Agilent Technologies has won expanded use for its Dako PD-L1 IHC 28-8 pharmDx test in Europe for squamous cell carcinoma of the head and neck (SCCHN) who are most likely to benefit from treatment with the Bristol-Myers Squibb (BMS) cancer immunotherapy Opdivo (nivolumab).
With the latest CE marking, European pathologists have access to a clinically validated test to determine tumor PD-L1 status in patients with SCCHN. The PD-L1 IHC 28-8 pharmDx test has been previously CE marked in both Europe and the U.S. as an Opdivo companion diagnostic for both tumor cell PD-L1 expression for nonsquamous, nonsmall-cell lung cancer (ns-NSCLC) and melanoma.
“We recently saw the first approval for the PD-L1 IHC 28-8 pharmDx test, in head and neck cancer in Japan, and are now pleased that the CE marked indication has been extended to Europe,” Jacob Thaysen, president of Agilent's Diagnostics and Genomics Group, said in a statement. The Group includes Dako, a provider of pathology solutions acquired by Agilent in 2012.
PD-L1 IHC 28-8 pharmDx is the first and only diagnostic assay approved to assess the survival benefit with Opdivo in patients with SCCHN, and was developed in collaboration with BMS.
Agilent said tumor PD-L1 expression, as detected by PD-L1 IHC 28-8 pharmDx in SCCHN, may be associated with an enhanced survival benefit for the patient from the use of Opdivo, based on data from a prespecified exploratory analysis of the Checkmate 141 clinical trial.
Opdivo is indicated in part as a monotherapy for treatment of SCCHN in adults progressing on, or after, platinum-based therapy.
PD-L1 IHC 28-8 pharmDx is a qualitative immunohistochemical assay using monoclonal rabbit anti-PD-L1, clone 28-8 intended for use in the detection of PD-L1 (programmed death ligand 1) protein in formalin-fixed paraffin-embedded (FFPE) NSCLC and melanoma tissue using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 protein expression is defined as the percentage of tumor cells exhibiting positive membrane staining at any intensity.