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FDA Approves Keytruda (pembrolizumab) for the Treatment of Patients with Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma

KENILWORTH, N.J.--(BUSINESS WIRE) December 19, 2018 --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 treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC), based on the results of the Cancer Immunotherapy Trials Network (CITN)’s CITN-09/KEYNOTE-017 trial. In this Phase 2 trial of 50 patients with recurrent locally advanced or metastatic MCC who had not received prior systemic therapy for their advanced disease, Keytruda monotherapy demonstrated an objective response rate of 56 percent (95% CI, 41-70), with a complete response rate of 24 percent (95% CI, 13-38) and a partial response rate of 32 percent (95% CI, 20-47). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

“The CITN-09/KEYNOTE-017 trial demonstrates that first-line treatment with anti-PD1 therapy provides a meaningful advance for Merkel cell carcinoma patients who have historically had a poor long-term prognosis,” said Dr. Paul Nghiem, lead investigator, professor of dermatology at the University of Washington School of Medicine in Seattle and affiliate investigator at Fred Hutchinson Cancer Research Center. “A few years ago, patients with Merkel cell carcinoma did not have treatment options beyond chemotherapy. As a practicing physician I am pleased that this approval provides another option for patients facing this rare and challenging disease.”

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.

“Merkel cell carcinoma is an aggressive and fast-growing form of skin cancer that has historically been challenging to treat,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “We thank the Cancer Immunotherapy Trials Network for initiating and conducting the trial, the National Cancer Institute for their sponsorship of the research that led to this approval, and the investigators who contributed to the findings. We also thank the patients who participated in the trial and are pleased to provide an important new therapeutic option for Merkel cell carcinoma patients.”

Data Supporting the Approval

The approval was based on data from CITN-09/KEYNOTE-017, a Phase 2, non-randomized, multicenter, open-label trial, initiated and conducted by the Cancer Immunotherapy Trials Network (CITN) based at the Fred Hutchinson Cancer Research Center and sponsored by the National Cancer Institute, evaluating Keytruda in 50 patients with recurrent locally advanced or metastatic MCC who had not received prior systemic therapy for their advanced disease. Patients with active autoimmune disease or a medical condition that required immunosuppression were ineligible.

Patients received Keytruda 2 mg/kg every three weeks until unacceptable toxicity or disease progression that was symptomatic, rapidly progressive, required urgent intervention, occurred with a decline in performance status, or was confirmed at least four weeks later with repeat imaging. Patients without disease progression were treated for up to 24 months. Assessment of tumor status was performed at 13 weeks followed by every nine weeks for the first year and every 12 weeks thereafter. The major efficacy outcome measures were objective response rate (ORR) and duration of response (DOR) as assessed by blinded independent central review per RECIST v1.1.

Among the 50 patients treated, the median age was 71 years (range, 46 to 91 years; 80% age 65 or older); 68 percent were male; 90 percent were White; and ECOG performance score was 0 (48%) and 1 (52%). Fourteen percent had stage IIIB disease, and 86 percent had stage IV. For patients with local or locoregional disease, 84 percent had prior surgery, and 70 percent had prior radiation therapy.

In CITN-09/KEYNOTE-017, the ORR was 56 percent (95% CI, 41-70), with a complete response rate of 24 percent (95% CI, 13-38) and a partial response rate of 32 percent (95% CI, 20-47). Among the responding patients, median DOR was not reached (range, 5.9 to 34.5+ months). Ninety-six percent of responding patients experienced a DOR for six months or longer, and 54 percent experienced a DOR for 12 months or longer.

Among the 50 patients with MCC enrolled in CITN-09/KEYNOTE-017, the median duration of exposure to Keytruda was 6.6 months (range, 1 day to 23.6 months).

Adverse reactions occurring in patients with MCC were generally similar to those in patients with melanoma or NSCLC.

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).

Source: Merck

Posted: December 2018

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