Amgen will collaborate with the National Cancer Institute (NCI), part of the NIH, and other public and private sector partners, on the Lung Master Protocol (Lung-MAP), a new clinical trial program that will use biomarker-driven research and genomic profiling to match squamous cell lung cancer patients to investigational treatments based on their individual cancer profiles. Lung-MAP is the first trial of its kind to study a large number of rare lung cancer subsets under one trial protocol.
Approximately 500 to 1,000 patients will be screened each year for more than 200 cancer-related genes, and the screenings will inform trial arm selection. Five investigational drugs have been selected for inclusion in the initial trial, including Amgen's rilotumumab, an investigational fully human monoclonal antibody designed to inhibit cancer cell growth and migration.
"Amgen has been at the forefront of biomarker research in an effort to help the medical community understand the different mechanisms of cancer progression and ensure that patients receive treatments that will provide the greatest benefit," said Sean E. Harper, M.D., executive vice president of R&D at Amgen. "This latest collaboration can significantly speed our understanding of targeted approaches for this complex and underserved form of lung cancer, while demonstrating how genomic testing can drive the evolution of clinical trial design. It may ultimately tell us more about how best to match patients to the right treatments."
In the U.S., lung cancer is the leading cause of cancer death and the second most common cancer. Approximately 25%-30% of non-small cell lung cancers, the most common form of lung cancer, are squamous cell carcinomas. However, there are limited treatment options available for squamous cell carcinomas and development of treatments has been further complicated by the number of potential genetic mutations associated with this form of cancer. Research has demonstrated that squamous cell lung cancer has more than double the genetic mutations compared to other forms of cancer.
Lung-MAP is a biomarker-driven, multi-drug, multi-arm phase II/III registration clinical trial for patients with squamous cell lung cancer. The trial will evaluate five investigational compounds intended to treat squamous cell lung cancer and use genomic sequencing to assign enrolled patients to the treatment arms most likely to provide benefit. Patients will then be randomized into one of five sub-studies where they will receive either standard of care (docetaxel or erlotinib) or biomarker-driven targeted therapy with an investigational agent. Each of these sub-studies will be independently powered for overall survival with an interim analysis for progression-free survival to determine whether to proceed from phase II into phase III.
Lung-MAP is being conducted in collaboration with the NCI, SWOG Cancer Research, Friends of Cancer Research, the Foundation for the National Institutes of Health (FNIH), five pharmaceutical companies (Amgen, Genentech, Pfizer, AstraZeneca and MedImmune) and Foundation Medicine.