Roche launches VENTANA PD-L1 Assay in CE markets as companion diagnostic to identify triple-negative

Roche launches VENTANA PD-L1 Assay in CE markets as companion diagnostic to identify triple-negative

Roche has announced the expanded use of the VENTANA PD-L1 (SP142) Assay in triple-negative breast cancer (TNBC) for patients living in CE (Conformité Européene) markets where the Roche cancer immunotherapy medicine Tecentriq is approved. It is the first companion diagnostic to aid in identifying triple-negative breast cancer patients eligible for treatment with Tecentriq (atezolizumab)5 plus chemotherapy (nab-paclitaxel). Assessment of PD-L1 biomarker status on tumour-infiltrating immune cells with the assay is essential for identifying those patients most likely to benefit from the treatment.

Today’s announcement follows the U.S. Food and Drug Administration approval of the assay in March 2019 as the first companion diagnostic to identify triple-negative breast cancer patients eligible for the Tecentriq combination. A diagnosis of triple-negative breast cancer means that the three most common proteins associated with breast cancer growth – estrogen receptor, progesterone receptor and HER2/neu – are not expressed on the tumour.

“Until recently, the only treatment option for metastatic triple-negative breast cancer patients was chemotherapy,” said Thomas Schinecker, Head of Roche Diagnostics. “With our expanding menu of companion diagnostics and targeted cancer immunotherapies, Roche is proud to continue to deliver on our mission to make personalised healthcare a global reality, ensuring the right treatment for the right patient at the right time.”

The VENTANA PD-L1 (SP142) Assay was developed to enhance visual contrast of tumour-infiltrating immune cell staining. In triple-negative breast cancer, PD-L1 is primarily expressed on tumour-infiltrating immune cells rather than on tumour cells themselves.

Launched in 2016, the VENTANA PD-L1 (SP142) Assay is the primary diagnostic assay within the Tecentriq clinical development program and was used to enroll and stratify patients in Tecentriq clinical trials. It was the enrollment assay used in the IMpassion130 trial, the first positive phase III immunotherapy regimen study in triple-negative breast cancer. The assay was the first to evaluate patient PD-L1 biomarker status using immune cell staining and scoring within the tumour microenvironment.8

About the VENTANA PD-L1 (SP142) Assay

The VENTANA PD-L1 (SP142) Assay is available on the fully automated BenchMark IHC/ISH series instruments and uses the OptiView DAB IHC Detection Kit with OptiView Amplification Kit. The VENTANA PD-L1 (SP142) Assay performs specific staining of tumour cells and immune cells. The assay was previously approved by the FDA and CE marked for use as a companion diagnostic in urothelial carcinoma (UC)5 and as a predictive assay in non-small cell lung cancer (NSCLC) with Tecentriq. See the Tecentriq product label for more information on PD-L1 expression levels in therapeutic guidance for various cancer indications.