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FDA Approves Keytruda (pembrolizumab) for the Adjuvant Treatment of Patients with Melanoma with Involvement of Lymph Node(s) Following Complete Resection

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KENILWORTH, N.J.–(BUSINESS WIRE) February 19, 2019 –Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection based on results from the EORTC1325/KEYNOTE-054 trial. This pivotal Phase 3 trial, which was conducted in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC), demonstrated that Keytruda significantly prolonged recurrence-free survival (RFS), reducing the risk of disease recurrence or death by 43 percent compared to placebo in patients with resected, high-risk stage III melanoma (HR=0.57 [95% CI, 0.46, 0.70]; p<0.001). Keytruda is the first anti-PD-1 therapy studied in the adjuvant setting across patients with stage IIIA (>1 mm lymph node metastasis), IIIB and IIIC melanoma.

Immune-mediated adverse reactions, which may be severe or fatal, can occur with Keytruda, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation (HSCT). Based on the severity of the adverse reaction, Keytruda should be withheld or discontinued and corticosteroids administered if appropriate. Keytruda can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, Keytruda can cause fetal harm when administered to a pregnant woman. For more information, see “Selected Important Safety Information” below.

“In the fight against cancer, progress is made one step at a time, and today we’re pleased to take another important step – making Keytruda available as an adjuvant therapy for patients with stage III melanoma,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “At Merck, we are committed to transforming the treatment of cancer, as is exemplified by this important advance in the adjuvant treatment of melanoma.”

“The collaborative study from EORTC and Merck demonstrated a significant reduction in the risk of cancer returning after surgery,” said Dr. Alexander Eggermont, study chair, Director General at the Gustave Roussy Cancer Institute, Professor of Oncology, University of Paris-Saclay. “This approval in the adjuvant setting marks another milestone in the treatment of melanoma patients, who often have a high risk of disease recurrence.”

“As physicians, we are always looking to find ways to prevent cancer from returning in our patients,” said Dr. Alain Algazi, associate clinical professor of medicine, Department of Medicine, Hematology/Oncology, University of California, San Francisco, Medical Center. “Keytruda has demonstrated significant improvement in recurrence-free survival among stage III melanoma patients when compared to a placebo, and we now have a new option to help patients who have a high risk of recurrence.”

“Not too long ago, there were limited treatment options for patients with advanced melanoma,” said Marc Hurlbert, Ph.D., chief science officer, Melanoma Research Alliance. “Today’s approval of Keytruda in the adjuvant setting provides melanoma patients with another option to prevent their cancer from returning, giving hope to those facing this disease.”

About EORTC1325/KEYNOTE-054

The approval was based on data from the EORTC1325/KEYNOTE-054 trial, a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial in patients with completely resected stage IIIA (>1 mm lymph node metastasis), IIIB or IIIC melanoma. In total, the study enrolled 1,019 patients who were randomized 1:1 to receive Keytruda 200 mg every three weeks (n=514) or placebo (n=505) for up to one year or until disease recurrence or unacceptable toxicity. Randomization was stratified by the American Joint Committee on Cancer 7th edition (AJCC) stage (IIIA vs. IIIB vs. IIIC 1-3 positive lymph nodes vs. IIIC ≥4 positive lymph nodes) and geographic region (North America, European countries, Australia and other countries as designated). Patients must have undergone lymph node dissection and, if indicated, radiotherapy within 13 weeks prior to starting treatment. The major efficacy outcome measures were investigator-assessed RFS in the whole population and in the population with PD-L1 positive tumors where RFS was defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis) or death, whichever occurs first. Patients underwent imaging every 12 weeks after the first dose of Keytruda for the first two years, then every six months from year three to five, and then annually.

Among the 1,019 patients, the baseline characteristics were median age of 54 years (range, 19 to 88 years; 25% age 65 or older); 62 percent male; and ECOG PS of 0 (94%) and 1 (6%). Sixteen percent had stage IIIA; 46 percent had stage IIIB; 18 percent had stage IIIC (1-3 positive lymph nodes) and 20 percent had stage IIIC (≥4 positive lymph nodes); 50 percent were BRAF V600 mutation positive, and 44 percent were BRAF wild-type; and 84 percent had PD-L1 positive melanoma determined by tumor proportion score (Tumor Proportion Score [TPS] ≥1%) measured with an investigational use only (IUO) assay.

Patients with active autoimmune disease or a medical condition that required immunosuppression or mucosal or ocular melanoma were ineligible. The most common adverse reaction (reported in at least 20% of study patients) was diarrhea (28%).

About EORTC

European Organisation for Research and Treatment of Cancer (EORTC) conducts clinical research in cancer, defining new standards of practice for better treatment and care of cancer patients. EORTC network comprises more than 5,500 multidisciplinary collaborators in more than 930 hospitals and institutions in 27 countries. Through translational and clinical research, EORTC offers an integrated approach to therapeutic strategies, drug evaluation programs, outcomes research and quality of life. For more information, visit www.eortc.org.

About Keytruda ® (pembrolizumab) Injection, 100mg

Keytruda is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 900 trials studying Keytruda across a wide variety of cancers and treatment settings. The Keytruda clinical program seeks to understand the role of Keytruda across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with Keytruda, including exploring several different biomarkers.

Merck’s Focus on Cancer

Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.

About the Merck Access Program for Keytruda

At Merck, we are committed to supporting accessibility to our cancer medicines. Merck provides multiple programs to help ensure that appropriate patients who are prescribed Keytruda have access to our anti-PD-1 therapy. The Merck Access Program provides reimbursement support for patients receiving Keytruda, including information to help with out-of-pocket costs and co-pay assistance for eligible patients. Merck also offers free product through our patient assistance program to eligible patients, primarily the uninsured, who, without our assistance, could not afford their medicine. More information is available by calling 855-257-3932 or visiting www.merckaccessprogram-keytruda.com.

About Merck’s Patient Support Program for Keytruda

Merck is committed to helping provide patients and their caregivers support throughout their treatment with Keytruda. The KEY+YOU Patient Support Program provides a range of resources and services. For further information and to sign up, patients and physicians may call 85-KEYTRUDA (855-398-7832) or visit www.keytruda.com.

About Merck

For more than a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. 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 health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world – including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’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 health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’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 the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company 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 the company’s 2017 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).

Please see Prescribing Information for Keytruda at  http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf  and Medication Guide for Keytruda at  http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf .

Source: Merck & Co., Inc.

Posted: February 2019

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