Results From Clinical Trials With KEYTRUDA® (pembrolizumab): Advanced Melanoma
Melanoma

RESULTS FROM CLINICAL TRIALS WITH KEYTRUDA

Advanced melanoma

Living longer with advanced melanoma is possible

A clinical trial compared patients with advanced melanoma who received 10 mg/kg of KEYTRUDA every 2 weeks (279 patients) or 3 weeks (277 patients) with those who received ipilimumab (278 patients).

KEYTRUDA helped certain patients with melanoma live longer compared to another immunotherapy*

More patients treated with KEYTRUDA were alive at the time of follow-up compared to patients treated with ipilimumab. 33% (92 of 277 patients) treated with KEYTRUDA every 3 weeks were not alive at follow-up, compared to 40% (112 of 278 patients) treated with ipilimumab. KEYTRUDA given every 3 weeks was shown to reduce the risk of dying by 31% compared to ipilimumab.

*KEYTRUDA was compared to ipilimumab.

100%
0%
67%
60%
185 out of 277 patients were alive
166 out of 278 patients were alive

KEYTRUDA

Ipilimumab

KEYTRUDA helped shrink melanoma tumors

100%
0%
33%
12%
91 out of 277 patients had their tumors shrink
33 out of 278 patients had their tumors shrink

KEYTRUDA

Ipilimumab

Partial Response: 27%

(74 out of 277 patients)

Partial Response: 10%

(29 out of 278 patients)

Complete Response: 6%

(17 out of 277 patients)

Complete Response: 1%

(4 out of 278 patients)

In Advanced Melanoma, KEYTRUDA® (pembrolizumab) Reduced the Risk of Disease Progression by 42% Compared to Ipilimumab

In advanced melanoma, KEYTRUDA reduced the risk of disease progression by 42% compared to ipilimumab

KEYTRUDA given every 3 weeks reduced the risk of cancer spreading, growing, or getting worse by 42% compared to ipilimumab.

Half of the patients on KEYTRUDA given every 3 weeks were alive without their cancer spreading, growing, or getting worse at 4.1 months, compared to 2.8 months for patients on ipilimumab.

How KEYTRUDA compared to chemotherapy for advanced melanoma

Another clinical trial compared patients with advanced melanoma who received KEYTRUDA every 3 weeks with those who received chemotherapy.

Nearly 5 times as many patients on KEYTRUDA saw their melanoma tumors shrink compared to chemotherapy

100%
0%
21%
4%
38 out of 180 patients had their tumors shrink
8 out of 179 patients had their tumors shrink

KEYTRUDA

Chemotherapy

Partial Response: 19%

(34 out of 180 patients)

All of these patients saw partial responses and no complete responses were seen.

Complete Response: 2%

(4 out of 180 patients)

KEYTRUDA® (pembrolizumab) Reduced the Risk of Disease Progression in Advanced Melanoma by 43% Compared to Chemotherapy

KEYTRUDA reduced the risk of disease progression by 43% compared to chemotherapy

Half of the patients on KEYTRUDA were alive without their cancer spreading, growing, or getting worse at 2.9 months, compared to 2.7 months for patients on chemotherapy.

FDA-Approved Indications

KEYTRUDA is a prescription medicine used to treat a kind of skin cancer called melanoma. KEYTRUDA may be used:

  • when your melanoma has spread or cannot be removed by surgery (advanced melanoma), or
  • to help prevent your melanoma from coming back after it and lymph nodes that contain cancer have been removed by surgery.
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. These problems may happen any time during treatment or even after your treatment has ended.

Call or see your doctor right away if you develop any symptoms of the following problems or these symptoms get worse:

Lung problems (pneumonitis). Symptoms of pneumonitis may include shortness of breath, chest pain, or new or worse cough.

Intestinal problems (colitis) that can lead to tears or holes in your intestine. Signs and symptoms of colitis may include diarrhea or more 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, including hepatitis. Signs and symptoms of liver problems may include yellowing of your skin or the whites of your eyes, nausea or vomiting, pain on the right side of your stomach area (abdomen), dark urine, or bleeding or bruising more easily than normal.

Hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas). Signs and symptoms that your hormone glands are not working properly may include rapid heartbeat, weight loss or weight gain, increased sweating, feeling more hungry or thirsty, urinating more often than usual, hair loss, feeling cold, constipation, your voice gets deeper, muscle aches, feeling very weak, dizziness or fainting, or headaches that will not go away or unusual headache.

Kidney problems, including nephritis and kidney failure. Signs of kidney problems may include change in the amount or color of your urine.

Skin problems. Signs of skin problems may include rash, itching, blisters, peeling or skin sores, or painful sores or ulcers in your mouth or in your nose, throat, or genital area.

Problems in other organs. Signs and symptoms of these problems may include changes in eyesight; severe or persistent muscle or joint pains; severe muscle weakness; low red blood cells (anemia); swollen lymph nodes, rash or tender lumps on skin, cough, shortness of breath, vision changes, or eye pain (sarcoidosis); confusion, fever, muscle weakness, balance problems, nausea, vomiting, stiff neck, memory problems, or seizures (encephalitis); pain, numbness, tingling, or weakness in the arms or legs; bladder or bowel problems including needing to urinate more frequently, urinary incontinence, difficulty urinating, or constipation (myelitis); and shortness of breath, irregular heartbeat, feeling tired, or chest pain (myocarditis).

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

Rejection of a transplanted organ. People who have had an organ transplant may have an increased risk of organ transplant rejection if they are treated with KEYTRUDA.

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 severe and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with KEYTRUDA. Your doctor will monitor you for the following signs and symptoms: skin rash, liver inflammation, abdominal pain, and diarrhea.

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

Before you receive KEYTRUDA, tell your doctor if you have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus; have had an organ transplant or plan to have or have had a bone marrow (stem cell) transplant that used donor stem cells (allogeneic); have lung or breathing problems; have liver problems; or have any other medical problems.

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

If you are breastfeeding or plan to breastfeed, tell your doctor. 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 doctor 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.

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; and mouth sores.

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.

In children, feeling tired, vomiting and stomach-area (abdominal) pain, and increased levels of liver enzymes and decreased levels of salt (sodium) in the blood are more common than in adults.

These are not all the possible side effects of KEYTRUDA. Tell your doctor if you have any side effect that bothers you or that does not go away. For more information, ask your doctor or pharmacist.

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.