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Keytruda (pembrolizumab)

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What is Keytruda?

New medicine Pembrolizumab (trade name Keytruda) is a humanized antibody derived from non-human species (in this case from a mouse) used in cancer immunotherapy.

The drug was initially used to treat metastatic melanoma — a type of skin cancer. In May, 2017 FDA approved Keytruda for treatment of any unresectable or metastatic solid tumor with certain genetic qualities without regard to the tissue type or site of the tumor.

Pembrolizumab mechanism of action

Pembrolizumab belongs to the group of the immunotherapy drugs — type of medicine that can treat certain cancers by influencing on patient's immune system. It blocks a protective mechanism of cancer cells and allows the immune system to destroy them. Drug targets and blocks the cellular pathway of specific protein (programmed cell death protein P1) activating the immune system to attack cancer cells.

Pembrolizumab FDA approval

On May 23, 2017 the U.S. Food and Drug Administration granted for Pembrolizumab (Keytruda) an accelerated approval — faster approval of drugs for serious conditions that fill an unmet medical need. FDA allowed to prescribe immunotherapy new drug to treat patients whose cancers have a specific genetic feature (biomarker).

Pembrolizumab is indicated for the treatment of adult and pediatric patients with unresectable (unable to be removed with surgery) or metastatic solid tumors. If these tumors have a biomarker — microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR) — forms of genetic instability.

Tumors with these biomarkers are most commonly found in colorectal, endometrial and gastrointestinal cancers, but also less commonly appear in cancers arising in the breast, prostate, bladder, thyroid gland and other organs.

For example, approximately 15 % of colorectal carcinomas with a tendency to arise in the proximal colon display high level of MSI-H.

Keytruda Success Rate

During the clinical trials of Keytruda, the following indicators were achieved:

Period

The survival rate of patients with 3-4 stages of cancer

6 month

92%

1 year

69%

1,5 years

62%

2 years

58%

What is Keytruda used for?

This drug covers patients with solid tumors that have been progressed after the course of treatment and for patients who have no satisfactory alternative therapy options.
It is actively used for:

  • melanoma (kind of skin cancer);
  • non–small cell lung cancer (NSCLC);
  • head and neck squamous cell cancer (HNSCC);
  • bladder and urinary tract cancer (advanced urothelial carcinoma);
  • classical Hodgkin lymphoma (cHL);
  • colorectal cancer;
  • breast cancer.

Keytruda for melanoma

This immunotherapeutic drug is indicated for the treatment of patients with unresectable or metastatic melanoma. On September 4, 2014, the US FDA approved it as a breakthrough therapy for melanoma treatment. In clinical trials, Keytruda provided partial tumor regression in patients, who have not seen further progression of their disease in over 6 months.

Keytruda for lung cancer

In October 2015, the FDA approved it for the treatment of patients with metastatic non–small cell lung cancer (NSCLC). It can be used as a single agent and in combination with other chemotherapy drugs as first-line treatment. It is also helpful for patients who undergo platinum-containing chemotherapy without success as well.

Keytruda for head and neck cancer

In August 2016, the FDA gave an accelerated approval. Keytruda is appointed for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression during or after platinum-containing chemotherapy.

Squamous cell (epidermoid) carcinoma is a cancer type that arises from particular cells called squamous cells. They compose the surface of the skin, lining of hollow organs in the body, and the respiratory and digestive tracts.

 

Keytruda for lymphoma

Keytruda is given for the treatment of adult and pediatric patients with refractory (resistant to primary treatment) classical Hodgkin lymphoma (cHL), or who have relapsed (the disease returns following a remission) after 3 or more prior lines of therapy.

Keytruda for bladder cancer

This medicine is recommended for the treatment of patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy, or if there were no positive results during or following platinum-containing chemotherapy, or within a year of neo- or adjuvant treatment with platinum-containing chemotherapy.

Keytruda for colon cancer

In May 2017, pembrolizumab was approved by the FDA for use in cases of colon cancer. It is prescribed for the treatment of adult and pediatric patients with colorectal cancer that has not been cured by following treatment with other chemotherapeutic drugs such as fluoropyrimidine, oxaliplatin, and irinotecan.

Side effects of pembrolizumab

Pembrolizumab can make immune system attack normal organs and tissues in any area of the body. Thus problems in organ functioning can sometimes become serious. It even can lead to a life-threatening conditions.

Common side effects of Keytruda

When used alone include: fatigue (feeling tired), pruritus (itching), diarrhea, decreased appetite, rash, pyrexia (fever), cough, dyspnea (shortness of breath), pain in muscles (also in joints), constipation, and nausea.

Common side effects of Keytruda in children: feeling tired, vomiting, abdominal (stomach-area) pain, and increased levels of liver enzymes.

Patients who experienced severe or life-threatening infusion-related reactions should stop taking Keytruda.

Call your doctor right away if you develop any symptoms of the following problems or these symptoms are getting worse.

Possible side effects (Clinical trials)

Keytruda can cause serious conditions known as immune-mediated side effects — a number of adverse drug reactions that are mediated by the immune system. They can affect any organ or system, including inflammation of the lungs (pneumonitis), colon (colitis), liver (hepatitis), endocrine glands (endocrinopathies) and kidneys (nephritis).

Lung problems (pneumonitis)

This immunotherapy drug can cause immune-mediated pneumonitis (it occurs in 3.4% patients), including fatal cases.

Symptoms: shortness of breath, chest pain, cough.

Intestinal problems (colitis)

Colitis occurs in 1.7% of patients. Keytruda injections сan damage the tissue of intestines.

Signs of colitis: diarrhea, stools with blood, pain in stomach-area.

Liver problems (hepatitis)

Hepatitis occurs in 0.7% of patients.

Signs and symptoms of hepatitis: yellowing of skin, nausea or vomiting, pain on the right side of stomach area, dark urine.

Hormone gland problems

Usually pembrolizumab can lead to hyperthyroidism (problem with thyroid gland). This side-effect noticed in 3.4% of patients receiving Keytruda. Other hormone-producing glands that can be affected are: pituitary, adrenal, and pancreas.

Symptoms may include rapid heartbeat, weight loss or weight gain, increased sweating, hair loss, voice change, dizziness or fainting, unusual headache.

Keytruda side effects in stem cell transplant recipient

Complications after stem cell transplantation using donor stem cells (allogeneic) are detected. Treatment with Keytruda may increase the risk of rejection in solid organ transplant recipients.

These complications can lead to death.

Contraindications of Keytruda

The drug is contraindicated in pregnancy or breastfeeding. Keytruda may cause harm to a developing fetus or newborn baby.

Keytruda prescribing information

Keytruda is given directly into vein through an intravenous line over 30 minutes.

It is usually given every 3 weeks.

Doctor (oncologist) will decide how many treatments a patient needs.

Patients have to do blood tests regularly to be checked for side effects.

Doctor may delay or completely stop treatment with this drug if patient will develop severe side effects.

Keytruda dosing

The recommended dose — is 200 mg administered as an intravenous infusion.

Depending on the type of cancer and individual patients response duration of treatment and dosing of Pembrolizumab are different for every case.

For example in case of bladder cancer: treatment lasts a year. Dosing regimen - 10 mg every 2 weeks.

In case of breast cancer: 200 mg every 3 weeks for 2 years.

How much does keytruda cost?

Country

Clinics

Cost per 50 mg

Cost of Keytruda in Israel

$2,000

Cost of Keytruda in Germany

€1,950

Cost of Keytruda in India

$2,000

Cost of Keytruda in Spain

€1,912

Cost of Keytruda in Czech Republic

€1,950

Current clinical trials of Keytruda

Keytruda for breast cancer

One of the testings of keytruda regarding treatment of breast cancer has been finished finished recently.

The trial included 2 groups of patients with advanced breast cancer that had spread to other locations. Keytruda (pembrolizumab) was effective in treating triple-negative breast cancer regardless of whether women had received previous treatment.

Among pre-treated patients, treatment led to tumor shrinking by more than 30% in 5% of the women. The progress of disease was stabilized in 21% of patients. 12% of patients experienced such side effects as fatigue and nausea.

Among the group that received Keytruda as their first treatment, 23% saw tumors shrink by more than 30%. The treatment also stabilized disease in another 17%. Only 8% of patients experienced severe adverse events. Fatigue and nausea were the most common side effects reported.

All patients who saw their tumors shrink lived for at least another year.

Keytruda for pancreatic cancer

High MSI status can be found in pancreatic tumors, though it’s not common. MSI is found in 2-3% of patients with pancreatic cancer. The clinical trial is in process now. Scientists are testing a combination of immunotherapy agents. The final data of the study will be available in the fall of 2017.

Keytruda for ovarian cancer

The drug is still under investigation for the treatment of ovarian cancer. There is a large number of clinical trials. For example, the combination of pembrolizumab with two other drugs that have already been approved to treat ovarian cancer — Avastin and low-dose oral cyclophosphamide is currently in process and supported by a grant from Merck & Co. Inc. (manufacturer of Keytruda).

Keytruda for prostate cancer

Immunotherapy with this drug may be an effective way to treat advanced-stage prostate cancer. For example, it showed clinical activity against some cases of enzalutamide (Xtandi)-refractory metastatic prostate cancer (mCRPC). Results were achieved in a preliminary study from a small phase II clinical trial with a dosing of pembrolizumab 200 mg every 3 weeks for 4 doses with continued enzalutamide. 25% of patients experienced significant immune-related adverse events (colitis, hypothyroidism).

Keytruda for liver cancer

The testings of keytruda regarding treatment of liver cancer are currently in process.

Reviews for Keytruda (pembrolizumab)

Patients review of the treatment of metastatic melanoma (skin cancer):

«In January, 2017 I began treatment of progressive melanoma. Among the negative side effects only fatigue was detected. The first course lasted for 12 weeks. PET-CT scan showed that Keytruda stopped the spread of melanoma. New tumors did not appear. Doctor decided to extend treatment for additional 3 months.»

Patients comment on treatment of melanoma:

«This drug gave me all kinds of side effects that made it impossible to continue using it. I wish I never would have started the treatment. I don't recommend this drug and would encourage patients to look for a second medical opinion.»

Feedback on treatment of Hodgkin's lymphoma:

«Keytruda saved my husband's life! He took the course of medicine for Hodgkin's lymphoma treatment. The only side effect was increased levels of hepatic enzymes. I consider this drug to be a remedy.»

Who makes Keytruda?

The manufacturer is Merck & Co., Inc. — an American pharmaceutical company and one of the largest pharmaceutical companies in the world. Research performed at Merck has led to FDA approval of 63 new drugs. Company has developed more new drugs than any other company in the USA.

J code for Keytruda


The drug has been assigned a permanent HCPCS* code, effective January 1, 2016: HCPCS Code J9271: Injection, pembrolizumab, 1 mg.

*Healthcare Common Procedure Coding System (HCPCS) codes is based on guidance issued by the Centers for Medicare & Medicaid Services (CMS).

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