The FLEX trial, a European study of cisplatin/Navelbine (vinorelbine) with or without the monoclonal antibody against EGFR Erbitux (cetuximab), was a technically positive study that was initially reported at ASCO 2008. However, showing an improvement in median survival of just 1.2 months, most oncologists came away feeling that the trial illustrated the difference between a statistically vs.
EGFR stands for epidermal growth factor receptor, which is a molecule on the surface of many cancer cells that can be activated to activate signals that promote cell growth and cell division. Though this target may play a role for many kinds of cancer, non-small cell lung cancer (NSCLC) is one type in which this target protein is seen in a majority of people's cancers.
Completing our tour of clinical factors that we might use for predicting benefit with the EGFR monoclonal antibody Erbitux (cetuximab) in the FLEX trial is the development of a rash. We're actually discussing rash separately from the other clinical factors from the FLEX trial that we discussed in the prior post for a couple of reasons.
In the last post that presented the highlights of the FLEX trial that tested the benefit of adding Ebritux (cetuximab) to standard chemo.
I covered the highlights of the FLEX trial, reported at the Plenary Session of ASCO 2008, a full year ago, but in that time, we never showed the survival curves or covered all of the details.
There has been quite a lot of discussion recently about the EGFR tyrosine kinase inhibitors (TKIs), erlotinib (Tarceva) and gefitinib (Iressa). Recently however the final results of the FLEX trial were published in The Lancet, bringing attention back to one of the antibodies against EGFR, cetuximab (Erbitux). Dr.
In my last post, I noted that the FLEX trial of cisplatin/navelbine with or without the EGFR monoclonal antibody erbitux was reported to be positive, demonstrating a significant survival benefit.
Merck KgAA, the company developing cetuximab/Erbitux, the monoclonal antibody against EGFR, reviewed here) outside of the US, has announced that their pivotal FLEX trial (for First-Line Trial for patients with EGFR-Expressing Advanced NSCLC) is positive, demonstrating a signficant improvement in overall survival, as indicated