PD-L1 Assay Wins FDA Nod for Lung Cancer Patients

Test supports treatment decisions for Tecentriq in NSCLC

The FDA has approved the Ventana PD-L1 (SP142) assay (Roche) as a complementary diagnostic to identify programmed death ligand-1 (PD-L1) expression levels in patients considering treatment with the FDA-approved cancer immunotherapy atezolizumab (Tecentriq, Roche) for previously treated metastatic non–small-cell lung cancer (NSCLC). The PD-L1 (SP142) assay is also indicated to identify patients with urothelial cancer who may benefit from treatment with atezolizumab.

The biomarker assay is the first to evaluate PD-L1 expression using both tumor-cell and immune-cell staining. Determining a patient’s PD-L1 expression level can provide insight into the survival benefit of treatment with atezolizumab, according to Roche.

The Ventana PD-L1 (SP142) assay is a qualitative immunohistochemical assay using rabbit monoclonal anti–PD-L1 clone SP142. It is intended for use in the assessment of the PD-L1 protein in formalin-fixed, paraffin-embedded urothelial carcinoma and NSCLC tissue stained with the OptiView DAB IHC detection kit and the OptiView amplification kit on a Ventana BenchMark Ultra instrument. The determination of a patient’s PD-L1 status is indication-specific, and the evaluation is based on either the proportion of tumor area occupied by PD-L1–expressing tumor-infiltrating immune cells of any intensity or the percentage of PD-L1–expressing tumor cells of any intensity.

PD-L1 expression in greater than or equal to 5% inorganic carbon (IC) determined by the Ventana PD-L1 (SP142) assay in urothelial carcinoma tissue was associated with an increased objective response rate in a nonrandomized study of atezolizumab. PD-L1 expression in greater than or equal to 50% total carbon (TC) or greater than or equal to 10% IC determined by the Ventana PD-L1 (SP142) assay in NSCLC tissue may be associated with enhanced overall survival with atezolizumab. The product is intended for in vitro diagnostic use.

NSCLC, one of two major types of lung cancer, accounts for approximately 85% of all lung cancer cases.

Source: PR Newswire; October 27, 2016.