Pivotal Study Results Published in Journal of Clinical Oncology Showed Talimogene Laherparepvec Improved Durable Response Rates in Patients With Metastatic Melanoma

THOUSAND OAKS, Calif., May 26, 2015 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the publication of primary results from the Phase 3 OPTiM study in the Journal of Clinical Oncology (JCO). The data published in JCO, which were previously presented at the Annual Meetings of the American Society of Clinical Oncology (ASCO) in 2013 and 2014, demonstrated a significantly higher durable response rate (DRR) in patients with unresected stage IIIB, IIIC or IV metastatic melanoma receiving the investigational oncolytic immunotherapy talimogene laherparepvec compared to those who received granulocyte-macrophage colony-stimulating factor (GM-CSF). Results showed that the primary endpoint of DRR was met, however the secondary endpoint of overall survival (OS) was not met, although there was a strong trend in favor of talimogene laherparepvec.

"Oncolytic virus immunotherapy may become a new approach to melanoma treatment, and the OPTiM study demonstrated durable responses in talimogene laherparepvec treated patients with metastatic melanoma," said lead investigator Howard L. Kaufman, M.D., associate director for Clinical Science at the Rutgers Cancer Institute of New Jersey and president of the Society for Immunotherapy of Cancer. "Talimogene laherparepvec may offer a potential new treatment option for patients with this aggressive form of skin cancer."

A DRR measures the number of patients who had a complete response or partial response within the first 12 months of treatment and maintained the response continuously for at least 6 months.

The most frequent adverse events (AEs) observed in this study were chills, pyrexia, injection-site pain, nausea, flu-like symptoms and fatigue. The most common serious AEs included disease progression, cellulitis and pyrexia. No treatment-related deaths were observed.

"While there have been some important new treatment options in recent years, the incidence of melanoma has risen dramatically, and we need additional approaches for treating advanced disease," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "The OPTiM trial data provide strong evidence supporting the local and distant effects of talimogene laherparepvec and its potential to stimulate a systemic anti-tumor immune response."

The OPTiM data serve as the basis of a Biologics License Application which has been accepted for review by the U.S. Food and Drug Administration (FDA), and a Marketing Authorization Application in the European Union for talimogene laherparepvec for the treatment of adults with regionally or distantly metastatic melanoma. The FDA has set a review goal date under the Prescription Drug User Fee Act of Oct. 27, 2015.

Trial Design
The OPTiM study was a global, randomized, open-label, Phase 3 trial designed to evaluate the safety and efficacy of talimogene laherparepvec compared to a control therapy with GM-CSF in over 400 patients with unresected stage IIIB, IIIC or IV melanoma.

Patients were randomized 2:1 to receive either talimogene laherparepvec intralesionally every two weeks or GM-CSF subcutaneously for the first 14 days of each 28 day cycle. Treatment could last for up to 18 months. Where appropriate, stable or responding patients could receive additional treatment on an extension protocol.

About Talimogene Laherparepvec
Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumors (but not normal tissue) and to initiate an immune response to target cancer cells that have metastasized. Talimogene laherparepvec was designed to work in two important and complementary ways. First, it is injected directly into tumors where it replicates inside the tumor's cells causing the cell to rupture and die in a process called lysis. Then, the rupture of the cancer cells can release tumor-derived antigens, along with GM-CSF, that can stimulate a system-wide immune response where white blood cells are able to seek out and target cancer that has spread throughout the body.

Amgen has initiated a comprehensive clinical development program for talimogene laherparepvec in metastatic melanoma, which includes combination studies with checkpoint inhibitors in patients with late-stage disease and monotherapy prior to surgery (neoadjuvant) in patients with resectable disease. Additionally, based on its clinical profile, talimogene laherparepvec has the potential to be studied in a variety of solid tumor types.

About Melanoma
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 five percent of skin cancer cases, it causes the most skin cancer deaths.³ The number of new cases of melanoma in the U.S. has been increasing for the last 30 years.³

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.⁴

About Amgen 
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 one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

Forward-Looking Statements
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 May 26, 2015, and expressly disclaims any duty to update information contained in this news release.

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CONTACT: Amgen, Thousand Oaks
Kristen Davis, 805-447-3008 (media) 
Arvind Sood, 805-447-1060 (investors)

 References:
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 2010. http://www.cancer.gov/cancertopics/wyntk/skin. Accessed February 26, 2015.
2. World Health Organization. Ultraviolet radiation and the INTERSUN Programme. http://www.who.int/uv/faq/skincancer/en/index1.html. Accessed February 26, 2015.
3. Melanoma skin cancer overview. American Cancer Society website. http://www.cancer.org/acs/groups/cid/documents/webcontent/003063-pdf.pdf.  Accessed February 26, 2015
4. American Cancer Society. Melanoma Skin Cancer. http://www.cancer.org/acs/groups/cid/documents/webcontent/003120-pdf.pdf.  Accessed February 26, 2015

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