National Cancer Institute
Because lung cancer has proven to be one of the more intractable cancers to treat, NCI recently launched a large national clinical trial for non-small cell lung cancer to validate whether a biomarker can predict clinical benefit in the treatment of the disease. The biomarker 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.
The study, called MARVEL (Marker Validation for Erlotinib in Lung Cancer), is also important because of its collaborative nature. “The MARVEL trial is unique and an important first because it is an outgrowth of specific NCI initiatives designed to advance lung cancer therapies and received broad input from the FDA, NCI cooperative groups, the biomarker industry, and the pharmaceutical industry,” said Alex A. Adjei, M.D., Ph.D., senior vice president of Clinical Research at Roswell Park Cancer Institute in Buffalo, N.Y., and chair of the study.
Both EGFR-positive and EGFR-negative patients will receive either erlotinib (Tarceva®) or pemetrexed (Alimta®) 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. As with most newer trials that NCI currently supports, MARVEL will incorporate genetic studies that should help identify patients with different sensitivity and toxicity profiles to these therapies.
MARVEL is the outcome of a unique and innovative collaboration, formed in 2006 between NCI, the FDA, and the Centers for Medicare and Medicaid Services, called the Oncology Biomarkers Qualification Initiative. The initiative was designed to qualify biomarkers for use in clinical trials and, ultimately, to speed better agents to cancer patients.
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