KEYTRUDA® (pembrolizumab) Alone as a First Treatment Helped Patients Live Longer Compared to Chemotherapy
Advanced non–small cell lung cancer​

RESULTS FOR KEYTRUDA USED ALONE

As a first treatment, KEYTRUDA used alone is a chemotherapy-free option that has been proven to help patients live longer compared to chemotherapy

A clinical trial compared patients with advanced non–small cell lung cancer who received KEYTRUDA with those who received chemotherapy containing platinum. All patients in the trial had no previous drug treatment and did not have an abnormal EGFR or ALK gene. 154 patients received 200 mg of KEYTRUDA every 3 weeks, and 151 patients received chemotherapy.

All patients in this clinical trial tested positive for the biomarker PD-L1 at a level of 50% or more.

More patients lived longer

100%
0%
71%
58%
110 out of 154 patients were alive
87 out of 151 patients were alive

KEYTRUDA

Chemotherapy

More patients saw tumors shrink

100%
0%
45%
28%
69 out of 154 patients had tumors shrink
42 out of 151 patients had tumors shrink

KEYTRUDA

Chemotherapy

41% had tumors get smaller (partial response)

(63 out of 154 patients)

27% had tumors get smaller (partial response)

(41 out of 151 patients)

4% had tumors disappear (complete response)

(6 out of 154 patients)

1% had tumors disappear (complete response)

(1 out of 151 patients)

KEYTRUDA® (pembrolizumab) Reduced the Risk of Disease Progression by 50% Compared to Chemotherapy

KEYTRUDA reduced the risk of disease progression by 50% compared to chemotherapy

KEYTRUDA reduced the risk of cancer spreading, growing, or getting worse by 50% compared to chemotherapy.

Half of the patients on KEYTRUDA were alive without their cancer spreading, growing, or getting worse at 10.3 months, compared to 6 months for patients on chemotherapy. Cancer did not progress in 53% of patients receiving KEYTRUDA compared to 23% of patients receiving chemotherapy.

Another clinical trial also showed KEYTRUDA, used alone as a first treatment, helped patients live longer compared to chemotherapy

This clinical trial compared patients with advanced non–small cell lung cancer who received KEYTRUDA with those who received chemotherapy containing platinum. All patients in the trial had no previous drug treatment, and did not have an abnormal EGFR or ALK gene. 637 patients received 200 mg of KEYTRUDA every 3 weeks, and 637 patients received chemotherapy.

All patients in this clinical trial tested positive for the biomarker PD-L1 at a level of 1% or more.

The results of the trial are shown below in 2 groups: the first group are patients who tested positive for PD-L1 (≥1%), and the second group are patients who tested positive for a high level of PD-L1 (≥50%).

Results in the group of patients whose tumors had high levels of PD-L1 (≥50%)

More patients lived longer

100%
0%
47%
34%
142 out of 299 patients were alive
101 out of 300 patients were alive

KEYTRUDA

Chemotherapy

Patients treated with KEYTRUDA and patients treated with chemotherapy both saw tumors shrink

100%
0%
39%
32%
118 out of 299 patients had tumors shrink
96 out of 300 patients had tumors shrink

KEYTRUDA

Chemotherapy

39% had tumors get smaller (partial response)

(116 out of 299 patients)

32% had tumors get smaller (partial response)

(95 out of 300 patients)

0.7% had tumors disappear (complete response)

(2 out of 299 patients)

0.3% had tumors disappear (complete response)

(1 out of 300 patients)

In the Clinical Trial, Half the Patients Treated With KEYTRUDA® (pembrolizumab) Were Alive Without Their Cancer Spreading, Growing, or Getting Worse at 7.1 Months Compared to 6.4 Months for Patients Treated With Chemotherapy

Disease progression

In the clinical trial, half the patients treated with KEYTRUDA were alive without their cancer spreading, growing, or getting worse at 7.1 months compared to 6.4 months for patients treated with chemotherapy. Cancer did not progress in 26% of the patients receiving KEYTRUDA compared to 22% of patients treated with chemotherapy.

Results for all patients in the trial (tumor PD-L1 level ≥1%)

More patients lived longer

100%
0%
42%
31%
266 out of 637 patients were alive
199 out of 637 patients were alive

KEYTRUDA

Chemotherapy

Patients treated with KEYTRUDA and patients treated with chemotherapy both saw tumors shrink

100%
0%
27%
27%
174 out of 637 patients had tumors shrink
169 out of 637 patients had tumors shrink

KEYTRUDA

Chemotherapy

27% had tumors get smaller (partial response)

(171 out of 637 patients)

26% had tumors get smaller (partial response)

(166 out of 637 patients)

0.5% had tumors disappear (complete response)

(3 out of 637 patients)

0.5% had tumors disappear (complete response)

(3 out of 637 patients)

In the Clinical Trial, Half the Patients Treated With KEYTRUDA® (pembrolizumab) Were Alive Without Their Cancer Spreading, Growing, or Getting Worse at 5.4 Months Compared to 6.5 Months for Patients Treated With Chemotherapy

Disease progression

In the clinical trial, half the patients treated with KEYTRUDA were alive without their cancer spreading, growing, or getting worse at 5.4 months compared to 6.5 months for patients treated with chemotherapy. Cancer did not progress in 20% of the patients receiving KEYTRUDA compared to 21% of patients treated with chemotherapy.

FDA-Approved Indications

KEYTRUDA is a prescription medicine used to treat a kind of lung cancer called non–small cell lung cancer (NSCLC).

KEYTRUDA may be used with the chemotherapy medicines pemetrexed and a platinum as your first treatment when your lung cancer has spread (advanced NSCLC) and is a type called "nonsquamous" and your tumor does not have an abnormal "EGFR" or "ALK" gene.

KEYTRUDA may be used with the chemotherapy medicines carboplatin and either paclitaxel or paclitaxel protein-bound as your first treatment when your lung cancer has spread (advanced NSCLC), and is a type called "squamous."

KEYTRUDA may be used alone as your first treatment when your lung cancer has not spread outside your chest (stage III) and you cannot have surgery or chemotherapy with radiation, or your NSCLC has spread to other areas of your body (advanced NSCLC), and your tumor tests positive for "PD-L1and does not have an abnormal "EGFR" or "ALK" gene.

KEYTRUDA may also be used alone for advanced NSCLC if you have tried chemotherapy that contains platinum and it did not work or is no longer working and, your tumor tests positive for "PD-L1and if your tumor has an abnormal "EGFR" or "ALK" gene, you have also received an "EGFR" or "ALK" inhibitor medicine that did not work or is no longer working.

PD-L1 = programmed death ligand 1; EGFR = epidermal growth factor receptor; ALK = anaplastic lymphoma kinase.

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); 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.