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Merck Announces Longer-Term Follow-Up of Overall Survival Data for KEYTRUDA® (pembrolizumab) in Patients with Advanced Melanoma from KEYNOTE-002 Presented at ESMO 2016 Congress

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced findings from the final overall survival (OS) analysis from the KEYNOTE-002 study investigating the use of KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, compared to investigator-choice chemotherapy with a crossover to KEYTRUDA design, in patients with ipilimumab-refractory advanced melanoma. Results presented at the ESMO 2016 Congress, the annual meeting of the European Society for Medical Oncology, in Copenhagen include follow-up of up to 35 months for the study’s co-primary endpoints of OS and progression-free survival (PFS). Data showed prolonged OS with KEYTRUDA (2 mg/kg and 10 mg/kg), with a median OS of 13.4 months and 14.7 months and a two-year OS rate of 35.9 percent and 38.2 percent, respectively, compared to a median OS of 11.0 months and a two-year OS rate of 29.7 percent with chemotherapy.

“Now, with longer follow-up, we continue to show clinically meaningful outcomes with KEYTRUDA as monotherapy in these ipilimumab-refractory patients,” said Dr. Roger Dansey, senior vice president, oncology late-stage development, Merck Research Laboratories. “These results provide further evidence supporting the use of KEYTRUDA as a standard of care for patients with advanced melanoma.”

Today, KEYTRUDA is approved for the treatment of advanced melanoma in more than 50 countries, including the United States and throughout Europe. The KEYTRUDA clinical development program includes more than 30 tumor types in more than 350 clinical studies, including more than 100 trials that combine KEYTRUDA (pembrolizumab) with other cancer treatments.

The final analysis from KEYNOTE-002 is being presented at the ESMO 2016 Congress by Dr. Omid Hamid, director of the Melanoma Center at The Angeles Clinic and Research Institute, on Oct. 8 from 2:45 - 4:15 p.m. CEST (Abstract: #1107O).

Additional Findings from KEYNOTE-002

KEYNOTE-002 is a multicenter, randomized, controlled phase 2 study of KEYTRUDA (2 mg/kg or 10 mg/kg every three weeks) compared to investigator’s choice chemotherapy (paclitaxel plus carboplatin, paclitaxel, carboplatin, dacarbazine, or temozolomide) in patients with ipilimumab-refractory advanced melanoma (n=540). The co-primary endpoints were PFS and OS; secondary endpoints included overall response rate (ORR), duration of response, and safety. Tumor response was assessed at week 12, then every six weeks through week 48, followed by every 12 weeks thereafter as assessed by independent central review using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Per the study protocol, after three months, patients who experienced disease progression on the chemotherapy arm were eligible to cross over to receive KEYTRUDA. In total, 55 percent (n=98/179) of patients in the chemotherapy arm crossed over to receive KEYTRUDA monotherapy.

In the final analysis, which included the 98 patients who crossed over from the chemotherapy arm to receive KEYTRUDA, the median OS was 13.4 months with KEYTRUDA 2 mg/kg (95% CI, 11.0-16.4 months) and 14.7 months with KEYTRUDA 10 mg/kg (95% CI 11.3-19.5 months), compared to 11.0 months with chemotherapy (95% CI, 8.9-13.8 months) (hazard ratio: 0.86 [95% CI, 0.67-1.10; p=0.1173] and hazard ratio: 0.74 [95% CI, 0.57-0.96; p=0.0106], respectively); the two-year (24-month) OS rate was 35.9 percent and 38.2 percent with KEYTRUDA (2 mg/kg and 10 mg/kg, respectively), compared to 29.7 percent with chemotherapy.

While improvements in OS between KEYTRUDA (2 mg/kg or 10 mg/kg) and chemotherapy did not meet the protocol-specified significance threshold, longer follow-up continued to show a clinically meaningful improvement in PFS, the study’s co-primary endpoint, with PFS of up to 31 months in patients treated with KEYTRUDA. Median PFS was approximately three months for each of the patient groups (95% CI of 2.8-3.8 months with KEYTRUDA 2 mg/kg; 95% CI of 2.8-5.2 months with KEYTRUDA 10 mg/kg; and 95% CI of 2.6-2.8 months with chemotherapy) (hazard ratio: 0.58 [95% CI, 0.46-0.73; p<0.0001] and hazard ratio: 0.47 [95% CI, 0.37-0.60; p<0.0001], respectively). The two-year PFS rate was 16.0 percent and 21.9 percent with KEYTRUDA (pembrolizumab) (2 mg/kg and 10 mg/kg, respectively), compared to less than one percent (0.6 percent) of patients treated with chemotherapy.

ORR was 22.2 percent and 27.6 percent with KEYTRUDA (2 mg/kg and 10 mg/kg, respectively), compared to 4.5 percent with chemotherapy. At the time of analysis, 50 percent and 58 percent of patients who responded to KEYTRUDA (2 mg/kg and 10 mg/kg, respectively) were alive with no subsequent progression or anti-tumor therapy, compared to 12 percent of patients who responded to chemotherapy.

With longer follow-up, adverse events have remained consistent with previously reported safety data. Treatment-related immune-mediated adverse events of Grade 3-4 were pneumonitis, colitis (10 mg/kg only), adrenal insufficiency, severe skin toxicity, hypophysitis, hepatitis, nephritis (2 mg/kg only), pancreatitis (10 mg/kg only), and myasthenia (10 mg/kg only).

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 – approximately 232,000 new cases were diagnosed worldwide in 2012. In the U.S., melanoma is one of the most common types of cancer diagnosed and is responsible for the vast majority of skin cancer deaths. In 2016, an estimated 76,380 people are expected to be diagnosed and an estimated 10,130 people are expected to die of the disease in the U.S. alone. The five-year survival rates for advanced or metastatic melanoma (Stage IV) are estimated to be 15 to 20 percent.

About KEYTRUDA ® (pembrolizumab)

KEYTRUDA is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA 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.

KEYTRUDA is administered as an intravenous infusion over 30 minutes every three weeks for the approved indications. KEYTRUDA for injection is supplied in a 100 mg single use vial.

KEYTRUDA (pembrolizumab) Indications and Dosing

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma at a dose of 2 mg/kg every three weeks.

Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy, at a dose of 2 mg/kg every three weeks. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. 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.

Head and Neck Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy at a fixed dose of 200 mg every three weeks. 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.

Selected Important Safety Information for KEYTRUDA ®  (pembrolizumab) in Melanoma

Immune-mediated pneumonitis, including fatal cases, occurred in patients receiving KEYTRUDA. Pneumonitis occurred in 32 (2.0%) of 1567 patients, including Grade 1 (0.8%), 2 (0.8%), and 3 (0.4%) pneumonitis. Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-mediated colitis occurred in 31 (2%) of 1567 patients, including Grade 2 (0.5%), 3 (1.1%), and 4 (0.1%) colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA (pembrolizumab) for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-mediated hepatitis occurred in 16 (1%) of 1567 patients, including Grade 2 (0.1%), 3 (0.7%), and 4 (0.1%) hepatitis. Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hypophysitis occurred in 13 (0.8%) of 1567 patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (0.1%) hypophysitis. Monitor patients for signs and symptoms of hypophysitis (including hypopituitarism and adrenal insufficiency). Administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2; withhold or discontinue for Grade 3 or 4 hypophysitis.

Hyperthyroidism occurred in 51 (3.3%) of 1567 patients, including Grade 2 (0.6%) and 3 (0.1%) hyperthyroidism. Hypothyroidism occurred in 127 (8.1%) of 1567 patients, including Grade 3 (0.1%) hypothyroidism. Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation) and for clinical signs and symptoms of thyroid disorders. Administer replacement hormones for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism.

Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 3 (0.1%) of 2117 patients. Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer anti-hyperglycemics in patients with severe hyperglycemia.

Immune-mediated nephritis occurred in 7 (0.4%) of 1567 patients, including Grade 2 (0.2%), 3 (0.2%), and 4 (0.1%) nephritis. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 nephritis.

Other clinically important immune-mediated adverse reactions can occur. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA (pembrolizumab) when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant, immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 1567 patients: arthritis (1.6%), exfoliative dermatitis, bullous pemphigoid, uveitis, myositis, Guillain-Barré syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, and partial seizures arising in a patient with inflammatory foci in brain parenchyma.

Severe and life-threatening infusion-related reactions have been reported in 3 (0.1%) of 2117 patients. Monitor patients for signs and symptoms of infusion-related reactions including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. If used during pregnancy, or if the patient becomes pregnant during treatment, apprise the patient of the potential hazard to a fetus. Advise females of reproductive potential to use highly effective contraception during treatment and for 4 months after the last dose of KEYTRUDA.

In KEYNOTE-002, KEYTRUDA was discontinued due to adverse reactions in 12% of 357 patients; the most common (≥1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). Adverse reactions leading to interruption of KEYTRUDA occurred in 14% of patients; the most common (≥1%) were dyspnea (1%), diarrhea (1%), and maculopapular rash (1%). The most common adverse reactions with KEYTRUDA vs chemotherapy were fatigue (43% with KEYTRUDA), pruritus (28% vs 8%), rash (24% vs 8%), constipation (22% vs 20%), nausea (22% with KEYTRUDA), diarrhea (20% vs 20%), and decreased appetite (20% with KEYTRUDA). Corresponding incidence rates are listed for chemotherapy only for those adverse reactions that occurred at the same or lower rate than with KEYTRUDA

It is not known whether KEYTRUDA is excreted in human milk. Because many drugs are excreted in human milk, instruct women to discontinue nursing during treatment with KEYTRUDA and for 4 months after the final dose.

Safety and effectiveness of KEYTRUDA have not been established in pediatric patients.

Our Focus on Cancer

Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck 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.

As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the fastest-growing development programs in the industry. We are currently executing an expansive research program that includes more than 350 clinical trials evaluating our anti-PD-1 therapy across more than 30 tumor types. We also continue to strengthen our immuno-oncology portfolio through strategic acquisitions and are prioritizing the development of several promising immunotherapeutic 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 Merck

For 125 years, Merck has been a global health care leader working to help the world be well. Merck is known as MSD outside the United States and Canada. 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. For more information, visit www.merck.com and connect with us on Twitter, Facebook, 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. 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 2015 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 (pembrolizumab) at  http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf  and

Patient Information/Medication Guide for KEYTRUDA at  http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf .

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