Roche Diagnostics' Companion Diagnostics for Lung Cancer Wins Regulatory Nod

Roche Diagnostics Korea said Wednesday that its VENTANA PD-L1 (SP142) Assay, a companion diagnostic biomarker for non-small cell lung cancer (NSCLC), has won approval from the Ministry of Food and Drug Safety.

Roche Diagnostics Korea said Wednesday that its VENTANA PD-L1 (SP142) Assay in companion diagnostics of non-small cell lung cancer (NSCLC) has won regulatory approval.

With the nod, medical professionals also can use PD-L1 assay for comorbid testing to screen patients prescribed Tecentriq (ingredient: atezolizumab).

The PD-L1 SP142 assay has been used as companion diagnostics to help predict the overall survival of NSCLC patients when prescribed with Tecentriq according to PD-L1 expression rate in tumor cells (TC) and immune cells (IC).

In May last year, the company's cancer immunotherapy Tecentriq received approval from the U.S. Food and Drug Administration and the PD-L1 (SP142) diagnostics accompanying NSCLC's first-line monotherapy in the IMpower110 study.

Patients with high PD-L1 expression rates, either above 50 percent in a tumor cell or 10 percent in the immune cell, demonstrated significant OS improvement compared to platinum-based chemotherapy.

PD-L1 is a protein expressed in tumor and immune cells and blocks the activity of T cells by binding the PD-1 receptor and B7.1 receptor on the surface of T cells. This mechanism allows activation of T cells using Tcentriq and enhances the immune response against cancer.

Various studies have been conducted, as PD-L1 is a significant diagnostic marker in the treatment of cancer patients, acting as an immunosuppressive mechanism in many cancers.

"Our PD-L1 assay has proved its excellence and importance once again, and we expect it to help diagnose and treat non-small cell lung cancer patients," said Kim Hyung-ju, head of the marketing division at Roche Diagnostics Korea. "Roche will make the most of its superior anticancer drugs and companion diagnostics to provide customized treatment directions to patients."