Kenilworth, NJ (Press Release) – Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has placed a clin­i­cal hold on KEYNOTE-183, KEYNOTE-185 and KEYNOTE-023, three combi­na­tion studies of KEYTRUDA® (pembro­lizu­mab), the com­pany’s anti-PD-1 ther­apy, in the blood cancer multiple myeloma. This de­ci­sion follows a review of data by the Data Monitor­ing Committee in which more deaths were observed in the KEYTRUDA arms of KEYNOTE-183 and KEYNOTE-185 and which led to the pause in new patient enroll­ment, as announced on June 12, 2017. The FDA has determined that the data avail­able at the present time indicate that the risks of KEYTRUDA plus poma­lido­mide or lena­lido­mide outweigh any poten­tial benefit for patients with multiple myeloma. All patients enrolled in KEYNOTE-183 and KEYNOTE-185 and those in the KEYTRUDA / lena­lido­mide / dexa­meth­a­sone cohort in KEYNOTE-023 will dis­con­tinue inves­ti­ga­tional treat­ment with KEYTRUDA. This clin­i­cal hold does not apply to other studies with KEYTRUDA.

The fol­low­ing studies have been placed on full clin­i­cal hold:

• KEYNOTE-183: “A Phase III study of Pomalidomide and low-dose Dexamethasone with or without Pembrolizumab (MK3475) in refractory or relapsed and refractory Multiple Myeloma (KEYNOTE-183).”
• KEYNOTE-185: “A Phase III study of Lenalidomide and low-dose Dexamethasone with or without Pembrolizumab (MK3475) in newly diagnosed and treatment naïve Multiple Myeloma (KEYNOTE-185).”

The fol­low­ing study has been placed on partial clin­i­cal hold:

• KEYNOTE-023 Cohort 1: “A Phase I Multi-Cohort Trial of Pembrolizumab (MK-3475) in Combination with Backbone Treatments for Subjects with Multiple Myeloma (KEYNOTE 023).” Cohort 1 of KEYNOTE-023 evaluated KEYTRUDA (pembrolizumab) in combination with lenalidomide and dexamethasone in patients who received prior anti-multiple myeloma treatment with an immuno­modulatory (IMiD) treatment (lenalidomide, pomalidomide or thalidomide).

“Patient safety is Merck’s pri­mary concern, and we are grateful to the study investigators and patients involved in these studies for their commitment to this important research,” said Dr. Roger M. Perlmutter, pres­i­dent, Merck Research Laboratories. “Merck’s devel­op­ment pro­gram for KEYTRUDA, spanning more than 30 dif­fer­en­t tumor types, has one priority: helping patients suffering from cancer.”

KEYTRUDA ® (pem­bro­lizu­mab) Injection Indications and Dosing

Melanoma

KEYTRUDA is indicated for the treat­ment of patients with unresectable or metastatic mel­anoma at a fixed dose of 200 mg every three weeks until disease pro­gres­sion or unacceptable toxicity.

Lung Cancer

KEYTRUDA, as a single agent, is indicated for the first-line treat­ment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 ex­pres­sion [tumor proportion score (TPS) ≥50%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, as a single agent, is also indicated for the treat­ment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease pro­gres­sion on or after platinum-containing chemo­ther­apy. Patients with EGFR or ALK genomic tumor aberrations should have disease pro­gres­sion on FDA-approved ther­apy for these aberrations prior to receiving KEYTRUDA.

KEYTRUDA, in com­bi­na­tion with pemetrexed and carboplatin, is indicated for the first-line treat­ment of patients with metastatic nonsquamous NSCLC. This indi­ca­tion is approved under accelerated approval based on tumor response rate and pro­gres­sion-free survival. Continued approval for this indi­ca­tion may be contingent upon veri­fi­ca­tion and description of clin­i­cal benefit in the con­firmatory trials.

In metastatic NSCLC, KEYTRUDA (pem­bro­lizu­mab) is admin­istered at a fixed dose of 200 mg every three weeks until disease pro­gres­sion, unacceptable toxicity, or up to 24 months in patients without disease pro­gres­sion.

When admin­istering KEYTRUDA in com­bi­na­tion with chemo­ther­apy, KEYTRUDA should be admin­istered prior to chemo­ther­apy when given on the same day. See also the Prescribing Information for pemetrexed and carboplatin.

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. 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. In HNSCC, KEYTRUDA is admin­istered at a fixed dose of 200 mg every three weeks until disease pro­gres­sion, unacceptable toxicity, or up to 24 months in patients without disease pro­gres­sion.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treat­ment of adult and pediatric patients with refractory classical Hodgkin lym­phoma (cHL), or who have re­lapsed after three or more prior lines of ther­apy. 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. In adults with cHL, KEYTRUDA is admin­istered at a fixed dose of 200 mg every three weeks until disease pro­gres­sion or unacceptable toxicity, or up to 24 months in patients without disease pro­gres­sion. In pediatric patients with cHL, KEYTRUDA is admin­istered at a dose of 2 mg/kg (up to a maximum of 200 mg) every three weeks until disease pro­gres­sion or unacceptable toxicity, or up to 24 months in patients without disease pro­gres­sion.

Urothelial Carcinoma

KEYTRUDA (pem­bro­lizu­mab) is indicated for the treat­ment of patients with locally ad­vanced or metastatic urothelial carcinoma who are not eli­gible for cisplatin-containing chemo­ther­apy. This indi­ca­tion is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indi­ca­tion may be contingent upon veri­fi­ca­tion and description of clin­i­cal benefit in the con­firmatory trials.

KEYTRUDA is also indicated for the treat­ment of patients with locally ad­vanced or metastatic urothelial carcinoma who have disease pro­gres­sion during or fol­low­ing platinum-containing chemo­ther­apy or within 12 months of neoadjuvant or adjuvant treat­ment with platinum-containing chemo­ther­apy.

In locally ad­vanced or metastatic urothelial carcinoma, KEYTRUDA is admin­istered at a fixed dose of 200 mg every three weeks until disease pro­gres­sion or unacceptable toxicity, or up to 24 months in patients without disease pro­gres­sion.

Microsatellite Instability-High (MSI-H) Cancer

KEYTRUDA is indicated for the treat­ment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

• solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or
• colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.

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 safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been estab­lish­ed.

In adult patients with MSI-H cancer, KEYTRUDA is admin­istered at a fixed dose of 200 mg every three weeks until disease pro­gres­sion, unacceptable toxicity, or up to 24 months in patients without disease pro­gres­sion. In pediatric patients with MSI-H cancer, KEYTRUDA is admin­istered at a dose of 2 mg/kg (up to a maximum of 200 mg) every three weeks until disease pro­gres­sion or unacceptable toxicity, or up to 24 months in patients without disease pro­gres­sion.

Selected Important Safety Information for KEYTRUDA ® (pem­bro­lizu­mab)

KEYTRUDA can cause immune-mediated pneu­mo­nitis, in­­clud­ing fatal cases. Pneumonitis occurred in 94 (3.4%) of 2799 patients receiving KEYTRUDA, in­­clud­ing Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%) pneu­mo­nitis, and occurred more frequently in patients with a history of prior thoracic radiation (6.9%) compared to those without (2.9%). 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.

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 48 (1.7%) of 2799 patients receiving KEYTRUDA, in­­clud­ing Grade 2 (0.4%), 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 for Grade 2 or 3; perma­nently dis­con­tinue KEYTRUDA for Grade 4 colitis.

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 19 (0.7%) of 2799 patients receiving KEYTRUDA, in­­clud­ing Grade 2 (0.1%), 3 (0.4%), 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.

KEYTRUDA can cause hypophysitis. Hypophysitis occurred in 17 (0.6%) of 2799 patients receiving KEYTRUDA, in­­clud­ing Grade 2 (0.2%), 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.

KEYTRUDA can cause thyroid disorders, in­­clud­ing hyperthyroidism, hypo­thy­roid­ism, and thyroiditis. Hyperthyroidism occurred in 96 (3.4%) of 2799 patients receiving KEYTRUDA, in­­clud­ing Grade 2 (0.8%) and 3 (0.1%) hyperthyroidism. Hypothyroidism occurred in 237 (8.5%) of 2799 patients receiving KEYTRUDA, in­­clud­ing Grade 2 (6.2%) and 3 (0.1%) hypo­thy­roid­ism. Thyroiditis occurred in 16 (0.6%) of 2799 patients receiving KEYTRUDA, in­­clud­ing Grade 2 (0.3%) thyroiditis. 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 (pem­bro­lizu­mab) for Grade 3 or 4 hyperthyroidism.

KEYTRUDA can cause type 1 diabetes mellitus, in­­clud­ing diabetic ketoacidosis, which have been reported in 6 (0.2%) of 2799 patients. Monitor patients for hyperglycemia or other signs and symp­toms of diabetes. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and admin­ister antihyperglycemics in patients with severe hyperglycemia.

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 9 (0.3%) of 2799 patients receiving KEYTRUDA, in­­clud­ing Grade 2 (0.1%), 3 (0.1%), 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.

KEYTRUDA can cause other clin­i­cally important immune-mediated adverse reac­tions. These immune-mediated reac­tions may occur in any organ system. 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 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 2799 patients: arthritis (1.5%), exfoliative dermatitis, bullous pemphigoid, rash (1.4%), uveitis, myositis, Guillain-Barré syn­drome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, and partial seizures arising in a patient with inflammatory foci in brain parenchyma. In addi­tion, myelitis and myocarditis were reported in other clin­i­cal trials, in­­clud­ing classical Hodgkin lym­phoma, and postmarketing use.

Solid organ trans­plant rejection has been reported in postmarketing use of KEYTRUDA. Treatment with KEYTRUDA may in­­crease the risk of rejection in solid organ trans­plant recipients. Consider the benefit of treat­ment with KEYTRUDA vs the risk of possible organ rejection in these patients.

KEYTRUDA can cause severe or life-threatening infusion-related reac­tions, in­­clud­ing hypersensitivity and anaphylaxis, which have been reported in 6 (0.2%) of 2799 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 (pem­bro­lizu­mab).

Immune-mediated com­pli­ca­tions, in­­clud­ing fatal events, occurred in patients who underwent allogeneic hematopoietic stem cell trans­plan­ta­tion (HSCT) after being treated with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after treat­ment with KEYTRUDA on any trial, 6 patients (26%) developed graft-versus-host-disease (GVHD), one of which was fatal, and 2 patients (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity con­di­tioning, one of which was fatal. Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lym­phoma who received a PD-1 re­cep­tor–blocking anti­body before trans­plan­ta­tion. These com­pli­ca­tions may occur despite intervening ther­apy between PD-1 blockade and allogeneic HSCT. Follow patients closely for early evi­dence of trans­plant-related com­pli­ca­tions such as hyperacute GVHD, severe (Grade 3 to 4) acute GVHD, steroid-requiring febrile syn­drome, hepatic VOD, and other immune-mediated adverse reac­tions, and intervene promptly.

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-006, KEYTRUDA was dis­con­tinued due to adverse reac­tions in 9% of 555 patients with ad­vanced mel­anoma; adverse reac­tions leading to dis­con­tinu­a­tion in more than one patient were colitis (1.4%), auto­immune hepatitis (0.7%), allergic reac­tion (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). Adverse reac­tions leading to inter­rup­tion of KEYTRUDA occurred in 21% of patients; the most common (≥1%) was diarrhea (2.5%). The most common adverse reac­tions with KEYTRUDA vs ipilimumab were fatigue (28% vs 28%), diarrhea (26% with KEYTRUDA), rash (24% vs 23%), and nausea (21% with KEYTRUDA). Corresponding incidence rates are listed for ipilimumab only for those adverse reac­tions that occurred at the same or lower rate than with KEYTRUDA.

In KEYNOTE-002, KEYTRUDA was dis­con­tinued due to adverse reac­tions in 12% of 357 patients with ad­vanced mel­anoma; 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 (pem­bro­lizu­mab) 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.

KEYTRUDA mono­therapy was dis­con­tinued due to adverse reac­tions in 8% of 682 patients with metastatic NSCLC. The most common adverse event resulting in perma­nent dis­con­tinu­a­tion of KEYTRUDA was pneu­mo­nitis (1.8%). Adverse reac­tions leading to inter­rup­tion of KEYTRUDA occurred in 23% of patients; the most common (≥1%) were diarrhea (1%), fatigue (1.3%), pneu­monia (1%), liver enzyme elevation (1.2%), de­creased appetite (1.3%), and pneu­mo­nitis (1%). The most common adverse reac­tions (occurring in at least 20% of patients and at a higher incidence than with docetaxel) were de­creased appetite (25% vs 23%), dyspnea (23% vs 20%), and nausea (20% vs 18%).

When KEYTRUDA was admin­istered in com­bi­na­tion with carboplatin and pemetrexed (carbo/pem), KEYTRUDA was dis­con­tinued in 10% of 59 patients. The most common adverse reac­tion resulting in dis­con­tinu­a­tion of KEYTRUDA (≥2%) was acute kidney injury (3.4%). Adverse reac­tions leading to inter­rup­tion of KEYTRUDA occurred in 39% of patients; the most common (≥2%) were fatigue (8%), neu­tro­phil count de­creased (8%), anemia (5%), dyspnea (3.4%), and pneu­mo­nitis (3.4%).The most common adverse reac­tions (≥20%) with KEYTRUDA compared to carbo/pem alone were fatigue (71% vs 50%), nausea (68% vs 56%), con­sti­pa­tion (51% vs 37%), rash (42% vs 21%), vomiting (39% vs 27%), dyspnea (39% vs 21%), diarrhea (37% vs 23%), de­creased appetite (31% vs 23%), headache (31% vs 16%), cough (24% vs 18%), dizzi­ness (24% vs 16%), insomnia (24% vs 15%), pruritus (24% vs 4.8%), periph­eral edema (22% vs 18%), dysgeusia (20% vs 11%), alopecia (20% vs 3.2%), upper res­pira­tory tract in­fec­tion (20% vs 3.2%), and arthralgia (15% vs 24%). This study was not designed to dem­onstrate a statistically sig­nif­i­cant dif­fer­ence in adverse reac­tion rates for KEYTRUDA as compared to carbo/pem alone for any specified adverse reac­tion.

KEYTRUDA was dis­con­tinued due to adverse reac­tions in 17% of 192 patients with HNSCC. Serious adverse reac­tions occurred in 45% of patients. The most frequent serious adverse reac­tions reported in at least 2% of patients were pneu­monia, dyspnea, confusional state, vomiting, pleural effusion, and res­pira­tory failure. The most common adverse reac­tions (reported in at least 20% of patients) were fatigue, de­creased appetite, and dyspnea. Adverse reac­tions occurring in patients with HNSCC were generally similar to those occurring in patients with mel­anoma or NSCLC, with the exception of in­­creased incidences of facial edema (10% all Grades; 2.1% Grades 3 or 4) and new or worsening hypo­thy­roid­ism.

KEYTRUDA (pem­bro­lizu­mab) was dis­con­tinued due to adverse reac­tions in 5% of 210 patients with cHL, and treat­ment was interrupted due to adverse reac­tions in 26% of patients. Fifteen per­cent (15%) of patients had an adverse reac­tion requiring systemic corticosteroid ther­apy. Serious adverse reac­tions occurred in 16% of patients. The most frequent serious adverse reac­tions (≥1%) in­cluded pneu­monia, pneu­mo­nitis, pyrexia, dyspnea, GVHD, and herpes zoster. Two patients died from causes other than disease pro­gres­sion; one from GVHD after sub­se­quent allogeneic HSCT and one from septic shock. The most common adverse reac­tions (occurring in ≥20% of patients) were fatigue (26%), pyrexia (24%), cough (24%), mus­cu­lo­skel­etal pain (21%), diarrhea (20%), and rash (20%).

KEYNOTE-052, KEYTRUDA was dis­con­tinued due to adverse reac­tions in 11% of 370 patients with locally ad­vanced or metastatic urothelial carcinoma. The most common adverse reac­tions (in ≥20% of patients) were fatigue (38%), mus­cu­lo­skel­etal pain (24%), de­creased appetite (22%), con­sti­pa­tion (21%), rash (21%), and diarrhea (20%). Eighteen patients (5%) died from causes other than disease pro­gres­sion. Five patients (1.4%) who were treated with KEYTRUDA ex­peri­enced sepsis which led to death, and 3 patients (0.8%) ex­peri­enced pneu­monia which led to death. Adverse reac­tions leading to inter­rup­tion of KEYTRUDA occurred in 22% of patients; the most common (≥1%) were liver enzyme in­­crease, diarrhea, urinary tract in­fec­tion, acute kidney injury, fatigue, joint pain, and pneu­monia. Serious adverse reac­tions occurred in 42% of patients, the most frequent (≥2%) of which were urinary tract in­fec­tion, hematuria, acute kidney injury, pneu­monia, and urosepsis.

In KEYNOTE-045, KEYTRUDA was dis­con­tinued due to adverse reac­tions in 8% of 266 patients with locally ad­vanced or metastatic urothelial carcinoma. The most common adverse reac­tion resulting in perma­nent dis­con­tinu­a­tion of KEYTRUDA was pneu­mo­nitis (1.9%). Adverse reac­tions leading to inter­rup­tion of KEYTRUDA occurred in 20% of patients; the most common (≥1%) were urinary tract in­fec­tion (1.5%), diarrhea (1.5%), and colitis (1.1%). The most common adverse reac­tions (≥20%) in patients who received KEYTRUDA vs those who received chemo­ther­apy were fatigue (38% vs 56%), mus­cu­lo­skel­etal pain (32% vs 27%), pruritus (23% vs 6%), de­creased appetite (21% vs 21%), nausea (21% vs 29%), and rash (20% vs 13%). Serious adverse reac­tions occurred in 39% of KEYTRUDA-treated patients, the most frequent (≥2%) of which were urinary tract in­fec­tion, pneu­monia, anemia, and pneu­mo­nitis.

It is not known whether KEYTRUDA (pem­bro­lizu­mab) 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.

Our Focus on Cancer

Our goal is to translate breakthrough science into inno­va­tive on­col­ogy medicines to help people with cancer world­wide. At Merck, 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 500 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 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.

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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 2016 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 .

Source: Merck.