Non⁠–⁠small cell lung cancer (NSCLC)

RESULTS FOR KEYTRUDA® (pembrolizumab) 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% of patients had tumors get smaller (partial response)

(63 out of 154 patients)

27% of patients had tumors get smaller (partial response)

(41 out of 151 patients)

4% of patients had tumors disappear (complete response)

(6 out of 154 patients)

1% of patients had tumors disappear (complete response)

(1 out of 151 patients)

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% of patients had tumors get smaller (partial response)

(116 out of 299 patients)

32% of patients had tumors get smaller (partial response)

(95 out of 300 patients)

0.7% of patients had tumors disappear (complete response)

(2 out of 299 patients)

0.3% of patients had tumors disappear (complete response)

(1 out of 300 patients)

Disease progression

In the clinical trial, half the patients treated with KEYTRUDA were alive without their cancer spreading, growing, or getting worse at 6.9 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% of patients had tumors get smaller (partial response)

(171 out of 637 patients)

26% of patients had tumors get smaller (partial response)

(166 out of 637 patients)

0.5% of patients had tumors disappear (complete response)

(3 out of 637 patients)

0.5% of patients had tumors disappear (complete response)

(3 out of 637 patients)

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-⁠L1” and 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.

KEYTRUDA may be used in combination with chemotherapy that contains platinum and another chemotherapy medicine before surgery when you have early-stage NSCLC, which can be removed by surgery, and then continued alone after surgery to help prevent your lung cancer from coming back.

KEYTRUDA may be used alone as a treatment in adults for your lung cancer to help prevent your lung cancer from coming back after your tumor(s) has been removed by surgery and you have received platinum-based chemotherapy, and you have stage IB and your tumor(s) is 4 cm or greater in size, stage II, or stage IIIA NSCLC.

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. 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 4 months after your last 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 last 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; rash; diarrhea; fever; cough; decreased appetite; itching; shortness of breath; constipation; bones or joints and stomach-area (abdominal) pain; nausea; and low levels of thyroid hormone.

In children, when KEYTRUDA is used alone, fever, vomiting, headache, stomach area (abdominal) pain, and low levels of white blood cells and red blood cells (anemia) are more common than in adults.

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; trouble sleeping; bleeding, blisters, or rash on the palms of your hands and soles of your feet; urinary tract infection; and low levels of thyroid hormone.

Common side effects of KEYTRUDA when given with chemotherapy with radiation therapy 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; trouble sleeping; bleeding, blisters, or rash on the palms of your hands and soles of your feet; urinary tract infection; and low levels of thyroid hormone.

Common side effects of KEYTRUDA when given with enfortumab vedotin include rash; tingling or numbness of the arms or legs; feeling tired; itching; diarrhea; hair loss; weight loss; decreased appetite; dry eye; nausea; constipation; changes in sense of taste; and urinary tract infection.

Common side effects of KEYTRUDA when given with chemotherapy and bevacizumab include tingling or numbness of the arms or legs; hair loss; low red blood cell count; feeling tired or weak; nausea; low white blood cell count; diarrhea; high blood pressure; decreased platelet count; constipation; joint aches; vomiting; urinary tract infection; rash; low levels of thyroid hormone; and decreased appetite.

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.

These are not all the possible side effects of KEYTRUDA. Talk to your health care provider for medical advice about side effects.

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.