Keytruda (pembrolizumab)

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Keytruda (pembrolizumab)

How to buy Keytruda: You can order Keytruda (pembrolizumab) via TheSocialMedwork if the drug has not been approved and/or is not available in the patient's country. TheSocialMedwork - helping patients and doctors access the latest approved medicines and at the lowest price possible worldwide.

Manufacturer Merck & co
Disease Head and Neck Cancer / Lung Cancer / Urothelial Carcinoma / Skin Cancer / Lymphoma / MSI-H or dMMR solid tumours
Indication Melanoma; NSCLC; Head and Neck Squamous Cell Carcinoma (HNSCC); Classical Hodgkin Lymphoma (cHL); MSI-H or dMMR solid tumours; Locally advanced or metastatic urothelial carcinoma
Mode of Action Monoclonal antibody (immunotherapy)
Approval Status EMA approved (EU); FDA approved (USA); TGA approved (AUS)
CAS Number 1374853-91-4
HS Code 30021091
Strength 50 mg, 100 mg

Who is Keytruda (pembrolizumab) for?

Pembrolizumab is indicated for the treatment of patients with advanced (unresectable or metastatic) melanoma [1][2][3]; metastatic NSCLC; metastatic nonsquamous NSCLC as first-line treatment in combination with pemetrexed and carboplatin; recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC); recurrent classical Hodgkin Lymphoma (cHL) in adults and paediatric patients [2]; locally advanced or metastatic urothelial carcinoma [2][17]; and solid tumours having the biomarkers MSI-H or dMMR [16].

Recommended dose

Complete information about pembrolizumab dosage and administration can be found here [1][2][3].The recommended therapy consists of:
  • Melanoma: 2 mg/kg every 3 weeks [1][2][3]
  • NSCLC, HNSCC and urothelial carcinoma: 200 mg every 3 weeks [2]
  • cHL, and MSI-H cancer: 200 mg every 3 weeks for adults; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics [2]
Consult your treating doctor for personalised dosing.

What is Keytruda (pembrolizumab) and how does it work?

Pembrolizumab is an antibody indicated for the treatment of patients with:
  • advanced (unresectable or metastatic) melanoma [1][2][3],
  • metastatic NSCLC,
  • metastatic nonsquamous NSCLC as first-line treatment in combination with pemetrexed and carboplatin,
  • recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC),
  • recurrent classical Hodgkin Lymphoma (cHL) in adults and paediatric patients [2],
  • locally advanced or metastatic urothelial carcinoma [2][17] 
  • solid tumours having the biomarkers MSI-H or dMMR [16].
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. 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 cells [1].

What is pembrolizumab's approval status?

Pembrolizumab was approved by
  • FDA (USA)
    • on September 4, 2014, for advanced or unresectable melanoma [2]
    • on October 2, 2015, for advanced (metastatic) NSCLC which progressed after other treatments and with tumours that express a protein called PD-L1 [4]
    • on August 8, 2016, for recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HBSCC) [7]
    • on 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 pembrolizumab [2][6]
    • on March 14, 2017, for adult and pediatric patients with refractory cHL, or who have relapsed after 3 or more prior lines of therapy [13]
    • on May 10, 2017, in combination with pemetrexed and carboplatin, as first-line treatment for metastatic nonsquamous NSCLC [13]
    • on 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 chemotherapies [2]
    • on 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 options [16]
  • EMA (EU)
    • on July 17, 2015, for advanced or unresectable melanoma [1]
    • on June 23, 2016, for locally advanced or metastatic NSCLC [12]
    • on January 31, 2017, as first-line treatment of patients with metastatic NSCLC with PD-L1 on ≥50% of cells and without EGFR or ALK mutation [8][9]
    • on July 20, 2017, for locally advanced or metastatic urothelial carcinoma (CHMP opinion) [17]
  • TGA (Australia)
    • on April 16, 2015, for advanced melanoma [3]
    • on 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 mutation [12]
    • on March 7, 2017, for advanced non-small cell lung carcinoma (NSCLC) [12]
    • on March 21, 2017, for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) [12]
The efficacy of pembrolizumab on melanoma was investigated in several studies. One multicenter, open-label study enrolled 173 patients with unresectable or metastatic melanoma with progression of disease after previous treatments. Patients were randomised to receive 2 mg/kg (n=89) or 10 mg/kg (n=84) of pembrolizumab every 3 weeks until unacceptable toxicity or disease progression that was symptomatic, was rapidly progressive, required urgent intervention, occurred with a decline in performance status, or was confirmed at 4 to 6 weeks with repeat imaging. The overall response rate (ORR) was 24 % (95 % confidence interval: 15, 34) in the 2 mg/kg arm, consisting of 1 complete response and 20 partial responses. Among the 21 patients with an objective response, 3 (14 %) had progression of disease 2.8, 2.9, and 8.2 months after initial response. The remaining 18 patients (86 %) had ongoing responses with durations ranging from 1.4+ to 8.5+ months, which included 8 patients with ongoing responses of 6 months or longer [2]. Another study included 540 patients who were previously treated with another monoclonal antibody medicine for melanoma, ipilimumab. Patients received either pembrolizumab 2 mg/kg every three weeks or pembrolizumab 10 mg/kg every three weeks or chemotherapy (medicines used to treat cancer). Early results showed that 6 months after start of treatment, the disease had not worsened in 34 % of patients treated with pembrolizumab compared with 16% of patients treated with chemotherapy [5]. A third study looked at 834 patients who were not previously treated with ipilimumab. Patients received either pembrolizumab or ipilimumab. Early results showed that the patients treated with pembrolizumab lived for up to 5.5 months without their disease getting worse compared with 2.8 months with ipilimumab. The study also found that the overall survival of patients treated with pembrolizumab was longer than for patients who received ipilimumab. Up 71 % of patients lived for at least 12 months after start of their treatment compared with 58 % of patients on ipilimumab [5].
The approval of pembrolizumab on NSCLC as second-line treatment was based on data from the KEYNOTE-001 trial. In this trial, the efficacy and safety op PD-1 inhibition with pembrolizumab in 550 patients with advanced non-small cell lung cancer was assessed. A subgroup of 61 patients had PD-L1 positive tumours. In this group, tumours shrank in 41 % of the patients and the effect lasted between 2.1 and 9.1 months [4]. The FDA and EMA approval for first-line treatment of NSCLC was based on a trial including 305 patients who had no prior treatment for metastatic NSCLC and high PD-L1 expression. The median progression-free survival was 10.3 months versus 6.0 months for those receiving platinum-based chemotherapy [6][9]. The FDA approval as second-line treatment of lung cancer to include all patients with PD-L1-expressing NSCLC was based on a three-arm trial including 1033 patients who were previously treated for metastatic NSCLC. The median survival was 10.4 months in the pembrolizumab 2 mg/kg arm, 12.7 months in the pembrolizumab 10 mg/kg arm, and 8.5 months in the docetaxel arm [6].
The approval of pembrolizumab on metastatic nonsquamous NSCLC as first-line treatment irrespective of PD-L1 expression was based on data from the KEYNOTE-021 study which involeved in 123 previously untreated patients with metastatic nonsquamous NSCLC with no EGFR or ALK genomic tumor aberrations and irrespective of PD-L1 expression. The trial compared the addition of pembrolizumab to a treatment of pemetrexed and carboplatin (pem/carbo). The objective response rate (ORR) with the addition of pembrolizumab was 55 % [95% CI: 42, 68] compared to 29 % [95% CI: 18, 41] of pem/carbo alone, all responses were partial responses. Among patients who received pembrolizumab in addition to pem/carbo, 93 % had a duration of response of six months or more compared to 81 % of those on pem/carbo alone. In addition, the median progression-free survival was 13.0 months (95% CI, 8.3-not estimable) for patients treated with pembrolizumab + pem/carbo compared to 8.9 months (95% CI, 4.4-10.3) with pem/carbo alone [15].
The approval of pembrolizumab on HNSCC was based on a data from the KEYNOTE-012 study which showed an objective response rate (ORR) of 16 %, complete response rate (CRR) of 5 %, with responses of 6 months or longer observed in 82 % (n=23/28) of the responding patients [7].
The approval of pembrolizumab on cHL was based on data from the KEYNOTE-087 study which showed an ORR of 69 %, a CRR of 22 % and a partial remission rate (PRR) of 47 %. Among the 145 responding patients (out of 210), the median duration of response was 11.1 months [10].
The approval of pembrolizumab on urothelial carcinoma as second-line treatment was based on data from the KEYNOTE-045 trial which involved 542 patients and compared pembrolizumab (N = 270) to other chemotherapy regimens (paclitaxel [N = 84], docetaxel [N = 84], or vinflunine [N = 87]). The median overall survival was 10.3 and 7.4 months in the pembrolizumab and chemotherapy arms, respectively. The objective response rate (ORR) was 21 % for pembrolizumab and 11 % for chemotherapy. No statistically significant difference in progression-free survival between the two arms was observed [14].
The approval of pembrolizumab on urothelial carcinoma as first-line treatment was based on a single-arm, open-label trial (KEYNOTE-052) in 370 patients with locally advanced or metastatic urothelial carcinoma who were not eligible for cisplatin-containing chemotherapy. The ORR was 28.6% (95% CI 24, 34) and the median response duration was not reached (range 1.4+, 17.8+ months) [14].
The approval of pembrolizumab on MSI-H or dMMR solid tumours was based on the results of several trials which enrolled a total of 149 patients with 15 different tumour types. Among the patients treated with pembrolizumab 39.6 % had a complete or partial response, and for 78 % of those patients, the response lasted for six months or more [16].
References
[1] Summary of Product Characteristics: Keytruda (pembrolizumab), Merck, EMA, May 2017.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003820/WC500190990.pdf
[2] Summary of Product Characteristics: Keytruda (pembrolizumab), Merck, FDA, May 2017.
https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf
[3] Summary of Product Characteristics: Keytruda (pembrolizumab), Merck, EMA, Mar 2017.
https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2015-PI-01639-1&d=2017052316114622483
[4] FDA News Release: FDA approves Keytruda for advanced non-small cell lung cancer, 02/10/2015.
http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm465444.htm
[5] EMA. Human Medicines: Keytruda (pembrolizumab), 30/07/2015 (last update: 22/05/2017), cited on 16/03/2017.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003820/human_med_001886.jsp&mid=WC0b01ac058001d124
[6] FDA: Approved Drugs. Pembrolizumab (Keytruda) Checkpoint Inhibitor. 24/10/2016.
http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm526430.htm
[7] FDA: Approved Drugs. Pembrolizumab (Keytruda). 05/08/2016.
http://www.mercknewsroom.com/news-release/prescription-medicine-news/fda-approves-mercks-keytruda-pembrolizumab-patients-recurr-0
[8] EMA. Pending EC Decisions: Keytruda, 15/12/2016.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003820/smops/Positive/human_smop_001066.jsp&mid=WC0b01ac058001d127
[9] Inman, S. EC Approves Frontline Pembrolizumab for PD-L1+ Metastatic NSCLC. OncLive. 31/01/2017.
http://www.onclive.com/web-exclusives/ec-approves-frontline-pembrolizumab-for-pdl1-metastatic-nsclc
[10] Drugs.com. FDA Approves Merck’s Keytruda (pembrolizumab) for Classical Hodgkin Lymphoma (cHL), 14/03/2017.
https://www.drugs.com/newdrugs/fda-approves-merck-s-keytruda-pembrolizumab-classical-hodgkin-lymphoma-chl-4497.html?utm_source=ddc&utm_medium=email&utm_campaign=FDA+Approves+Merck%E2%80%99s+Keytruda+%28pembrolizumab%29+for+Classical+Hodgkin+Lymphoma+%28cHL%29
[11] EMA. Extension of indication variation assessment report. 23/06/2016.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/003820/WC500212039.pdf
[12] TGA. Prescription medicines: new or extended uses, or new combinations of registered medicines. May 2017.
https://www.tga.gov.au/prescription-medicines-new-or-extended-uses-registered-medicines
[13] EMA. Assessment report. 23/03/2017.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/003820/WC500228144.pdf
[14] FDA. Approved drugs. Pembrolizumab (Keytruda): Advanced or Metastatic Urothelial Carcinoma. 18/05/2017.
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm559300.htm
[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. 10/05/2017.
https://www.drugs.com/newdrugs/fda-approves-merck-s-keytruda-pembrolizumab-first-line-combination-therapy-patients-metastatic-4533.html
[16] FDA News Release: FDA approves first cancer treatment for any solid tumor with a specific genetic feature. 23/05/2017.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm560167.htm
[17] EMA. Pending EC decisions. Keytruda. 20/07/2017.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003820/smops/Positive/human_smop_001170.jsp&mid=WC0b01ac058001d127








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