| Zynlonta

Zynlonta (Loncastuximab tesirine) is an FDA-approved antibody-drug conjugate (ADC) for relapsed/refractory large B-cell lymphoma (LBCL), designed to target CD19-positive cancer cells and deliver a cytotoxic pyrrolobenzodiazepine (PBD) toxin that irreversibly damages DNA, triggering tumor cell death. Approved in 2021 for adults with ≥2 prior DLBCL therapies, it achieved a 48% objective response rate in clinical trials.
 

| 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)	20	10	5	2.5	1.25	0.625	0.312	0
OD	2.41	1.73	1.1	0.63	0.36	0.24	0.16	0.12
Corrected OD	2.29	1.61	0.98	0.51	0.24	0.12	0.04	-

 

| Repeatability

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

| Recovery

The recovery of Zynlonta 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)	88-102	97
Plasma(n=8)	92-106	103
Cell Culture Supernates(n=8)	95-110	105

 

| Linearity

Samples were spiked with high concentrations of Zynlonta 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 (%)	82-93	88-95	90-111
	Average (%)	94	91	97
1 : 4	Range (%)	89-102	88-110	105-115
	Average (%)	94	97	109