| Enfortumab

Enumab (Padcev, generic enfortumab vedotin-ejfv) is an antibody-drug coupling (ADC) that delivers cytotoxic drugs directly to cancer cells by specifically binding to the Nectin-4 receptor on uroepithelial cancer cells, allowing for the precise killing of tumor cells while minimizing damage to normal cells. This drug is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma, especially those who have received PD-1 or PD-L1 inhibitors and platinum-containing chemotherapy.
 

| Typical data

As the OD values of the standard curve may vary according to the conditions of the actual assay performance (e.g. operator, pipetting technique, wash technique or temperature effects), the operator should establish a standard curve for each test. Typical standard curve and data are provided below for reference only.

 

Concentration (ng/mL)	50	25	12.5	6.25	3.12	1.56	0.78	0
OD	2	1.56	1.14	0.76	0.49	0.33	0.24	0.1
Corrected OD	1.9	1.46	1.04	0.66	0.39	0.23	0.14	-

 

| Repeatability

Intra-assay Precision (Precision within an assay)：CV% < 10%; Inter-assay Precision (Precision between assays)：CV% < 10%
 

| Recovery

The recovery of HumanEnfortumab spiked at three different levels in samples throughout the range of the assay was evaluated in various matrices.

 

Sample Type	Range(%)	Average Recovery(%)
Serum(n=8)	84-108	90
Plasma(n=8)	92-106	97
Cell Culture Supernates(n=8)	95-110	98

 

| Linearity

Samples were spiked with high concentrations of HumanEnfortumab and diluted with Universal Diluent to produce samples with values within the range of the assay.

 

		Serum(n=4)	Plasma(n=4)	Cell Culture Supernates(n=4)
1 : 2	Range (%)	84-98	88-96	90-110
	Average (%)	90	91	95
1 : 4	Range (%)	89-103	87-108	105-115
	Average (%)	96	93	105