Dako, an Agilent Technologies company and a worldwide provider of cancer diagnostics, today announced the commercial availability in the EU of a new test that can identify PD-L1 expression levels on the surface of non-small cell lung cancer tumor cells and provide information on the survival benefit with OPDIVO® (nivolumab) for patients with non-squamous NSCLC.
The diagnostic, known as PD-L1 IHC 28-8 pharmDx, was developed through a collaboration with Bristol-Myers Squibb, the maker of OPDIVO®, an immuno-oncology therapy for patients with previously treated NSCLC.
PD-L1 IHC 28-8 pharmDx was used to assess PD-L1 expression in the Phase 3 CheckMate 057 trial, in which OPDIVO® demonstrated superior overall survival in patients with previously treated metastatic non-squamous NSCLC when compared to chemotherapy.
Lung cancer is the leading cause of cancer-related deaths worldwide. Historically, the one-year overall survival in the second-line treatment of NSCLC has been about 26 percent.
"Immuno-oncology is an important area within cancer treatment, and we are excited about Agilent's involvement in the potential PD-L1 IHC 28-8 pharmDx has in helping to provide information to oncologists considering OPDIVO for patients with non-squamous non-small cell lung cancer," said Jacob Thaysen, president of Agilent's Diagnostics and Genomics Group.
PD-L1 IHC 28-8 pharmDx is the first and only diagnostic assay approved to assess the survival benefit associated with OPDIVO®. PD-L1 testing is not required for the use of OPDIVO®, but it may provide additional information for physicians and inform patient dialogue.
Dako is a worldwide leader in partnering with pharmaceutical companies to develop immunohistochemical-based diagnostics for cancer therapy.