Stratified Medicine
Adapting therapeutic options through the use of biomarkers
Until recently, most of the pharmaceutical industry has adopted a "one-size-fits-all" approach to developing new drugs. Experience has shown, however, that a number of major drugs do not deliver the expected benefits to many patients.
At Merck Serono, we are committed to understanding and meeting individual patient needs, and investing in specialized areas of medical science to deliver tailored treatments.
This is reflected in our approach to stratified medicine, which is designed to adapt treatment options to different patient groups through the use of biomarkers. These include specific proteins or metabolites in the blood that reflect a change of a biological state with prognostic and/or predictive power. The objective is to get effective treatments to patients and limit adverse events.
Merck Serono is already implementing stratified medicine with Erbitux® in the treatment of metastatic colorectal cancer by using KRAS mutation status as a biomarker. Erbitux® is an antibody targeting the epidermal growth factor receptor (EGFR) and KRAS is part of the signal transduction cascade activated by the binding of EGF to the EGFR. Apart from the colorectal cancer indication Erbitux® is used for the treatment of head and neck cancer.
In metastatic colorectal cancer, studies have shown that individuals with tumors harboring the KRAS wild-type gene are most likely to benefit from therapy with Erbitux®. The analysis of the KRAS gene in tumor samples prior to the initiation of treatment allows physicians to treat only those patients. This information is now included in the drug labeling and a genetic test is available to prescribing doctors.
Merck Serono’s Research and Development organization has integrated the stratified medicine approach into the drug discovery process. For more than 80% of the drug candidates in our R&D pipeline, we analyze and evaluate genetic profiles and other biomarkers to try to determine which patients respond well to specific therapies.
The search for biomarkers is only beginning. Our goal for the future is to provide truly personalized healthcare that will match individual patient profiles with the latest medical advances and targeted therapeutic options.
In metastatic colorectal cancer, studies have shown that individuals with tumors harboring the KRAS wild-type gene are most likely to benefit from therapy with Erbitux®. The analysis of the KRAS gene in tumor samples prior to the initiation of treatment allows physicians to treat only those patients. This information is now included in the drug labeling and a genetic test is available to prescribing doctors.
Merck Serono’s Research and Development organization has integrated the stratified medicine approach into the drug discovery process. For more than 80% of the drug candidates in our R&D pipeline, we analyze and evaluate genetic profiles and other biomarkers to try to determine which patients respond well to specific therapies.
The search for biomarkers is only beginning. Our goal for the future is to provide truly personalized healthcare that will match individual patient profiles with the latest medical advances and targeted therapeutic options.
“We have created a framework in which the scientific merits and viability of each drug candidate can be judged in a rigorous and consistent manner. We don’t have the resources to pursue every possible project, so we have to make some tough choices.”
DeeAnn
Global Head Portfolio Management & Interfaces, Discovery Research and Oncology, Geneva.
DeeAnn
Global Head Portfolio Management & Interfaces, Discovery Research and Oncology, Geneva.
