Biomarkers making a difference in clinical trials

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Biomarkers play a major role in personalized medicine, supporting diagnosis and identifying those patients who are (or aren't) likely to respond, and supporting drugs through clinical trials. I've been writing about biomarkers for a year now, and I've seen biomarkers come and go, some to disappear forever into the depths of academic literature as interesting observations, and others to appear on the market as full-fledged diagnostics or to make a major difference in drug development.

One of the most exciting biomarker news stories of the year was the finding that using validated biomarkers in clinical trials of breast cancer drugs cut costs 27% and reduced clinical trial risk 50%.

Another role of biomarkers is to rescue drugs that are failing in clinical trials because they are not focused on quite the right patient group. Amgen ($AMGN) had put aside development of its monoclonal antibody, rilotumumab, which was targeted for the treatment of gastric cancer, because the improvements in survival were not enough to support development. However, in further analysis, the monoclonal antibody helps a subgroup of patients with high levels of the biomarker c-Met, improving their overall survival when given with chemotherapy.

Findings like these could speed drugs through development or could make the difference between drug development being canceled, losing the major investments made to date, and products actually reaching the market for a more tightly defined patient cohort. -- Suzanne Elvidge (email)