Avastin in combination with Tarceva for patients with advanced, metastatic or recurrent non-squamous non-small cell lung cancer with EGFR-activating mutations, EC approved
The European Commission ( EC ) has approved the use of Avastin ( Bevacizumab ) in combination with Tarceva ( Erlotinib ) for the first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer ( NSCLC ) with EGFR-activating mutations.
The pivotal phase II JO25567 study showed a statistically significant 46% relative reduction in the risk of disease progression or death ( median progression-free survival, PFS: 16.0 months versus 9.7 months; hazard ratio, HR=0.54, p=0.0015 ) for people treated with the combination of Bevacizumab plus Erlotinib compared to Erlotinib alone.
Bevacizumab and Erlotinib each target pathways which are known to be key drivers in the development and growth of tumours. The beneficial effect of Bevacizumab plus Erlotinib is supported by results of other clinical studies which showed the combination was effective and tolerable.
No new and clinically significant adverse events were observed and the toxicity profile was shown to be managable.
NSCLC is the most common type of lung cancer, the leading cause of cancer-related death in Europe and across the world.
Epidermal growth factor receptor ( EGFR ) is a protein that sits across the cell membrane and forms part of normal cell signalling.
NSCLC with EGFR-activating mutations occurs when there is a mutation in a specific area of DNA in the EGFR gene ( commonly exon 19 and exon 21 ), which leads to a change in the structure and function of the EGFR proteins and results in EGFR signalling being constantly active. This can cause accelerated cell growth and division, angiogenesis and the development of metastases.
Approximately 10-15% of Europeans with NSCLC will have tumours with EGFR-activating mutations, representing an estimated 33,000 cases in Europe per year. ( Xagena )
Source: Roche, 2016