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KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), accepted as MSD alfresco the United States and Canada, today appear the aboriginal presentation of acting abstracts from the cardinal Phase 3 KEYNOTE-048 balloon investigating KEYTRUDA, Merck’s anti-PD-1 therapy, as both monotherapy and in aggregate with chemotherapy, for the first-line assay of alternate or metastatic arch and close squamous corpuscle blight (HNSCC). These acting after-effects are actuality presented today during the Presidential Symposium at the ESMO 2018 Congress (Abstract # LBA8_PR) and are included in the official Press Program.

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Acting abstracts from KEYNOTE-048 showed KEYTRUDA monotherapy bigger all-embracing adaptation (OS), a primary endpoint of the study, by 39 percent (HR 0.61 [95% CI, 0.45-0.83]; p=0.0007) in patients whose tumors bidding PD-L1 with Combined Positive Score (CPS) ≥20, and by 22 percent (HR 0.78 [95% CI, 0.64-0.96]; p=0.0086) in patients with CPS≥1, compared to the EXTREME dieting (cetuximab with carboplatin or cisplatin added 5-fluorouracil (5-FU), the accepted accepted of care. In addition, KEYTRUDA in aggregate with chemotherapy (carboplatin or cisplatin added 5-FU) (KEYTRUDA combination) accustomed bigger OS compared to the EXTREME dieting by 23 percent (HR 0.77 [95% CI, 0.63-0.93]; p=0.0034), behindhand of PD-L1 expression. At the final analysis, ahead for OS will be evaluated for KEYTRUDA monotherapy in the absolute citizenry and KEYTRUDA aggregate in patients whose tumors accurate PD-L1 at CPS≥20 and CPS≥1; at this acting analysis, based aloft the prespecified testing algorithm, non-inferiority for KEYTRUDA monotherapy in the absolute citizenry was accustomed and statistical acceptation was not accomplished for the KEYTRUDA aggregate in the subset of patients whose tumors bidding PD-L1 at CPS ≥20 or ≥1. Additionally, at this time point there was no aberration in progression-free-survival (PFS), a bifold primary endpoint of the study, in any of the groups studied. There were no new assurance apropos articular with the use of KEYTRUDA in KEYNOTE-048.

“In this study, KEYTRUDA showed the abeyant to decidedly prolong adaptation back acclimated as first-line assay for patients whose arch and close blight had recurred or spread,” said Dr. Barbara Burtness, beforehand investigator for KEYNOTE-048, assistant of anesthetic at Yale School of Anesthetic and co-director, Development Therapeutics Analysis Program, Yale Blight Center. ”This is a adverse blight back it recurs, and there has not been any beforehand in first-line assay for over a decade. It is blood-tingling to see these new data, which accept the abeyant to adapt the accepted of affliction in the first-line assay of arch and close cancer.”

“KEYTRUDA is the aboriginal anti-PD-1 assay to appearance above all-embracing adaptation as first-line assay compared to the EXTREME regimen, the accepted accepted of affliction in patients with alternate or metastatic arch and close cancer,” said Dr. Roy Baynes, arch carnality admiral and arch of All-around Analytic Development, arch medical officer, Merck Analysis Laboratories. “Recurrent or metastatic arch and close blight is a absolute arduous disease. Merck would like to acknowledge the patients and board for accommodating in this important study, which is allowance to beforehand our compassionate of the abeyant for KEYTRUDA and PD-1 inhibition in the first-line setting.”

KEYTRUDA is currently accustomed in 61 countries for the assay of second-line alternate or metastatic HNSCC, including the U.S. and Europe. Merck affairs to book a added Biologics License Application (sBLA) with the U.S. Food and Drug Administering (FDA) for a first-line adumbration based on KEYNOTE-048 abstracts and will accommodate abstracts from the Phase 3 KEYNOTE-040 balloon as admiring data. Based on these results, Merck has aloof the sBLA for KEYNOTE-040 for KEYTRUDA as a second-line assay in patients with alternate or metastatic HNSCC, which was ahead assigned a Decree Drug User Fee Act (PDUFA) or ambition activity date of Dec. 28, 2018. The after-effects from KEYNOTE-048 will additionally be submitted to authoritative authorities worldwide.

Abstraction Design and Added Abstracts from KEYNOTE-048 (Abstract # LBA8_PR)

KEYNOTE-048, a randomized, open-label Phase 3 balloon (ClinicalTrials.gov, NCT02358031), evaluated KEYTRUDA monotherapy or KEYTRUDA combination, compared with the EXTREME regimen, as first-line assay in 882 patients with alternate or metastatic HSNCC. The bifold primary endpoints were OS and PFS. The accessory endpoints were PFS (at 6 months and 12 months), cold acknowledgment amount (ORR) and time to abasement in Quality of Activity All-around Bloom Status/Quality of Activity Scales of the European Organization for Analysis and Assay of Blight (EORTC) Quality of Activity Questionnaire and Safety. Continuance of acknowledgment (DOR) was evaluated as allotment of a pre-specified basic analysis. The primary and accessory endpoints, as able-bodied as basic DOR analysis, were evaluated in patients whose tumors bidding PD-L1 with CPS ≥20 and CPS ≥1, and in the absolute population, behindhand of PD-L1 expression, based on a anchored consecutive testing strategy. At the time of the analysis, the average aftereffect was 11.7 months for KEYTRUDA monotherapy, 13.0 months for KEYTRUDA aggregate and 10.7 months for the EXTREME regimen, respectively.

In the aboriginal allegory group, OS in the CPS ≥20 citizenry was decidedly best with KEYTRUDA monotherapy (14.9 months) (n=133) compared to the EXTREME dieting (10.7 months) (n=122) (HR 0.61 [95% CI, 0.45-0.83]; p=0.0007). There was no aberration in PFS amid the abstraction accoutrements (HR 0.99 [95% CI, 0.75-1.29]; p=0.5). ORR was 23.3 percent for KEYTRUDA monotherapy and 36.1 percent for the EXTREME regimen, respectively. The average DOR was essentially best with KEYTRUDA monotherapy (20.9 months) compared to the EXTREME dieting (4.2 months).

Similarly, OS in the CPS ≥1 citizenry was decidedly best with KEYTRUDA monotherapy (12.3 months) (n=257) compared to the EXTREME dieting (10.3 months) (n=255) (HR 0.78 [95% CI, 0.64-0.96]; p=0.0086). There was no aberration in PFS amid the abstraction accoutrements (HR 1.16 [95% CI, 0.96-1.39]). ORR was 19.1 percent for KEYTRUDA monotherapy and 34.9 percent for the EXTREME regimen, respectively. The average DOR was essentially best with KEYTRUDA (20.9 months) compared to the EXTREME dieting (4.5 months).

In the added allegory group, OS in the absolute citizenry was decidedly best with the KEYTRUDA aggregate (13.0 months) (n=281) compared to the EXTREME dieting (10.7 months) (n=278) (HR 0.77 [95% CI, 0.63-0.93]; p=0.0034). There was no aberration in PFS amid the abstraction accoutrements (HR 0.92; 95% CI, 0.77-1.10). ORR was 35.6 percent for the KEYTRUDA aggregate and 36.3 percent for the EXTREME regimen, respectively. The average DOR was best with KEYTRUDA aggregate (6.7 months) compared to the EXTREME dieting (4.3 months).

There were no new assurance apropos articular with the use of KEYTRUDA in KEYNOTE-048. Grade 3-5 treatment-related adverse contest (TRAEs) occurred in 16.7 percent, 71.0 percent and 69.0 percent (n=198/287) of patients in the KEYTRUDA monotherapy, KEYTRUDA aggregate and the EXTREME dieting arms, respectively. TRAEs consistent in cessation occurred in 4.7 percent, 22.8 percent and 19.9 percent of patients in the KEYTRUDA monotherapy, KEYTRUDA aggregate and the EXTREME dieting arms, respectively. There were no TRAEs empiric with an accident of ≥15% in the KEYTRUDA monotherapy arm. The best accepted TRAEs (occurring in ≥15% of patients) in the KEYTRUDA aggregate arm included anemia (48.2%), abhorrence (44.9%), neutropenia (33.0%), fatigue (30.4%), mucosal deepening (27.9%), thrombocytopenia (27.2%), airsickness (27.2%), stomatitis (24.3%), decreased appetence (22.5%), platelet calculation decreased (18.5%), diarrhea (17.8%) and neutrophil calculation decreased (16.7%).

Immune-mediated adverse contest in patients accepting KEYTRUDA monotherapy or aggregate assay were hypothyroidism (18.0% and 15.2%, respectively), pneumonitis (6.0% and 5.4%, respectively), hyperthyroidism (2.7% and 4.7%, respectively), astringent bark reactions (2.7% and 0.7%, respectively), beverage reactions (1.3% and 2.2%, respectively), colitis (1.0% and 2.5%, respectively), nephritis (0.7% in both arms), pancreatitis (0.7% and 0.4%, respectively), hypophysitis (0.3% and 0.4%, respectively); hepatitis (0.7% monotherapy only); myocarditis and thyroiditis (0.4% each, aggregate only); and adrenal insufficiency, encephalitis and uveitis (0.3% each, monotherapy only). Treatment-related deaths occurred in 3 patients in the KEYTRUDA monotherapy arm [auto-inflammatory disease, broadcast intravascular coagulation, and pneumonitis (n=1 each)]; 10 patients in the KEYTRUDA aggregate arm [septic shock (n=5), bookish ischemia, hemorrhage, interstitial lung disease, sepsis, and bump drain (n=1 each)]; and 8 patients in the EXTREME dieting arm [pneumonia (n=3), sepsis (n=2), and hypoxia, osteomyelitis, and pulmonary avenue occlusion (n=1 each)].

Added Advice About KEYNOTE-048

KEYNOTE-048 enrolled 882 patients with alternate or metastatic HSNCC who were randomized to one of three regimens as first-line therapy, as follows:

About Arch and Close Blight

Arch and close blight describes a cardinal of altered tumors that beforehand in or about the throat, larynx, nose, sinuses and mouth. Best arch and close cancers are squamous corpuscle carcinomas that activate in the flat, squamous beef that accomplish up the attenuate apparent band of the structures in the arch and neck. The arch adjustable accident factors for arch and close blight accommodate tobacco and abundant booze use. Added accident factors accommodate infection with assertive types of HPV, additionally alleged beastly papillomaviruses. Worldwide, an estimated 835,000 new arch and close blight cases will be diagnosed in 2018, and an estimated 431,000 bodies will die from the ache this year. In the U.S., there were an estimated 63,000 new cases diagnosed in 2017.

About KEYTRUDA® (pembrolizumab) Injection 100mg

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KEYTRUDA is an anti-PD-1 assay that works by accretion the adeptness of the body’s allowed arrangement to advice ascertain and activity bump cells. KEYTRUDA is a humanized monoclonal antibiotic that blocks the alternation amid PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both bump beef and advantageous cells.

Merck has the industry’s better immuno-oncology analytic analysis program. There are currently added than 850 trials belief KEYTRUDA beyond a avant-garde array of cancers and assay settings. The KEYTRUDA analytic affairs seeks to accept the role of KEYTRUDA beyond cancers and the factors that may adumbrate a patient’s likelihood of benefitting from assay with KEYTRUDA, including exploring several altered biomarkers.

KEYTRUDA® (pembrolizumab) Indications and Dosing

Melanoma

KEYTRUDA is adumbrated for the assay of patients with unresectable or metastatic melanoma at a anchored dosage of 200 mg every three weeks until ache progression or unacceptable toxicity.

Lung Blight

KEYTRUDA, in aggregate with pemetrexed and platinum chemotherapy, is adumbrated for the first-line assay of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic bump aberrations.

KEYTRUDA, as a distinct agent, is adumbrated for the first-line assay of patients with metastatic non-small corpuscle lung blight (NSCLC) whose tumors accept aerial PD-L1 announcement [Tumor Proportion Score (TPS) ≥50%] as bent by an FDA-approved test, with no EGFR or ALK genomic bump aberrations.

KEYTRUDA, as a distinct agent, is additionally adumbrated for the assay of patients with metastatic NSCLC whose tumors accurate PD-L1 (TPS ≥1%) as bent by an FDA-approved test, with ache progression on or afterwards platinum-containing chemotherapy. Patients with EGFR or ALK genomic bump aberrations should accept ache progression on FDA-approved assay for these aberrations above-mentioned to accepting KEYTRUDA.

In metastatic NSCLC, KEYTRUDA is administered at a anchored dosage of 200 mg every three weeks until ache progression, unacceptable toxicity, or up to 24 months in patients afterwards ache progression.

Back administering KEYTRUDA in aggregate with chemotherapy, KEYTRUDA should be administered above-mentioned to chemotherapy back accustomed on the aforementioned day. See additionally the Prescribing Advice for pemetrexed and carboplatin or cisplatin, as appropriate.

Arch and Close Blight

KEYTRUDA is adumbrated for the assay of patients with alternate or metastatic arch and close squamous corpuscle blight (HNSCC) with ache progression on or afterwards platinum-containing chemotherapy. This adumbration is accustomed beneath accelerated approval based on bump acknowledgment amount and backbone of response. Continued approval for this adumbration may be accidental aloft analysis and description of analytic account in the acknowledging trials. In HNSCC, KEYTRUDA is administered at a anchored dosage of 200 mg every three weeks until ache progression, unacceptable toxicity, or up to 24 months in patients afterwards ache progression.

Classical Hodgkin Lymphoma

KEYTRUDA is adumbrated for the assay of developed and pediatric patients with adverse classical Hodgkin lymphoma (cHL), or who accept relapsed afterwards three or added above-mentioned curve of therapy. This adumbration is accustomed beneath accelerated approval based on bump acknowledgment amount and backbone of response. Continued approval for this adumbration may be accidental aloft analysis and description of analytic account in the acknowledging trials. In adults with cHL, KEYTRUDA is administered at a anchored dosage of 200 mg every three weeks until ache progression or unacceptable toxicity, or up to 24 months in patients afterwards ache progression. In pediatric patients with cHL, KEYTRUDA is administered at a dosage of 2 mg/kg (up to a best of 200 mg) every three weeks until ache progression or unacceptable toxicity, or up to 24 months in patients afterwards ache progression.

Primary Mediastinal Ample B-Cell Lymphoma

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KEYTRUDA is adumbrated for the assay of developed and pediatric patients with adverse primary mediastinal ample B-cell lymphoma (PMBCL), or who accept relapsed afterwards 2 or added above-mentioned curve of therapy. This adumbration is accustomed beneath accelerated approval based on bump acknowledgment amount and backbone of response. Continued approval for this adumbration may be accidental aloft analysis and description of analytic account in acknowledging trials. KEYTRUDA is not recommended for the assay of patients with PMBCL who crave burning cytoreductive therapy.

In adults with PMBCL, KEYTRUDA is administered at a anchored dosage of 200 mg every three weeks until ache progression, unacceptable toxicity, or up to 24 months in patients afterwards ache progression. In pediatric patients with PMBCL, KEYTRUDA is administered at a dosage of 2 mg/kg (up to a best of 200 mg) every three weeks until ache progression or unacceptable toxicity, or up to 24 months in patients afterwards ache progression.

Urothelial Blight

KEYTRUDA is adumbrated for the assay of patients with locally avant-garde or metastatic urothelial blight (mUC) who are not acceptable for cisplatin-containing chemotherapy and whose tumors accurate PD-L1 [Combined Positive Score (CPS) ≥10] as bent by an FDA-approved test, or in patients who are not acceptable for any platinum-containing chemotherapy behindhand of PD-L1 status. This adumbration is accustomed beneath accelerated approval based on bump acknowledgment amount and continuance of response. Continued approval for this adumbration may be accidental aloft analysis and description of analytic account in the acknowledging trials.

KEYTRUDA is additionally adumbrated for the assay of patients with locally avant-garde or metastatic urothelial blight (mUC) who accept ache progression during or afterward platinum-containing chemotherapy or aural 12 months of neoadjuvant or accessory assay with platinum-containing chemotherapy.

In locally avant-garde or metastatic urothelial carcinoma, KEYTRUDA is administered at a anchored dosage of 200 mg every three weeks until ache progression or unacceptable toxicity, or up to 24 months in patients afterwards ache progression.

Microsatellite Instability-High (MSI-H) Blight

KEYTRUDA is adumbrated for the assay of developed and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or conflict adjustment amiss (dMMR)

This adumbration is accustomed beneath accelerated approval based on bump acknowledgment amount and backbone of response. Continued approval for this adumbration may be accidental aloft analysis and description of analytic account in the acknowledging trials. The assurance and capability of KEYTRUDA in pediatric patients with MSI-H axial afraid arrangement cancers accept not been established.

In developed patients with MSI-H cancer, KEYTRUDA is administered at a anchored dosage of 200 mg every three weeks until ache progression, unacceptable toxicity, or up to 24 months in patients afterwards ache progression. In accouchement with MSI-H cancer, KEYTRUDA is administered at a dosage of 2 mg/kg (up to a best of 200 mg) every three weeks until ache progression or unacceptable toxicity, or up to 24 months in patients afterwards ache progression.

Belly Blight

KEYTRUDA is adumbrated for the assay of patients with alternate locally avant-garde or metastatic belly or gastroesophageal alliance (GEJ) adenocarcinoma whose tumors accurate PD-L1 [Combined Positive Score (CPS) ≥1] as bent by an FDA-approved test, with ache progression on or afterwards two or added above-mentioned curve of assay including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This adumbration is accustomed beneath accelerated approval based on bump acknowledgment amount and backbone of response. Continued approval for this adumbration may be accidental aloft analysis and description of analytic account in the acknowledging trials. The recommended dosage of KEYTRUDA is a anchored dosage of 200 mg every three weeks until ache progression, unacceptable toxicity, or up to 24 months in patients afterwards ache progression.

Cervical Blight

KEYTRUDA is adumbrated for the assay of patients with alternate or metastatic cervical blight with ache progression on or afterwards chemotherapy whose tumors accurate PD-L1 (CPS ≥1) as bent by an FDA-approved test. This adumbration is accustomed beneath accelerated approval based on bump acknowledgment amount and backbone of response. Continued approval for this adumbration may be accidental aloft analysis and description of analytic account in the acknowledging trials. The recommended dosage of KEYTRUDA is a anchored dosage of 200 mg every three weeks until ache progression, unacceptable toxicity or up to 24 months in patients afterwards ache progression.

Selected Important Assurance Advice for KEYTRUDA

Immune-Mediated Pneumonitis

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KEYTRUDA can account immune-mediated pneumonitis, including baleful cases. Pneumonitis occurred in 3.4% (94/2799) of patients accepting KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%), and occurred added frequently in patients with a history of above-mentioned thoracic radiation (6.9%) compared to those afterwards (2.9%). Monitor patients for signs and affection of pneumonitis. Evaluate doubtable pneumonitis with radiographic imaging. Administrate corticosteroids for Grade 2 or greater pneumonitis. Abstain KEYTRUDA for Grade 2; assuredly abandon for Grade 3 or 4 or alternate Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can account immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients accepting KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and affection of colitis. Administrate corticosteroids for Grade 2 or greater colitis. Abstain KEYTRUDA for Grade 2 or 3; assuredly abandon for Grade 4 colitis.

Immune-Mediated Hepatitis

KEYTRUDA can account immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients accepting KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in alarmist function. Administrate corticosteroids for Grade 2 or greater hepatitis and, based on severity of alarmist agitator elevations, abstain or abandon KEYTRUDA.

Immune-Mediated Endocrinopathies

KEYTRUDA can account hypophysitis, thyroid disorders, and blazon 1 diabetes mellitus. Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The accident of new or deepening hypothyroidism was college in patients with HNSCC occurring in 15% (28/192) of patients. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Blazon 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and affection of hypophysitis (including hypopituitarism and adrenal insufficiency), thyroid activity (prior to and periodically during treatment), and hyperglycemia. For hypophysitis, administrate corticosteroids and hormone backup as clinically indicated. Abstain KEYTRUDA for Grade 2 and abstain or abandon for Grade 3 or 4 hypophysitis. Administrate hormone backup for hypothyroidism and administrate hyperthyroidism with thionamides and beta-blockers as appropriate. Abstain or abandon KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administrate insulin for blazon 1 diabetes, and abstain KEYTRUDA and administrate antihyperglycemics in patients with astringent hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can account immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients accepting KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients accepting KEYTRUDA in aggregate with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administrate corticosteroids for Grade 2 or greater nephritis. Abstain KEYTRUDA for Grade 2; assuredly abandon for Grade 3 or 4 nephritis.

Immune-Mediated Bark Reactions

Immune-mediated rashes, including Stevens-Johnson affection (SJS), baneful epidermal necrolysis (TEN) (some cases with baleful outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for doubtable astringent bark reactions and based on the severity of the adverse reaction, abstain or assuredly abandon KEYTRUDA and administrate corticosteroids. For signs or affection of SJS or TEN, abstain KEYTRUDA and accredit the accommodating for specialized affliction for appraisal and treatment. If SJS or TEN is confirmed, assuredly abandon KEYTRUDA.

Added Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be astringent or fatal, can activity in any agency arrangement or tissue in patients accepting KEYTRUDA and may additionally activity afterwards cessation of treatment. For doubtable immune-mediated adverse reactions, ensure able appraisal to affirm analysis or exclude added causes. Based on the severity of the adverse reaction, abstain KEYTRUDA and administrate corticosteroids. Aloft beforehand to Grade 1 or less, admit corticosteroid abate and abide to abate over at atomic 1 month. Based on bound abstracts from analytic studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administering of added systemic immunosuppressants can be considered. Resume KEYTRUDA back the adverse acknowledgment charcoal at Grade 1 or beneath afterward corticosteroid taper. Assuredly abandon KEYTRUDA for any Grade 3 immune-mediated adverse acknowledgment that recurs and for any life-threatening immune-mediated adverse reaction.

The afterward clinically cogent immune-mediated adverse reactions occurred in beneath than 1% (unless contrarily indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barré syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were appear in added analytic trials and postmarketing use.

Assay with KEYTRUDA may admission the accident of bounce in solid agency displace recipients. Consider the account of assay vs the accident of accessible agency bounce in these patients.

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Infusion-Related Reactions

KEYTRUDA can account astringent or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which accept been appear in 0.2% (6/2799) of patients. Monitor patients for signs and affection of infusion-related reactions. For Grade 3 or 4 reactions, stop beverage and assuredly abandon KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Corpuscle Transplantation (HSCT)

Immune-mediated complications, including baleful events, occurred in patients who underwent allogeneic HSCT afterwards assay with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT afterwards KEYTRUDA, 6 developed graft-versus-host ache (GVHD) (1 baleful case) and 2 developed astringent hepatic veno-occlusive ache (VOD) afterwards reduced-intensity conditioning (1 baleful case). Cases of baleful hyperacute GVHD afterwards allogeneic HSCT accept additionally been appear in patients with lymphoma who accustomed a PD-1 receptor–blocking antibiotic afore transplantation. Follow patients carefully for aboriginal affirmation of transplant-related complications such as hyperacute graft-versus-host ache (GVHD), Grade 3 to 4 astute GVHD, steroid-requiring delirious syndrome, hepatic veno-occlusive ache (VOD), and added immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, astute GVHD (including baleful GVHD) has been appear afterwards assay with KEYTRUDA. Patients who accomplished GVHD afterwards their displace activity may be at added accident for GVHD afterwards KEYTRUDA. Consider the account of KEYTRUDA vs the accident of GVHD in these patients.

Added Bloodshed in Patients with Assorted Myeloma

In analytic trials in patients with assorted myeloma, the accession of KEYTRUDA to a thalidomide alternation added dexamethasone resulted in added mortality. Assay of these patients with a PD-1 or PD-L1 blocking antibiotic in this aggregate is not recommended alfresco of controlled analytic trials.

Embryofetal Toxicity

Based on its apparatus of action, KEYTRUDA can account fetal abuse back administered to a abundant woman. If acclimated during pregnancy, or if the accommodating becomes abundant during treatment, accustom the accommodating of the abeyant hazard to a fetus. Advise females of changeable abeyant to use awful able contraception during assay and for 4 months afterwards the aftermost dosage of KEYTRUDA.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with avant-garde melanoma; adverse reactions arch to abiding cessation in added than one accommodating were colitis (1.4%), autoimmune hepatitis (0.7%), allergic acknowledgment (0.4%), polyneuropathy (0.4%), and cardiac abortion (0.4%). The best accepted adverse reactions (≥20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), adventurous (24%), and abhorrence (21%).

In KEYNOTE-189, back KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The best accepted adverse reactions consistent in abiding cessation of KEYTRUDA were pneumonitis (3%) and astute branch abrasion (2%). The best accepted adverse reactions (≥20%) with KEYTRUDA were abhorrence (56%), fatigue (56%), ache (35%), diarrhea (31%), decreased appetence (28%), adventurous (25%), airsickness (24%), ahem (21%), dyspnea (21%), and agitation (20%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC. The best accepted adverse accident consistent in abiding cessation of KEYTRUDA was pneumonitis (1.8%). The best accepted adverse reactions (≥20%) were decreased appetence (25%), fatigue (25%), dyspnea (23%), and abhorrence (20%).

In KEYNOTE-012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Austere adverse reactions occurred in 45% of patients. The best accepted austere adverse reactions appear in at atomic 2% of patients were pneumonia, dyspnea, confusional state, ing, pleural effusion, and respiratory failure. The best accepted adverse reactions (≥20%) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were about agnate to those occurring in patients with melanoma or NSCLC, with the barring of added incidences of facial edema and new or deepening hypothyroidism.

In KEYNOTE-087, KEYTRUDA was discontinued due to adverse reactions in 5% of 210 patients with cHL. Austere adverse reactions occurred in 16% of patients; those ≥1% included pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and canker zoster. Two patients died from causes added than ache progression; 1 from GVHD afterwards consecutive allogeneic HSCT and 1 from catchbasin shock. The best accepted adverse reactions (≥20%) were fatigue (26%), agitation (24%), ahem (24%), musculoskeletal affliction (21%), diarrhea (20%), and adventurous (20%).

In KEYNOTE-170, KEYTRUDA was discontinued due to adverse reactions in 8% of 53 patients with PMBCL. Austere adverse reactions occurred in 26% of patients and included arrhythmia (4%), cardiac tamponade (2%), myocardial infarction (2%), pericardial address (2%), and pericarditis (2%). Six (11%) patients died aural 30 canicule of alpha of treatment. The best accepted adverse reactions (≥20%) were musculoskeletal affliction (30%), high respiratory amplitude infection and agitation (28% each), ahem (26%), fatigue (23%), and dyspnea (21%).

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In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally avant-garde or metastatic urothelial carcinoma. Austere adverse reactions occurred in 42% of patients; those ≥2% were urinary amplitude infection, hematuria, astute branch injury, pneumonia, and urosepsis. The best accepted adverse reactions (≥20%) were fatigue (38%), musculoskeletal affliction (24%), decreased appetence (22%), ache (21%), adventurous (21%), and diarrhea (20%).

In KEYNOTE-045, KEYTRUDA was discontinued due to adverse reactions in 8% of 266 patients with locally avant-garde or metastatic urothelial carcinoma. The best accepted adverse acknowledgment consistent in abiding cessation of KEYTRUDA was pneumonitis (1.9%). Austere adverse reactions occurred in 39% of KEYTRUDA-treated patients; those ≥2% were urinary amplitude infection, pneumonia, anemia, and pneumonitis. The best accepted adverse reactions (≥20%) in patients who accustomed KEYTRUDA were fatigue (38%), musculoskeletal affliction (32%), pruritus (23%), decreased appetence (21%), abhorrence (21%), and adventurous (20%).

In KEYNOTE-158, KEYTRUDA was discontinued due to adverse reactions in 8% of 98 patients with alternate or metastatic cervical cancer. Austere adverse reactions occurred in 39% of patients accepting KEYTRUDA; the best accepted included anemia (7%), fistula, hemorrhage, and infections [except urinary amplitude infections] (4.1% each). The best accepted adverse reactions (≥20%) were fatigue (43%), musculoskeletal affliction (27%), diarrhea (23%), affliction and belly affliction (22% each), and decreased appetence (21%).

Lactation

It is not accepted whether KEYTRUDA is excreted in beastly milk. Because abounding drugs are excreted in beastly milk, acquaint women to abandon nursing during assay with KEYTRUDA and for 4 months afterwards the final dose.

Pediatric Use

There is bound acquaintance in pediatric patients. In a abstraction in 40 pediatric patients with avant-garde melanoma, lymphoma, or PD-L1–positive advanced, relapsed, or adverse solid tumors, the assurance contour was agnate to that apparent in adults advised with KEYTRUDA. Toxicities that occurred at a college amount (≥15% difference) in these patients back compared to adults beneath 65 years of age were fatigue (45%), airsickness (38%), belly affliction (28%), hypertransaminasemia (28%), and hyponatremia (18%).

Merck’s Focus on Blight

Our ambition is to construe beforehand science into avant-garde oncology medicines to advice bodies with blight worldwide. At Merck, the abeyant to accompany new achievement to bodies with blight drives our purpose and acknowledging accessibility to our blight medicines is our commitment. As allotment of our focus on cancer, Merck is committed to exploring the abeyant of immuno-oncology with one of the better development programs in the industry beyond added than 30 bump types. We additionally abide to strengthen our portfolio through cardinal acquisitions and are prioritizing the development of several able oncology candidates with the abeyant to beforehand the assay of avant-garde cancers. For added advice about our oncology analytic trials, appointment www.merck.com/clinicaltrials.

About Merck

For added than a century, Merck, a arch all-around biopharmaceutical aggregation accepted as MSD alfresco of the United States and Canada, has been inventing for life, bringing advanced medicines and vaccines for abounding of the world’s best arduous diseases. Through our decree medicines, vaccines, biologic therapies and beastly bloom products, we assignment with barter and accomplish in added than 140 countries to bear avant-garde bloom solutions. We additionally authenticate our charge to accretion admission to bloom affliction through extensive policies, programs and partnerships. Today, Merck continues to be at the beginning of analysis to beforehand the blockage and assay of diseases that abuse bodies and communities about the apple – including cancer, cardio-metaic diseases, arising beastly diseases, Alzheimer’s ache and communicable diseases including HIV and Ea. For added information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

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

This account absolution of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” aural the acceptation of the safe anchorage accoutrement of the U.S. Private Securities Action Reform Act of 1995. These statements are based aloft the accepted behavior and expectations of the company’s administration and are accountable to cogent risks and uncertainties. There can be no guarantees with account to activity articles that the articles will accept the all-important authoritative approvals or that they will prove to be commercially successful. If basal assumptions prove inaccurate or risks or uncertainties materialize, absolute after-effects may alter materially from those set alternating in the advanced statements.

Risks and uncertainties accommodate but are not bound to, accepted industry altitude and competition; accepted bread-and-er factors, including absorption amount and bill barter amount fluctuations; the appulse of biologic industry adjustment and bloom affliction legislation in the United States and internationally; all-around trends against bloom affliction amount containment; abstruse advances, new articles and patents accomplished by competitors; challenges inherent in new artefact development, including accepting authoritative approval; the company’s adeptness to accurately adumbrate approaching bazaar conditions; accomplishment difficulties or delays; banking alternation of all-embracing economies and absolute risk; assurance on the capability of the company’s patents and added protections for avant-garde products; and the acknowledgment to litigation, including apparent litigation, and/or authoritative actions.

The aggregation undertakes no obligation to about amend any advanced statement, whether as a aftereffect of new information, approaching contest or otherwise. Added factors that could account after-effects to alter materially from those declared in the advanced statements can be begin in the company’s 2017 Annual Report on Form 10-K and the company’s added filings with the Securities and Barter Commission (SEC) accessible at the SEC’s Internet armpit (www.sec.gov).

Please see Prescribing Advice for KEYTRUDA at

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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.

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