Amgen (AMGN)'s Talimogene Shines In Phase 3 Melanoma Trial
3/17/2014 6:38:52 AM
Amgen's Talimogene Laherparepvec Reduced Size Of Melanoma Tumors In New Phase 3 Retrospective Analysis
THOUSAND OAKS, Calif., March 14, 2014 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced findings from a pre-specified retrospective analysis of patients with metastatic melanoma that showed talimogene laherparepvec reduced the size of injected tumors and also non-injected tumors that had metastasized to other parts of the body. The analysis recorded tumor-level responses from a pivotal Phase 3 study evaluating talimogene laherparepvec in patients with injectable unresected stage IIIB, IIIC or IV melanoma compared to granulocyte-macrophage colony-stimulating factor (GM-CSF). Full results were presented today during an oral session at the Society of Surgical Oncology (SSO) 67th Annual Cancer Symposium in Phoenix.
Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumor tissue and to initiate a systemic anti-tumor immune response.
Of the 295 patients treated with talimogene laherparepvec, almost 4,000 tumor lesions were tracked for this analysis. Half of these lesions were injected with talimogene laherparepvec at least once, while the rest were not injected, including visceral tumor lesions (tumors involving solid organs such as the lungs and liver). The results showed a 50 percent or greater reduction in tumor size in 64 percent of injected tumors. In addition, one-third of uninjected non-visceral tumors, and 15 percent of visceral tumors were also reduced by at least 50 percent. There were 35 melanoma-related surgeries performed during this trial of which 30 percent successfully removed all residual disease.
The most frequently observed adverse events in the Phase 3 study were fatigue, chills and pyrexia. The most common serious adverse events include disease progression in both groups, and cellulitis and pyrexia in the talimogene laherparepvec group. Serious adverse events occurred in 26 percent of talimogene laherparepvec patients and 13 percent of GM-CSF patients. Immune-mediated events were reported infrequently.
"These data add to the body of evidence supporting talimogene laherparepvec's local and distant effect, and its potential ability to stimulate a systemic anti-tumor immune response," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Melanoma remains a devastating and difficult-to-treat disease, and talimogene laherparepvec continues to demonstrate encouraging results in this setting."
About Talimogene Laherparepvec
Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumor tissue and to initiate a systemic anti-tumor immune response. Talimogene laherparepvec is injected directly into tumor tissue and is intended to replicate preferentially in tumor cells causing lytic cell death and releasing an array of tumor-derived antigens. Talimogene laherparepvec is also engineered to express granulocyte-macrophage colony-stimulating factor (GM-CSF), a white blood cell growth factor, which can help to activate the immune system. The aim of this combination of actions is to initiate a systemic anti-tumor immune response that targets tumor cells throughout the body.
Melanoma is a type of skin cancer that is characterized by the uncontrolled growth of melanocytes, which are the cells responsible for providing the pigment to skin.1 Melanoma is the most aggressive and serious form of skin cancer. Currently, 132,000 melanoma cases occur globally each year.2 In the U.S., while melanoma accounts for less than 5 percent of skin cancer cases, it causes the most skin cancer deaths.2 The number of new cases of melanoma in the U.S. has been increasing for the last 30 years.2
Melanoma is considered to be advanced when it has spread, or metastasized, from the origin site to deeper parts of the skin or other organs such as the lymph nodes, lungs or other parts of the body distant from the primary tumor site.3
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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This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen Inc. and its subsidiaries (Amgen or us) and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen Inc., including Amgen Inc.'s most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen Inc.'s most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of March 14, 2014, and expressly disclaims any duty to update information contained in this news release.
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Kristen Davis, 805-447-3008(media)
Arvind Sood, 805-447-1060 (investors)
1 National Cancer Institute, National Institute of Health, U.S. Dept. of Health and Human Services. What You Need to Know About Melanoma and Other Skin Cancers. June 2010http://www.cancer.gov/cancertopics/wyntk/skin. Posted January 11, 2011. Accessed February 21, 2014.
2 Ultraviolet radiation and the INTERSUN Programme. World Health Organization. http://www.who.int/uv/intersunprogramme/en/. Accessed February 21, 2014.
3 American Cancer Society. Melanoma Skin Cancer. http://www.cancer.org/acs/groups/cid/documents/webcontent/003120-pdf.pdf. Accessed February 21, 2014.
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