Lung-MAP Trial Will Test Five Investigational Approaches, Including Amgen's Rilotumumab, an Investigational Fully Human Monoclonal Antibody
THOUSAND OAKS, Calif., June 16, 2014 /PRNewswire/ -- Amgen (NASDAQ:AMGN) announced today that it will collaborate with the National Cancer Institute (NCI), part of the National Institutes of Health, and other public and private sector partners on the Lung Master Protocol (Lung-MAP), a groundbreaking 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 Research and Development 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.1 Approximately 25-30 percent of non-small cell lung cancers, the most common form of lung cancer, are squamous cell carcinomas.2 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.3
Lung-MAP is a biomarker-driven, multi-drug, multi-arm Phase 2/3 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 (OS) with an interim analysis for progression-free survival (PFS) to determine whether to proceed from Phase 2 into Phase 3.4,5
Lung-MAP is being conducted in collaboration with the NCI, part of the National Institutes of Health, SWOG Cancer Research, Friends of Cancer Research (Friends), the Foundation for the National Institutes of Health (FNIH), five pharmaceutical companies (Amgen, Genentech, Pfizer, AstraZeneca, and MedImmune, AstraZeneca's global biologics R&D arm), and Foundation Medicine.
Rilotumumab is an investigational fully human monoclonal antibody designed to inhibit the hepatocyte growth factor/scatter factor (HGF/SF):MET pathway, which has the potential to reduce cell proliferation, impair survival signals, and prevent the migration and invasion of tumor cells. In addition to evaluating the potential of rilotumumab in the treatment of squamous cell carcinomas in lung cancer as part of the Lung-MAP clinical trial program, the compound is also currently undergoing Phase 3 evaluation in advanced gastric/gastroesophageal junction cancer.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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- Centers for Disease Control and Prevention. Lung Cancer. Available at http://www.cdc.gov/cancer/lung/. Accessed May 2014.
- American Cancer Society. What is Non-Small Cell Lung Cancer? Available at http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-what-is-non-small-cell-lung-cancer. Accessed May 2014.
- Kan Z et al. Diverse somatic mutation patterns and pathway alterations in human cancers. Nature. 2010;466:869–873.
- Friends of Cancer Research. Master Protocol. Available at http://www.focr.org/master-protocol. Accessed May 2014.
- SWOG Cancer Research. S1400: Lung-MAP, the Lung Master Protocol, coming soon. Available at http://www.swog.org/Visitors/newsletters/2014/04/index.asp?a=s1400. Accessed May 2014.