Ventana PD-L1 (SP142) Assay given CE mark approval in the EU as diagnostic for triple-negative breast cancer

Roche announced the expanded use of the Ventana PD-L1 (SP142) Assay in triple-negative breast cancer (TNBC) for patients living in CE (Conformité Européenne) 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) 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.

Approval was based on the IMpassion130 study, a phase III, multicenter, randomized, double-blind study evaluating the efficacy, safety and pharmacokinetics of Tecentriq plus nab-paclitaxel compared with placebo plus nab-paclitaxel in people with unresectable locally advanced or metastatic triple-negative breast cancer who have not received prior systemic therapy for metastatic breast cancer (mBC).

Comment: The FDA has approved 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.