Amgen Joins The National Cancer Institute And Research Partners To Help Accelerate Development Of Personalized Treatment Approaches For Squamous Cell Lung Cancer
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
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
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.
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In addition, sales of our products (including products of our wholly-owned subsidiaries) are affected by the reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while
The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the
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.