Agilent's PD-L1 IHC 22C3 pharmDx Receives FDA Approval for Esophageal Squamous Cell Carcinoma as Companion Diagnostic for Keytruda

On July 31, 2019, VCBeat (WeChat ID: vcbeat) learned from foreign media reports that the U.S. Food and Drug Administration (FDA) had approved Agilent’s PD-L1 IHC 22C3 pharmDx assay for use in the detection of esophageal squamous cell carcinoma.

The PD-L1 IHC 22C3 pharmDx assay is the only FDA-approved companion diagnostic to help guide second-line treatment with Keytruda for patients with esophageal squamous cell carcinoma (ESCC). ESCC represents the sixth cancer indication for which the PD-L1 IHC 22C3 pharmDx assay has received FDA approval. In 2019, esophageal cancer was projected to cause approximately 16,000 deaths in the United States. Patients with ESCC account for about 30% of all esophageal cancer cases in the U.S., with a five-year survival rate of 12%.

The PD-L1 IHC 22C3 pharmDx assay is a product developed in collaboration between Agilent and Merck. The PD-L1 IHC 22C3 pharmDx assay helps physicians identify patients with non-small cell lung cancer (NSCLC), cervical cancer, gastric or gastroesophageal junction (GEJ) adenocarcinoma, urothelial carcinoma, and head and neck squamous cell carcinoma (HNSCC) for treatment with Keytruda.

Keytruda is the first FDA-approved drug that blocks the PD-1 pathway for patients with recurrent locally advanced or metastatic ESCC. Keytruda is a humanized monoclonal antibody that enhances the body’s immune system to detect and fight tumor cells.

Keytruda blocks the interaction between PD-1 and its ligands, as well as between PD-L1 and PD-L2, thereby activating T lymphocytes that can affect both tumor cells and healthy cells. Keytruda and other targeted immunotherapies represent a revolutionary breakthrough in cancer treatment, with their therapeutic value validated across an increasing number of cancer types.

Keytruda has garnered significant attention since its approval in 2014. This blockbuster cancer immunotherapy has demonstrated promising efficacy across multiple malignancies and is approved for the treatment of melanoma, head and neck cancer, non-small cell lung cancer, classical Hodgkin lymphoma, bladder cancer, and gastric cancer.

PD-1 and PD-L1 are two types of proteins found on human cells. PD-1 is constitutively expressed on T cells, a type of immune cell, where it serves to prevent T cells from attacking other cells in the body. PD-L1 is a protein attached to the surface of certain cells, including both normal and cancerous cells, and it helps these cells evade attack by immune cells. Many cancer cells express high levels of PD-L1, thereby escaping detection and destruction by the immune system. Immunotherapies targeting PD-1 or PD-L1 can help the body eliminate hidden cancer cells; Keytruda is an immunotherapy that targets PD-1.

“PD-L1 has become an important biomarker for testing PD-1/PD-L1 inhibitors,” said Sam Raha, President of Agilent’s Diagnostics and Genomics Group. “As a growing number of patients receive treatment with these inhibitors, it is crucial that pathologists have confidence in their PD-L1 testing. With the expanding use of the PD-L1 IHC 22C3 pharmDx assay, Agilent is able to support Keytruda treatment for patients with esophageal squamous cell carcinoma (ESCC), while providing pathologists with diagnostic results of high quality, reliability, and accuracy.”

Agilent, founded in 1999, is a biotechnology company headquartered in Santa Clara, California, USA. The company specializes in the development of test and analytical instruments, with a focus on manufacturing life sciences instruments, semiconductor products, fiber-optic network devices, and measurement instruments. In fiscal year 2018, Agilent generated $4.91 billion in revenue and employed 15,500 people worldwide.

(Compiled by Cheng Tao)