Opinion for Pembrolizumab Based on Efficacy and Safety Data in More than 1,500 Patients with Advanced Melanoma as First-Line Therapy and in those Previously Treated

MSD, known as Merck (NYSE:MRK) in the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of pembrolizumab, the company’s anti-PD-1 therapy, for the treatment of advanced (unresectable or metastatic) melanoma as both first-line therapy and in previously-treated patients. The CHMP positive opinion for pembrolizumab, which is based on data in more than 1,500 adult patients with advanced melanoma, will now be reviewed by the European Commission for central marketing authorization in the European Union (EU).

“MSD is committed to bringing pembrolizumab to people with advanced melanoma in Europe as rapidly as possible, and the positive CHMP opinion marks a significant step forward,” said Roger Dansey, therapeutic area head and senior vice president, oncology late stage development, Merck Research Laboratories. “We have established a broad data set for pembrolizumab in the treatment of advanced melanoma, and have demonstrated improvements in progression free survival compared to chemotherapy and a survival benefit compared to ipilimumab. We look forward to working with European health authorities to make pembrolizumab available to patients.”

Pembrolizumab, which will be marketed under the worldwide brand name of KEYTRUDA, is one of the first of a new generation of immunotherapies that works by blocking the PD-1 pathway. Pembrolizumab was the first anti-PD-1 therapy approved in the United States and the first medicine to be accepted under the UK’s Early Access to Medicines Scheme (EAMS), which was introduced to help patients benefit from promising, innovative treatments before a European license has been granted.

Data Supporting the CHMP Positive Opinion

The positive opinion was based on data from more than 1,500 patients with advanced melanoma treated with pembrolizumab as monotherapy in three studies – from a large Phase 1b study, KEYNOTE-001; from a randomized, controlled study, KEYNOTE-002; and an interim analysis from a second, randomized controlled study, KEYNOTE-006. In KEYNOTE-001, the largest Phase 1b study to date of an anti-PD-1 antibody, pembrolizumab demonstrated durable objective responses in patients with advanced melanoma. KEYNOTE-002, a Phase 2 study, showed pembrolizumab was superior to chemotherapy for progression-free survival in ipilimumab refractory advanced melanoma. KEYNOTE-006, a Phase 3 study, showed pembrolizumab was superior to ipilimumab for overall survival, progression-free survival, and overall response rate. The trial was stopped early in March 2015 based on the recommendation of the study’s independent Data Monitoring Committee as it had met its two primary endpoints. The CHMP recommended approval of pembrolizumab monotherapy at a dose of 2 mg/kg every three weeks, which is the currently approved dose for advanced melanoma in the U.S.

About Melanoma

Melanoma, the most serious form of skin cancer, is characterized by the uncontrolled growth of pigment-producing cells. The incidence of melanoma has been increasing over the past four decades. In 2012, approximately 232,130 new cases were diagnosed worldwide, and the incidence in Europe was estimated to be 100,300. The five-year survival rates for advanced or metastatic melanoma (Stage IV) are estimated to be 15 to 20 percent.

About Pembrolizumab

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, pembrolizumab releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.

MSD is advancing a broad and fast-growing clinical development program for pembrolizumab with more than 85 clinical trials – across more than 30 tumor types and over 14,000 patients – both as a monotherapy and in combination with other therapies.

Our Focus on Cancer

Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At MSD Oncology, helping people fight cancer is our passion and supporting accessibility to our cancer medicines is our commitment. Our focus is on pursuing research in immuno-oncology and we are accelerating every step in the journey – from lab to clinic – to potentially bring new hope to people with cancer.

About MSD

Today's MSD is a global healthcare leader working to help the world be well. MSD is a trade name of Merck & Co., Inc., with headquarters in Kenilworth, N.J., U.S.A. Through our prescription medicines, vaccines, biologic therapies, and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships.

Forward-Looking Statement

This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of MSD’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include, but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation in the United States and internationally; global trends toward healthcare cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; MSD’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

MSD undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in MSD’s/Merck’s 2014 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

MSDMedia:Pam Eisele, (267) 305-3558orClaire Mulhearn, (908) 236-1118orInvestor:Joseph Romanelli, (908) 740-1986orJustin Holko, (908) 740-1879

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