Keytruda (pembrolizumab)

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Keytruda (pembrolizumab)

Keytruda (pembrolizumab) is a medication used for the treatment of advanced melanoma, metastatic nonsquamous NSCLC, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC), recurrent classical Hodgkin Lymphoma (cHL), locally advanced or metastatic urothelial carcinoma, solid tumours having the biomarkers MSI-H or dMMR, recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.

Oncology Urothelial Carcinoma, Gastric Cancer, Head and Neck Cancer, Lung Cancer, Lymphoma, Skin Cancer
Marketing Authorisation Holder Merck Sharp & Dohme Limited
Mode of Action Monoclonal antibody (immunotherapy)
Administration Intravenous
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia

What is Keytruda (pembrolizumab) for?

Keytruda (pembrolizumab) is a monoclonal antibody (immunotherapy) indicated for the treatment of people with:

  • advanced (unresectable or metastatic) melanoma1,2,3

  • metastatic nonsquamous NSCLC as first-line treatment in combination with pemetrexed and carboplatin1,2,3

  • recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)2,3

  • recurrent classical Hodgkin Lymphoma (cHL)1,2,3

  • locally advanced or metastatic urothelial carcinoma1,2,17

  • solid tumours having the biomarkers MSI-H or dMMR1,16

  • recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma2,18

How does Keytruda (pembrolizumab) work?

Keytruda (pembrolizumab) is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a specific structure (called an antigen) that is found in certain cells in the body. Keytruda (pembrolizumab) has been designed to attach to and block a receptor called ‘programmed cell death-1’ (PD-1), which switches off the activity of certain cells of the immune system (the body’s natural defences) called T cells. By blocking PD-1, pembrolizumab prevents PD-1 from switching off these immune cells, thereby increasing the ability of the immune system to kill cancer cells1.

Where has Keytruda (pembrolizumab) been approved?

Keytruda (pembrolizumab) was approved by:

  • Food and Drug Administration (FDA), USA:

    • September 4, 2014, for advanced or unresectable melanoma2

    • October 2, 2015, for advanced (metastatic) NSCLC which progressed after other treatments and with tumours that express a protein called PD-L14

    • August 8, 2016, for recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HBSCC)7

    • October 24, 2016, as first-line treatment for metastatic NSCLC with PD-L1 expression on ≥ 50 % of cells as determined by an FDA-approved test; in absence of EGFR or ALK genomic tumour aberrations, and for patients with metastatic NSCLC whose tumours express PD-L1 on ≥ 1 % of cells with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on other therapies approved for these aberrations prior to receiving pembrolizumab2,6

    • March 14, 2017, for adult and pediatric patients with refractory cHL, or who have relapsed after 3 or more prior lines of therapy13

    • May 10, 2017, in combination with pemetrexed and carboplatin, as first-line treatment for metastatic nonsquamous NSCLC13

    • May 18, 2017, for locally advanced or metastatic urothelial carcinoma in patients who are not eligible to (first-line treatment) or have disease progression during or following (second-line treatment) certain chemotherapies2

    • May 23, 2017, for adult and pediatric patients with unresectable or metastatic solid tumors having a biomarker referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). The indication is for tumours that progressed following prior treatment and who have no satisfactory alternative treatment options16

    • September 22, 2017, for patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma (PD-L1 Combined Positive Score (CPS) ≥1), 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 therapy2.

  • European Medical Agency (EMA), European Union:

    • July 17, 2015, for advanced or unresectable melanoma1

    • June 23, 2016, for locally advanced or metastatic NSCLC12

    • January 31, 2017, as first-line treatment of patients with metastatic NSCLC with PD-L1 on ≥50% of cells and without EGFR or ALK mutation8,9

    • May 2017, for relapsed or refractory classical Hodgkin lymphoma (cHL)

    • July 20, 2017, for locally advanced or metastatic urothelial carcinoma17

  • Therapeutic Goods Administration (TGA), Australia:

    • April 16, 2015, for advanced melanoma3

    • March 6, 2017, for as first-line treatment of patients with metastatic NSCLC with PD-L1 on ≥50% of cells and without EGFR or ALK mutation12

    • March 7, 2017, for advanced non-small cell lung carcinoma (NSCLC)12

    • March 21, 2017, for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)3

    • for relapsed or refractory classical Hodgkin Lymphoma (cHL)3

    • for locally advanced or metastatic urothelial carcinoma3

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Keytruda (pembrolizumab) taken?

The standard dosage is1,2,3:

  • Melanoma: 200 mg every 3 weeks
  • NSCLC: 200 mg every 3 weeks
  • HNSCC: 200 mg every 3 weeks
  • cHL: 200 mg every 3 weeks for adults and 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics
  • Urothelial Carcinoma: 200 mg every 3 weeks
  • MSI-H Cancer: 200 mg every 3 weeks for adults and 2 mg/kg (up to 200 mg) every 3 weeks for children
  • Gastric Cancer: 200 mg every 3 weeks.

Administer as an intravenous infusion over 30 minutes.

Complete information about Keytruda (pembrolizumab) dosage and administration can be found in the official prescribing information listed in our resources section1,2,3.

Note: Please consult with your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Keytruda (pembrolizumab)?

Common side effects

The most common adverse reactions ( ≥20% of patients) listed in the prescribing information include1,2,3:

  • fatigue
  • musculoskeletal pain
  • decreased appetite
  • pruritus
  • diarrhea
  • nausea
  • rash
  • pyrexia
  • cough
  • dyspnea
  • constipation.

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include1,2,3:

  • immune-mediated pneumonitis
  • immune-mediated colitis
  • immune-mediated hepatitis
  • immune-mediated endocrinopathies:
    • Hypophysitis
    • Thyroid disorders
    • Type 1 diabetes mellitus
  • immune-mediated nephritis
  • immune-mediated skin adverse reactions including, StevensJohnson syndrome (SJS) and toxic epidermal necrolysis (TEN)
  • Other immune-mediated adverse reactions: In organ transplant recipients
  • Infusion-related reactions
  • Complications of allogeneic HSCT.

Use in a specific population

Keytruda (pembrolizumab) can be fatal for a fetus; it is not advised for women who are pregnant or breast feeding1,2,3.

Avoid use in patients with a severely damaged immune system1,2,3.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1,2,3.

More Information
Working ingredient pembrolizumab
Shipping method Cold chain (temperature controlled)
Therapeutic Area Oncology
Oncology Urothelial Carcinoma, Gastric Cancer, Head and Neck Cancer, Lung Cancer, Lymphoma, Skin Cancer
Indication Recurrent classical Hodgkin Lymphoma (cHL)
Indication Recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma
Indication recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
Indication Metastatic nonsquamous NSCLC
Indication Metastatic melanoma
Indication Locally advanced or metastatic urothelial carcinoma
Administration Intravenous
Mode of Action Monoclonal antibody (immunotherapy)
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Marketing Authorisation Holder Merck Sharp & Dohme Limited
HS Code 30021091
CAS Number 1374853-91-4

Melanoma

The approvals from the the Food and Drug Administration (FDA), USA, European Medical Agency (EMA), European Union, Therapeutic Goods Administration (TGA), Australia, for Keytruda (pembrolizumab) for unresectable or metastatic melanoma in previously treated patients were based on several studies (KEYNOTE-0061,2,3, KEYNOTE-0021,2, KEYNOTE-0011,2,3). Patients were treated until disease progression or toxicity.

  • KEYNOTE-006 was a multicentre, controlled, Phase III study and involved a total of 834 patients naïve to ipilimumab and who received no or one prior systemic therapy. Patients were randomly assigned to one of 3 groups of similar size and received Keytruda at a dose of 10 mg/kg every 2 or 3 weeks or ipilimumab, another immunotherapy. Subgroups of patients were identified and compared according to their PD-L1 expression (positive or negative).

  • KEYNOTE-002 was a multicentre controlled study and involved a total of 540 patients previously treated with ipilimumab and if BRAF V600 mutation-positive, a BRAF or MEK inhibitor. Patients were randomly assigned to one of 3 groups of similar size and received Keytruda at a dose of 2 or 10 mg/kg every 3 weeks or chemotherapy (including dacarbazine, temozolamide, carboplatin, paclitaxel, or carboplatin+paclitaxel). Subgroups of patients were identified and compared according to their PD-L1 expression (positive or negative).

  • KEYNOTE-001 open-label study and involved 276 patients who had either been previously treated with ipilimumab (and if BRAF V600 mutation-positive, a BRAF or MEK inhibitor) or who were naïve to treatment with ipilimumab. Patients were randomly assigned to one of 3 groups of similar size and received Keytruda at a dose of 2 or 10 mg/kg every 3 weeks.

Results

The major efficacy outcome measures were progression free survival (PFS), overall survival (OS), overall response rate (ORR), duration of response (DOR).

The median PFS was:

  • in KEYNOTE-0061:

    • 4.1 months [95% CI: 2.9, 7.2] with Keytruda (pembrolizumab) 10 mg/kg every 3 weeks

    • 5.6 months [95% CI: 3.4, 8.2] with Keytruda (pembrolizumab) 10 mg/kg every 2 weeks

    • 2.8 months [95% CI: 2.8, 2.9] with Ipilimumab 3 mg/kg every 3 weeks

  • in KEYNOTE-0021:

    • 2.9 months [95% CI: 2.8, 3.8] with Keytruda (pembrolizumab) 2 mg/kg every 3 weeks

    • 3 months [95% CI: 2.8, 5.2] with Keytruda (pembrolizumab) 10 mg/kg every 3 weeks

    • 2.8 months [95% CI: 2.6, 2.6] with chemotherapy

The median OS was:

  • in KEYNOTE-006:

    • Not reached [95% CI: 24 months, NA] with Keytruda (pembrolizumab) 10 mg/kg every 3 weeks

    • Not reached [95% CI: 22 months, NA] with Keytruda (pembrolizumab) 10 mg/kg every 2 weeks

    • 16 months [95% CI: 14, 22] with Ipilimumab 3 mg/kg every 3 weeks

  • in KEYNOTE-002:

    • 13.4 months [95% CI: 11.0, 16.4] with Keytruda (pembrolizumab) 2 mg/kg every 3 weeks

    • 14.7 months [95% CI: 11.3, 19.5] with Keytruda (pembrolizumab) 10 mg/kg every 3 weeks

    • 11.0 months [95% CI: 8.9, 13.8] with chemotherapy

The ORR was:

  • in KEYNOTE-006:

    • 36% [95% CI: 30, 42] with Keytruda (pembrolizumab) 10 mg/kg every 3 weeks

      • 13% complete responses

    • 37% [95% CI: 31, 43] with Keytruda (pembrolizumab) 10 mg/kg every 2 weeks

      • 12% complete responses

    • 13% [95% CI: 10, 18] with Ipilimumab 3 mg/kg every 3 weeks

      • 5% complete responses

    • PD L1 positive/negative subgroup:

      • 40% in PD-L1 positive with Keytruda (pembrolizumab) 10 mg/kg every 2 or 3 weeks vs. 14% with ipilimumab

      • 24% in PD-L1 negative with Keytruda (pembrolizumab) 10 mg/kg every 2 or 3 weeks vs. 13% with ipilimumab

  • in KEYNOTE-002:

    • 22% [95% CI: 16, 29] with Keytruda (pembrolizumab) 2 mg/kg every 3 weeks

      • 3% complete responses

    • 28% [95% CI: 21, 35] with Keytruda (pembrolizumab) 10 mg/kg every 3 weeks

      • 7% complete responses

    • 5% [95% CI: 2, 9] with chemotherapy

      • 0% complete responses

    • PD L1 positive/negative subgroup:

      • 25% in PD-L1 positive with Keytruda (pembrolizumab) 2 mg/kg every 2 or 3 weeks vs. 4% with ipilimumab

      • 10% in PD-L1 negative with Keytruda (pembrolizumab) 2 mg/kg every 2 or 3 weeks vs. 8% with ipilimumab

The DOR was:

  • in KEYNOTE-0061:

    • Not reached [95% CI: 24 months, NA] with Keytruda (pembrolizumab) 10 mg/kg every 3 weeks

    • Not reached [95% CI: 22 months, NA] with Keytruda (pembrolizumab) 10 mg/kg every 2 weeks

    • 16 months [95% CI: 14, 22] with Ipilimumab 3 mg/kg every 3 weeks

  • in KEYNOTE-0021:

    • 22.8 months [range: 1.4+, 25.3+] with Keytruda (pembrolizumab) 2 mg/kg every 3 weeks

    • Not reached [range: 1.1+, 28.3+] with Keytruda (pembrolizumab) 10 mg/kg every 3 weeks

    • 6.8 months [range: 2.8, 11.3] with chemotherapy

  • in KEYNOTE-0011:

    • 30.5 months [range: 2.8+, 30.6+] with Keytruda (pembrolizumab) 2 mg/kg every 3 weeks in patients previously treated with ipilimumab

    • 27.4 months [range: 1.6+, 31.8+] with Keytruda (pembrolizumab) 2 mg/kg every 3 weeks  in patients naïve to treatment with ipilimumab

Non-small cell lung cancer

1st line approval

The approvals from the Food and Drug Administration (FDA), USA, European Medical Agency (EMA), European Union, Therapeutic Goods Administration (TGA), Australia, of Keytruda (pembrolizumab) for previously untreated metastatic NSCLC were based on one study (KEYNOTE-0241,2,3). This study involved a total of 305 patients whose tumours had a PD-L1 expression of at least 50%; the study excluded patients with EGFR or ALK mutations. Patients were randomly assigned to one of 2 groups of similar size and received either pembrolizumab at a dose of 200 mg every 3 weeks or investigator’s choice platinum-containing chemotherapy (including pemetrexed+carboplatin, pemetrexed+cisplatin, gemcitabine+cisplatin, gemcitabine+carboplatin, or paclitaxel+carboplatin. Non-squamous patients could receive pemetrexed maintenance). Patients were treated with pembrolizumab until unacceptable toxicity or disease progression up to a maximum of 24 months1.

Results

The major efficacy outcome measures were progression free survival (PFS), overall survival (OS), overall response rate (ORR), and duration of response (DOR).

The median PFS was1,2,3:

  • 10.3 months [95% CI: 6.7, N.A.] with Keytruda (pembrolizumab) 200 mg every 3 weeks

  • 6.0 months [95% CI: 4.2, 6.2] with chemotherapy

The median OS was1,2,3:

  • Not reached

The ORR was1,2,3:

  • 45% [95% CI: 37, 53] with Keytruda (pembrolizumab) 200 mg every 3 weeks

    • 4% complete responses

  • 28% [95% CI: 21, 36] with chemotherapy

    • 1% complete responses

The median DOR was1,2,3:

  • Not reached [range: 1.9+, 14.5+] with Keytruda (pembrolizumab) 200 mg every 3 weeks

  • 6.3 months [range: 2.1+, 12.6+]  with chemotherapy

2nd line approval

The approvals from the Food and Drug Administration (FDA), USA, European Medical Agency (EMA), European Union, Therapeutic Goods Administration (TGA), Australia, of Keytruda (pembrolizumab) for patients previously treated with platinum-containing chemotherapy were based on one study (KEYNOTE-0101,2,3). This study involved a total of 1033 patients whose tumours had a PD-L1 expression of at least 1%; the study included patients with EGFR or ALK mutations who progressed on medicines specific for these indications. Patients were randomly assigned to one of 3 groups of similar size and received either pembrolizumab at a dose of 2 mg/kg every 3 weeks, pembrolizumab at a dose of 10 mg/kg every 3 weeks or docetaxel at a dose of 75 mg/m2 every 3 weeks. Patients were treated with pembrolizumab until unacceptable toxicity or disease progression1.

Results

The major efficacy outcome measures were progression-free survival (PFS), overall survival (OS), overall response rate (ORR), and duration of response (DOR).

The median PFS was1,2,3:

  • PD-L1 expression above 1%

    • 3.9 months [95% CI: 3.1, 4.1] with Pembrolizumab 2 mg/kg every 3 weeks

    • 4.0 months [95% CI: 2.6, 4.3] with Pembrolizumab 10 mg/kg every 3 weeks

    • 4.0 months [95% CI: 3.1, 4.2] with docetaxel 75 mg/m2 every 3 weeks

  • PD-L1 expression above 50%

    • 5.2 months [95% CI: 4.0, 6.5] with Pembrolizumab 2 mg/kg every 3 weeks

    • 5.2 months [95% CI: 4.1, 8.1] with Pembrolizumab 10 mg/kg every 3 weeks

    • 4.1 months [95% CI: 3.6, 4.3] with docetaxel 75 mg/m2 every 3 weeks

The median OS was1,2,3:

  • PD-L1 expression above 1%

    • 10.4 months [95% CI: 9.4, 11.9] with Pembrolizumab 2 mg/kg every 3 weeks

    • 12.7 months [95% CI: 10.0, 17.3] with Pembrolizumab 10 mg/kg every 3 weeks

    • 8.5 months [95% CI: 7.5, 9.8] with docetaxel 75 mg/m2 every 3 weeks

  • PD-L1 expression above 50%

    • 14.9 months [95% CI: 10.4, NA] with Pembrolizumab 2 mg/kg every 3 weeks

    • 17.3 months [95% CI: 11.8, NA] with Pembrolizumab 10 mg/kg every 3 weeks

    • 8.2 months [95% CI: 6.4, 10.7] with docetaxel 75 mg/m2 every 3 weeks

The ORR was1,2,3:

  • PD-L1 expression above 1%

    • 18% [95% CI: 14, 23] with Pembrolizumab 2 mg/kg every 3 weeks

    • 18% [95% CI: 15, 23]  with Pembrolizumab 10 mg/kg every 3 weeks

    • 9% [95% CI: 7, 13] with docetaxel 75 mg/m2 every 3 weeks

  • PD-L1 expression above 50%

    • 30% [95% CI: 23, 29] with Pembrolizumab 2 mg/kg every 3 weeks

    • 29% [95% CI: 22, 37]  with Pembrolizumab 10 mg/kg every 3 weeks

    • 8% [95% CI: 4, 13] with docetaxel 75 mg/m2 every 3 weeks

Head and neck cancer

The approvals from the The Food and Drug Administration (FDA), USA, and Therapeutic Goods Administration (TGA), Australia, of Keytruda (pembrolizumab) for recurrent or metastatic head and neck cancer (Head and Neck Squamous Cell Cancer - HNSCC) were based on one study (KEYNOTE-0122,3).

This study involved a total of 174 patients with recurrent or metastatic HNSCC who had disease progression on or after platinum-containing chemotherapy2. Patients were divided in two groups and received Keytruda 10 mg/kg every 2 weeks (53 patients) or 200 mg every 3 weeks (121 patients) until unacceptable toxicity or disease progression under certain conditions. Patients without disease progression were treated for up to 24 months2.  

Results

Among the efficacy outcome measures were the overall response rate (ORR), and duration of response (DOR). These were similar irrespective of dosage regimen (10 mg/kg every 2 weeks or 200 mg every 3 weeks).

The ORR was1,2,3:

  • 16% (95% CI: 11, 22)

  • complete response rate: 5%

The DOR among the 28 responding patients was1,2,3:  

  • range: 2.4+ to 27.7+ months

  • 23 patients having responses of 6 months or longer

  • The median was not reached

Classical Hodgkin Lymphoma

The approvals from the Food and Drug Administration (FDA), USA, European Medical Agency (EMA), European Union, and Therapeutic Goods Administration (TGA), Australia, of Keytruda (pembrolizumab) for relapsed or refractory classical Hodgkin lymphoma (cHL) were based on two multicentre, open-label studies (KEYNOTE-087 and KEYNOTE-0131,2,3). These studies involved a total of 241 patients with cHL. Both studies included patients regardless of PD-L1 expression.

Results

Among the efficacy outcome measures were the overall response rate (ORR), duration of response (DOR), time to response, progression-free survival (PFS) and overall survival (OS).

The ORR was1,2,3:

  • 69% (95% CI: 62.3, 75.2) in KEYNOTE-087

    • Complete remission: 22%

  • 58% (95% CI: 39.1, 75.5) in KEYNOTE-013

    • Complete remission: 19%

The median DOR was1,2,3:  

  • 11.1 months (range: 0.0+, 11.1) in KEYNOTE-087

    • % of patients with duration above 6 months: 76%

  • Not reached (range: 0.0+, 26.1+) in KEYNOTE-013

    • % of patients with duration above 6 months: 80%

    • % of patients with duration above 12 months: 70%

The median time to response was1,2,3:  

  • 2.8 months (range: 2.1, 8.8) in KEYNOTE-087

  • 2.8 months (range: 2.4, 8.6) in KEYNOTE-013

The median PFS was1,2,3:  

  • 11.3 months (95% CI: 10.8, not reached) in KEYNOTE-087

  • 11.4 months (95% CI: 4.9, 27.8) in KEYNOTE-013

The OS rate was1,2,3:  

  • 99.5% after 6 months in KEYNOTE-087

  • 100% after 6 months in KEYNOTE-013

  • 97.6% after 12 months in KEYNOTE-087

  • 87.1% after 12 months in KEYNOTE-013

Urothelial carcinoma

Cisplatin Ineligible Patients with Urothelial Carcinoma

The Food and Drug Administration (FDA), USA, European Medical Agency (EMA), European Union, and Therapeutic Goods Administration (TGA), Australia, approvals of Keytruda (pembrolizumab) for advanced or metastatic urothelial carcinoma in patients who were not eligible for cisplatin-containing chemotherapy were based on one open-label, single-arm trial (KEYNOTE-0521,2,3). This study involved a total of 370 patients. Patients received KEYTRUDA 200 mg every 3 weeks until unacceptable toxicity or disease progression up to a maximum of 24 months1,2,3.

Results

Among the efficacy outcome measures were the overall response rate (ORR), and duration of response (DOR).

The ORR was1,2,3:

  • 29% (95% CI: 24, 34)

    • Complete response: 7%

The median DOR was1,2,3:  

  • Not reached (range: 1.4+, 17.8+)

Previously treated urothelial carcinoma

The Food and Drug Administration (FDA), USA, European Medical Agency (EMA), European Union, and Therapeutic Goods Administration (TGA), Australia, approvals of Keytruda (pembrolizumab) for advanced or metastatic urothelial carcinoma in patients whose disease progressed on or after platinum-containing chemotherapy were based on one randomised, active-controlled trial (KEYNOTE-0451,2,3). This study involved a total of 542 patients. Patients received KEYTRUDA 200 mg every 3 weeks or chemotherapy (paclitaxel, docetaxel, or vinflunine) until unacceptable toxicity or disease progression up to a maximum of 24 months1,2,3.

Results

Among the efficacy outcome measures were the overall survival (OS), progression-free survival (PFS), and overall response rate (ORR).

The ORR was1,2,3:

  • 21% (95% CI: 16, 27) with Keytruda (pembrolizumab)

    • Complete response: 7%

  • 11% (95% CI: 8, 16) with chemotherapy

    • Complete response: 3%

The median OS was1,2,3:  

  • 10.3 months (95% CI: 8.0, 11.8) with Keytruda (pembrolizumab)

    • %deaths: 57%

  • 7.4 months (95% CI 6.1, 8.3 ) with chemotherapy

    • %deaths: 66%

The median PFS was1,2,3:

  • 2.1 months (95% CI: 2.0, 2.2) with Keytruda (pembrolizumab)

  • 3.3 months (95% CI: 2.3, 3.5) with chemotherapy

MSI-H Cancer

The Food and Drug Administration (FDA), USA, approval of Keytruda (pembrolizumab) for Microsatellite Instability-High Cancer (MSI-H) or mismatch repair deficient (dMMR) solid tumours were based on 5 studies (KEYNOTE-016, KEYNOTE-164, KEYNOTE-012, KEYNOTE-028, KEYNOTE-158). These studies involved a total of 149 patients with MSI-H/dMMR solid tumours. Patients received either Keytruda (pembrolizumab) 200 mg every 3 weeks or Keytruda (pembrolizumab) 10 mg/kg every 2 weeks. Treatment continued until unacceptable toxicity or disease progression, or up to a maximum of 24 months2.

Results

Among the efficacy outcome measures were the overall response rate (ORR), and the duration of response2.

The ORR was2:

  • 39.6% (95% CI: 31.7, 47.9)

    • complete response rate: 7.4%

The median DOR was2:  

  • Not reached (range: 1.6+, 22.7+ months)

  • 78% of patients had DOR or more than 6 months

Gastric Cancer

The Food and Drug Administration (FDA), USA, approval of Keytruda (pembrolizumab) for gastric cancer were based on one non-randomised, open-label studies (KEYNOTE-059). These studies involved a total of 259 patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma who progressed on at least 2 prior systemic treatments for advanced disease. Patients received KEYTRUDA 200 mg every 3 weeks until unacceptable toxicity or disease progression or up to 24 months2.

Among the 259 patients, 55% (n = 143) had tumours that expressed PD-L1 with a combined positive score (CPS) of greater than or equal to 1 and microsatellite stable (MSS) tumor status or undetermined MSI or MMR status. The approval was based on the results of this subgroup.

Results

Among the efficacy outcome measures were the overall response rate (ORR), and the duration of response2.

The ORR was2:

  • among the 143 patients subgroup

    • 13.3% (95% CI: 8.2, 20.0)

    • complete response rate: 1.4%

The median DOR was2:  

  • among the 143 patients subgroup

    • Not reached (range: 2.8+, 19.4+  months)

    • 26% of patients had DOR or more than 6 months

1. Summary of Product Characteristics [EMA]: Keytruda (pembrolizumab) [PDF]
    Merck, May 2017.

2. Summary of Product Characteristics [FDA]: Keytruda (pembrolizumab) [PDF]
    Merck, Nov 2017.

3. Summary of Product Characteristics [TGA]: Keytruda (pembrolizumab) [PDF]
    Merck, EMA, Jan 2018.

4. FDA News Release: FDA approves Keytruda for advanced non-small cell lung cancer
    Oct 2015

5. EMA. Human Medicines: Keytruda (pembrolizumab)
    cited March 2017

6. FDA: Approved Drugs. Pembrolizumab (Keytruda) Checkpoint Inhibitor
    Oct 2016

7. FDA: Approved Drugs. Pembrolizumab (Keytruda)
    Aug 2016 

8. EMA. Pending EC Decisions: Keytruda
    Dec 2016

9. Inman, S. EC Approves Frontline Pembrolizumab for PD-L1+ Metastatic NSCLC
    OncLive, Jan 2017 

10. Drugs.com. FDA Approves Merck’s Keytruda (pembrolizumab) for Classical Hodgkin Lymphoma (cHL)
      March 2017 

11. EMA. Extension of indication variation assessment report
      June 2016 

12. TGA. Prescription medicines: new or extended uses, or new combinations of registered medicines
      May 2017.

13. EMA. Assessment report
      March 2017

14. FDA. Approved drugs. Pembrolizumab (Keytruda): Advanced or Metastatic Urothelial Carcinoma
      May 2017

15. Drugs.com. FDA Approves Merck’s Keytruda (pembrolizumab) as First-Line Combination Therapy for Patients with Metastatic Nonsquamous Non-Small Cell Lung Cancer (NSCLC), Irrespective of PD-L1 Expression
      May 2017 

16. FDA News Release: FDA approves first cancer treatment for any solid tumor with a specific genetic feature 
      May 2017 

17. EMA. Pending EC decisions. Keytruda
      July 2017

18. OncLive. FDA approves pembrolizumab for PD-L1+ gastric cancer
      Sept 2017


Shipping Type Cold Chain
Shipping method Cold chain (temperature controlled)
This content has been reviewed by our medical doctor Jan de Witt.

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The Social Medwork is registered with the Dutch Ministry of Health in The Hague as an independent intermediary, Registration number 6730 BEM
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Registered with the Dutch Ministry of Health as an independent intermediary.

 

Registration number 6730 BEM
Secured logistics globally
• Standard and express delivery (DHL or UPS)
• 24/7 track & trace delivery
• Temperature regulated shipping
Secure payments
All payments are handled securely and are SSL encrypted.
We accept:
Bank transfer & Credit card

 

Patient reviews

 Tomasz Maćkowiak

During the transaction process I was very well informed by the TheSocialMedwork team. They have put as much of their effort to offer best service to me. Moreover the medicine I have ordered was imported two weeks earlier then it was expected. I highly recommend The Social Med Work.

Patient reviews

 Emina Mušović

Thank you for the wonderful cooperation! It's very reserved of us to say we're pleased because you really resolved all our doubts. The medicine has now arrived and we hope it helps. We know we were difficult, with the million different questions but well... That's all behind us now. Strongly recommended! :)

Patient reviews

 Mohamed Rahmat

I am fully satisfied with your online support service. Happy to deal with you.. fast & very fast support.. did not have to wait even 5 minutes! THANK YOU MEDWORK

Questions our patients are asking

visit our support page
You always need a prescription from a doctor based in your country. Other documents, such as an import license from the Ministry of Health, may be needed and depend on your country’s regulations. Contact us and we will provide you with all of the information about the required documents needed for your country.
For prescription medicines you will always need a prescription from your treating doctor. This is to ensure that your treatment is monitored and led by a doctor who is responsible for administering the medicine to you. The prescription is the evidence that your doctor gives you their medical support.
Your order will be shipped to you by our partner couriers, such as DHL, UPS and specialised medicine couriers. If you want us to use a specific courier please inform us when you place your order.
Yes. TheSocialMedwork is registered with the Dutch Ministry of Health as an independent medicines intermediary (registration number 6730 BEM). We always follow your country’s laws and regulations and will discuss any legal requirements with you. We only ship medicines when our patients have a prescription from their treating doctor.
By using TheSocialMedwork you will receive genuine medicines in perfect condition, no matter where you live.
Yes, you are welcome to visit us. We are located in the city centre of Amsterdam at the Herengracht 480. Contact us to schedule the best time for your visit.

 

You can order and receive your
medicine in 5 simple steps

1

Talk to your doctor

2

Place order
and send
prescription

3

Pay for order

4

Check documents
for delivery

5

Receive your medicine

Totally awesome!
Keep up the great
work you’re doing!


Dee Penfold - December 3, 2016
On TheSocialMedwork Facebook

Need a medicine that’s not
approved in your country?

We help patients, physicians and pharmacists acquire the latest life-changing medicines. Not available in your country? No problem - as long as it's approved by a reputable medical authority somewhere, we can help! Contact us today and our experienced team of qualified pharmacists and industry professionals will help you.


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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.