Agilent Technologies Inc. announced that its Dako PD-L1 IHC 22C3 pharmDx now has an expanded label approved by the U.S. Food and Drug Administration (FDA) for use in determining PD-L1 expression status to inform treatment in metastatic non-small cell lung cancer (NSCLC) with KEYTRUDA^® (pembrolizumab). This expanded intended use now allows the PD-L1 IHC 22C3 pharmDx test to detect PD-L1 expression in a broader range of patients–those with a PD-L1 tumor proportion score (TPS) of 1 percent or more.

The FDA also announced that KEYTRUDA is now approved for the first-line treatment of metastatic NSCLC patients whose tumors express high levels of PD-L1 (TPS of 50 percent or more) or for previously treated metastatic NSCLC patients whose tumors express PD-L1 (TPS of 1 percent or more).

This updated approval 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. The labeling update also means that more patients in the second-line or later treatment setting–including patients with levels of PD-L1 expression of 1 percent or more–can also be identified for treatment with KEYTRUDA.

“This expanded intended use for our FDA-approved PD-L1 IHC 22C3 pharmDx assay is a step towards providing first-line metastatic NSCLC patients with immunotherapy as an option. PD-L1 IHC 22C3 pharmDx allows pathologists to confidently determine, and report PD-L1 expression status for a patient’s tumor. This critical diagnostic information informs oncologists’ treatment decisions around KEYTRUDA,” said Jacob Thaysen, president of Agilent's Diagnostics and Genomics Group. “Pathologists recognize the need for approved and validated tests, and our companion diagnostic gives them a highly accurate tool to inform oncologists on PD-L1 expression.”

“PD-L1 is an important biomarker for use in identifying those patients with metastatic non-small cell lung cancer who are most likely to benefit from treatment with KEYTRUDA,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “With the approval of both the medicine and companion diagnostic to include first-line evaluation and treatment, and the broadening of the Dako PD-L1 IHC 22C3 pharmDx label in the second-line and later treatment setting, we now have the opportunity to help many more patients with this devastating disease.”

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

PD-L1 IHC 22C3 pharmDx was developed in partnership with Merck & Co., Inc. (known as MSD outside the U.S. and Canada), 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.