of patients with locally advanced or metastatic urothelial carcinoma (n = 748). Intravenous enfortumab vedotin 0.5-1.25 mg/kg on days 1, 8, and 15 of a 28-day cycle showed linear, dose-proportional PK. No significant differences in exposure or safety of enfortumab vedotin and free MMAE were observed in mild, moderate, or severe renal impairment versus normal renal function. Patients with mildly impaired versus normal hepatic function had a 37% increase in area under the concentration-time curve (0-28 days), a 31% increase in maximum concentration of free MMAE, and a similar adverse event profile. No clinically significant PK differences were observed based on race/ethnicity with weight-based dosing, and no clinically meaningful QT prolongation was observed. Concomitant use with dual P-glycoprotein and strong cytochrome P450 3A4 inhibitors may increase MMAE exposure and the risk of adverse events. Approximately 3% of patients developed antitherapeutic antibodies against enfortumab vedotin 1.25 mg/kg. These findings support enfortumab vedotin 1.25 mg/kg monotherapy on days 1, 8, and 15 of a 28-day cycle. No dose adjustments are required for patients with renal impairment or mild hepatic impairment, or by race/ethnicity.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.