Keytruda is a type of cancer treatment called immunotherapy. Immunotherapy works by using the body's immune system to fight cancer cells. Keytruda is designed to help the immune system fight a type of cancer called endometrial cancer. Below you’ll find common questions and answers about Keytruda to help decide whether it’s right for you.
How Does Keytruda Work for Endometrial Cancer?
Some cancer cells have what are called checkpoint proteins known as PD-L1 on their cell surface. Some immune cells in our bodies called T cells have proteins on their surface that bind to PD-L1. When these proteins bind to each other, the T cells in our body get turned “off,” which stops them from killing cancer cells. Keytruda acts on proteins on the T cell and prevents these proteins from binding to PD-L1 proteins on the tumor cell. This turns the T cell back “on” and allows it to do its job of attacking and killing the tumor cell.
What Kinds of Endometrial Cancer Does Keytruda Treat?
- Endometrial cancer that has spread (advanced) or has come back (recurred)
- Advanced endometrial cancer that is mismatch repair proficient (pMMR) or not microsatellite instability-high (MSI-H), has grown (progressed) after other treatment, and is not treatable by surgery or radiation
- Advanced endometrial cancer that is MSI-H or mismatch repair deficient (dMMR), has progressed after other treatment, and is not treatable by surgery or radiation
How Will I Get Keytruda?
Keytruda is put into a vein as an intravenous (IV) infusion. It will be given to you by a health care provider in a health care setting. Keytruda doses are usually given every three or six weeks. Your health care provider will decide the dose that is right for you and how often you will need to receive Keytruda. They may pause or stop your Keytruda doses if your cancer gets worse (progresses) or if you have certain side effects.
How Was Keytruda Studied for Endometrial Cancer?
Keytruda was studied in people with endometrial cancer that was advanced or was recurrent who had never received prior treatment or had not received treatment in the last 12 months. People in this study got either Keytruda plus chemotherapy or a placebo plus chemotherapy. There were 810 people in this study, and they were split into two groups based on whether they had mismatch repair deficient (dMMR) or mismatch repair proficient (pMMR) disease. Five hundred and eighty-eight people had pMMR tumor status, and 222 had dMMR tumor status. The average age of people in this study was 66 years old, ranging from 29 to 94. In the dMMR group, 79% of people were White, 9% were Black, 3% were Asian, and 5% were Hispanic or Latino. In the pMMR group, 72% of people were White, 16% were Black, 5% were Asian, and 6% were Hispanic or Latino. The study looked at progression-free survival (PFS), which measures how long people lived without progression of their cancer. In the people with pMMR, those in the Keytruda group had a median PFS of 11.1 months, compared to 8.5 months in the placebo group. This means that half of the people with pMMR getting Keytruda lived at least 11.1 months. For the people who got Keytruda plus chemotherapy, the risk of death or disease progression was reduced by 70% in the dMMR group and by 40% in the pMMR group. For the people in the dMMR group, the endpoint of PFS was not met. This means that the treatment didn’t work as well as expected in preventing the disease from getting worse in this group of people.
Keytruda was also studied in people with advanced microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR) endometrial cancer who had received previous treatment for their cancer. There was one group in this study where people got only Keytruda. There were 90 people in this study, and the median age was 64 years (with a range of 42 to 86 years). Eighty-three percent of people in this study were White, 8% were Asian, 3% were Black, and 12% were Hispanic or Latino. The study looked at overall response rate (ORR) and the median length of time the response lasted, which is called duration of response (DOR). ORR is made up of complete response, which means that all signs of cancer have disappeared, and partial response, which means that the tumor has shrunk in size by at least 30%. The ORR in this study was 46%. Sixty-eight percent of people had a response that lasted at least 12 months, and 44% had a response that lasted at least 24 months.
Keytruda was studied in people whose cancer was pMMR and not MSI-H and had progressed after they got at least one type of chemotherapy. People in this study got either Keytruda plus an oral medicine called lenvatinib or chemotherapy alone. There were 697 people in this trial. The median age was 65 years old (with a range 30 to 86) and 52% were 65 and older. Sixty-two percent of people in this trial were White, 22% were Asian, and 3% were Black. This study looked at overall survival (OS), which measured how long people lived, and PFS, as well as ORR. The median PFS was 6.6 months in the Keytruda/lenvatinib group and was 3.8 months in the chemotherapy group. This means that half the people in the Keytruda group lived at least 6.6 months without their cancer progressing. The median OS was 17.4 months in the Keytruda/lenvatinib group and was 12 months in the chemotherapy group. This means that half the people in the Keytruda group lived at least 17.4 months. The ORR was greater in the Keytruda group, at 30%, versus 15% in the chemotherapy group.
What Are Some Unique Considerations to Be Aware Of?
Keytruda can harm a fetus. Your health care provider will discuss options for contraception while you take Keytruda. You should use an effective method of birth control while you are receiving Keytruda and for four months after your last dose. If you and your partner are pregnant or are planning to become pregnant, talk with your health care provider about your options. Keytruda may pass into your breast milk if you are breastfeeding. You should not breastfeed while you are getting Keytruda and for four months after your last dose.
Keytruda can cause very serious side effects. These include problems with your lungs, intestines, liver, hormone glands, kidneys, and skin. Problems can also happen in other organs and tissues. It is important to tell your health care provider as soon as you have any side effects, including chest pain, a fast heartbeat, shortness of breath, confusion, double or blurry vision, severe muscle pains, or bruising more easily than usual.
What Are the Side Effects of Keytruda, and How Can I Prevent or Manage Them?
Keytruda can cause severe side effects, including fatigue, skin reactions, diarrhea, and muscle or bone pain.
Feeling tired is a common side effect of Keytruda, but there are some things you can do to help increase your energy. Exercising each day, even if it is just for a short time, can help boost your energy. Eating a healthy diet of fruits, vegetables, lean protein, and whole grains while avoiding sugary foods may also help you fight fatigue. Your doctor may be able to give you medicines to treat other side effects such as depression, pain, or low blood counts, which may help with your fatigue.
Contact your health care provider right away if you notice any new rash or existing rash that is getting worse; reddening of the skin; a fever; blistering of the lips, eyes, or mouth; blisters on the skin; skin peeling; or dry skin. They will decide whether you should stop taking Keytruda. They may also recommend creams or antihistamines to help with your rash and itchiness. Skin reactions are a common side effect of Keytruda and can happen any time after you start taking it and even after you stop. You may also be given a corticosteroid to treat your rash.
Tell your health care provider as soon as diarrhea starts, and start taking your diarrhea medicine. Drink more fluids to avoid losing too much of your body water (dehydration). Mild to moderate diarrhea can happen any time after you start taking Keytruda. Your health care provider may treat you with corticosteroids if your diarrhea is mild or moderate. If you have severe diarrhea, you may receive another immunosuppressive treatment given to you as an IV infusion.
You may also have muscle, bone, or joint pain while taking Keytruda. Your health care provider may recommend that you use over-the-counter pain relievers such as ibuprofen or Tylenol. You should contact your health care provider if you have pain that does not go away with over-the-counter medicines.
If you are receiving Keytruda with certain chemotherapy, you may have hair loss (alopecia). You may lose some or all of your hair on your scalp, face, and other body parts, and this may happen gradually or hair may come out in clumps. Your scalp may become sensitive with hair loss, so you should try to avoid products with harsh chemicals and instead use moisturizing shampoos, conditioners, and lotions. Also, be sure to cover your head with a scarf or hat and apply sunscreen to your scalp when you go outside. You can ask your doctor about “scalp cooling,” which is a tight-fitting cap filled with cooling gel that may help reduce hair loss for some people.
When used along with chemotherapy or lenvatinib, Keytruda may cause oral toxicity, such as stomatitis (inflammation of the mouth). Good dental hygiene, such as brushing your teeth several times a day with a soft toothbrush and flossing at least once a day, can help prevent mouth sores and dry mouth. If you get mouth sores, you can use a mixture of baking soda, salt, and warm water to rinse your mouth. Avoiding spicy, acidic, and hard foods, such as chips, and eating softer foods instead can help if you have mouth pain. You can try over-the-counter medications that help to numb your mouth sores, or your doctor may give you something to treat your pain if it becomes severe.
If you’re receiving Keytruda with platinum-based chemotherapy, your health care provider will typically recommend taking certain medications before your infusion to help prevent common side effects like nausea and vomiting, which are usually caused by the chemotherapy. It’s important to follow their instructions carefully. Besides taking prescribed medications, you can ask your health care provider for other ways to manage or prevent side effects. For example, eating bland foods and having several small meals throughout the day, avoiding greasy foods, and drinking only small amounts of clear liquids can help manage nausea and vomiting.
If you have certain side effects while you take Keytruda, your health care provider may need to change how often you get infusions, pause your infusions, or even stop your medicine altogether. This will depend on how severe the side effect is and what type of treatment it requires.
These are not all the side effects you may have with Keytruda. Talk with your health care provider if you have side effects that bother you. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
How Do I Know if Keytruda Is Working?
Your health care provider will regularly check how well Keytruda is working for your cancer by looking at results of tests such as blood tests, CT scans, and MRI scans. You may notice improvements within a few weeks to months after starting Keytruda. The complete therapeutic effect can take longer, depending on individual factors and disease progression.
How Long Does Keytruda Stay in My System?
Keytruda remains in the body for several months after the last dose. Even after you stop taking Keytruda, immune-related side effects may continue. Regular follow-up is essential to manage any lingering side effects and ensure a smooth transition off the treatment.
How Can I Get Keytruda?
Your cancer doctor (oncologist) will arrange for you to receive Keytruda in a health care setting, such as a hospital or infusion center.
If you need support paying for Keytruda, the drugmaker may be able to help you. Check out their Merck Financial Support website at www.keytruda.com/financial-support/ to learn more about their patient assistance program or to ask questions about insurance coverage and out-of-pocket costs. You can also contact the drugmaker at 855-398-7832.
