THOUSAND OAKS, Calif., Oct. 23, 2015 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion recommending that IMLYGIC™ (talimogene laherparepvec) be granted approval for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease. If approved by the European Commission, IMLYGIC would be the first in a class of novel agents known as oncolytic immunotherapies.
IMLYGIC, administered via intralesional injection, is designed to cause the death of tumor cells and to initiate an anti-tumor immune response.
"We are pleased that IMLYGIC has received a positive opinion from the CHMP, and if approved by the European Commission, we look forward to continuing to work with European regulatory authorities to bring this innovative therapy to patients," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Metastatic melanoma continues to be one of the most difficult-to-treat cancers, often requiring the use of multiple treatment modalities. Despite recent advances, the five-year survival rate for patients who cannot be cured with surgery remains unacceptably low, demonstrating the critical need for additional approaches to control this disease."
The positive CHMP opinion was based on a global, randomized, open-label Phase 3 trial evaluating the safety and efficacy of IMLYGIC in patients with Stage IIIB, IIIC or IV melanoma when resection was not recommended compared to granulocyte-macrophage colony-stimulating factor (GM-CSF). In the 436-patient study, IMLYGIC significantly improved durable response rate (DRR), the primary endpoint of the trial, in the intent-to-treat population. DRR is defined as the percent of patients with complete response (CR) or partial response (PR) maintained continuously for a minimum of six months. A key secondary endpoint was overall survival (OS). The positive CHMP opinion reflects subgroup analyses where the effect on OS was largest in patients with unresectable melanoma that has not spread beyond the skin or lymph nodes.
The most commonly reported treatment-related adverse events were fatigue, chills, pyrexia, nausea, influenza-like illness and injection-site pain. Overall, 98 percent of these adverse reactions reported were mild or moderate in severity. The most common grade 3 or higher adverse reaction was cellulitis.
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, and remains a significant public health concern in the European Union (EU).2,3 In 2012, it was estimated that there were 56,000 new cases of melanoma in France, Italy, Spain, Germany and the U.K. causing nearly 9,500 deaths.4,5
Following this CHMP opinion, Amgen expects a decision on the Marketing Authorization from the European Commission in the coming months. IMLYGIC is also under review by the U.S. Food and Drug Administration.
About IMLYGIC (talimogene laherparepvec) in the EU
IMLYGIC is an oncolytic immunotherapy that is derived from HSV-1, which is commonly called the cold sore virus. IMLYGIC has been modified to replicate within tumors and to produce the immune stimulatory protein human GM-CSF. IMLYGIC causes the death of tumor cells and the release of tumor-derived antigens. It is thought that, together with GM-CSF, it will promote a systemic anti-tumor immune response and an effector T cell response.
About IMLYGIC (talimogene laherparepvec) in the U.S.
IMLYGIC is a genetically modified herpes simplex type 1 virus that is injected directly into tumors. IMLYGIC replicates inside tumor cells and produces GM-CSF, an immunostimulatory protein. IMLYGIC then causes the cell to rupture and die in a process called lysis. The rupture of the cancer cells causes the release of tumor-derived antigens, which together with virally derived GM-CSF may help to promote an anti-tumor immune response. However, the exact mechanism of action is unknown.
About Amgen's Immuno-Oncology Focused Partnerships
Amgen has in place a comprehensive clinical development program investigating oncolytic immunotherapies for their potential in melanoma and in a variety of other cancers.
Amgen's recent immuno-oncology focused partnerships include:
- A collaboration with Merck on developing IMLYGIC and KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in melanoma and squamous cell cancer of the head and neck.
- A collaboration with Roche on a Phase 1b study to evaluate the safety and efficacy of IMLYGIC in combination with Roche's investigational anti-PDL1 therapy, atezolizumab (also known as MPDL3280A), in patients with triple-negative breast cancer and colorectal cancer with liver metastases.
- A strategic research collaboration and license agreement to develop and commercialize the next generation of novel Chimeric Antigen Receptor (CAR) T cell immunotherapies with Kite Pharma.
- A research collaborative agreement focusing on Amgen's bispecific T cell engager (BiTE®) antibody constructs with MD Anderson's Moon Shots Program.
- A research and license agreement with Xencor to develop and commercialize novel therapeutics in the areas of cancer immunotherapy and inflammation. The research collaboration brings together Amgen's capabilities in target discovery and protein therapeutics with Xencor's XmAb® bispecific technology platform.
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.
About Amgen's Commitment to Oncology
Amgen Oncology is committed to helping patients take on some of the toughest cancers, such as those that have been resistant to drugs, those that progress rapidly through the body and those where limited treatment options exist. Amgen's supportive care treatments help patients combat certain side effects of strong chemotherapy, and our targeted medicines and immunotherapies focus on more than a dozen different malignances, ranging from blood cancers to solid tumors. With decades of experience providing treatments for cancer patients, Amgen continues to grow its portfolio of innovative and biosimilar oncology medicines.
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 Oct. 23, 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)
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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 October 8, 2015.
2. Melanoma Skin Cancer Overview. American Cancer Society. http://www.cancer.org/acs/groups/cid/documents/webcontent/003063-pdf.pdf. Accessed October 8, 2015.
3. Skin cancer incidence statistics. Cancer Research UK. http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/skin-cancer/incidence#heading-Six. Accessed October 8, 2015.
4. GLOBOCAN 2012. http://globocan.iarc.fr/old/summary_table_site-html.asp?selection=16120&title=Melanoma+of+skin&sex=0&type=1&window=1&europe=4&sort=0&submit=%C2%A0Execute. Accessed October 12, 2015.
5. GLOBOCAN 2012. http://globocan.iarc.fr/old/summary_table_site-html.asp?selection=16120&title=Melanoma+of+skin&sex=0&type=0&window=1&europe=4&sort=0&submit=%C2%A0Execute. Accessed October 12, 2015.
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