Roche announced Thursday updated results from the Phase III IMpower150 study evaluating the combination of Tecentriq (atezolizumab) and Avastin (bevacizumab) plus chemotherapy as a first-line treatment for people with advanced non-squamous non-small-cell lung cancer (NSCLC) ahead of presentation at the American Society of Clinical Oncology (ASCO) annual meeting. The company previously said that the trial met its co-primary endpoint of overall survival (OS).
The IMpower150 study randomised 1202 people with stage IV non-squamous NSCLC who had not been treated with chemotherapy for their advanced disease to receive Tecentriq plus carboplatin and paclitaxel, Tecentriq and Avastin plus carboplatin and paclitaxel or Avastin plus carboplatin and paclitaxel. The trial's co-primary endpoints were progression-free survival (PFS) and OS, with the analysis of the former goal only statistically powered to demonstrate a comparison between patients wo received Tecentriq and Avastin plus carboplatin and paclitaxel and those given Avastin plus carboplatin and paclitaxel.
In November last year, Roche reported that in the study, the combination of Tecentriq and Avastin plus chemotherapy provided a significant and clinically meaningful reduction in the risk of disease worsening or death compared to Avastin plus chemotherapy. Results later detailed at the European Society for Medical Oncology (ESMO) immuno-oncology congress showed that patients who received Tecentriq and Avastin plus chemotherapy had a 38-percent reduced risk of their disease worsening or death compared with those who received Avastin plus chemotherapy, with respective median PFS of 8.3 months and 6.8 months.
Roche on Thursday said that new data showed that median OS in patients given Tecentriq and Avastin plus carboplatin and paclitaxel was 19.2 months versus 14.7 months for Avastin plus carboplatin and paclitaxel. The drugmaker noted that the survival advantage was observed in all pre-specified exploratory biomarker-selected subgroups analysed, which included people with EGFR- and ALK-positive mutations, and those with varying levels of PD-L1 expression or with negative PD-L1 expression.
The company also reaffirmed that at the interim analysis, the combination of Tecentriq plus carboplatin and paclitaxel did not show a statistically significant OS benefit when compared to the combination of Avastin plus carboplatin and paclitaxel.
Earlier this month, the FDA granted priority review to a marketing application seeking approval of Tecentriq, in combination with Avastin and standard chemotherapy, for the first-line treatment of patients with metastatic non-squamous NSCLC, with the agency expected to render a decision on the filing by September 5.
For related analysis, see ViewPoints: Show me the data; Roche confirms survival benefit for Avastin/IO combo.
To read more Top Story articles, click here.