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Enfortumab ELISA Kit

Catalog #:   KDJ41001 Specific References (50) DATASHEET
Applications: Used for the quantitative determination of Enfortumab concentration in serum and plasma.
Sample type: Plasma, Serum
Sensitivity: 47.39 ng/mL
Range: 93.75 - 1,500 ng/mL
Overview

Catalog No.

KDJ41001

Description

PRINCIPLE OF THE ASSAY This assay employs the quantitative competitive enzyme immunoassay technique. Recombinant Human NECTIN4 has been pre-coated onto a microplate. Standards or samples are premixed with biotin-labeled antibody and then pipetted into the wells. Enfortumab in the sample competitively binds to the pre-coated protein with biotin-labeled Enfortumab. After washing away any unbound substances, Streptavidin-HRP is added to the wells. Following a wash to remove any unbound enzyme reagent, a substrate solution is added to the wells and color develops in inversely proportion to the amount of Enfortumab bound in the initial step. The color development is stopped and the intensity of the color is measured.

Applications

Used for the quantitative determination of Enfortumab concentration in serum and plasma.

Detection method

Colorimetric

Sample type

Plasma, Serum

Assay type

Quantitative

Range

93.75 - 1,500 ng/mL

Sensitivity

47.39 ng/mL

Precision

Intra-Assay Precision (Precision within an assay): <20%

Three samples of known concentration were tested sixteen times on one plate to assess intra-assay precision.

Inter-Assay Precision (Precision between assays): <20%

Three samples of known concentration were tested in twenty four separate assays to assess inter-assay precision.

 

Intra-Assay Precision

Inter-Assay Precision

Sample

1

2

3

1

2

3

n

16

16

16

24

24

24

Mean (ng/mL)

692.6

160.3

91.4

652.4

163.6

95.8

Standard deviation

47.1

12.0

14.9

80.2

27.9

18.1

CV (%)

6.8

7.5

16.3

12.3

17.0

18.9

 

Recovery

80-120%

Shipping

2-8 ℃

Stability and Storage

When the kit was stored at the recommended temperature for 6 months, the signal intensity decreased by less than 20%. For unopened kits, if you want to prolong the storage time, please store the Standard, Detection A, Detection B and Microplate at - 20℃, the rest reagents should be store at 4℃.

Alternative Names

AGS-22CE, AGS-22M, AGS-22M6E, unconjugated : AGS-22C3 or AGSM6, CAS: 1346452-25-2

Background

Enfortumab vedotin is an antibody-drug conjugate (ADC) designed for the treatment of cancer expressing Nectin-4. It was developed through two main lines, hybridoma (ASG-22ME) and Chinese hamster ovary (ASG-22CE). Enfortumab refers to the fully humanized (from mouse) monoclonal antibody (mAb) created by scientists at Agensys (part of Astellas) using Amgen’s transgenic system (XenoMouse), it is the first agent to target Nectin-4 that expressed on many solid tumors especially on bladder cancers. Vedotin refers to the payload drug microtubule-disrupting agent monomethyl auristatin E (MMAE) and the linker. The linker technology holding the antibody and the toxin together was provided by and licensed from Seattle Genetics. Preclinical studies showed that enfortumab vedotin effectively binds to target cells, internalizes and induces cell-killing activity. Mouse and patient xenograft models were used to test enfortumab vedotin’s antitumor activity in human breast, bladder, pancreatic and lung cancers. In March 2018, Seattle Genetics and Astellas received the U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation for enfortumab vedotin based on interim results from the phase 1 study examining enfortumab vedotin as monotherapy treatment for patients with metastatic urothelial cancer who were previously treated with checkpoint inhibitors.

Data Image
  • Experiment Example
    CALCULATION OF RESULTS
    Average the duplicate readings for each standard and sample. Construct a standard curve by plotting the mean absorbance for each standard on the Y-axis against the concentration on the X-axis and draw a best fit curve through the points on the graph. The data may be linearized by plotting the log of the Enfortumab concentrations versus the log of the O.D. and the best fit line can be determined by regression analysis. This procedure will produce an adequate but less precise fit of the data. If samples have been diluted, the concentration read from the standard curve must be multiplied by the dilution factor.
References

Avelumab maintenance in advanced urothelial carcinoma: real-world data from Northern Spain (AVEBLADDER study)., PMID:40514610

Mechanistic Insights into Anti-Nectin4-VcMMAE-Induced Ocular Toxicity: From Cellular Uptake Pathways to Molecular Modification., PMID:40507807

Enfortumab vedotin induced interstitial lung disease: A first case report with pathological evidence from transbronchial lung cryobiopsy., PMID:40496844

Enfortumab Vedotin-Induced Diabetic Ketoacidosis and Acute Tubulointerstitial Nephritis Requiring Intensive Care in the Treatment of Advanced Urothelial Carcinoma: A Case Report., PMID:40487556

Real-world clinical outcomes of sacituzumab govitecan after prior exposure to enfortumab vedotin in patients with metastatic urothelial carcinoma., PMID:40479863

Two Cases of Enfortumab Vedotin-Induced Drug Eruption Diagnosed Based on the Distinctive Epidermal Mitotic Figures in Patients Receiving Combination Therapy With Pembrolizumab., PMID:40476598

Nectin-4-Targeting Radiotracers: Novel Theranostic Agents for Precision Oncology in Cancer., PMID:40474033

Enfortumab Vedotin Plus Pembrolizumab in Untreated Locally Advanced or Metastatic Urothelial Carcinoma: 2.5-Year Median Follow-Up of the Phase III EV-302/KEYNOTE-A39 Trial., PMID:40460988

Adverse cardiac events associated with antibody drug conjugates in cancer patients: a retrospective analysis on the FAERS database and randomized controlled trials., PMID:40455883

Enfortumab vedotin plus pembrolizumab versus chemotherapy in patients with previously untreated locally advanced or metastatic urothelial cancer (EV-302): patient-reported outcomes from an open-label, randomised, controlled, phase 3 study., PMID:40449498

Antibody-drug conjugates as game changers in bladder cancer: current progress and future directions., PMID:40433388

Consolidative Surgery for Advanced Urothelial Carcinoma Following Induction Enfortumab Vedotin and/or Immune Checkpoint Inhibitor Therapy: A Multicenter Analysis., PMID:40425390

Mechanistic Insights and Future Directions for Enfortumab Vedotin in Urothelial Carcinoma: Highlights from the 10th Annual Leo & Anne Albert Institute for Bladder Cancer Care and Research Symposium., PMID:40422537

E-VIRTUE: a study of enfortumab vedotin with or without pembrolizumab in rare genitourinary tumors-design and rationale., PMID:40421891

Erythema multiforme-like eruption with severe epidermal necrosis after administration of enfortumab vedotin., PMID:40417899

A Case of Generalized Anhidrosis That Developed During Treatment With Enfortumab Vedotin., PMID:40401791

Zelenectide pevedotin (BT-8009): a bicyclic peptide toxin conjugate targeting nectin-4 for the treatment of bladder cancer., PMID:40401457

Progress of antibody-drug conjugates in the treatment of locally advanced or metastatic urothelial carcinoma: opportunities and challenges., PMID:40377724

The patients have spoken: how does enfortumab vedotin impact quality of life?, PMID:40376537

Evaluation of Optimal Sequential Treatment Patterns and Clinical Outcomes in Patients With Advanced Urothelial Carcinoma Treated With First-Line Platinum-Based Chemotherapy: A Multicenter Collaborative Study., PMID:40375459

Immune Checkpoint Inhibitors and Antibody-Drug Conjugates in Urothelial Carcinoma: Current Landscape and Future Directions., PMID:40361519

Increased Risk of Hyperglycemia in Advanced Urothelial Cancer Patients Treated with Enfortumab Vedotin: A Systematic Review and Meta-Analysis., PMID:40358559

Complete Response after Avelumab Maintenance Therapy: Successful Management of Metastatic Urothelial Carcinoma., PMID:40352709

Salvage Surgery Following Remarkable Tumor Shrinkage With Enfortumab Vedotin in Advanced Urothelial Carcinoma., PMID:40336728

Novel Molecular Biomarkers to Guide Treatment Decision-making in Metastatic Urothelial Cancer-A Patient Cohort Analysis., PMID:40300922

Advancements in systemic therapy for muscle-invasive bladder cancer: A systematic review from the beginning to the latest updates., PMID:40296876

Treatment Outcomes After Progression With Enfortumab Vedotin in Patients With Advanced Urothelial Carcinoma., PMID:40295063

Steroid Premedication Impact on Efficacy and Cutaneous Toxicity of Enfortumab Vedotin for Advanced Urothelial Carcinoma., PMID:40295014

Cancer-induced Pain Is Associated With Poor Overall Survival of Urothelial Carcinoma Patients Treated With Enfortumab Vedotin., PMID:40295006

Real-World Clinical Outcomes with First-Line Systemic Treatment and Avelumab Maintenance in US Patients with Locally Advanced or Metastatic Urothelial Carcinoma: The SPEAR Bladder-II Study., PMID:40277744

Evaluation of Nectin-4 and Trop-2: Implications for Patient Outcomes and Therapy in Penile Cancer., PMID:40252843

Association between drug-related cutaneous adverse events and survival outcomes in patients treated with enfortumab vedotin., PMID:40252634

Pembrolizumab after platinum-based chemotherapy for metastatic urothelial cancer: comparison between patients from a Dutch nationwide cohort and KEYNOTE-045., PMID:40250101

Clinical Response to Enfortumab Vedotin and Pembrolizumab in a Patient with Vaginal Squamous Cell Carcinoma: A Case Report., PMID:40235861

Balancing effectiveness, toxicity, and individualization: enfortumab vedotin in advanced urothelial cancer., PMID:40226067

Strategies to overcome resistance to enfortumab vedotin and pembrolizumab for patients with urothelial carcinoma: harnessing present knowledge for future advances., PMID:40225697

Cost-Effectiveness of Enfortumab Vedotin and Pembrolizumab for First-Line Metastatic Urothelial Cancer in the United States., PMID:40220863

High-glucose-associated YTHDC1 lactylation reduces the sensitivity of bladder cancer to enfortumab vedotin therapy., PMID:40215164

Nectin-4 expression patterns and therapeutics in oncology., PMID:40209851

[Enfortumab-vedotin in combination with pembrolizumab as first-line treatment for advanced/metastatic urothelial carcinoma]., PMID:40204543

Emerging Paradigms in Genitourinary Cancers: Integrating Molecular Imaging, Hypoxia-Inducible Factor-Targeted Therapies, and Antibody-Drug Conjugates in Renal Cell and Urothelial Carcinomas., PMID:40198857

Organ-specific tumor response to enfortumab vedotin in metastatic urothelial carcinoma: a multicenter retrospective study., PMID:40197493

Editorial Comment to "Impact of Skin Adverse Events on Prognosis in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Treated With Enfortumab Vedotin: A Real-World Multicenter Study"., PMID:40195588

Lines of Therapy for Locally Advanced/Metastatic Urothelial Carcinoma: The New Paradigm., PMID:40184571

Impact of Initial Relative Dose Intensity on Tumor Response and Survival Outcomes in Enfortumab Vedotin Monotherapy for Previously Treated Advanced Urothelial Carcinoma: A Real-world Analysis From a Multicenter Study., PMID:40175211

Oncology: What You May Have Missed in 2024., PMID:40163865

Clinical significance of the dose modification of enfortumab vedotin monotherapy for advanced urothelial carcinoma., PMID:40163660

A case of remarkable response to combined radiation therapy, enfortumab vedotin, and pembrolizumab in metastatic urothelial carcinoma., PMID:40160871

Recognition and management of adverse cutaneous reactions in patients on enfortumab vedotin and pembrolizumab in the inpatient setting., PMID:40144398

Treatment of Advanced or Metastatic Urothelial Cancer., PMID:40139170

Datasheet

Document Download

Enfortumab ELISA Kit.pdf

 

$ 1128
Product specifications
96 T 1128

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Enfortumab ELISA Kit [KDJ41001]
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