Enzyme immunoassay for determination of qualitative antibodies to durvalumab in serum and plasma samples.
Storage
The kit is shipped at ambient temperature (10-30°C) and should be stored at 2-8°C for long term storage. Keep away from heat or direct sunlight. The strips of microtiter plate are stable up to the expiry date of the kit in the broken, but tightly closed bag when stored at 2-8°C.
Precision
Intra-assay and inter-assay CVs < 30%
General Description
Immune checkpoint inhibitors targeting programmed death 1 (PD-1) and programmed death ligand 1 (PD-L1) have shown activity in the treatment of numerous cancers, including advanced NSCLC (non-small cell lung cancer). Durvalumab is a selective, high-affinity, engineered, human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that blocks PD-L1 binding to PD-1 and CD80, allowing T cells to recognize and kill tumor cells. Preclinical evidence suggests that chemoradiotherapy may up-regulate PD-L1 expression in tumor cells and it is hypothesized that PD-L1 blockade may help restore systemic and long-term immune response after chemoradiotherapy. Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell suspension culture, durvalumab is a programmed death-ligand 1 (PD-L1) blocking antibody that works to promote normal immune responses that attack tumour cells. Durvalumab is marketed under the brand name Imfinzi, which is available for intravenous injections. It was granted accelerated approval by the FDA in May 2017 for the treatment of selected patients with locally advanced or metastatic urothelial carcinoma. In September 2018, durvalumab was approved by the EMA for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC), only if PD-L1 is expressed in ≥ 1% of tumour cells and there was no observable disease progression following platinum-based chemoradiation therapy.
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