Dako, an Agilent Technologies Company, Announces Availability of New Lung Cancer Test in Europe

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.