Agilent Technologies Inc. (NYSE: A) today announced that the U.S. Food and Drug Administration has updated its approval of the company's PD-L1 IHC 22C3 pharmDx assay.

The assay can now be used as a companion diagnostic to identify a broader range of patients with stage III or metastatic non-small cell lung cancer (NSCLC) for first-line treatment with KEYTRUDA, a targeted anti-PD-1 therapy manufactured by Merck & Co. (known as MSD outside the United States and Canada).

The FDA previously approved the assay to identify metastatic NSCLC patients whose tumors express PD-L1 Tumor Proportion Score (TPS) ≥ 50% for first-line treatment with KEYTRUDA. Now, patients with stage III NSCLC who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1 TPS ≥ 1% are eligible for first-line treatment. This expanded indication enables pathologists to identify a larger population of previously untreated patients who are now eligible for treatment with KEYTRUDA.

"Anti-PD-1 therapies are a promising treatment class for many cancer types, and PD-L1 testing provides key information to physicians managing stage III or metastatic NSCLC patients," said Sam Raha, president of Agilent's Diagnostics and Genomics Group. "The updated FDA approval of PD-L1 IHC 22C3 pharmDx broadens the scope of patients that can be identified for first-line treatment with KEYTRUDA and offers new hope to the many patients diagnosed with stage III or metastatic NSCLC. By expanding the use of PD-L1 IHC 22C3 pharmDx, Agilent strives to continue our legacy of pioneering companion diagnostics to support the launch of landmark therapies."

Lung cancer is the leading cause of cancer-related mortality in the United States, with an estimated incidence of 154,000 deaths in 2018 alone.1 Among these cases, NSCLC accounts for nearly 85% of all diagnoses, and carries a 5-year survival rate of 15%.2 PD-L1 is a critical biomarker for response to anti-PD-1 therapy, and pathology labs play an important role in identifying appropriate patients for these treatments.

Agilent's PD-L1 IHC 22C3 pharmDx is the first and only companion diagnostic that has been clinically validated and approved to identify NSCLC patients eligible for KEYTRUDA.

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, and their therapeutic value is 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 & Co. PD-L1 IHC 22C3 pharmDx also helps physicians identify cervical cancer, gastric or GEJ adenocarcinoma, and urothelial carcinoma patients for treatment with KEYTRUDA. PD-L1 expression in NSCLC tissues is interpreted using Tumor Proportion Score (TPS). PD-L1 expression in urothelial carcinoma, cervical cancer, and gastric or GEJ adenocarcinoma tissues is interpreted using Combined Positive Score (CPS).