Ventana Medical Systems, a member of the Roche Group, and MedImmune, the global biologics R&D arm of AstraZeneca, are jointly developing a PD-L1 (SP263) immunohistochemistry assay to enroll patients in clinical trials for MedImmune's MEDI4736 anti-PD-L1 therapy for non-small cell lung carcinoma. This includes the recently commenced MEDI4736 ATLANTIC trial that only will enroll patients who express PD-L1 as determined by the VENTANA assay.
MEDI4736 is an investigational, engineered, human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumors avoid detection by the immune system. It is believed that by targeting PD-L1, MEDI4736 may block this ligand from sending out signals to T-cells to “ignore” tumor cells, thereby countering cancer's immune-evading tactics.
"Cancer immunotherapy is a promising area that may provide long lasting benefit not achieved with other treatment approaches. This collaboration is another strong example of the importance of companion diagnostics and their role in supporting the use of novel immunotherapies to target human malignancies," said Doug Ward, vice president and lifecycle leader for the Ventana Companion Diagnostics business unit.
The PD-L1 (SP263) assay has been validated for use on the VENTANA BenchMark series of advanced staining instruments deployed globally. Testing for MedImmune's trials is being performed at the Ventana companion diagnostics (CDx) CAP/CLIA laboratory in Tucson, Ariz., and select testing sites.