Amgen (NASDAQ:AMGN) and Merck, known as MSD outside the United States and Canada, announced today that they have entered into an agreement through a subsidiary to evaluate the safety and efficacy of talimogene laherparepvec, an investigational oncolytic immunotherapy, combined with MK-3475, an investigational anti-PD-1 immunotherapy, in a Phase 1b/2 study of patients with mid- to late-stage melanoma.
"Talimogene laherparepvec has shown encouraging Phase 3 clinical results as a monotherapy in patients with metastatic melanoma," said David D. Chang, M.D., Ph.D., vice president of Global Development at Amgen. "We look forward to working with Merck on this collaboration to evaluate the potential of these two novel immunotherapies to improve clinical outcomes for patients."
"We are pleased to be collaborating with Amgen to study MK-3475 as part of this novel combination regimen," said Dr. Eric Rubin, vice president, clinical development for oncology, Merck Research Laboratories. "Early evaluation of immunotherapeutic combinations is important in accelerating the development of new options for patients with cancer."
The multicenter, open-label clinical trial will be conducted in two parts and is planned to begin in the fall of 2014. Phase 1b is designed to determine the safety and tolerability of talimogene laherparepvec in combination with MK-3475 in patients with previously untreated, unresected, stage IIIB to IVM1a melanoma. The Phase 2 portion will evaluate efficacy, as assessed by the confirmed objective response rate (ORR), with talimogene laherparepvec in combination with MK-3475 versus MK-3475 alone in patients with previously untreated, unresected, stage IIIB to IVM1c melanoma. The study will also evaluate the efficacy of treatment with talimogene laherparepvec in combination with MK-3475 following disease progression on MK-3475 alone.
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.
About MK-3475
Many tumors are able to evade the immune system through a mechanism that exploits the PD-1 inhibitory checkpoint protein. MK-3475 is an investigational, highly selective anti-PD-1 immunotherapy designed to restore the natural ability of the immune system to recognize and target cancer cells by selectively achieving dual ligand blockade (PD-L1 and PD-L2) of the PD-1 protein. By blocking PD-1, MK-3475 enables activation of the immune system's T-cells that target cancer by essentially releasing a brake on the immune system.
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 United States, while melanoma accounts for less than five 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 lesion site.(3)
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 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.
1. National Cancer Institute, National Institute of Health, Dept. of Health and Human Services; What You Need to Know About Melanoma and Other Skin Cancers; June 2010.
2. Ultraviolet radiation and the INTERSUN Programme. World Health Organization. http://www.who.int/uv/intersunprogramme/en/. Accessed May 13, 2013.
3. Melanoma Skin Cancer, American Cancer Society, http://www.cancer.org/acs/groups/cid/documents/webcontent/003120-pdf.pdf. Accessed May 13, 2013.