• For Oncologists
  • For Pathologists
 
Biomarker Testing
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BIOMARKER STATUS INFORMS TREATMENT DECISIONS
WITH KEYTRUDA

  • PD-L1 is an immune-related biomarker that can be expressed on tumor cells.
  • Evaluating PD-L1 expression level at diagnosis of NSCLC contributes to a better understanding of your patient’s tumor and helps inform treatment decisions.

    PD-L1 = programmed death ligand 1; NSCLC = non–small cell lung cancer.

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend PD-L1 testing as a part of the diagnostic evaluation of patients for treatment of mNSCLC.1

National Comprehensive Cancer Network® (NCCN®) makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.


PD-L1 EXPRESSION LEVEL AND/OR HISTOLOGY HELP INFORM TREATMENT DECISIONS WITH KEYTRUDA

  No PD-L1 Expression
(TPS <1%)
PD-L1 Expression
(TPS 1% to 49%)
High PD-L1 Expression
(TPS ≥50%)
 
First-line KEYTRUDA + cisplatin or carboplatin and pemetrexed (nonsquamous; no EGFR or ALK genomic tumor aberrations)
No PD-L1 Expression
(TPS <1%)
 
PD-L1 Expression
(TPS 1% to 49%)
 
High PD-L1 Expression
(TPS ≥50%)
 
 
First-line KEYTRUDA (nonsquamous or squamous; no EGFR or ALK genomic tumor aberrations)
No PD-L1 Expression
(TPS <1%)
 
PD-L1 Expression
(TPS 1% to 49%)
 
High PD-L1 Expression
(TPS ≥50%)
 
 
Second-line or greater KEYTRUDA (nonsquamous or squamous; prior treatment required for patients with EGFR or ALK genomic tumor aberrations)
No PD-L1 Expression
(TPS <1%)
 
PD-L1 Expression
(TPS 1% to 49%)
 
High PD-L1 Expression
(TPS ≥50%)
 

Request PD-L1 testing for patients at diagnosis of NSCLC to help personalize treatment decisions with KEYTRUDA.

EGFR = epidermal growth factor receptor; ALK = anaplastic lymphoma kinase; TPS = tumor proportion score.


WHERE TO TEST

  • PD-L1 testing can be conducted within your hospital or facility, or you may order testing from a reference laboratory.
    • The reference laboratories below offer the PD-L1 IHC 22C3 pharmDx, the first FDA-approved companion diagnostic test for PD‑L1 testing in NSCLC.2

IHC = immunohistochemistry.

PD-L1 expression testing is available at these national reference laboratories

  • The above national reference laboratories do not represent an exclusive network of accredited pathology laboratories offering PD‑L1 testing. PD-L1 testing may be offered by accredited pathology laboratories other than the national reference laboratories identified above.
  • Regional reference laboratories that offer accredited PD-L1 testing include:

Merck does not endorse the use of any particular laboratory over another or guarantee the work performed by any laboratory.

Keytruda Key
Contact your pathologist or a Merck representative with questions about PD-L1 testing.

WATCH A VIDEO ON THE ROLE OF BIOMARKERS IN NSCLC

BIOMARKER STATUS INFORMS TREATMENT DECISIONS WITH KEYTRUDA

Tumor Proportion Score (TPS)1,2

Evaluate the percentage of viable tumor cells showing partial or complete membrane staining at any intensity.

Metastatic NSCLCTPS=# of PD-L1–positive tumor cellsTotal # of PD-L1–positive + PD-L1–negative tumor cellsx 100
  • PD-L1 expression level in mNSCLC is determined by the TPS, which is reported as a percentage on a scale of 0% to 100%.1,2
  • A minimum of 100 viable tumor cells in the PD-L1–stained slide is required for the specimen to be considered adequate for PD‑L1 evaluation.1

PD-L1 = programmed death ligand 1; NSCLC = non–small cell lung cancer.

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend PD-L1 testing as a part of the diagnostic evaluation of patients for treatment of mNSCLC.3

National Comprehensive Cancer Network® (NCCN®) makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.


INTERPRETING PD-L1 EXPRESSION IN mNSCLC1,2

ALTALT

The PD-L1 IHC 22C3 pharmDx is a qualitative immunohistochemical assay that was used in the mNSCLC clinical trials with KEYTRUDA1

  • Intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded specimens
Keytruda Key
To learn more about scoring and interpreting TPS, please refer to the PD-L1 IHC 22C3 Instructions for Use and the PD-L1 IHC 22C3 Interpretation Manual, both published by Agilent Technologies.

IHC = immunohistochemistry.


YOUR REPORTING OF BIOMARKER STATUS IS IMPORTANT for personalizing patient treatment

Prepare an actionable lab report that includes:
TPS TPS as a percentage between 0% and 100%1,2
PD-L1 PD-L1 expression level1,2
  Treatment options with KEYTRUDA

ENSURE YOUR REPORT INDICATES ELIGIBILITY FOR TREATMENT WITH KEYTRUDA ACCORDING TO THE FDA-APPROVED INDICATIONS

  No PD-L1 Expression
(TPS <1%)
PD-L1 Expression
(TPS 1% to 49%)
High PD-L1 Expression
(TPS ≥50%)
 
First-line KEYTRUDA + cisplatin or carboplatin and pemetrexed (nonsquamous; no EGFR or ALK genomic tumor aberrations)
No PD-L1 Expression
(TPS <1%)
 
PD-L1 Expression
(TPS 1% to 49%)
 
High PD-L1 Expression
(TPS ≥50%)
 
 
First-line KEYTRUDA (nonsquamous or squamous; no EGFR or ALK genomic tumor aberrations)
No PD-L1 Expression
(TPS <1%)
 
PD-L1 Expression
(TPS 1% to 49%)
 
High PD-L1 Expression
(TPS ≥50%)
 
 
Second-line or greater KEYTRUDA (nonsquamous or squamous; prior treatment required for patients with EGFR or ALK genomic tumor aberrations)
No PD-L1 Expression
(TPS <1%)
 
PD-L1 Expression
(TPS 1% to 49%)
 
High PD-L1 Expression
(TPS ≥50%)
 
Keytruda Key
Include TPS, an assessment of PD-L1 expression level, and treatment options with KEYTRUDA in your pathology report to optimize the oncologist’s treatment decisions.

EGFR = epidermal growth factor receptor; ALK = anaplastic lymphoma kinase; PD-L1 = programmed death ligand 1.


WHERE TO TEST

  • PD-L1 testing can be conducted within your hospital or facility, or you may order testing from a reference laboratory.
    • The reference laboratories below offer the PD-L1 IHC 22C3 pharmDx, the first FDA-approved companion diagnostic test for PD‑L1 testing in NSCLC.4

PD-L1 expression testing is available at these national reference laboratories

  • The above national reference laboratories do not represent an exclusive network of accredited pathology laboratories offering PD‑L1 testing. PD-L1 testing may be offered by accredited pathology laboratories other than the national reference laboratories identified above.
  • Regional reference laboratories that offer accredited PD-L1 testing include:

Merck does not endorse the use of any particular laboratory over another or guarantee the work performed by any laboratory.


ALL INDICATIONS

  • ADVANCED MELANOMA:KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.
  • FIRST-LINE COMBINATION THERAPY:KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non‒small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
  • FIRST-LINE MONOTHERAPY:KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic NSCLC whose tumors have high programmed death ligand 1 (PD-L1) expression [tumor proportion score (TPS) ≥50%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
  • SECOND-LINE OR GREATER MONOTHERAPY:KEYTRUDA, as a single agent, is 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.
  • RECURRENT OR METASTATIC HEAD AND NECK SQUAMOUS CELL CARCINOMA ON OR AFTER PLATINUM-CONTAINING CHEMOTHERAPY: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.
  • REFRACTORY OR RELAPSED cHL:KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 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.
  • REFRACTORY OR RELAPSED PMBCL:KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 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 confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.
  • FIRST-LINE MONOTHERAPY—CISPLATIN (PD-L1 EXPRESSION [COMBINED POSITIVE SCORE (CPS) ≥10]) AND PLATINUM CHEMOTHERAPY INELIGIBLE:KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) ≥10] as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. 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 confirmatory trials.
  • SECOND-LINE MONOTHERAPY—POST–PLATINUM FAILURE:KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
  • ADVANCED MSI-H/dMMR CANCERS: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.
  • ADVANCED GASTRIC OR GEJ CANCER:KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 [combined positive score (CPS) ≥1] as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2/neu-targeted 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.
  • ADVANCED CERVICAL CANCER:KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. 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.
PD-L1 = programmed death ligand 1;
EGFR = epidermal growth factor receptor;
ALK = anaplastic lymphoma kinase;
HER2/neu = human epidermal growth factor receptor 2.
mNSCLC = metastatic NSCLC; 
EGFR = epidermal growth factor receptor;
ALK = anaplastic lymphoma kinase;
PD-L1 = programmed death ligand 1.
PD-L1 = programmed death ligand 1;
HER2/neu = human epidermal growth factor receptor 2.
SELECTED 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. The incidence of new or worsening hypothyroidism was higher in patients with HNSCC, occurring in 28 (15%) of 192 patients with HNSCC, including Grade 3 (0.5%) 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. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. 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.
  • Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.
  • Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA. While immune-mediated adverse reactions usually occur during treatment with programmed death receptor-1 (PD-1)/PD-L1 blocking antibodies, they may occur after discontinuation of treatment. 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%), uveitis, myositis, Guillain-Barré syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma (cHL), 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.
  • Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic hematopoietic stem cell transplantation (HSCT) after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 developed graft-versus-host disease (GVHD) (1 fatal case) and 2 developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). 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. Follow patients closely for early evidence of transplant-related complications such as hyperacute GVHD, Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic VOD, and other immune-mediated adverse reactions, and intervene promptly.
  • In patients with a history of allogeneic HSCT, acute GVHD, including fatal GVHD, has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.
  • In clinical trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled clinical trials.
  • 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-189, when 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 most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (≥20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).
  • In KEYNOTE-010, 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%).
  • In KEYNOTE-012, 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.
  • In KEYNOTE-087, KEYTRUDA 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; 1 from GVHD after subsequent allogeneic HSCT and 1 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%).
  • In KEYNOTE-170, KEYTRUDA was discontinued due to adverse reactions in 8% of 53 patients with PMBCL, and treatment was interrupted due to adverse reactions in 15%. Twenty-five percent (25%) of patients had an adverse reaction requiring systemic corticosteroid therapy. Serious adverse reactions occurred in 26% of patients and included: arrhythmia (4%), cardiac tamponade (2%), myocardial infarction (2%), pericardial effusion (2%), and pericarditis (2%). Six (11%) patients died within 30 days of start of treatment. The most common adverse reactions (occurring in ≥20% of patients) were musculoskeletal pain (30%), upper respiratory tract infection and pyrexia (28% each), cough (26%), fatigue (23%), and dyspnea (21%).
  • In 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.
  • In KEYNOTE-158, KEYTRUDA was discontinued due to adverse reactions in 8% of 98 patients (in Cohort E) with recurrent or metastatic cervical cancer. Serious adverse reactions occurred in 39% of patients receiving KEYTRUDA. The most frequent serious adverse reactions reported included anemia (7%), fistula, hemorrhage, and infections [except urinary tract infections] (4.1% each). The most common adverse reactions (occurring in ≥20% of patients) were fatigue (43%), musculoskeletal pain (27%), diarrhea (23%), pain and abdominal pain (22% each), and decreased appetite (21%).
  • 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.
  • There is limited experience in pediatric patients. In a study, 40 pediatric patients (16 children aged 2 years to younger than 12 years and 24 adolescents aged 12 years to 18 years) with advanced melanoma, lymphoma, or PD-L1–positive advanced, relapsed, or refractory solid tumors were administered KEYTRUDA 2 mg/kg every 3 weeks. Patients received KEYTRUDA for a median of 3 doses (range 1–17 doses), with 34 patients (85%) receiving 2 doses or more. The safety profile in these pediatric patients was similar to that seen in adults treated with KEYTRUDA. Toxicities that occurred at a higher rate (≥15% difference) in these patients when compared to adults under 65 years of age were fatigue (45%), vomiting (38%), abdominal pain (28%), hypertransaminasemia (28%), and hyponatremia (18%).
HER2/neu = human epidermal growth factor receptor 2. Before prescribing KEYTRUDA, please read the accompanying Prescribing Information. The Medication Guide also is available.

References:
  1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.6.2018. © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed August 17, 2018. To view the most recent and complete version of the guidelines, go online to NCCN.org.
  2. FDA approves Keytruda for advanced non-small cell lung cancer [news release]. Silver Spring, MD: U.S. Food and Drug Administration; October 2, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm465444.htm. Accessed July 8, 2016.
References:
  1. Agilent Technologies, Inc. Instructions for Use: PD-L1 IHC 22C3 pharmDx.
  2. Agilent Technologies, Inc. PD-L1 IHC 22C3 pharmDx Interpretation Manual.
  3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.6.2018. © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed August 17, 2018. To view the most recent and complete version of the guidelines, go online to NCCN.org. 4. FDA approves Keytruda for advanced non-small cell lung cancer [news release]. Silver Spring, MD: U.S. Food and Drug Administration; October 2, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm465444.htm. Accessed July 8, 2016.


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