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 cervical 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 Cervical 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 Cervical Cancer Does Keytruda Treat?
- Cervical cancer that has spread to nearby tissues or organs or to your kidneys
- Cervical cancer that has spread, come back (recurred), will not go away (persistent) and is also positive for PD-L1
- Cervical cancer that is positive for PD-L1 and has returned or spread (metastatic) after or during chemotherapy
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 Cervical Cancer?
Keytruda was studied in people who had cervical cancer that was newly diagnosed, high risk, locally advanced, and who had not received any prior treatment for their cancer. People in this trial got either pembrolizumab plus chemoradiotherapy (chemotherapy plus radiation) or placebo plus chemoradiotherapy. There were 1,060 people in this study, and half were in each group. Five hundred ninety-six people out of the 1,060 had advanced (stage III or IV) cancer. This study looked at progression-free survival (PFS), which looked at how long people lived without their cancer growing. The median age of those with advanced cancer was 52 (range 22-87). Seventeen percent of people were over 64. In this study, 36% of people were White, 34% were Asian, and 1% were Black. After 12 months, 81% of people in the pembrolizumab group were alive without progression of their cancer versus 70% in the placebo group.
Keytruda was also studied in people whose cervical cancer was recurrent, persistent, or metastatic and who were positive for PD-L1. People in this trial got either pembrolizumab with combination chemotherapy or placebo plus combination chemotherapy. There were 617 people in this study and they were split evenly between the two groups. This study looked at overall survival (OS), which measured how long people survived after getting their treatment, and PFS. It also looked at the overall rate of response (ORR) and the median duration of response (DOR). This measures what percentage of people had a response and how long that response lasted. The median age in this study was 51 (range 22-82) with 16% being age 65 and older. Fifty-nine percent of the people were White, 18% were Asian, 6% were American Indian or Alaska Native, 37% were Hispanic or Latin, and 1% were Black. The median PFS was longer in the pembrolizumab group at 10.4 months versus 8.2 months in the placebo group. This means that half of the patients in the pembrolizumab group lived at least 10.4 months without their cancer progressing. In the pembrolizumab group, median OS was 28.6 months versus 16.5 months in the placebo group. This means that half of the people in the pembrolizumab group lived at least 28.6 months. People in the pembrolizumab group also had a greater ORR of 68% with a median DOR lasting 18 months compared to ORR of 50% and median DOR of 10.4 months in the placebo group.
Keytruda was also studied in people with recurrent or metastatic cervical cancer that was positive for PD-L1. There was one group in this trial where the people got pembrolizumab. There were 98 people in this trial and 77 were positive for PD-LI. The median age was 45 years old (range 27 to 75). Eighty one percent were White, 14% were Asian, and 3% were Black. The study looked at ORR and DOR. The ORR was 14.3%. Of the patients that had a response, 2.6% had a complete response and 11.7% had a partial response. Most patients (91%) had a response that lasted at least six months.
What Are Some Unique Considerations to Be Aware Of?
Keytruda can cause harm to 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 or are planning to become pregnant, talk with your health care provider about your options. Keytruda may pass into your breastmilk 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 lung problems, intestinal problems, liver problems, hormone gland problems, kidney problems, and skin problems. Problems can also happen in other organs and tissues. It is important to tell your health care provider as soon as you experience any side effects including chest pain, 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; 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 at any time after you start taking it and even after you stop. You may also be given a corticosteroid to treat your rash.
Notify 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 intravenous infusion.
You may also experience muscle, bone, or joint pain while taking Keytruda. Your health care provider may recommend that you use over-the-counter pain relievers such as acetaminophen or ibuprofen. 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 or chemoradiation therapy, you may experience 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.
Keytruda when used in combination with chemotherapy or chemoradiation 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 experience 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 alongside 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. In addition to taking prescribed medications, you can ask your health care provider for additional strategies 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.
There may be other side effects of Keytruda that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatchcheck or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffectcheck 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 through looking at results of tests such as blood tests and CT scans or 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 stopping 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 your questions about insurance coverage and out-of-pocket costs. You can also contact the drugmaker at 855-398-7832.
