Amgen and Merck Announce Expansion of Collaboration to Support Studies of Talimogene Laherparepvec in Combination with KEYTRUDA® (pembrolizumab) in Patients with Head and Neck Cancer

Amgen and Merck today announced an expanded collaboration to evaluate the efficacy and safety of Amgen's investigational oncolytic immunotherapy, in combination with Merck's anti-PD-1 therapy.

PRESS RELEASE

THOUSAND OAKS, Calif. and KENILWORTH, N.J., - May 29, 2015 — Amgen (NASDAQ: AMGN) and Merck (NYSE: MRK), known as MSD outside the U.S. and Canada, today announced an expanded collaboration to evaluate the efficacy and safety of talimogene laherparepvec, Amgen’s investigational oncolytic immunotherapy, in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in a Phase 1, open-label trial of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).

In addition, the companies announced that a global, randomized Phase 3 trial evaluating the combination in patients with regionally or distantly metastatic melanoma is being initiated. As previously announced, the compounds are being studied in a Phase 1, open-label trial in this patient population.

Both immunotherapies are designed to modulate the immune system. Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumors (but not normal tissue) and to initiate an immune response against cancer cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 (programmed death receptor-1) and its ligands, PD-L1 and PD-L2.

“We believe that talimogene laherparepvec has potential in several cancer types based on its proposed mechanism of action to initiate tumor antigen release and presentation, important steps in activating a systemic anti-tumor immune response,” said Elliott M. Levy, M.D., senior vice president of Global Development at Amgen. “Talimogene laherparepvec and KEYTRUDA are designed to result in anti-tumor immune responses through different and potentially complementary mechanisms of action. We hope these trials will provide us with insights on the combination of these therapies for patients with this form of cancer for whom treatment options are currently limited. We will discuss the design of the Phase 3 melanoma trial with global regulators and look forward to collaborating with Merck on this study.”

“Expanding our collaboration with Amgen is a testament to our belief in the potential for immuno-oncology therapies to change the way we approach the treatment of many cancers, including advanced head and neck cancer where the options are limited,” said Dr. Eric Rubin, vice president and therapeutic head, oncology early stage development, Merck Research Laboratories. "We look forward to studying the combination of talimogene laherparepvec and KEYTRUDA in head and neck cancer, and to advancing our collaboration in metastatic melanoma into a Phase 3 clinical trial."

About Squamous Cell Carcinoma of the Head and Neck

Squamous cell carcinomas of the head and neck (SCCHN) are cancers that begin in the squamous cells that line the mucosal surfaces inside the head and neck.1 This includes cancers of the nasal cavity, sinuses, lips, mouth, salivary glands, throat, and larynx.2 SCCHN is the sixth most common type of cancer, representing approximately 6 percent of all new cases.3 It is thought to account for an estimated 650,000 new cancer cases and 350,000 cancer deaths worldwide per year.3,-5

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 KEYTRUDA® (pembrolizumab)

KEYTRUDA (pembrolizumab) is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. By binding to the PD-1 receptor and blocking the interaction with the receptor ligands, KEYTRUDA releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.

KEYTRUDA is indicated in the United States at a dose of 2 mg/kg administered as an intravenous infusion over 30 minutes every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merck is advancing a broad and fast-growing clinical development program for KEYTRUDA with more than 100 clinical trials — across more than 30 tumor types and enrolling more than 16,000 patients – both as a monotherapy and in combination with other therapies.