The approval has been granted for Tecentriq plus chemotherapy (Abraxane [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) to treat adult patients with unresectable locally advanced or metastatic TNBC whose tumours have PD-L1 expression (≥1%) and who have not received prior chemotherapy for metastatic disease.
Tecentriq, which is a monoclonal antibody designed to bind with PD-L1 protein, is believed to have potential to use as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.
Roche also secured CE mark approval for its Ventana PD-L1 (SP142) assay. It is now commercially available in the European Union (EU) for identifying patients with TNBC eligible for treatment with the Tecentriq combination.
The approval was based on data from the phase III IMpassion130 study, which is a Phase III, multicentre, randomised and double-blind study assessing the efficacy, safety and pharmacokinetics of Tecentriq plus nab-paclitaxel compared with placebo plus nab-paclitaxel in people with unresectable locally advanced or metastatic TNBC who have not received prior systemic therapy for metastatic breast cancer.
According to the company, the progression-free survival (PFS) results showed that Tecentriq plus nab-paclitaxel significantly reduced the risk of disease worsening or PFS by 38% compared with nab-paclitaxel alone in people who were tested positive for PD-L1 expression on tumour-infiltrating immune cells.
Tecentriq and nab-paclitaxel demonstrated a clinically meaningful overall survival (OS) improvement of seven months against placebo and nab-paclitaxel in the PD-L1-positive population at the second interim analysis.
Roche chief medical officer and global product development head Dr 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.”
Earlier this month, Roche announced that its Tecentriq (atezolizumab) plus platinum-based chemotherapy has significantly reduced the risk of disease worsening or death in people with previously untreated advanced bladder cancer in the phase III IMvigor130 study.