Drugs Q & A

What Are The Signs That Keytruda Is Working?

Keytruda is a cancer medicine used to treat:

•        melanoma, a skin cancer,

•        non-small cell lung cancer (NSCLC), a type of lung cancer,

•        classical Hodgkin lymphoma, a cancer of the white blood cells,

•        urothelial cancer, a cancer of the bladder and urinary tract,

•        a cancer affecting the head and neck known as head and neck squamous cell carcinoma (HNSCC),

•        renal cell carcinoma (a type of kidney cancer),

•        a kind of cancer of the colon or rectum (lower part of the gut) that is described as microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR).

Keytruda is mainly used in adults for cancers that are advanced, have spread to other parts of the body (metastatic) or are not responding to other treatments. For classical Hodgkin lymphoma, it is also used in children. In some cancers, it is only given to patients whose tumours produce high levels of a protein known as PD-L1.

Keytruda is also used to help prevent the cancer from coming back after patients had surgery to remove melanoma (adjuvant therapy).

How Keytruda works

Keytruda is not chemotherapy or radiation therapy—it is an immunotherapy and it works with your immune system to help fight cancer. 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 serious 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.

How is Keytruda used?

Keytruda is given as an infusion (drip) into a vein. When Keytruda is given alone the dose is either 200 mg every three weeks or 400 mg every six weeks. When it is given with other cancer medicines, the dose is always 200 mg every three weeks. The dose for children is based on their body weight.

The doctor may delay doses if certain side effects occur or stop treatment altogether if side effects are severe. Before starting treatment, patients with NSCLC, previously untreated urothelial cancer or HNSCC should have tests to check their levels of PD-L1.

The medicine can only be obtained with a prescription and treatment must be started and supervised by a doctor experienced in the treatment of cancer. For more information about using Keytruda, see the package leaflet or contact your doctor or pharmacist.

What Are The Signs That Keytruda Is Working?

Skin cancer

Keytruda can delay worsening of melanoma and improve survival. Results from a study of 540 previously treated patients with melanoma showed that 2 years after start of treatment, the disease had not worsened in 16% of patients treated with Keytruda compared with less than 1% of patients treated with chemotherapy.

A second study looked at 834 patients with melanoma who received either Keytruda or another medicine, ipilimumab. Patients treated with Keytruda lived for up to 5.6 months without their disease getting worse compared with 2.8 months with ipilimumab. Also, up to 74% of patients treated with Keytruda lived for at least 12 months after the start of their treatment compared with 59% of patients on ipilimumab.

A third study in 1,019 patients who had surgery and who were at high risk for their cancer coming back compared Keytruda to placebo (a dummy treatment). After one and a half years of treatment, 72% of patients on Keytruda were still disease-free compared with 54% of patients on placebo.

Non-small cell lung cancer (NSCLC)

Keytruda is also effective in delaying worsening of the disease and improving survival in patients with NSCLC that tested positive for the PD-L1 protein.

In a study looking at around 1,000 previously treated patients, patients lived longer with Keytruda given alone (around 11 months) than with another cancer medicine called docetaxel (around 8 months) and the period during which the disease did not get worse was around 4 months with both treatments. Keytruda was more effective in patients who tested strongly for PD-L1, with these patients living for 15 months on average, 5 months of which without their disease worsening.

In a second lung cancer study of 305 patients whose tumours tested strongly for PD-L1 who had not been treated before, patients on Keytruda lived for around 10 months without their disease getting worse compared with 6 months in patients receiving platinum-based chemotherapy.

Keytruda is also effective in combination treatment of a type of NSCLC known as ‘non-squamous’ cancer, based on the type of cancer cells involved. In a study of 616 patients with non-squamous NSCLC that had spread, 69% of patients taking Keytruda with pemetrexed and platinum chemotherapy were alive at 11 months, compared with less than half of patients who had only pemetrexed and platinum chemotherapy. In addition, patients who had Keytruda treatment lived on average for 8.8 months without the disease getting worse compared with 4.9 months for patients who were not given Keytruda.

In a further study of 559 patients with ‘squamous’ NSCLC that had spread, patients given Keytruda with carboplatin and paclitaxel or nab-paclitaxel lived on average for 15.9 months compared with 11.3 months for patients given placebo with carboplatin and paclitaxel or nab-paclitaxel. Patients in the Keytruda group lived on average for around 6 months without their disease getting worse compared with 4.8 months for patients in the placebo group.

Hodgkin lymphoma

Keytruda partially or completely clears cancer cells in classical Hodgkin lymphoma that has not improved or had returned after previous treatment.

In a main study of 210 adult patients, Keytruda produced a complete or partial remission (clearing) of the cancer in 71% of the patients; a complete remission occurred in 28% of them, meaning they no longer had any signs of cancer. The average time that patients lived without their disease getting worse again was around 14 months.

Another main study of 304 adults showed that Keytruda was also effective in patients who had tried stem cell transplant and those who had had two other treatments and were unable to have a stem cell transplant. In this study, patients who received Keytruda lived on average for 13 months without their disease getting worse compared with around 8 months for those treated with brentuximab vedotin. Data from a study in children indicate that the medicine could also be effective in that age group.

Urothelial cancer

Keytruda improves survival of patients with urothelial cancer. A study looked at 542 patients previously treated with platinum-based medicines who received either Keytruda or another cancer medicine chosen by the doctor (paclitaxel, docetaxel or vinflunine). Patients treated with Keytruda lived on average around 10 months compared with around 7 months with the other cancer medicines. Keytruda did not delay worsening of the disease compared with the other cancer medicines (time to disease worsening was 2 and 3 months respectively).

In a second study of 370 patients who could not be treated with cisplatin-containing medicines, Keytruda produced a complete or partial remission (clearing) of the cancer in 108 patients (29%); a complete remission occurred in 30 (8%) of them, meaning they no longer had any signs of cancer.

Head and neck cancer

Keytruda is also effective in improving survival of patients with head and neck squamous cell carcinoma (HNSCC) that had spread or come back. In a study of 495 patients, patients treated with Keytruda who had high levels of PD-L1 lived on average for 11.6 months while those taking standard cancer treatments lived for 6.6 months.

Another study in 882 patients with HNSCC showed that Keytruda alone or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy is effective at prolonging patients’ lives when HNSCC tests positive for a certain level of PD-L1. Patients taking the Keytruda combination lived on average for 13.6 months compared with 10.4 months for patients taking other standard treatments. In addition, patients taking Keytruda alone lived on average 12.3 months compared with 10.3 months for patients taking other standard treatments.

In this study, disease did not get worse for 5.1 months on average in patients taking Keytruda combination, 3.2 months in patients taking Keytruda alone and 5.0 months in patients taking other standard treatments.

Kidney cancer

In a study of 861 patients with renal cell carcinoma, patients given Keytruda in combination with an already authorised medicine for renal cell carcinoma, axitinib, lived for around 15 months without their disease getting worse, compared with 11 months for patients who received treatment with another renal cell carcinoma medicine, sunitinib, which was used as a control treatment. Keytruda is also effective in improving survival of patients with renal cell cancer. At 18 months, 81% of the patients given the combination were alive, compared with 71% in the sunitinib group.

Colorectal cancer with MSI-H or dMMR cells

A main study compared Keytruda with standard treatment, including chemotherapy, in 307 patients with MSI-H or dMMR colorectal cancer that had spread. Patients who received Keytruda lived for around 17 months without the disease getting worse compared with 8 months for patients who received standard treatments.

What are the risks associated with Keytruda?

The side effects of Keytruda are mostly related to the activity of the immune system, which may cause inflammation of body organs and tissues and can be serious, although most side effects resolve with appropriate treatment or on stopping Keytruda.

Common side effects of Keytruda when given with certain chemotherapy medicines include feeling tired or weak; nausea; constipation; diarrhea; decreased appetite; rash; vomiting; cough; trouble breathing; fever; hair loss; inflammation of the nerves that may cause pain, weakness, and paralysis in the arms and legs; swelling of the lining of the mouth, nose, eyes, throat, intestines, or vagina; mouth sores; headache; weight loss; stomach-area (abdominal) pain; joint and muscle pain; and trouble sleeping.

Common side effects of Keytruda when given with axitinib include diarrhea; feeling tired or weak; high blood pressure; liver problems; low levels of thyroid hormone; decreased appetite; blisters or rash on the palms of your hands and soles of your feet; nausea; mouth sores or swelling of the lining of the mouth, nose, eyes, throat, intestines, or vagina; hoarseness; rash; cough; and constipation.

Important Safety Information

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 any time during treatment or even after your treatment has ended.

Call or see your health care provider right away if you develop any signs or symptoms of the following problems or if they get worse. These are not all of the signs and symptoms of immune system problems that can happen with Keytruda:

Lung problems: cough, shortness of breath, or chest pain.

Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; or severe stomach-area (abdomen) pain or tenderness.

Liver problems: yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach area (abdomen); dark urine (tea colored); or bleeding or bruising more easily than normal.

Hormone gland problems: headaches that will not go away or unusual headaches; eye sensitivity to light; eye problems; rapid heartbeat; increased sweating; extreme tiredness; weight gain or weight loss; feeling more hungry or thirsty than usual; urinating more often than usual; hair loss; feeling cold; constipation; your voice gets deeper; dizziness or fainting; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness.

Kidney problems: decrease in the amount of your urine; blood in your urine; swelling of your ankles; loss of appetite.

Skin problems: rash; itching; skin blistering or peeling; painful sores or ulcers in your mouth or in your nose, throat, or genital area; fever or flu-like symptoms; swollen lymph nodes.

Problems can also happen in other organs and tissues. Signs and symptoms of these problems may include: chest pain; irregular heartbeat; shortness of breath; swelling of ankles; confusion; sleepiness; memory problems; changes in mood or behavior; stiff neck; balance problems; tingling or numbness of the arms or legs; double vision; blurry vision; sensitivity to light; eye pain; changes in eyesight; persistent or severe muscle pain or weakness; muscle cramps; low red blood cells; bruising.

Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feeling like passing out, fever, and back pain.

Rejection of a transplanted organ. Your health care provider should tell you what signs and symptoms you should report and they will monitor you, depending on the type of organ transplant that you have had.

Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Keytruda. Your health care provider will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. Your health care provider will check you for these problems during treatment with Keytruda. They may treat you with corticosteroid or hormone replacement medicines. They may also need to delay or completely stop treatment with Keytruda if you have severe side effects.

Before you receive Keytruda, tell your health care provider if you have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus; have had an organ transplant or have had or plan to have a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic); have had radiation treatment in your chest area; have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome.

If you are pregnant or plan to become pregnant, tell your health care provider. Keytruda can harm your unborn baby. If you are able to become pregnant, you will be given a pregnancy test before you start treatment. Use effective birth control during treatment and for at least 4 months after your final dose of Keytruda. Tell them right away if you think you may be pregnant or you become pregnant during treatment with Keytruda.

Tell your health care provider if you are breastfeeding or plan to breastfeed. It is not known if Keytruda passes into your breast milk. Do not breastfeed during treatment with Keytruda and for 4 months after your final dose of Keytruda.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Common side effects of Keytruda when used alone include feeling tired; pain, including pain in muscles, bones or joints, and stomach-area (abdominal) pain; decreased appetite; itching; diarrhea; nausea; rash; fever; cough; shortness of breath; and constipation.

In children, when Keytruda is used alone, fever, vomiting, upper respiratory tract infection, headache, and low levels of white blood cells and red blood cells (anemia) are more common than in adults.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please read the accompanying Medication Guide for Keytruda and discuss it with your doctor. The physician Prescribing Information also is available.

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