Agilent Technologies Expands Dako’s CE Marked PD-L1 IHC 22C3 pharmDx Companion Diagnostic

Agilent Technologies Inc recently announced that its CE marked Dako PD-L1 IHC 22C3 pharmDx can now be used to determine PD-L1 expression status to inform the first-line treatment of metastatic non-small cell lung cancer (NSCLC) patients with KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy manufactured by Merck (known as MSD outside the U.S. and Canada). This intended use allows PD-L1 IHC 22C3 pharmDx to detect PD-L1 expression in both untreated and previously treated metastatic NSCLC patients.

KEYTRUDA is now approved for the first-line treatment of metastatic NSCLC patients whose tumors express high levels of PD-L1 (tumor proportion score of 50% or more) or for previously treated metastatic NSCLC patients whose tumors express PD-L1 (tumor proportion score of 1% or more).

This update of PD-L1 IHC 22C3 pharmDx means that the assay can be used to identify previously untreated patients with metastatic NSCLC expressing high levels of PD-L1 for treatment with KEYTRUDA. Prior to this, chemotherapy was the standard first-line treatment for most NSCLC patients. Patients in the second-line or later treatment settings can also be identified for treatment with KEYTRUDA using PD-L1 IHC 22C3 pharmDx.

PD-L1 IHC 22C3 pharmDx is the only assay shown to select NSCLC patients with benefit from first-line treatment with anti-PD-1 monotherapy.

“We are so pleased that first-line metastatic NSCLC patients in Europe will now be included in the expansion of the intended use of PD-L1 IHC 22C3 pharmDx. With PD-L1 IHC 22C3 pharmDx, European pathologists have the ability to accurately identify the PD-L1 expression of a patient’s tumor, which ultimately enables the oncologist to provide the best treatment for that particular patient” said Jacob Thaysen, president of Agilent's Diagnostics and Genomics Group. “Pathologists recognise the need for validated tests, and our companion diagnostic gives them a highly accurate tool to inform oncologists on PD-L1 expression.”

“KEYTRUDA data continues to demonstrate the important role of PD-L1 testing in the treatment of patients with non-small cell lung cancer in order to identify those patients most likely to respond to treatment,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “The expansion of the companion diagnostic’s approval to include first-line evaluation means European oncologists have the ability to help even more patients with lung cancer.”

Lung cancer is the leading cause of cancer-related death worldwide, and NSCLC accounts for 80% of all lung cancers.

PD-L1 IHC 22C3 pharmDx was developed in partnership with Merck & Co, Inc, Kenilworth, NJ, USA, maker of the anti-PD-1 therapy KEYTRUDA.

KEYTRUDA is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.