NCI Launches Study to Determine if Biomarkers Can Help Guide Treatment

NCI Launches First-Ever Study to Determine if Biomarkers Can Help Guide Treatment for Lung Cancer
National Cancer Institute, October 1, 2008
http://www.cancer.gov/newscenter/pressreleases/MARVELrelease

Today, a large national clinical trial for non-small cell lung cancer was launched to validate whether a biomarker can predict clinical benefit in the treatment of this disease. Biomarkers, which are molecules found in the body that can signal an abnormal process or disease, would identify a target known as epidermal growth factor receptor (EGFR). This receptor can be increased in some lung cancers due to the presence of extra copies of its coding gene. These extra copies can result in activation of tumor growth, so drugs that block this activation could have a significant impact on lung cancer treatment. This study, sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, is called MARVEL (Marker Validation for Erlotinib in Lung Cancer) and will attempt to definitively establish the future value of selecting patients for treatment based on the presence or absence of EGFR activation .

Approximately 1,200 lung cancer patients will be tested for the status of this biomarker, and then will be randomly assigned to treatment based on the test results. Both EGFR-positive and EGFR-negative patients will receive either the chemotherapy drugs erlotinib (Tarceva ®, Genentech) or pemetrexed (Alimta ®, Eli Lilly) after they have received their initial, standard chemotherapy. Erlotinib specifically targets EGFR, whereas pemetrexed blocks tumor cell growth by another mechanism.

It is hypothesized that erlotinib will be superior in the patients with EGFR-positive lung cancer, whereas pemetrexed would be favored in patients with EGFR-negative lung cancer, based on knowledge from earlier, smaller studies. MARVEL will incorporate genetic studies for erlotinib and pemetrexed that will be important to further identify patients with different sensitivity and toxicity profiles to these therapies. . .