FDA approves Dako PD-L1 IHC 22C3 pharmDx assay for expanded use in urothelial carcinoma

Agilent Technologies Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved its Dako PD-L1 IHC 22C3 pharmDx assay for expanded use in urothelial carcinoma.

The assay is now approved to identify patients with urothelial carcinoma who may benefit from KEYTRUDA, an anti-PD-1 therapy manufactured by Merck (known as MSD outside the United States and Canada), as a first-line treatment option. KEYTRUDA is approved for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [Combined Positive Score (CPS) ≥ 10] as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

PD-L1 IHC 22C3 pharmDx is the only FDA-approved companion diagnostic to identify patients with urothelial carcinoma for treatment with KEYTRUDA. This follows previous FDA approvals for PD-L1 IHC 22C3 pharmDx in non-small cell lung cancer (NSCLC), gastric or gastroesophageal junction (GEJ) adenocarcinoma, and cervical cancer.

"Anti-PD-1 therapies are a promising treatment class for many cancer types, and early PD-L1 testing can provide critical information to physicians managing urothelial carcinoma patients," said Sam Raha, president of Agilent's Diagnostics and Genomics Group. "By expanding the use of PD-L1 IHC 22C3 pharmDx, Agilent strives to address the unmet need for treatment options in patients who are ineligible for cisplatin-containing chemotherapy. Through these efforts, we maintain our commitment to bringing companion diagnostics to the market in support of groundbreaking immuno-oncology therapeutics."

Urothelial carcinoma is the fifth most common cancer in the United States, with an estimated incidence of 81,000 new cases in 2018 alone. For patients with advanced/metastatic urothelial carcinoma, cancer-related mortality has not improved in the past 30 years and the five-year survival rate is approximately 15%. Additionally, age- and disease-associated comorbidities affect patient eligibility for standard cisplatin-containing chemotherapy. For patients ineligible for cisplatin-containing chemotherapy, there is a significant unmet need for new, effective treatments.

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