Switzerland-based healthcare company Roche announced that the European Commission has approved its Tecentriq (atezolizumab) plus chemotherapy for the treatment of adult patients with metastatic triple-negative breast cancer (TNBC).

According to Roche, breast cancer is the most common cancer among women, affecting more than two million women across the world each year and is prevalent in women under the age of 50.

The chemotherapy is advised for TNBC patients whose tumours have PD-L1 expression and have not received prior chemotherapy for metastatic disease.

Rochechief medical officer and global product developmenthead Sandra Horning said: “For the past 30 years, we have been dedicated to transforming the lives of people with breast cancer.

“Now, we are pleased to build on this foundation with the news that the first immunotherapy treatment for triple-negative breast cancer is available to people in Europe with PD-L1-positive, metastatic triple-negative breast cancer. The European approval of this Tecentriq combination represents a significant step forward in the treatment of this aggressive breast cancer, where the unmet medical need is great.”

VENTANA PD-L1 (SP142) Assay is used with Tecentriq combination

Roche has secured CE mark for its VENTANA PD-L1 (SP142) Assay as an aid for identifying patients with TNBC, and is approved for treatment with the Tecentriq combination.

The company said that the approval is based on the results from its Phase III IMpassion130 study, a multicentre, randomised, double-blind study, aimed at evaluating the efficacy, safety and pharmacokinetics of Tecentriq plus nab-paclitaxel, compared with placebo plus nab-paclitaxel.

Tecentriq is a monoclonal antibody that binds with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors.

It acts as a cancer immunotherapy by inhibiting PD-L1 to activate the T cells, and has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.

Roche said that it has secured approval for Tecentriqin the US, EU and countries around the world, either alone or in combination with targeted therapies or chemotherapies in several forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and in PD-L1-positive metastatic triple-negative breast cancer.