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KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.


Pivotal trial for first-line use
 

For 1st-line use in patients with advanced melanoma

Superior overall survival vs ipilimumab

68% 1-year overall survival rate with KEYTRUDAa in KEYNOTE-0061

Kaplan-Meier Estimates of Overall Survivalb

Kaplan-Meier Estimates of Overall Survival: KEYTRUDA® (pembrolizumab) vs Ipilimumab
a10 mg/kg Q3W.
bResults were similar in the 2 treatment arms for KEYTRUDA.
From The New England Journal of Medicine, Robert C, Schachter J, Long GV, et al, for the KEYNOTE-006 investigators, Pembrolizumab versus ipilimumab in advanced melanoma, Vol 372, Pages 2521–2532. Copyright © 2015 Massachusetts Medical Society. Adapted with permission from Massachusetts Medical Society.1
  • Statistically significant improvements in overall survival with KEYTRUDA
    10 mg/kg Q3W vs ipilimumab (hazard ratio [HR]=0.69; 95% confidence interval [CI], 0.52–0.90; P=0.004) and with KEYTRUDA 10 mg/kg Q2W vs ipilimumab (HR=0.63; 95% CI, 0.47–0.83; P<0.001).
  • Number of deaths observed in each arm: 92/277 (33%) and 85/279 (30%) with KEYTRUDA 10 mg/kg Q3W and Q2W, respectively, and 112/278 (40%) with ipilimumab.

Superior progression-free survival

46% 6-month progression-free survival rate with KEYTRUDAc in KEYNOTE-0061

Kaplan-Meier Estimates of Progression-free Survival

Kaplan-Meier Estimates of Progression-free Survival: KEYTRUDA® (pembrolizumab) vs Ipilimumab
c10 mg/kg Q3W.

From The New England Journal of Medicine, Robert C, Schachter J, Long GV, et al, for the KEYNOTE-006 investigators, Pembrolizumab versus ipilimumab in advanced melanoma, Vol 372, Pages 2521–2532. Copyright © 2015 Massachusetts Medical Society. Adapted with permission from Massachusetts Medical Society.1
  • 42% reduction in the risk of disease progression or death with KEYTRUDA
    10 mg/kg Q3W vs ipilimumab (HR=0.58; 95% CI, 0.47–0.72; P<0.001) and with KEYTRUDA Q2W vs ipilimumab (HR=0.58; 95% CI, 0.46–0.72; P<0.001).
    • Results based on 502 events (157/277 [57%] and 157/279 [56%] with KEYTRUDA 10 mg/kg Q3W and Q2W, respectively, and 188/278 [68%] with ipilimumab).
  • Median progression-free survival was 4.1 months (95% CI, 2.9–6.9), 5.5 months (95% CI, 3.4–6.9), and 2.8 months (95% CI, 2.8–2.9) with KEYTRUDA 10 mg/kg Q3W, KEYTRUDA 10 mg/kg Q2W, and ipilimumab, respectively.

Superior overall response rate (ORR)

Nearly 3 times higher overall response rate with single-agent KEYTRUDAd vs ipilimumab in KEYNOTE-006

Overall Response Rates With KEYTRUDA® (pembrolizumab) vs Ipilimumab

Percentages have been rounded to the nearest integer.

d10 mg/kg Q3W.
  • 34% (n=94/2792; 95% CI, 28–40) of patients responded to KEYTRUDA 10 mg/kg Q2W.
  • 5% complete response rate and 29% partial response rate with KEYTRUDA 10 mg/kg Q2W.
  • Among the 91 patients randomized to KEYTRUDA 10 mg/kg Q3W with an objective response, response durations ranged from 1.4+ to 8.1+ months.
  • Among the 94 patients randomized to KEYTRUDA 10 mg/kg Q2W with an objective response, response durations ranged from 1.4+ to 8.2 months.

References: 1. Robert C, Schachter J, Long GV, et al, for the KEYNOTE-006 investigators. Pembrolizumab versus ipilimumab in advanced melanoma. N Engl J Med. 2015;372(26):2521–2532. 2. Robert C, Schachter J, Long GV, et al, for the KEYNOTE-006 investigators. Supplementary Appendix to: Pembrolizumab versus ipilimumab in advanced melanoma. (N Engl J Med. 2015;372(26):2521–2532.) http://www.nejm.org/action/showSupplements?doi=10.1056%2FNEJMoa1503093&viewType=Popup&viewClass=Suppl.

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ONCO-1164838-0002 01/17

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

selected safety information

  • 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 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. 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.

  • KEYTRUDA can cause severe or life-threatening infusion-related reactions, 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.

  • 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.

  • 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.

Before prescribing KEYTRUDA, please read the accompanying Prescribing Information. The Medication Guide also is available.

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ONCO-1164838-0002 01/17