Agilent Technologies Inc. (NYSE: A) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's PD-L1 IHC 22C3 pharmDx assay for expanded use.
The assay is now approved as an aid in identifying patients with ESCC for treatment with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy manufactured by Merck (known as MSD outside the United States and Canada). KEYTRUDA is approved for patients with recurrent locally advanced or metastatic ESCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥ 10] as determined by an FDA-approved test, with disease progression on or after one prior line of systemic therapy.
PD-L1 IHC 22C3 pharmDx is the only companion diagnostic FDA-approved to aid in identifying ESCC patients for second-line treatment with KEYTRUDA. This is the sixth cancer type for which PD-L1 IHC 22C3 pharmDx has gained FDA approval in the United States.
"PD-L1 has been established as an essential biomarker for PD-1/PD-L1 checkpoint inhibitors," said Sam Raha, president of Agilent's Diagnostics and Genomics Group. "As a growing number of patients are becoming eligible for treatment with these inhibitors, pathologists' confidence in their PD-L1 test is critical. With the approval of expanded use of our PD-L1 IHC 22C3 pharmDx assay, Agilent is able to aid in the identification of patients with ESCC for treatment with KEYTRUDA, while providing pathologists the quality, reliability, and accuracy they need to ensure diagnostic confidence."
In the United States, esophageal cancer is expected to cause approximately 16,000 deaths in 2019.3 ESCC accounts for approximately 30% of all esophageal cancers diagnosed in the United States4 and has a 5-year survival rate of 12%.5
Agilent developed PD-L1 IHC 22C3 pharmDx in collaboration with Merck.
KEYTRUDA is a humanized monoclonal antibody that increases 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. KEYTRUDA and other targeted immunotherapies are revolutionizing cancer treatment, with their therapeutic value being demonstrated across a growing list of cancer types.
Agilent is a worldwide leader in partnering with pharmaceutical companies to develop immunohistochemical-based diagnostics for cancer therapy. Agilent developed PD-L1 IHC 22C3 pharmDx in partnership with Merck. PD-L1 IHC 22C3 pharmDx also helps physicians identify non-small cell lung cancer (NSCLC), cervical cancer, gastric or GEJ adenocarcinoma, urothelial carcinoma and head and neck squamous cell carcinoma (HNSCC) patients for treatment with KEYTRUDA. PD-L1 expression in NSCLC tissues is interpreted using Tumor Proportion Score (TPS). PD-L1 expression in HNSCC, urothelial carcinoma, cervical cancer, gastric or GEJ adenocarcinoma, and ESCC tissues is interpreted using Combined Positive Score (CPS).