Investor Update

Basel, 02 June 2015

Roche announces collaboration with Amgen on cancer immunotherapy study with investigational medicines talimogene laherparepvec and atezolizumab (MPDL3280A)

First trial to combine these investigational immunotherapies for triple-negative breast cancer and colorectal cancer with liver metastases

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced a collaboration with Amgen 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 tumours (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 combination of investigational agents talimogene laherparepvec, which could activate tumour-specific immune response, with atezolizumab, which could restore immunity by blocking inhibitory T-cell checkpoints, has the potential to increase anti-tumour activity relative to each agent alone.

“Atezolizumab is our most advanced cancer immunotherapy, with ten ongoing phase III pivotal trials across lung, bladder, breast and kidney cancers,” said Sandra Horning, M.D., Roche’s Chief Medical Officer and Head of Global Product Development. “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 tumour types.”

“We believe that talimogene laherparepvec has potential to help patients in several cancer types based on its mechanism of action to promote tumour 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.”

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 tumour cells and tumour-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 tumour cells.

About talimogene laherparepvec

Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumours (but not normal tissue) and to initiate an immune response to target cancer cells that have metastasised. Talimogene laherparepvec was designed to work in two important and complementary ways. First, it is injected directly into tumours where it replicates inside the tumour’s cells causing the cell to rupture and die in a process called lysis. Then, the rupture of the cancer cells can release tumour-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. Based on its clinical profile, talimogene laherparepvec has the potential to be studied in a variety of solid tumour types.

About Roche in cancer immunotherapy

For more than 30 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer. Our personalised cancer immunotherapy research and development programme comprises more than 20 investigational candidates, seven of which are in clinical trials. All studies include the evaluation of biomarkers to determine which people may be appropriate candidates for our medicines.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-eight medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.

In 2014, the Roche Group employed 88,500 people worldwide, invested 8.9 billion Swiss francs in R&D and posted sales of 47.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

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