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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.
This news release contains forward-looking statements that are based on the current expectations and beliefs of
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us and our partners to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.
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.