The EC approves Tecentriq in combination with Avastin

The European Commission approves Roche's Tecentriq in combination with Avastin

The European Commission approves Roche’s Tecentriq in combination with Avastin and chemotherapy for the initial treatment of metastatic lung cancer

Roche has announced that the European Commission has approved and granted marketing authorisation for Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab), paclitaxel and carboplatin, for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC).

In people with EGFR mutant or ALK-positive NSCLC, Tecentriq, in combination with Avastin, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies.

This approval is based on results from the Phase III IMpower150 study, which showed that Tecentriq in combination with Avastin and chemotherapy helped people live significantly longer, compared with Avastin and chemotherapy in the intention-to-treat (ITT) population. Roche released the results of this study in July 2018. 

In addition, Tecentriq in combination with Avastin and chemotherapy reduced the risk of disease worsening or death (PFS) by 41%, compared with Avastin and chemotherapy. Tecentriq in combination with Avastin and chemotherapy shrank tumours in 56.4% of people compared with 40.2% of people on Avastin and chemotherapy.

The safety profile of the Tecentriq combination was consistent with that observed in previous studies.

Lung cancer is the leading cause of cancer death globally. Each year 1.76 million people die as a result of the disease; this translates into more than 4,800 deaths worldwide every day.  Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases. NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope.

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T cells. Tecentriq has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.

Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development said, “Today’s announcement makes the combination of Tecentriq, Avastin and chemotherapy available to people in Europe with advanced, non-squamous non-small cell lung cancer. This approval includes EGFR mutant or ALK-positive non-small cell lung cancer after failure of a targeted therapy marking a first for this subgroup of patients, in which there is a significant need for alternative treatment options.”

FDA accelerated approval 

It has also been announced that the FDA has granted Roche’s Tecentriq in combination with Abraxane accelerated approval for people with PD-L1-positive, metastatic triple-negative breast cancer.

This accelerated approval is based on data from the Phase III IMpassion130 study, Roche announced positive results from this study. The study demonstrated that Tecentriq plus nab-paclitaxel significantly reduced the risk of disease worsening or death (PFS) by 40% compared with nab-paclitaxel alone in PD-L1-positive patients with unresectable locally advanced or metastatic TNBC who had not received prior chemotherapy for metastatic disease.