Amgen Announces Collaboration With Roche On Cancer Immunotherapy Study With Investigational Medicines Talimogene Laherparepvec And Atezolizumab

THOUSAND OAKS, Calif., June 2, 2015 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced a collaboration with Roche on a Phase 1b study to evaluate the safety and efficacy of talimogene laherparepvec, Amgen's investigational oncolytic immunotherapy, 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.

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. Atezolizumab is an investigational monoclonal antibody designed to interfere with the PD-L1 protein.

The rationale for combining these two investigational agents is to activate an anti-tumor immune response with talimogene laherparepvec and to block inhibitory T cell checkpoints with atezolizumab, to potentially increase the anti-tumor activity relative to each agent alone.

"We believe that talimogene laherparepvec has potential to help patients in several cancer types based on its mechanism of action to promote tumor antigen release and presentation, important steps in activating a systemic immune response," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "This further builds our alliance network in oncology and we look forward to collaborating with Roche on this study as part of our increasing efforts in immuno-oncology."

"Atezolizumab is our most advanced cancer immunotherapy with 10 ongoing Phase 3 pivotal trials across lung, bladder, breast and kidney cancers," said Sandra Horning, M.D., chief medical officer and head of Global Product Development at Roche. "We are looking forward to working with Amgen on this trial, which can inform potential future treatment options for patients affected by very difficult-to-treat tumor types."

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 Atezolizumab (also known as MPDL3280A)
Atezolizumab  is an investigational monoclonal antibody designed to interfere with a protein called PD-L1. Atezolizumab is designed to target PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, preventing it from binding to PD-1 and B7.1 on the surface of T cells. By inhibiting PD-L1, atezolizumab may enable the activation of T cells, restoring their ability to effectively detect and attack tumor cells.

About Amgen's Immuno-Oncology Focused Partnerships
Amgen's recent immuno-oncology focused partnerships include:

• A collaboration with Merck on developing talimogene laherparepvec and KEYTRUDA^® (pembrolizumab) in melanoma and small cell cancer of the head and neck.
• 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.

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
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CONTACT: Amgen Thousand Oaks
Kristen Davis, 805-447-3008 (media)
Trish Hawkins, 805-447-5631 (media)
Arvind Sood, 805-447-1060 (investors)

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