CHMP recommends EU approval of Roche’s Tecentriq in combination with Avastin and chemotherapy as an

CHMP recommends EU approval of Roche’s Tecentriq in combination with Avastin and chemotherapy as an

Roche has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of 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. Based on the positive CHMP recommendation, a final decision regarding the approval of this Tecentriq-based combination is expected from the European Commission in the near future.

The CHMP recommendation is based on results from the Phase III IMpower150 study, which showed that Tecentriq in combination with Avastin, paclitaxel and carboplatin helped people live significantly longer, compared with Avastin and chemotherapy (median overall survival [OS]=19.8 versus 14.9 months; hazard ratio [HR]=0.76; 95%, CI: 0.63–0.93; p=0.006) in the intention-to-treat (ITT) population.[1] The safety profile of the Tecentriq combination was consistent with that observed in previous studies.

“We are pleased to receive a positive opinion from the CHMP for this Tecentriq-based combination, which represents a significant step towards bringing a new treatment option to people across Europe with advanced, non-squamous non-small cell lung cancer,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “The IMpower150 study, on which this opinion is based, demonstrated an overall survival benefit, including those in key populations such as people with EGFR- or ALK-positive mutations or liver metastases.”

About the IMpower150 study

IMpower150 is a multicentre, open-label, randomised, controlled Phase III study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and paclitaxel) with or without Avastin in people with stage IV or recurrent metastatic non-squamous NSCLC who had not been treated with chemotherapy for their advanced disease. A total of 1,202 people were enrolled and randomised (1:1:1) to receive:

• Tecentriq plus carboplatin and paclitaxel (Arm A), or
• Tecentriq and Avastin plus carboplatin and paclitaxel (Arm B), or
• Avastin plus carboplatin and paclitaxel (Arm C, control arm).

The co-primary endpoints comparing Arms B and C were OS and progression-free survival (PFS), as determined by the investigator using Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) and assessed in the ITT-WT subpopulation. Key secondary endpoints included investigator-assessed PFS, OS and safety in the ITT population.

Lung cancer is the leading cause of cancer death globally.[2] 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.