Indications and Usage, Small Cell Lung Cancer – Accelerated Approval Indication Removed ( |
03/2021 |
Indications and Usage ( |
07/2021 |
Dosage and Administration ( |
07/2021 |
Warnings and Precautions ( |
07/2021 |
|
KEYTRUDA |
|
---|---|---|
|
||
Adult patients with unresectable or metastatic melanoma |
200 mg every 3 weeks or 400 mg every 6 weeks |
Until disease progression or unacceptable toxicity |
Adjuvant treatment of adult patients with melanoma |
200 mg every 3 weeks or 400 mg every 6 weeks |
Until disease recurrence, unacceptable toxicity, or up to 12 months |
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, Gastric Cancer, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC |
200 mg every 3 weeks or 400 mg every 6 weeks |
Until disease progression, unacceptable toxicity, or up to 24 months |
Adult patients with high-risk BCG- unresponsive NMIBC |
200 mg every 3 weeks or 400 mg every 6 weeks |
Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months |
Pediatric patients with cHL, PMBCL, MSI-H Cancer, MCC, or TMB-H Cancer |
2 mg/kg every 3 weeks (up to a maximum of 200 mg) |
Until disease progression, unacceptable toxicity, or up to 24 months |
|
||
Adult patients with NSCLC, HNSCC, or Esophageal Cancer |
200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day. |
Until disease progression, unacceptable toxicity, or up to 24 months |
Adult patients with Gastric Cancer | 200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day. |
Until disease progression, unacceptable toxicity, or up to 24 months |
Adult patients with RCC | 200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice daily. |
Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months |
Adult patients with Endometrial Carcinoma |
200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily. |
Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months |
Adult patients with high-risk early-stage TNBC |
200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day. |
Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicity. |
Adult patients with locally recurrent unresectable or metastatic TNBC |
200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day. |
Until disease progression, unacceptable toxicity, or up to 24 months |
|
|
|
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ALT = alanine aminotransferase, AST = aspartate aminotransferase, DRESS = Drug Rash with Eosinophilia and Systemic Symptoms, SJS = Stevens Johnson Syndrome, TEN = toxic epidermal necrolysis, ULN = upper limit normal | ||
|
||
Pneumonitis | Grade 2 | Withhold |
Grade 3 or 4 | Permanently discontinue | |
Colitis | Grade 2 or 3 | Withhold |
Grade 4 | Permanently discontinue | |
Hepatitis with no tumor involvement of the liver |
AST or ALT increases to more than 3 and up to 8 times ULN or Total bilirubin increases to more than 1.5 and up to 3 times ULN |
Withhold |
For liver enzyme elevations in patients treated with combination therapy with axitinib, see |
AST or ALT increases to more than 8 times ULN or Total bilirubin increases to more than 3 times ULN |
Permanently discontinue |
Hepatitis with tumor involvement of the liver |
Baseline AST or ALT is more than 1 and up to 3 times ULN and increases to more than 5 and up to 10 times ULN or Baseline AST or ALT is more than 3 and up to 5 times ULN and increases to more than 8 and up to 10 times ULN |
Withhold |
ALT or AST increases to more than 10 times ULN or Total bilirubin increases to more than 3 times ULN |
Permanently discontinue | |
Endocrinopathies | Grade 3 or 4 | Withhold until clinically stable or permanently discontinue depending on severity |
Nephritis with Renal Dysfunction | Grade 2 or 3 increased blood creatinine | Withhold |
Grade 4 increased blood creatinine | Permanently discontinue | |
Exfoliative Dermatologic Conditions | Suspected SJS, TEN, or DRESS | Withhold |
Confirmed SJS, TEN, or DRESS | Permanently discontinue | |
Myocarditis | Grade 2, 3, or 4 | Permanently discontinue |
Neurological Toxicities | Grade 2 | Withhold |
Grade 3 or 4 | Permanently discontinue | |
Hematologic toxicity in patients with cHL or PMBCL |
Grade 4 | Withhold until resolution to Grades 0 or 1 |
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||
Infusion-related reactions |
Grade 1 or 2 | Interrupt or slow the rate of infusion |
Grade 3 or 4 | Permanently discontinue |
|
|
|
|
---|---|---|---|
ALT = alanine aminotransferase, AST = aspartate aminotransferase, ULN = upper limit normal | |||
KEYTRUDA in combination with axitinib |
Liver enzyme elevations |
ALT or AST increases to at least 3 times but less than 10 times ULN without concurrent total bilirubin at least 2 times ULN | Withhold both KEYTRUDA and axitinib until resolution to Grades 0 or 1 |
ALT or AST increases to more than 3 times ULN with concurrent total bilirubin at least 2 times ULN or ALT or AST ≥10 times ULN |
Permanently discontinue both KEYTRUDA and axitinib |
Adverse Reaction | KEYTRUDA 10 mg/kg every 2 or 3 weeks |
Ipilimumab | ||
---|---|---|---|---|
n=555 | n=256 | |||
All Grades (%) |
Grades 3-4 (%) |
All Grades (%) |
Grades 3-4 (%) |
|
|
||||
Fatigue | 28 | 0.9 | 28 | 3.1 |
|
||||
Rash |
24 | 0.2 | 23 | 1.2 |
Vitiligo |
13 | 0 | 2 | 0 |
|
||||
Arthralgia | 18 | 0.4 | 10 | 1.2 |
Back pain | 12 | 0.9 | 7 | 0.8 |
|
||||
Cough | 17 | 0 | 7 | 0.4 |
Dyspnea | 11 | 0.9 | 7 | 0.8 |
|
||||
Decreased appetite | 16 | 0.5 | 14 | 0.8 |
|
||||
Headache | 14 | 0.2 | 14 | 0.8 |
Laboratory Test |
KEYTRUDA 10 mg/kg every 2 or 3 weeks |
Ipilimumab | ||
---|---|---|---|---|
All Grades % |
Grades 3-4 % |
All Grades % |
Grades 3-4 % |
|
|
||||
Hyperglycemia | 45 | 4.2 | 45 | 3.8 |
Hypertriglyceridemia | 43 | 2.6 | 31 | 1.1 |
Hyponatremia | 28 | 4.6 | 26 | 7 |
Increased AST | 27 | 2.6 | 25 | 2.5 |
Hypercholesterolemia | 20 | 1.2 | 13 | 0 |
|
||||
Anemia | 35 | 3.8 | 33 | 4.0 |
Lymphopenia | 33 | 7 | 25 | 6 |
Adverse Reaction | KEYTRUDA 2 mg/kg or 10 mg/kg every 3 weeks |
Chemotherapy |
||
---|---|---|---|---|
n=357 | n=171 | |||
All Grades (%) |
Grades 3-4 (%) |
All Grades (%) |
Grades 3-4 (%) |
|
|
||||
Pruritus | 28 | 0 | 8 | 0 |
Rash |
24 | 0.6 | 8 | 0 |
|
||||
Constipation | 22 | 0.3 | 20 | 2.3 |
Diarrhea | 20 | 0.8 | 20 | 2.3 |
Abdominal pain | 13 | 1.7 | 8 | 1.2 |
|
||||
Cough | 18 | 0 | 16 | 0 |
|
||||
Pyrexia | 14 | 0.3 | 9 | 0.6 |
Asthenia | 10 | 2.0 | 9 | 1.8 |
|
||||
Arthralgia | 14 | 0.6 | 10 | 1.2 |
Laboratory Test |
KEYTRUDA 2 mg/kg or 10 mg/kg every 3 weeks |
Chemotherapy | ||
---|---|---|---|---|
All Grades % |
Grades 3-4 % |
All Grades % |
Grades 3-4 % |
|
|
||||
Hyperglycemia | 49 | 6 | 44 | 6 |
Hypoalbuminemia | 37 | 1.9 | 33 | 0.6 |
Hyponatremia | 37 | 7 | 24 | 3.8 |
Hypertriglyceridemia | 33 | 0 | 32 | 0.9 |
Increased alkaline phosphatase | 26 | 3.1 | 18 | 1.9 |
Increased AST | 24 | 2.2 | 16 | 0.6 |
Decreased bicarbonate | 22 | 0.4 | 13 | 0 |
Hypocalcemia | 21 | 0.3 | 18 | 1.9 |
Increased ALT | 21 | 1.8 | 16 | 0.6 |
Adverse Reaction | KEYTRUDA 200 mg every 3 weeks n=509 |
Placebo n=502 |
||
---|---|---|---|---|
All Grades (%) |
Grades 3-4 (%) |
All Grades (%) |
Grades 3-4 (%) |
|
|
||||
Diarrhea | 28 | 1.2 | 26 | 1.2 |
Nausea | 17 | 0.2 | 15 | 0 |
|
||||
Pruritus | 19 | 0 | 12 | 0 |
Rash | 13 | 0.2 | 9 | 0 |
|
||||
Arthralgia | 16 | 1.2 | 14 | 0 |
|
||||
Hypothyroidism | 15 | 0 | 2.8 | 0 |
Hyperthyroidism | 10 | 0.2 | 1.2 | 0 |
|
||||
Cough | 14 | 0 | 11 | 0 |
|
||||
Asthenia | 11 | 0.2 | 8 | 0 |
Influenza like illness | 11 | 0 | 8 | 0 |
|
||||
Weight loss | 11 | 0 | 8 | 0 |
Laboratory Test |
KEYTRUDA 200 mg every 3 weeks |
Placebo | ||
---|---|---|---|---|
All Grades % |
Grades 3-4 % |
All Grades % |
Grades 3-4 % |
|
|
||||
Increased ALT | 27 | 2.4 | 16 | 0.2 |
Increased AST | 24 | 1.8 | 15 | 0.4 |
|
||||
Lymphopenia | 24 | 1 | 16 | 1.2 |
Adverse Reaction | KEYTRUDA 200 mg every 3 weeks Pemetrexed Platinum Chemotherapy n=405 |
Placebo Pemetrexed Platinum Chemotherapy n=202 |
||
---|---|---|---|---|
All Grades (%) |
Grades 3-4 (%) |
All Grades (%) |
Grades 3-4 (%) |
|
|
||||
Nausea | 56 | 3.5 | 52 | 3.5 |
Constipation | 35 | 1.0 | 32 | 0.5 |
Diarrhea | 31 | 5 | 21 | 3.0 |
Vomiting | 24 | 3.7 | 23 | 3.0 |
|
||||
Fatigue |
56 | 12 | 58 | 6 |
Pyrexia | 20 | 0.2 | 15 | 0 |
|
||||
Decreased appetite | 28 | 1.5 | 30 | 0.5 |
|
||||
Rash |
25 | 2.0 | 17 | 2.5 |
|
||||
Cough | 21 | 0 | 28 | 0 |
Dyspnea | 21 | 3.7 | 26 | 5 |
Laboratory Test |
KEYTRUDA 200 mg every 3 weeks Pemetrexed Platinum Chemotherapy |
Placebo Pemetrexed Platinum Chemotherapy |
||
---|---|---|---|---|
All Grades % |
Grades 3-4 % |
All Grades % |
Grades 3-4 % |
|
|
||||
Anemia | 85 | 17 | 81 | 18 |
Lymphopenia | 64 | 22 | 64 | 25 |
Neutropenia | 48 | 20 | 41 | 19 |
Thrombocytopenia | 30 | 12 | 29 | 8 |
|
||||
Hyperglycemia | 63 | 9 | 60 | 7 |
Increased ALT | 47 | 3.8 | 42 | 2.6 |
Increased AST | 47 | 2.8 | 40 | 1.0 |
Hypoalbuminemia | 39 | 2.8 | 39 | 1.1 |
Increased creatinine | 37 | 4.2 | 25 | 1.0 |
Hyponatremia | 32 | 7 | 23 | 6 |
Hypophosphatemia | 30 | 10 | 28 | 14 |
Increased alkaline phosphatase | 26 | 1.8 | 29 | 2.1 |
Hypocalcemia | 24 | 2.8 | 17 | 0.5 |
Hyperkalemia | 24 | 2.8 | 19 | 3.1 |
Hypokalemia | 21 | 5 | 20 | 5 |
Adverse Reaction | KEYTRUDA 200 mg every 3 weeks n=636 |
Chemotherapy n=615 |
||
---|---|---|---|---|
All Grades (%) |
Grades 3-5 (%) |
All Grades (%) |
Grades 3-5 (%) |
|
|
||||
Fatigue |
25 | 3.1 | 33 | 3.9 |
Pyrexia | 10 | 0.3 | 8 | 0 |
|
||||
Decreased appetite | 17 | 1.7 | 21 | 1.5 |
|
||||
Dyspnea | 17 | 2.0 | 11 | 0.8 |
Cough | 16 | 0.2 | 11 | 0.3 |
|
||||
Rash |
15 | 1.3 | 8 | 0.2 |
|
||||
Constipation | 12 | 0 | 21 | 0.2 |
Diarrhea | 12 | 0.8 | 12 | 0.5 |
Nausea | 12 | 0.5 | 32 | 1.1 |
|
||||
Hypothyroidism | 12 | 0.2 | 1.5 | 0 |
|
||||
Pneumonia | 12 | 7 | 9 | 6 |
|
||||
Weight loss | 10 | 0.9 | 7 | 0.2 |
Laboratory Test |
KEYTRUDA 200 mg every 3 weeks |
Chemotherapy | ||
---|---|---|---|---|
All Grades % |
Grades 3-4 % |
All Grades % |
Grades 3-4 % |
|
|
||||
Hyperglycemia | 52 | 4.7 | 51 | 5 |
Increased ALT | 33 | 4.8 | 34 | 2.9 |
Hypoalbuminemia | 33 | 2.2 | 29 | 1.0 |
Increased AST | 31 | 3.6 | 32 | 1.7 |
Hyponatremia | 31 | 9 | 32 | 8 |
Increased alkaline phosphatase | 29 | 2.3 | 29 | 0.3 |
Hypocalcemia | 25 | 2.5 | 19 | 0.7 |
Hyperkalemia | 23 | 3.0 | 20 | 2.2 |
Increased prothrombin INR | 21 | 2.0 | 15 | 2.9 |
|
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Anemia | 43 | 4.4 | 79 | 19 |
Lymphopenia | 30 | 7 | 41 | 13 |
Adverse Reaction | KEYTRUDA 2 or 10 mg/kg every 3 weeks n=682 |
Docetaxel 75 mg/m2 every 3 weeks n=309 |
||
---|---|---|---|---|
All Grades (%) |
Grades 3-4 (%) |
All Grades (%) |
Grades 3-4 (%) |
|
|
||||
Decreased appetite | 25 | 1.5 | 23 | 2.6 |
|
||||
Dyspnea | 23 | 3.7 | 20 | 2.6 |
Cough | 19 | 0.6 | 14 | 0 |
|
||||
Nausea | 20 | 1.3 | 18 | 0.6 |
Constipation | 15 | 0.6 | 12 | 0.6 |
Vomiting | 13 | 0.9 | 10 | 0.6 |
|
||||
Rash |
17 | 0.4 | 8 | 0 |
Pruritus | 11 | 0 | 3 | 0.3 |
|
||||
Arthralgia | 11 | 1.0 | 9 | 0.3 |
Back pain | 11 | 1.5 | 8 | 0.3 |
Laboratory Test |
KEYTRUDA 2 or 10 mg/kg every 3 weeks |
Docetaxel 75 mg/m2 every 3 weeks |
||
---|---|---|---|---|
All Grades % |
Grades 3-4 % |
All Grades % |
Grades 3-4 % |
|
|
||||
Hyponatremia | 32 | 8 | 27 | 2.9 |
Increased alkaline phosphatase | 28 | 3.0 | 16 | 0.7 |
Increased AST | 26 | 1.6 | 12 | 0.7 |
Increased ALT | 22 | 2.7 | 9 | 0.4 |
KEYTRUDA 200 mg every 3 weeks |
KEYTRUDA 200 mg every 3 weeks Platinum FU |
Cetuximab Platinum FU |
||||
---|---|---|---|---|---|---|
Adverse Reaction | n=300 | n=276 | n=287 | |||
All Grades (%) |
Grades 3-4 (%) |
All Grades (%) |
Grades 3-4 (%) |
All Grades (%) |
Grades 3-4 (%) |
|
|
||||||
Fatigue |
33 | 4 | 49 | 11 | 48 | 8 |
Pyrexia | 13 | 0.7 | 16 | 0.7 | 12 | 0 |
Mucosal inflammation | 4.3 | 1.3 | 31 | 10 | 28 | 5 |
|
||||||
Constipation | 20 | 0.3 | 37 | 0 | 33 | 1.4 |
Nausea | 17 | 0 | 51 | 6 | 51 | 6 |
Diarrhea |
16 | 0.7 | 29 | 3.3 | 35 | 3.1 |
Vomiting | 11 | 0.3 | 32 | 3.6 | 28 | 2.8 |
Dysphagia | 8 | 2.3 | 12 | 2.9 | 10 | 2.1 |
Stomatitis | 3 | 0 | 26 | 8 | 28 | 3.5 |
|
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Rash |
20 | 2.3 | 17 | 0.7 | 70 | 8 |
Pruritus | 11 | 0 | 8 | 0 | 10 | 0.3 |
|
||||||
Cough |
18 | 0.3 | 22 | 0 | 15 | 0 |
Dyspnea |
14 | 2.0 | 10 | 1.8 | 8 | 1.0 |
|
||||||
Hypothyroidism | 18 | 0 | 15 | 0 | 6 | 0 |
|
||||||
Decreased appetite | 15 | 1.0 | 29 | 4.7 | 30 | 3.5 |
Weight loss | 15 | 2 | 16 | 2.9 | 21 | 1.4 |
|
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Pneumonia |
12 | 7 | 19 | 11 | 13 | 6 |
|
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Headache | 12 | 0.3 | 11 | 0.7 | 8 | 0.3 |
Dizziness | 5 | 0.3 | 10 | 0.4 | 13 | 0.3 |
Peripheral sensory neuropathy |
1 | 0 | 14 | 1.1 | 7 | 1 |
|
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Myalgia |
12 | 1.0 | 13 | 0.4 | 11 | 0.3 |
Neck pain | 6 | 0.7 | 10 | 1.1 | 7 | 0.7 |
|
||||||
Insomnia | 7 | 0.7 | 10 | 0 | 8 | 0 |
KEYTRUDA 200 mg every 3 weeks |
KEYTRUDA 200 mg every 3 weeks Platinum FU |
Cetuximab Platinum FU |
||||
---|---|---|---|---|---|---|
Laboratory Test |
All Grades (%) |
Grades 3-4 (%) |
All Grades (%) |
Grades 3-4 (%) |
All Grades (%) |
Grades 3-4 (%) |
|
||||||
Lymphopenia | 54 | 25 | 69 | 35 | 74 | 45 |
Anemia | 52 | 7 | 89 | 28 | 78 | 19 |
Thrombocytopenia | 12 | 3.8 | 73 | 18 | 76 | 18 |
Neutropenia | 7 | 1.4 | 67 | 35 | 71 | 42 |
|
||||||
Hyperglycemia | 47 | 3.8 | 55 | 6 | 66 | 4.7 |
Hyponatremia | 46 | 17 | 56 | 20 | 59 | 20 |
Hypoalbuminemia | 44 | 3.2 | 47 | 4.0 | 49 | 1.1 |
Increased AST | 28 | 3.1 | 24 | 2.0 | 37 | 3.6 |
Increased ALT | 25 | 2.1 | 22 | 1.6 | 38 | 1.8 |
Increased alkaline phosphatase | 25 | 2.1 | 27 | 1.2 | 33 | 1.1 |
Hypercalcemia | 22 | 4.6 | 16 | 4.3 | 13 | 2.6 |
Hypocalcemia | 22 | 1.1 | 32 | 4 | 58 | 7 |
Hyperkalemia | 21 | 2.8 | 27 | 4.3 | 29 | 4.3 |
Hypophosphatemia | 20 | 5 | 35 | 12 | 48 | 19 |
Hypokalemia | 19 | 5 | 34 | 12 | 47 | 15 |
Increased creatinine | 18 | 1.1 | 36 | 2.3 | 27 | 2.2 |
Hypomagnesemia | 16 | 0.4 | 42 | 1.7 | 76 | 6 |
Adverse Reaction | KEYTRUDA 200 mg every 3 weeks N=148 |
Brentuximab Vedotin 1.8 mg/kg every 3 weeks N=152 |
||
---|---|---|---|---|
All Grades (%) |
Grades 3- 4 (%) |
All Grades (%) |
Grades 3- 4 (%) |
|
|
||||
Upper respiratory tract infection |
41 | 1.4 | 24 | 0 |
Urinary tract infection | 11 | 0 | 3 | 0.7 |
|
||||
Musculoskeletal pain |
32 | 0 | 29 | 1.3 |
|
||||
Diarrhea |
22 | 2.7 | 17 | 1.3 |
Nausea | 14 | 0 | 24 | 0.7 |
Vomiting | 14 | 1.4 | 20 | 0 |
Abdominal pain |
11 | 0.7 | 13 | 1.3 |
|
||||
Pyrexia | 20 | 0.7 | 13 | 0.7 |
Fatigue |
20 | 0 | 22 | 0.7 |
|
||||
Rash |
20 | 0 | 19 | 0.7 |
Pruritus | 18 | 0 | 12 | 0 |
|
||||
Cough |
20 | 0.7 | 14 | 0.7 |
Pneumonitis |
11 | 5 | 3 | 1.3 |
Dyspnea |
11 | 0.7 | 7 | 0.7 |
|
||||
Hypothyroidism | 19 | 0 | 3 | 0 |
|
||||
Peripheral neuropathy |
11 | 0.7 | 43 | 7 |
Headache |
11 | 0 | 11 | 0 |
Laboratory Abnormality |
KEYTRUDA 200 mg every 3 weeks |
Brentuximab Vedotin 1.8 mg/kg every 3 weeks |
||
---|---|---|---|---|
All Grades (%) |
Grades 3-4 (%) |
All Grades (%) |
Grades 3-4 (%) |
|
|
||||
Hyperglycemia | 46 | 4.1 | 36 | 2.0 |
Increased AST | 39 | 5 | 41 | 3.9 |
Increased ALT | 34 | 6 | 45 | 5 |
Hypophosphatemia | 31 | 5 | 18 | 2.7 |
Increased creatinine | 28 | 3.4 | 14 | 2.6 |
Hypomagnesemia | 25 | 0 | 12 | 0 |
Hyponatremia | 24 | 4.1 | 20 | 3.3 |
Hypocalcemia | 22 | 2.0 | 16 | 0 |
Increased alkaline phosphatase | 21 | 2.1 | 22 | 2.6 |
Hyperbilirubinemia | 16 | 2.0 | 9 | 1.3 |
Hypoalbuminemia | 16 | 0.7 | 19 | 0.7 |
Hyperkalemia | 15 | 1.4 | 8 | 0 |
|
||||
Lymphopenia | 35 | 9 | 32 | 13 |
Thrombocytopenia | 34 | 10 | 26 | 5 |
Neutropenia | 28 | 8 | 43 | 17 |
Anemia | 24 | 5 | 33 | 8 |
Adverse Reaction | KEYTRUDA 200 mg every 3 weeks N=210 |
|
---|---|---|
All Grades (%) |
Grade 3 (%) |
|
|
||
Fatigue |
26 | 1.0 |
Pyrexia | 24 | 1.0 |
|
||
Cough |
24 | 0.5 |
Dyspnea |
11 | 1.0 |
|
||
Musculoskeletal pain |
21 | 1.0 |
Arthralgia | 10 | 0.5 |
|
||
Diarrhea |
20 | 1.4 |
Vomiting | 15 | 0 |
Nausea | 13 | 0 |
|
||
Rash |
20 | 0.5 |
Pruritus | 11 | 0 |
|
||
Hypothyroidism | 14 | 0.5 |
|
||
Upper respiratory tract infection | 13 | 0 |
|
||
Headache | 11 | 0.5 |
Peripheral neuropathy |
10 | 0 |
Laboratory Abnormality |
KEYTRUDA 200 mg every 3 weeks |
|
---|---|---|
All Grades (%) |
Grades 3-4 (%) |
|
|
||
Hypertransaminasemia |
34 | 2 |
Increased alkaline phosphatase | 17 | 0 |
Increased creatinine | 15 | 0.5 |
|
||
Anemia | 30 | 6 |
Thrombocytopenia | 27 | 4 |
Neutropenia | 24 | 7 |
Adverse Reaction | KEYTRUDA 200 mg every 3 weeks N=53 |
|
---|---|---|
All Grades (%) |
Grades 3-4 (%) |
|
|
||
Musculoskeletal pain |
30 | 0 |
|
||
Upper respiratory tract infection |
28 | 0 |
|
||
Pyrexia | 28 | 0 |
Fatigue |
23 | 2 |
|
||
Cough |
26 | 2 |
Dyspnea | 21 | 11 |
|
||
Diarrhea |
13 | 2 |
Abdominal pain |
13 | 0 |
Nausea | 11 | 0 |
|
||
Arrhythmia |
11 | 4 |
|
||
Headache | 11 | 0 |
Laboratory Abnormality |
KEYTRUDA 200 mg every 3 weeks |
|
---|---|---|
All Grades (%) |
Grades 3-4 (%) |
|
|
||
Anemia | 47 | 0 |
Leukopenia | 35 | 9 |
Lymphopenia | 32 | 18 |
Neutropenia | 30 | 11 |
|
||
Hyperglycemia | 38 | 4 |
Hypophosphatemia | 29 | 10 |
Hypertransaminasemia |
27 | 4 |
Hypoglycemia | 19 | 0 |
Increased alkaline phosphatase | 17 | 0 |
Increased creatinine | 17 | 0 |
Hypocalcemia | 15 | 4 |
Hypokalemia | 15 | 4 |
Adverse Reaction | KEYTRUDA 200 mg every 3 weeks N=370 |
|
---|---|---|
All Grades (%) |
Grades 3–4 (%) |
|
|
||
Fatigue |
38 | 6 |
Pyrexia | 11 | 0.5 |
Weight loss | 10 | 0 |
|
||
Musculoskeletal pain |
24 | 4.9 |
Arthralgia | 10 | 1.1 |
|
||
Decreased appetite | 22 | 1.6 |
Hyponatremia | 10 | 4.1 |
|
||
Constipation | 21 | 1.1 |
Diarrhea |
20 | 2.4 |
Nausea | 18 | 1.1 |
Abdominal pain |
18 | 2.7 |
Elevated LFTs |
13 | 3.5 |
Vomiting | 12 | 0 |
|
||
Rash |
21 | 0.5 |
Pruritus | 19 | 0.3 |
Edema peripheral |
14 | 1.1 |
|
||
Urinary tract infection | 19 | 9 |
|
||
Anemia | 17 | 7 |
|
||
Cough | 14 | 0 |
Dyspnea | 11 | 0.5 |
|
||
Increased blood creatinine | 11 | 1.1 |
Hematuria | 13 | 3.0 |
Adverse Reaction | KEYTRUDA 200 mg every 3 weeks |
Chemotherapy |
||
---|---|---|---|---|
n=266 | n=255 | |||
All Grades (%) |
Grades 3-4 (%) |
All Grades (%) |
Grades 3-4 (%) |
|
|
||||
Fatigue |
38 | 4.5 | 56 | 11 |
Pyrexia | 14 | 0.8 | 13 | 1.2 |
|
||||
Musculoskeletal pain |
32 | 3.0 | 27 | 2.0 |
|
||||
Pruritus | 23 | 0 | 6 | 0.4 |
Rash |
20 | 0.4 | 13 | 0.4 |
|
||||
Nausea | 21 | 1.1 | 29 | 1.6 |
Constipation | 19 | 1.1 | 32 | 3.1 |
Diarrhea |
18 | 2.3 | 19 | 1.6 |
Vomiting | 15 | 0.4 | 13 | 0.4 |
Abdominal pain | 13 | 1.1 | 13 | 2.7 |
|
||||
Urinary tract infection | 15 | 4.9 | 14 | 4.3 |
|
||||
Decreased appetite | 21 | 3.8 | 21 | 1.2 |
|
||||
Cough |
15 | 0.4 | 9 | 0 |
Dyspnea |
14 | 1.9 | 12 | 1.2 |
|
||||
Hematuria |
12 | 2.3 | 8 | 1.6 |
Laboratory Test |
KEYTRUDA 200 mg every 3 weeks |
Chemotherapy | ||
---|---|---|---|---|
All Grades % |
Grades 3-4 % |
All Grades % |
Grades 3-4 % |
|
|
||||
Hyperglycemia | 52 | 8 | 60 | 7 |
Anemia | 52 | 13 | 68 | 18 |
Lymphopenia | 45 | 15 | 53 | 25 |
Hypoalbuminemia | 43 | 1.7 | 50 | 3.8 |
Hyponatremia | 37 | 9 | 47 | 13 |
Increased alkaline phosphatase | 37 | 7 | 33 | 4.9 |
Increased creatinine | 35 | 4.4 | 28 | 2.9 |
Hypophosphatemia | 29 | 8 | 34 | 14 |
Increased AST | 28 | 4.1 | 20 | 2.5 |
Hyperkalemia | 28 | 0.8 | 27 | 6 |
Hypocalcemia | 26 | 1.6 | 34 | 2.1 |
Adverse Reaction | KEYTRUDA 200 mg every 3 weeks N=148 |
|
---|---|---|
All Grades (%) |
Grades 3–4 (%) |
|
|
||
Fatigue |
29 | 0.7 |
Peripheral edema |
11 | 0 |
|
||
Diarrhea |
24 | 2.0 |
Nausea | 13 | 0 |
Constipation | 12 | 0 |
|
||
Rash |
24 | 0.7 |
Pruritus | 19 | 0.7 |
|
||
Musculoskeletal pain |
19 | 0 |
Arthralgia | 14 | 1.4 |
|
||
Hematuria | 19 | 1.4 |
|
||
Cough |
19 | 0 |
|
||
Urinary tract infection | 12 | 2.0 |
Nasopharyngitis | 10 | 0 |
|
||
Hypothyroidism | 11 | 0 |
Laboratory Test |
KEYTRUDA 200 mg every 3 weeks |
|
---|---|---|
All Grades (%) |
Grades 3-4 (%) |
|
|
||
Hyperglycemia | 59 | 8 |
Increased ALT | 25 | 3.4 |
Hyponatremia | 24 | 7 |
Hypophosphatemia | 24 | 6 |
Hypoalbuminemia | 24 | 2.1 |
Hyperkalemia | 23 | 1.4 |
Hypocalcemia | 22 | 0.7 |
Increased AST | 20 | 3.4 |
Increased creatinine | 20 | 0.7 |
|
||
Anemia | 35 | 1.4 |
Lymphopenia | 29 | 1.6 |
Adverse Reaction | KEYTRUDA 200 mg every 3 weeks Cisplatin FU n=370 |
Placebo Cisplatin FU n=370 |
||
---|---|---|---|---|
All Grades (%) |
Grades 3-4 (%) |
All Grades (%) |
Grades 3-4 (%) |
|
|
||||
Nausea | 67 | 7 | 63 | 7 |
Constipation | 40 | 0 | 40 | 0 |
Diarrhea | 36 | 4.1 | 33 | 3 |
Vomiting | 34 | 7 | 32 | 5 |
Stomatitis | 27 | 6 | 26 | 3.8 |
|
||||
Fatigue |
57 | 12 | 46 | 9 |
|
||||
Decreased appetite | 44 | 4.1 | 38 | 5 |
|
||||
Weight loss | 24 | 3.0 | 24 | 5 |
Laboratory Test |
KEYTRUDA 200 mg every 3 weeks Cisplatin FU |
Chemotherapy (Cisplatin and FU) |
||
---|---|---|---|---|
All Grades % |
Grades 3-4 % |
All Grades % |
Grades 3-4 % |
|
|
||||
Anemia | 83 | 21 | 86 | 24 |
Neutropenia | 74 | 43 | 71 | 41 |
Leukopenia | 72 | 21 | 73 | 17 |
Lymphopenia | 55 | 22 | 53 | 18 |
Thrombocytopenia | 43 | 5 | 46 | 8 |
|
||||
Hyperglycemia | 56 | 7 | 55 | 6 |
Hyponatremia | 53 | 19 | 54 | 19 |
Hypoalbuminemia | 52 | 2.8 | 52 | 2.3 |
Increased creatinine | 45 | 2.5 | 42 | 2.5 |
Hypocalcemia | 44 | 3.9 | 38 | 2 |
Hypophosphatemia | 37 | 9 | 31 | 10 |
Hypokalemia | 30 | 12 | 34 | 15 |
Increased alkaline phosphatase | 29 | 1.9 | 29 | 1.7 |
Hyperkalemia | 28 | 3.6 | 27 | 2.6 |
Increased AST | 25 | 4.4 | 22 | 2.8 |
Increased ALT | 23 | 3.6 | 18 | 1.7 |
Adverse Reaction | KEYTRUDA 200 mg every 3 weeks N=98 |
|
---|---|---|
All Grades (%) |
Grades 3–4 (%) |
|
|
||
Fatigue |
43 | 5 |
Pain |
22 | 2.0 |
Pyrexia | 19 | 1.0 |
Edema peripheral |
15 | 2.0 |
|
||
Musculoskeletal pain |
27 | 5 |
|
||
Diarrhea |
23 | 2.0 |
Abdominal pain |
22 | 3.1 |
Nausea | 19 | 0 |
Vomiting | 19 | 1.0 |
Constipation | 14 | 0 |
|
||
Decreased appetite | 21 | 0 |
|
||
Hemorrhage |
19 | 5 |
|
||
UTI |
18 | 6 |
Infection (except UTI) |
16 | 4.1 |
|
||
Rash |
17 | 2.0 |
|
||
Hypothyroidism | 11 | 0 |
|
||
Headache | 11 | 2.0 |
|
||
Dyspnea | 10 | 1.0 |
Laboratory Test |
KEYTRUDA 200 mg every 3 weeks |
|
---|---|---|
All Grades (%) |
Grades 3-4 (%) |
|
|
||
Anemia | 54 | 24 |
Lymphopenia | 47 | 9 |
|
||
Hypoalbuminemia | 44 | 5 |
Increased alkaline phosphatase | 42 | 2.6 |
Hyponatremia | 38 | 13 |
Hyperglycemia | 38 | 1.3 |
Increased AST | 34 | 3.9 |
Increased creatinine | 32 | 5 |
Hypocalcemia | 27 | 0 |
Increased ALT | 21 | 3.9 |
Hypokalemia | 20 | 6 |
Adverse Reaction | KEYTRUDA 200 mg every 3 weeks and Axitinib n=429 |
Sunitinib n=425 |
||
---|---|---|---|---|
All Grades (%) |
Grades 3-4 (%) |
All Grades (%) |
Grades 3-4 (%) |
|
|
||||
Diarrhea |
56 | 11 | 45 | 5 |
Nausea | 28 | 0.9 | 32 | 0.9 |
Constipation | 21 | 0 | 15 | 0.2 |
|
||||
Fatigue/Asthenia | 52 | 5 | 51 | 10 |
|
||||
Hypertension |
48 | 24 | 48 | 20 |
|
||||
Hepatotoxicity |
39 | 20 | 25 | 4.9 |
|
||||
Hypothyroidism | 35 | 0.2 | 32 | 0.2 |
|
||||
Decreased appetite | 30 | 2.8 | 29 | 0.7 |
|
||||
Palmar-plantar erythrodysesthesia syndrome | 28 | 5 | 40 | 3.8 |
Stomatitis/Mucosal inflammation | 27 | 1.6 | 41 | 4 |
Rash |
25 | 1.4 | 21 | 0.7 |
|
||||
Dysphonia | 25 | 0.2 | 3.3 | 0 |
Cough | 21 | 0.2 | 14 | 0.5 |
Laboratory Test |
KEYTRUDA 200 mg every 3 weeks and Axitinib |
Sunitinib | ||
---|---|---|---|---|
All Grades % |
Grades 3-4 % |
All Grades % |
Grades 3-4 % |
|
|
||||
Hyperglycemia | 62 | 9 | 54 | 3.2 |
Increased ALT | 60 | 20 | 44 | 5 |
Increased AST | 57 | 13 | 56 | 5 |
Increased creatinine | 43 | 4.3 | 40 | 2.4 |
Hyponatremia | 35 | 8 | 29 | 8 |
Hyperkalemia | 34 | 6 | 22 | 1.7 |
Hypoalbuminemia | 32 | 0.5 | 34 | 1.7 |
Hypercalcemia | 27 | 0.7 | 15 | 1.9 |
Hypophosphatemia | 26 | 6 | 49 | 17 |
Increased alkaline phosphatase | 26 | 1.7 | 30 | 2.7 |
Hypocalcemia |
22 | 0.2 | 29 | 0.7 |
Blood bilirubin increased | 22 | 2.1 | 21 | 1.9 |
Activated partial thromboplastin time prolonged |
22 | 1.2 | 14 | 0 |
|
||||
Lymphopenia | 33 | 11 | 46 | 8 |
Anemia | 29 | 2.1 | 65 | 8 |
Thrombocytopenia | 27 | 1.4 | 78 | 14 |
Endometrial Carcinoma (not MSI-H or dMMR) | ||||
---|---|---|---|---|
Adverse Reaction | KEYTRUDA 200 mg every 3 weeks and Lenvatinib n=342 |
Doxorubicin or Paclitaxel n=325 |
||
All Grades (%) |
Grades 3-4 (%) |
All Grades (%) |
Grades 3-4 (%) |
|
|
||||
Hypothyroidism |
67 | 0.9 | 0.9 | 0 |
|
||||
Hypertension |
67 | 39 | 6 | 2.5 |
Hemorrhagic events |
25 | 2.6 | 15 | 0.9 |
|
||||
Fatigue |
58 | 11 | 54 | 6 |
|
||||
Diarrhea |
55 | 8 | 20 | 2.8 |
Nausea | 49 | 2.9 | 47 | 1.5 |
Vomiting | 37 | 2.3 | 21 | 2.2 |
Stomatitis |
35 | 2.6 | 26 | 1.2 |
Abdominal pain |
34 | 2.6 | 21 | 1.2 |
Constipation | 27 | 0 | 25 | 0.6 |
|
||||
Musculoskeletal disorders |
53 | 5 | 27 | 0.6 |
|
||||
Decreased appetite |
44 | 7 | 21 | 0 |
|
||||
Weight loss | 34 | 10 | 6 | 0.3 |
|
||||
Proteinuria |
29 | 6 | 3.4 | 0.3 |
|
||||
Urinary tract infection |
31 | 5 | 13 | 1.2 |
|
||||
Headache | 26 | 0.6 | 9 | 0.3 |
|
||||
Dysphonia | 22 | 0 | 0.6 | 0 |
|
||||
Palmar-plantar erythrodysesthesia |
23 | 2.9 | 0.9 | 0 |
Rash |
20 | 2.3 | 4.9 | 0 |
Endometrial Carcinoma (not MSI-H or dMMR) | ||||
---|---|---|---|---|
Laboratory Test |
KEYTRUDA 200 mg every 3 weeks and Lenvatinib |
Doxorubicin or Paclitaxel |
||
All Grades % |
Grades 3-4 % |
All Grades % |
Grades 3-4 % |
|
|
||||
Hypertriglyceridemia | 70 | 6 | 45 | 1.7 |
Hypoalbuminemia | 60 | 2.7 | 42 | 1.6 |
Increased aspartate aminotransferase | 58 | 9 | 23 | 1.6 |
Hyperglycemia | 58 | 8 | 45 | 4.4 |
Hypomagnesemia | 53 | 6 | 32 | 3.8 |
Increased alanine aminotransferase | 55 | 9 | 21 | 1.2 |
Hypercholesteremia | 53 | 3.2 | 23 | 0.7 |
Hyponatremia | 46 | 15 | 28 | 7 |
Increased alkaline phosphatase | 43 | 4.7 | 18 | 0.9 |
Hypocalcemia | 40 | 4.7 | 21 | 1.9 |
Increased lipase | 36 | 14 | 13 | 3.9 |
Increased creatinine | 35 | 4.7 | 18 | 1.9 |
Hypokalemia | 34 | 10 | 24 | 5 |
Hypophosphatemia | 26 | 8 | 17 | 3.2 |
Increased amylase | 25 | 7 | 8 | 1 |
Hyperkalemia | 23 | 2.4 | 12 | 1.2 |
Increased creatine kinase | 19 | 3.7 | 7 | 0 |
Increased bilirubin | 18 | 3.6 | 6 | 1.6 |
|
||||
Lymphopenia | 50 | 16 | 65 | 20 |
Thrombocytopenia | 50 | 8 | 30 | 4.7 |
Anemia | 49 | 8 | 84 | 14 |
Leukopenia | 43 | 3.5 | 83 | 43 |
Neutropenia | 31 | 6 | 76 | 58 |
Adverse Reaction | KEYTRUDA 200 mg every 3 weeks with chemotherapy n=778 |
Placebo with chemotherapy n=389 |
||
---|---|---|---|---|
All Grades (%) |
Grades 3-4 (%) |
All Grades (%) |
Grades 3-4 (%) |
|
|
||||
Fatigue |
70 | 8 | 66 | 3.9 |
Pyrexia | 28 | 1.3 | 19 | 0.3 |
|
||||
Nausea | 67 | 3.7 | 66 | 1.8 |
Constipation | 42 | 0 | 39 | 0.3 |
Diarrhea | 41 | 3.2 | 34 | 1.8 |
Stomatitis |
34 | 2.7 | 29 | 1 |
Vomiting | 31 | 2.7 | 28 | 1.5 |
Abdominal pain |
24 | 0.5 | 23 | 0.8 |
|
||||
Alopecia | 61 | 0 | 58 | 0 |
Rash |
52 | 5 | 41 | 0.5 |
|
||||
Peripheral neuropathy |
41 | 3.3 | 42 | 2.3 |
Headache | 30 | 0.5 | 29 | 1 |
|
||||
Arthralgia | 29 | 0.5 | 31 | 0.3 |
Myalgia | 20 | 0.5 | 19 | 0 |
|
||||
Cough |
26 | 0.1 | 24 | 0 |
|
||||
Decreased appetite | 23 | 0.9 | 17 | 0.3 |
|
||||
Insomnia | 21 | 0.5 | 19 | 0 |
Laboratory Test |
KEYTRUDA 200 mg every 3 weeks with chemotherapy |
Placebo with chemotherapy |
||
---|---|---|---|---|
All Grades % |
Grades 3-4 % |
All Grades % |
Grades 3-4 % |
|
|
||||
Anemia | 97 | 22 | 96 | 19 |
Leukopenia | 93 | 41 | 91 | 32 |
Neutropenia | 88 | 62 | 89 | 62 |
Lymphopenia | 80 | 28 | 74 | 22 |
Thrombocytopenia | 58 | 11 | 57 | 9 |
|
||||
Increased ALT | 71 | 9 | 69 | 4.6 |
Increased AST | 66 | 6 | 58 | 1.8 |
Hyperglycemia | 65 | 5 | 62 | 2.8 |
Increased alkaline phosphatase | 41 | 1 | 37 | 0.8 |
Hyponatremia | 38 | 9 | 28 | 6 |
Hypoalbuminemia | 36 | 1.2 | 30 | 1.5 |
Hypocalcemia | 32 | 3.2 | 29 | 4.4 |
Hypokalemia | 32 | 6 | 24 | 2.8 |
Hypophosphatemia | 23 | 6 | 18 | 4.5 |
Hypercalcemia | 21 | 3 | 24 | 3.4 |
Adverse Reaction | KEYTRUDA 200 mg every 3 weeks with chemotherapy n=596 |
Placebo every 3 weeks with chemotherapy n=281 |
||
---|---|---|---|---|
All Grades (%) |
Grades 3-4 (%) |
All Grades (%) |
Grades 3-4 (%) |
|
|
||||
Fatigue |
48 | 5 | 49 | 4.3 |
|
||||
Nausea | 44 | 1.7 | 47 | 1.8 |
Diarrhea | 28 | 1.8 | 23 | 1.8 |
Constipation | 28 | 0.5 | 27 | 0.4 |
Vomiting | 26 | 2.7 | 22 | 3.2 |
|
||||
Alopecia | 34 | 0.8 | 35 | 1.1 |
Rash |
26 | 2 | 16 | 0 |
|
||||
Cough |
23 | 0 | 20 | 0.4 |
|
||||
Decreased appetite | 21 | 0.8 | 14 | 0.4 |
|
||||
Headache |
20 | 0.7 | 23 | 0.7 |
Laboratory Test |
KEYTRUDA 200 mg every 3 weeks with chemotherapy |
Placebo every 3 weeks with chemotherapy |
||
---|---|---|---|---|
All Grades % |
Grades 3-4 % |
All Grades % |
Grades 3-4 % |
|
|
||||
Anemia | 90 | 20 | 85 | 19 |
Leukopenia | 85 | 39 | 86 | 39 |
Neutropenia | 76 | 49 | 77 | 52 |
Lymphopenia | 70 | 26 | 70 | 19 |
Thrombocytopenia | 54 | 19 | 53 | 21 |
|
||||
Increased ALT | 60 | 11 | 58 | 8 |
Increased AST | 57 | 9 | 55 | 6 |
Hyperglycemia | 52 | 4.4 | 51 | 2.2 |
Hypoalbuminemia | 37 | 2.2 | 32 | 2.2 |
Increased alkaline phosphatase | 35 | 3.9 | 39 | 2.2 |
Hypocalcemia | 29 | 3.3 | 27 | 1.8 |
Hyponatremia | 28 | 5 | 26 | 6 |
Hypophosphatemia | 21 | 7 | 18 | 4.8 |
Hypokalemia | 20 | 4.4 | 18 | 4.0 |
Endpoint | KEYTRUDA 10 mg/kg every 3 weeks n=277 |
KEYTRUDA 10 mg/kg every 2 weeks n=279 |
Ipilimumab 3 mg/kg every 3 weeks n=278 |
---|---|---|---|
|
|||
Deaths (%) | 92 (33%) | 85 (30%) | 112 (40%) |
Hazard ratio |
0.69 (0.52, 0.90) | 0.63 (0.47, 0.83) | --- |
p-Value (stratified log-rank) | 0.004 | <0.001 | --- |
|
|||
Events (%) | 157 (57%) | 157 (56%) | 188 (68%) |
Median in months (95% CI) | 4.1 (2.9, 6.9) | 5.5 (3.4, 6.9) | 2.8 (2.8, 2.9) |
Hazard ratio |
0.58 (0.47, 0.72) | 0.58 (0.46, 0.72) | --- |
p-Value (stratified log-rank) | <0.001 | <0.001 | --- |
|
|||
ORR (95% CI) | 33% (27, 39) | 34% (28, 40) | 12% (8, 16) |
Complete response rate | 6% | 5% | 1% |
Partial response rate | 27% | 29% | 10% |
|
Endpoint | KEYTRUDA 2 mg/kg every 3 weeks |
KEYTRUDA 10 mg/kg every 3 weeks |
Chemotherapy |
---|---|---|---|
n=180 | n=181 | n=179 | |
|
|||
Number of Events, n (%) | 129 (72%) | 126 (70%) | 155 (87%) |
Progression, n (%) | 105 (58%) | 107 (59%) | 134 (75%) |
Death, n (%) | 24 (13%) | 19 (10%) | 21 (12%) |
Median in months (95% CI) | 2.9 (2.8, 3.8) | 2.9 (2.8, 4.7) | 2.7 (2.5, 2.8) |
p-Value (stratified log-rank) | <0.001 | <0.001 | --- |
Hazard ratio |
0.57 (0.45, 0.73) | 0.50 (0.39, 0.64) | --- |
|
|||
Deaths (%) | 123 (68%) | 117 (65%) | 128 (72%) |
Hazard ratio |
0.86 (0.67, 1.10) | 0.74 (0.57, 0.96) | --- |
p-Value (stratified log-rank) | 0.117 | 0.011 |
--- |
Median in months (95% CI) | 13.4 (11.0, 16.4) | 14.7 (11.3, 19.5) | 11.0 (8.9, 13.8) |
|
|||
ORR (95% CI) | 21% (15, 28) | 25% (19, 32) | 4% (2, 9) |
Complete response rate | 2% | 3% | 0% |
Partial response rate | 19% | 23% | 4% |
|
Endpoint | KEYTRUDA 200 mg every 3 weeks n=514 |
Placebo n=505 |
---|---|---|
NR = not reached | ||
|
||
Number (%) of patients with event | 135 (26%) | 216 (43%) |
Median in months (95% CI) | NR | 20.4 (16.2, NR) |
Hazard ratio |
0.57 (0.46, 0.70) | |
p-Value |
<0.001 |
|
Endpoint | KEYTRUDA 200 mg every 3 weeks Pemetrexed Platinum Chemotherapy n=410 |
Placebo Pemetrexed Platinum Chemotherapy n=206 |
---|---|---|
NR = not reached | ||
|
||
Number (%) of patients with event | 127 (31%) | 108 (52%) |
Median in months (95% CI) | NR (NR, NR) |
11.3 (8.7, 15.1) |
Hazard ratio |
0.49 (0.38, 0.64) | |
p-Value |
<0.0001 | |
|
||
Number of patients with event (%) | 245 (60%) | 166 (81%) |
Median in months (95% CI) | 8.8 (7.6, 9.2) | 4.9 (4.7, 5.5) |
Hazard ratio |
0.52 (0.43, 0.64) | |
p-Value |
<0.0001 | |
|
||
ORR |
48% (43, 53) | 19% (14, 25) |
Complete response | 0.5% | 0.5% |
Partial response | 47% | 18% |
p-Value |
<0.0001 | |
|
||
Median in months (range) | 11.2 (1.1+, 18.0+) | 7.8 (2.1+, 16.4+) |
|
Endpoint | KEYTRUDA 200 mg every 3 weeks Carboplatin Paclitaxel/Paclitaxel protein-bound n=278 |
Placebo Carboplatin Paclitaxel/Paclitaxel protein-bound n=281 |
---|---|---|
NE = not estimable | ||
|
||
Number of events (%) | 85 (31%) | 120 (43%) |
Median in months (95% CI) | 15.9 (13.2, NE) | 11.3 (9.5, 14.8) |
Hazard ratio |
0.64 (0.49, 0.85) | |
p-Value |
0.0017 | |
|
||
Number of events (%) | 152 (55%) | 197 (70%) |
Median in months (95% CI) | 6.4 (6.2, 8.3) | 4.8 (4.2, 5.7) |
Hazard ratio |
0.56 (0.45, 0.70) | |
p-Value |
<0.0001 | |
|
|
|
|
||
ORR (95% CI) | 58% (48, 68) | 35% (26, 45) |
Difference (95% CI) | 23.6% (9.9, 36.4) | |
p-Value |
0.0008 | |
|
||
Median duration of response in months (range) | 7.2 (2.4, 12.4+) | 4.9 (2.0, 12.4+) |
|
TPS ≥1% | TPS ≥50% | |||
---|---|---|---|---|
Endpoint | KEYTRUDA 200 mg every 3 weeks |
Chemotherapy | KEYTRUDA 200 mg every 3 weeks |
Chemotherapy |
n=637 | n=637 | n=299 | n=300 | |
|
||||
Number of events (%) | 371 (58%) | 438 (69%) | 157 (53%) | 199 (66%) |
Median in months (95% CI) | 16.7 (13.9, 19.7) | 12.1 (11.3, 13.3) | 20.0 (15.4, 24.9) | 12.2 (10.4, 14.2) |
Hazard ratio |
0.81 (0.71, 0.93) | 0.69 (0.56, 0.85) | ||
p-Value |
0.0036 | 0.0006 | ||
|
||||
Number of events (%) | 507 (80%) | 506 (79%) | 221 (74%) | 233 (78%) |
Median in months (95% CI) | 5.4 (4.3, 6.2) | 6.5 (6.3, 7.0) | 6.9 (5.9, 9.0) | 6.4 (6.1, 6.9) |
Hazard ratio |
1.07 (0.94, 1.21) |
0.82 (0.68, 0.99) |
||
p-Value |
- |
NS |
||
|
||||
ORR |
27% (24, 31) | 27% (23, 30) | 39% (33.9, 45.3) | 32% (26.8, 37.6) |
Complete response rate | 0.5% | 0.5% | 0.7% | 0.3% |
Partial response rate | 27% | 26% | 39% | 32% |
|
||||
% with duration ≥12 months |
47% | 16% | 42% | 17% |
% with duration ≥18 months |
26% | 6% | 25% | 5% |
|
|
Endpoint | KEYTRUDA 200 mg every 3 weeks |
Chemotherapy |
---|---|---|
n=154 | n=151 | |
NR = not reached | ||
|
||
Number (%) of patients with event | 73 (47%) | 116 (77%) |
Median in months (95% CI) | 10.3 (6.7, NR) | 6.0 (4.2, 6.2) |
Hazard ratio |
0.50 (0.37, 0.68) | |
p-Value (stratified log-rank) | <0.001 | |
|
||
Number (%) of patients with event | 44 (29%) | 64 (42%) |
Median in months (95% CI) |
30.0 (18.3, NR) |
14.2 (9.8, 19.0) |
Hazard ratio |
0.60 (0.41, 0.89) | |
p-Value (stratified log-rank) | 0.005 |
|
|
||
ORR (95% CI) | 45% (37, 53) | 28% (21, 36) |
Complete response rate | 4% | 1% |
Partial response rate | 41% | 27% |
p-Value (Miettinen-Nurminen) | 0.001 | |
Median duration of response in months (range) | NR (1.9+, 14.5+) |
6.3 (2.1+, 12.6+) |
|
Endpoint | KEYTRUDA 2 mg/kg every 3 weeks n=139 |
KEYTRUDA 10 mg/kg every 3 weeks n=151 |
Docetaxel 75 mg/m2 every 3 weeks n=152 |
---|---|---|---|
NR = not reached | |||
|
|||
Deaths (%) | 58 (42%) | 60 (40%) | 86 (57%) |
Median in months (95% CI) | 14.9 (10.4, NR) | 17.3 (11.8, NR) | 8.2 (6.4, 10.7) |
Hazard ratio |
0.54 (0.38, 0.77) | 0.50 (0.36, 0.70) | --- |
p-Value (stratified log-rank) | <0.001 | <0.001 | --- |
|
|||
Events (%) | 89 (64%) | 97 (64%) | 118 (78%) |
Median in months (95% CI) | 5.2 (4.0, 6.5) | 5.2 (4.1, 8.1) | 4.1 (3.6, 4.3) |
Hazard ratio |
0.58 (0.43, 0.77) | 0.59 (0.45, 0.78) | --- |
p-Value (stratified log-rank) | <0.001 | <0.001 | --- |
|
|||
ORR |
30% (23, 39) | 29% (22, 37) | 8% (4, 13) |
p-Value (Miettinen-Nurminen) | <0.001 | <0.001 | --- |
Median duration of response in months (range) | NR (0.7+, 16.8+) |
NR (2.1+, 17.8+) |
8.1 (2.1+, 8.8+) |
Endpoint | KEYTRUDA 2 mg/kg every 3 weeks n=344 |
KEYTRUDA 10 mg/kg every 3 weeks n=346 |
Docetaxel 75 mg/m2 every 3 weeks n=343 |
---|---|---|---|
NR = not reached | |||
|
|||
Deaths (%) | 172 (50%) | 156 (45%) | 193 (56%) |
Median in months (95% CI) | 10.4 (9.4, 11.9) | 12.7 (10.0, 17.3) | 8.5 (7.5, 9.8) |
Hazard ratio |
0.71 (0.58, 0.88) | 0.61 (0.49, 0.75) | --- |
p-Value (stratified log-rank) | <0.001 | <0.001 | --- |
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Events (%) | 266 (77%) | 255 (74%) | 257 (75%) |
Median in months (95% CI) | 3.9 (3.1, 4.1) | 4.0 (2.6, 4.3) | 4.0 (3.1, 4.2) |
Hazard ratio |
0.88 (0.73, 1.04) | 0.79 (0.66, 0.94) | --- |
p-Value (stratified log-rank) | 0.068 | 0.005 | --- |
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ORR |
18% (14, 23) | 19% (15, 23) | 9% (7, 13) |
p-Value (Miettinen-Nurminen) | <0.001 | <0.001 | --- |
Median duration of response in months (range) | NR (0.7+, 20.1+) |
NR (2.1+, 17.8+) |
6.2 (1.4+, 8.8+) |
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Endpoint | KEYTRUDA 200 mg every 3 weeks Platinum FU |
Cetuximab Platinum FU |
---|---|---|
n=281 | n=278 | |
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Number (%) of patients with event | 197 (70%) | 223 (80%) |
Median in months (95% CI) | 13.0 (10.9, 14.7) | 10.7 (9.3, 11.7) |
Hazard ratio |
0.77 (0.63, 0.93) | |
p-Value |
0.0067 | |
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Number of patients with event (%) | 244 (87%) | 253 (91%) |
Median in months (95% CI) | 4.9 (4.7, 6.0) | 5.1 (4.9, 6.0) |
Hazard ratio |
0.92 (0.77, 1.10) | |
p-Value |
0.3394 | |
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ORR |
36% (30.0, 41.5) | 36% (30.7, 42.3) |
Complete response rate | 6% | 3% |
Partial response rate | 30% | 33% |
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Median in months (range) | 6.7 (1.6+, 30.4+) | 4.3 (1.2+, 27.9+) |
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Endpoint | CPS ≥1 | CPS ≥20 | ||
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KEYTRUDA 200 mg every 3 weeks |
Cetuximab Platinum FU |
KEYTRUDA 200 mg every 3 weeks |
Cetuximab Platinum FU |
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n=257 | n=255 | n=133 | n=122 | |
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Number of events (%) | 177 (69%) | 206 (81%) | 82 (62%) | 95 (78%) |
Median in months (95% CI) | 12.3 (10.8, 14.9) | 10.3 (9.0,11.5) | 14.9 (11.6, 21.5) | 10.7 (8.8, 12.8) |
Hazard ratio |
0.78 (0.64, 0.96) | 0.61 (0.45, 0.83) | ||
p-Value |
0.0171 | 0.0015 | ||
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Number of events (%) | 225 (88%) | 231 (91%) | 113 (85%) | 111 (91%) |
Median in months (95% CI) | 3.2 (2.2, 3.4) | 5.0 (4.8, 5.8) | 3.4 (3.2, 3.8) | 5.0 (4.8, 6.2) |
Hazard ratio |
1.15 (0.95, 1.38) | 0.97 (0.74, 1.27) | ||
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ORR |
19% (14.5, 24.4) | 35% (29.1, 41.1) | 23% (16.4, 31.4) | 36% (27.6, 45.3) |
Complete response rate | 5% | 3% | 8% | 3% |
Partial response rate | 14% | 32% | 16% | 33% |
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Median in months (range) | 20.9 (1.5+, 34.8+) | 4.5 (1.2+, 28.6+) | 20.9 (2.7, 34.8+) | 4.2 (1.2+, 22.3+) |
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Endpoint | KEYTRUDA 200 mg every 3 weeks n=151 |
Brentuximab Vedotin 1.8 mg/kg every 3 weeks n=153 |
---|---|---|
+ Denotes a censored value. | ||
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Number of patients with event (%) | 81 (54%) | 88 (58%) |
Median in months (95% CI) |
13.2 (10.9, 19.4) | 8.3 (5.7, 8.8) |
Hazard ratio |
0.65 (0.48, 0.88) | |
p-Value |
0.0027 | |
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ORR |
66% (57, 73) | 54% (46, 62) |
Complete response | 25% | 24% |
Partial response | 41% | 30% |
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Median in months (range) |
20.7 (0.0+, 33.2+) | 13.8 (0.0+, 33.9+) |
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Endpoint | KEYTRUDA 200 mg every 3 weeks n=210 |
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ORR (95% CI) | 69% (62, 75) |
Complete response rate | 22% |
Partial response rate | 47% |
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Median in months (range) | 11.1 (0.0+, 11.1) |
Endpoint | KEYTRUDA 200 mg every 3 weeks n=53 |
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NR = not reached | |
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ORR (95% CI) | 45% (32, 60) |
Complete response rate | 11% |
Partial response rate | 34% |
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Median in months (range) | NR (1.1+, 19.2+) |
Endpoint | KEYTRUDA 200 mg every 3 weeks |
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All Subjects n=370 |
PD-L1 CPS <10 n=260 |
PD-L1 CPS ≥10 n=110 |
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+ Denotes ongoing response NR = not reached |
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ORR (95% CI) | 29% (24, 34) | 21% (16, 26) | 47% (38, 57) |
Complete response rate | 7% | 3% | 15% |
Partial response rate | 22% | 18% | 32% |
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Median in months (range) | NR (1.4+, 17.8+) |
NR (1.4+, 16.3+) |
NR (1.4+, 17.8+) |
KEYTRUDA 200 mg every 3 weeks |
Chemotherapy | |
---|---|---|
n=270 | n=272 | |
+ Denotes ongoing response NR = not reached |
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Deaths (%) | 155 (57%) | 179 (66%) |
Median in months (95% CI) | 10.3 (8.0, 11.8) | 7.4 (6.1, 8.3) |
Hazard ratio |
0.73 (0.59, 0.91) | |
p-Value (stratified log-rank) | 0.004 | |
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Events (%) | 218 (81%) | 219 (81%) |
Median in months (95% CI) | 2.1 (2.0, 2.2) | 3.3 (2.3, 3.5) |
Hazard ratio |
0.98 (0.81, 1.19) | |
p-Value (stratified log-rank) | 0.833 | |
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ORR (95% CI) | 21% (16, 27) | 11% (8, 16) |
Complete response rate | 7% | 3% |
Partial response rate | 14% | 8% |
p-Value (Miettinen-Nurminen) | 0.002 | |
Median duration of response in months (range) | NR (1.6+, 15.6+) |
4.3 (1.4+, 15.4+) |
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Endpoint | KEYTRUDA 200 mg every 3 weeks n=96 |
---|---|
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41% (31, 51) |
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Median in months (range) | 16.2 (0.0+, 30.4 |
% (n) with duration ≥12 months | 46% (18) |
Study | Design and Patient Population | Number of Patients | MSI-H/dMMR Testing | Dosage | Prior Therapy |
---|---|---|---|---|---|
CRC = colorectal cancer PCR = polymerase chain reaction IHC = immunohistochemistry |
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NCT01876511 |
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28 CRC 30 non-CRC |
local PCR or IHC | 10 mg/kg every 2 weeks |
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NCT02460198 |
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61 | local PCR or IHC | 200 mg every 3 weeks | Prior fluoropyrimidine, oxaliplatin, and irinotecan +/- anti-VEGF/EGFR mAb |
NCT01848834 |
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6 | central PCR | 10 mg/kg every 2 weeks | ≥1 prior regimen |
NCT02054806 |
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5 | central PCR | 10 mg/kg every 2 weeks | ≥1 prior regimen |
NCT02628067 |
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19 | local PCR or IHC (central PCR for patients in rare tumor non-CRC cohorts) | 200 mg every 3 weeks | ≥1 prior regimen |
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Endpoint | KEYTRUDA n=149 |
---|---|
NR = not reached | |
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ORR (95% CI) | 39.6% (31.7, 47.9) |
Complete response rate | 7.4% |
Partial response rate | 32.2% |
|
|
Median in months (range) | NR (1.6+, 22.7+) |
% with duration ≥6 months | 78% |
Objective Response Rate | Duration of Response range |
|||
---|---|---|---|---|
N | n (%) | 95% CI | (months) | |
CR = complete response PR = partial response SD = stable disease PD = progressive disease NE = not evaluable |
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90 | 32 (36%) | (26%, 46%) | (1.6+, 22.7+) |
|
59 | 27 (46%) | (33%, 59%) | (1.9+, 22.1+) |
Endometrial cancer | 14 | 5 (36%) | (13%, 65%) | (4.2+, 17.3+) |
Biliary cancer | 11 | 3 (27%) | (6%, 61%) | (11.6+, 19.6+) |
Gastric or GE junction cancer | 9 | 5 (56%) | (21%, 86%) | (5.8+, 22.1+) |
Pancreatic cancer | 6 | 5 (83%) | (36%, 100%) | (2.6+, 9.2+) |
Small intestinal cancer | 8 | 3 (38%) | (9%, 76%) | (1.9+, 9.1+) |
Breast cancer | 2 | PR, PR | (7.6, 15.9) | |
Prostate cancer | 2 | PR, SD | 9.8+ | |
Bladder cancer | 1 | NE | ||
Esophageal cancer | 1 | PR | 18.2+ | |
Sarcoma | 1 | PD | ||
Thyroid cancer | 1 | NE | ||
Retroperitoneal adenocarcinoma | 1 | PR | 7.5+ | |
Small cell lung cancer | 1 | CR | 8.9+ | |
Renal cell cancer | 1 | PD |
Endpoint | KEYTRUDA 200 mg every 3 weeks n=153 |
Chemotherapy n=154 |
---|---|---|
+ Denotes ongoing response NR = not reached |
||
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Number (%) of patients with event | 82 (54%) | 113 (73%) |
Median in months (95% CI) | 16.5 (5.4, 32.4) | 8.2 (6.1, 10.2) |
Hazard ratio |
0.60 (0.45, 0.80) | |
p-Value |
0.0004 | |
|
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ORR (95% CI) | 44% (35.8, 52.0) | 33% (25.8, 41.1) |
Complete response rate | 11% | 4% |
Partial response rate | 33% | 29% |
|
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Median in months (range) | NR (2.3+, 41.4+) | 10.6 (2.8, 37.5+) |
% with duration ≥12 months |
75% | 37% |
% with duration ≥24 months |
43% | 18% |
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Endpoint | KEYTRUDA 200 mg every 3 weeks Trastuzumab Fluoropyrimidine and Platinum Chemotherapy n=133 |
Placebo Trastuzumab Fluoropyrimidine and Platinum Chemotherapy n=131 |
---|---|---|
|
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ORR |
74% (66, 82) | 52% (43, 61) |
Complete response rate | 11% | 3.1% |
Partial response rate | 63% | 49% |
p-Value |
<0.0001 | |
|
n=99 | n=68 |
Median in months (range) | 10.6 (1.1+, 16.5+) | 9.5 (1.4+, 15.4+) |
% with duration ≥6 months | 65% | 53% |
Endpoint | KEYTRUDA 200 mg every 3 weeks Cisplatin FU n=373 |
Placebo Cisplatin FU n=376 |
---|---|---|
|
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Number (%) of events | 262 (70) | 309 (82) |
Median in months (95% CI) |
12.4 (10.5, 14.0) |
9.8 (8.8, 10.8) |
Hazard ratio |
0.73 (0.62, 0.86) | |
p-Value |
<0.0001 | |
|
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Number of events (%) | 297 (80) | 333 (89) |
Median in months (95% CI) |
6.3 (6.2, 6.9) |
5.8 (5.0, 6.0) |
Hazard ratio |
0.65 (0.55, 0.76) | |
p-Value |
<0.0001 | |
|
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ORR, % (95% CI) |
45 (40, 50) |
29 (25, 34) |
Number (%) of complete responses | 24 (6) | 9 (2.4) |
Number (%) of partial responses | 144 (39) | 101 (27) |
p-Value |
<0.0001 | |
|
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Median in months (range) |
8.3 (1.2+, 31.0+) |
6.0 (1.5+, 25.0+) |
|
Endpoint | KEYTRUDA 200 mg every 3 weeks n=85 |
Chemotherapy n=82 |
---|---|---|
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Number (%) of patients with event | 68 (80%) | 72 (88%) |
Median in months (95% CI) | 10.3 (7.0, 13.5) | 6.7 (4.8, 8.6) |
Hazard ratio |
0.64 (0.46, 0.90) | |
|
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Number (%) of patients with event | 76 (89%) | 76 (93%) |
Median in months (95% CI) | 3.2 (2.1, 4.4) | 2.3 (2.1, 3.4) |
Hazard ratio |
0.66 (0.48, 0.92) | |
|
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ORR (95% CI) | 22 (14, 33) | 7 (3, 15) |
Number (%) of complete responses | 4 (5) | 1 (1) |
Number (%) of partial responses | 15 (18) | 5 (6) |
Median duration of response in months (range) | 9.3 (2.1+, 18.8+) | 7.7 (4.3, 16.8+) |
|
Endpoint | KEYTRUDA 200 mg every 3 weeks n=77 |
---|---|
+ Denotes ongoing response NR = not reached |
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|
|
ORR (95% CI) | 14.3% (7.4, 24.1) |
Complete response rate | 2.6% |
Partial response rate | 11.7% |
|
|
Median in months (range) | NR (4.1, 18.6+) |
% with duration ≥6 months | 91% |
Endpoint | KEYTRUDA 200 mg every 3 weeks n=104 |
---|---|
|
|
ORR (95% CI) |
17% (11, 26) |
Complete response rate | 1% |
Partial response rate | 16% |
|
|
% with duration ≥6 months | 89% |
% with duration ≥12 months | 56% |
Endpoint | KEYTRUDA 2 mg/kg every 3 weeks n=50 |
---|---|
+ Denotes ongoing response | |
|
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ORR (95% CI) | 56% (41, 70) |
Complete response rate (95% CI) | 24% (13, 38) |
Partial response rate (95% CI) | 32% (20, 47) |
|
|
Range in months |
5.9, 34.5+ |
Patients with duration ≥6 months, n (%) | 27 (96%) |
Patients with duration ≥12 months, n (%) | 15 (54%) |
Endpoint | KEYTRUDA 200 mg every 3 weeks and Axitinib |
Sunitinib |
---|---|---|
n=432 | n=429 | |
NR = not reached | ||
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Number of patients with event (%) | 59 (14%) | 97 (23%) |
Median in months (95% CI) | NR (NR, NR) | NR (NR, NR) |
Hazard ratio |
0.53 (0.38, 0.74) | |
p-Value |
<0.0001 |
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12-month OS rate | 90% (86, 92) | 78% (74, 82) |
|
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Number of patients with event (%) | 183 (42%) | 213 (50%) |
Median in months (95% CI) | 15.1 (12.6, 17.7) | 11.0 (8.7, 12.5) |
Hazard ratio |
0.69 (0.56, 0.84) | |
p-Value |
0.0001 |
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ORR |
59% (54, 64) | 36% (31, 40) |
Complete response rate | 6% | 2% |
Partial response rate | 53% | 34% |
p-Value |
<0.0001 |
|
|
Endometrial Carcinoma (not MSI-H or dMMR) | ||
---|---|---|
Endpoint | KEYTRUDA 200 mg every 3 weeks and Lenvatinib n=346 |
Doxorubicin or Paclitaxel n=351 |
|
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Number (%) of patients with event | 165 (48%) | 203 (58%) |
Median in months (95% CI) | 17.4 (14.2, 19.9) | 12.0 (10.8, 13.3) |
Hazard ratio |
0.68 (0.56, 0.84) | |
p-Value |
0.0001 | |
|
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Number (%) of patients with event | 247 (71%) | 238 (68%) |
Median in months (95% CI) | 6.6 (5.6, 7.4) | 3.8 (3.6, 5.0) |
Hazard ratio |
0.60 (0.50, 0.72) | |
p-Value |
<0.0001 | |
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ORR |
30% (26, 36) | 15% (12, 19) |
Complete response rate | 5% | 3% |
Partial response rate | 25% | 13% |
p-Value |
<0.0001 | |
|
n=105 | n=53 |
Median in months (range) | 9.2 (1.6+, 23.7+) | 5.7 (0.0+, 24.2+) |
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Endpoint |
KEYTRUDA 200 mg every 3 weeks |
|
---|---|---|
TMB ≥10 mut/Mb n=102 |
TMB ≥13 mut/Mb n=70 |
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+ Denotes ongoing response NR = not reached |
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ORR (95% CI) | 29% (21, 39) | 37% (26, 50) |
Complete response rate | 4% | 3% |
Partial response rate | 25% | 34% |
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n=30 | n=26 |
Median in months (range) |
NR (2.2+, 34.8+) | NR (2.2+, 34.8+) |
% with duration ≥12 months | 57% | 58% |
% with duration ≥24 months | 50% | 50% |
Objective Response Rate | Duration of Response range | |||
---|---|---|---|---|
N | n (%) | 95% CI | (months) | |
CR = complete response PR = partial response SD = stable disease PD = progressive disease |
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102 | 30 (29%) | (21%, 39%) | (2.2+, 34.8+) |
Small cell lung cancer | 34 | 10 (29%) | (15%, 47%) | (4.1, 32.5+) |
Cervical cancer | 16 | 5 (31%) | (11%, 59%) | (3.7+, 34.8+) |
Endometrial cancer | 15 | 7 (47%) | (21%, 73%) | (8.4+, 33.9+) |
Anal cancer | 14 | 1 (7%) | (0.2%, 34%) | 18.8+ |
Vulvar cancer | 12 | 2 (17%) | (2%, 48%) | (8.8, 11.0) |
Neuroendocrine cancer | 5 | 2 (40%) | (5%, 85%) | (2.2+, 32.6+) |
Salivary cancer | 3 | PR, SD, PD | 31.3+ | |
Thyroid cancer | 2 | CR, CR | (8.2, 33.2+) | |
Mesothelioma cancer | 1 | PD |
Endpoint | KEYTRUDA Recurrent or Metastatic cSCC n=105 |
KEYTRUDA Locally Advanced cSCC n=54 |
---|---|---|
+ Denotes ongoing response | ||
|
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ORR (95% CI) | 35% (26, 45) | 50% (36, 64) |
Complete response rate | 11% | 17% |
Partial response rate | 25% | 33% |
|
n=37 | n=27 |
Median in months (range) | NR (2.7, 30.4+) | NR (1.0+, 17.2+) |
% with duration ≥6 months | 76% | 81% |
% with duration ≥12 months | 68% | 37% |
Endpoint | KEYTRUDA 200 mg every 3 weeks with chemotherapy/KEYTRUDA n=784 |
Placebo with chemotherapy/Placebo n=390 |
---|---|---|
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Number of patients with pCR | 494 | 217 |
pCR Rate (%), (95% CI) | 63.0 (59.5, 66.4) | 55.6 (50.6, 60.6) |
Treatment difference (%) estimate (95% CI) |
7.5 (1.6, 13.4) | |
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Number of patients with event (%) | 123 (16%) | 93 (24%) |
Hazard ratio (95% CI) |
0.63 (0.48, 0.82) | |
p-Value |
0.00031 |
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Endpoint | KEYTRUDA 200 mg every 3 weeks with chemotherapy n=220 |
Placebo every 3 weeks with chemotherapy n=103 |
---|---|---|
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Number of patients with event (%) |
136 (62%) | 79 (77%) |
Median in months (95% CI) | 9.7 (7.6, 11.3) | 5.6 (5.3, 7.5) |
Hazard ratio |
0.65 (0.49, 0.86) | |
p-Value |
0.0012 | |
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Objective confirmed response rate (95% CI) |
53% (46, 60) | 40% (30, 50) |
Complete response rate | 17% | 13% |
Partial response rate | 36% | 27% |
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Median in months (95% CI) | 19.3 (9.9, 29.8) | 7.3 (5.3, 15.8) |
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This Medication Guide has been approved by the U.S. Food and Drug Administration. | Revised: July 2021 | ||
KEYTRUDA® (key-true-duh) (pembrolizumab) injection |
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KEYTRUDA is a medicine that may treat certain cancers by working with your immune system. KEYTRUDA can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended. | |||
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KEYTRUDA is a prescription medicine used to treat: | |||
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These are not all the possible side effects of KEYTRUDA. | |||
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | |||
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Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about KEYTRUDA that is written for health professionals. | |||
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Manufactured by: Merck Sharp & Dohme Corp., a subsidiary of |
U.S. License No. 0002 For patent information: Copyright © 2014-2021 Merck Sharp & Dohme Corp., a subsidiary of All rights reserved. usmg-mk3475-iv-2107r043 For more information, go to |