Results From a Clinical Trial With KEYTRUDA® (pembrolizumab) With Chemotherapy: Advanced Triple-Negative Breast Cancer (TNBC)
Advanced triple-negative breast cancer (TNBC)

RESULTS FROM A CLINICAL TRIAL WITH KEYTRUDA + CHEMOTHERAPY

KEYTRUDA + chemotherapy is a treatment option that may help you fight advanced TNBC

Cancer was the last word you wanted to hear. With KEYTRUDA + chemotherapy, you have a treatment option that may help fight advanced TNBC, which is when your breast cancer has returned and cannot be removed by surgery or has spread (also known as metastatic cancer).

A clinical trial compared women with advanced TNBC who received KEYTRUDA in combination with chemotherapy with those who received chemotherapy alone.

Among the 847 women in this trial, 323 had tumors that tested positive for PD-L1 with a combined positive score (CPS) of 10 or more (CPS ≥10). Of those women, 220 received 200 mg of KEYTRUDA every 3 weeks with chemotherapy and 103 received chemotherapy alone. The chemotherapies used were paclitaxel, or paclitaxel protein-bound, or gemcitabine and carboplatin.

This biomarker test for PD-L1, CPS, evaluates the person’s likelihood of responding to KEYTRUDA—a programmed death receptor 1 (PD-1) inhibitor.

PD-L1 = programmed death ligand 1.

The clinical trial enrolled:

  • Women with TNBC which returned and could not be removed by surgery or had spread (metastatic), who had not been previously treated with chemotherapy for metastatic cancer, and
  • Whose tumors were tested for PD-L1. This information helps doctors decide what cancer treatment is right for you

Results in the 323 women studied who had a PD-L1 with a CPS of ≥10

KEYTRUDA® (pembrolizumab) With Chemotherapy Reduced the Risk of Advanced Triple-Negative Breast Cancer Spreading, Growing, or Getting Worse by 35% Compared to Chemotherapy

KEYTRUDA + chemotherapy reduced the risk of cancer spreading, growing, or getting worse by 35% compared to chemotherapy alone.

Half of the women receiving KEYTRUDA with chemotherapy were alive without their cancer spreading, growing, or getting worse at 9.7 months, compared to 5.6 months for women on chemotherapy alone. Cancer did not progress in 38% of women receiving KEYTRUDA with chemotherapy (84 out of 220 women) compared to 23% of women receiving chemotherapy alone (24 out of 103 women).

More women had their tumors shrink

100%
0%
53%
40%
116 out of 220 women had their tumors shrink
41 out of 103 women had their tumors shrink

KEYTRUDA + chemotherapy

(paclitaxel, paclitaxel protein-bound, or gemcitabine and carboplatin)

Chemotherapy

(paclitaxel, paclitaxel protein-bound, or gemcitabine and carboplatin)

36% had tumors get smaller (partial response)

(79 out of 220 women)

27% had tumors get smaller (partial response)

(28 out of 103 women)

17% had tumors disappear (complete response)

(37 out of 220 women)

13% had tumors disappear (complete response)

(13 out of 103 women)

The median duration of response was 19.3 months for women taking KEYTRUDA with chemotherapy compared to 7.3 months for women taking chemotherapy alone.

The length of time women responded ranged from 9.9 to 29.8 months for women taking KEYTRUDA with chemotherapy, compared to 5.3 to 15.8 months for women taking chemotherapy alone.

Understanding Different Types of Results

Understanding different types of results

There’s a lot to take in when learning about your diagnosis. And several terms your doctor may use to talk about your treatment goals are important to understand.

Time without the cancer spreading, growing, or getting worse

Your doctor may measure the amount of time the cancer is not getting worse or spreading. This is called progression-free survival (PFS).

Getting tumors to shrink

Another goal is to have your tumors shrink (or get smaller). Your doctor may refer to this as objective response rate, or ORR. When a tumor becomes smaller, it is called a partial response. When it disappears, this is called a complete response.

Time responding to treatment

Your doctor may also measure the duration of response (DOR), which is how long you respond to treatment until the time that you are no longer responding.

FDA-Approved Indications

KEYTRUDA is a prescription medicine used to treat a kind of cancer called triple-negative breast cancer (TNBC). KEYTRUDA may be used with chemotherapy medicines when your breast cancer has returned and cannot be removed by surgery or has spread, and tests positive for “PD-L1.”

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.

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.

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.