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 lung cancer called non-small-cell lung cancer (NSCLC). Keytruda was the first immunotherapy called a checkpoint inhibitor that was approved for first‐line treatment of lung 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 NSCLC?
Some cancer cells have what are called checkpoint proteins known as PD-L1 on their cell surface. The immune cells in our bodies also have proteins on their surface. 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 called PD-1 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 Lung Cancer Does Keytruda Treat?
Keytruda may be used to treat certain types of these lung cancers:
- NSCLC that has spread to other parts of the body (metastatic)
- PD-L1 positive NSCLC that is either metastatic or locally advanced
- NSCLC that can be removed by surgery (resectable)
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 NSCLC?
The FDA approved Keytruda for NSCLC based on several clinical trials.
Keytruda was studied in people whose NSCLC had spread to other parts of the body (metastatic) and who had received no prior treatment for their cancer. People in this trial got either Keytruda plus chemotherapy or placebo plus chemotherapy. There were 616 people in this trial. Two-thirds of them were in the Keytruda group, the other third was in the placebo group. This study looked at overall survival (OS), which measured how long people survived after getting their treatment, and progression-free survival (PFS), which looked at how long people lived without their cancer growing. The median age was 64 with ages ranging from 34 to 84. There were more men in the Keytruda group (62%), and most of the people in each group were current or former smokers (88%). Most of the people in the study were White (94%) and 3% were Asian. At one year, the estimated OS was 69.2% for people in the Keytruda group versus 49.4% for the placebo group. This means people in the Keytruda group lived significantly longer. The median PFS in the Keytruda group was 8.8 months as compared to 4.9 months in the placebo group. This means that at least half of the people who received Keytruda had not had their cancer get worse after 8.8 months, compared to 4.9 months who received placebo.
Keytruda was also studied in people who had NSCLC that was positive for PDL-1 and progressed after chemotherapy. People in this trial got either Keytruda 2 mg/kg, Keytruda 10 mg/kg, or chemotherapy. There were 1,475 people in this study, and they were evenly distributed between all three groups. The ages for each group ranged from 56 to 69 with 63 as the median age. There were more men in each group than women (about 62%). Most of the people in the study were white (72%) and 21% of people were Asian. This study looked at OS and PFS between all three groups. Median OS was 10.4 months for the Keytruda 2 mg/kg group, 12.7 months for the Keytruda 10 mg/kg group, and 8.5 months for the chemotherapy group. There was no difference in how long it took people's cancer to progress between the three groups.
Another study looked at Keytruda in people who had planned surgery for their NSCLC. People in this study received either Keytruda and chemotherapy or placebo and chemotherapy before their surgery, and either Keytruda or placebo alone after their surgery. There were 797 people in this study, and they were split almost evenly between the two study groups. This study included people who had NSCLC and had not received any treatment for their cancer prior to the study. The median age of people in this trial was 64 with ages ranging from 26 to 83. Most of the people in this trial were men (about 70%). Most people were white (61%), 31% were Asian, 2% were Black, 9% were Hispanic or Latino, and for 4% the race was not reported. About 70% of people had stage III NSCLC with the rest being stage II. This study looked at event-free survival, which measures how long people lived without having an event including progression, recurrence (cancer coming back), or death. OS was also measured in this study. The estimated percentages of people alive without an event at 24 months was 62.4% in the Keytruda group and 40.6% in the placebo group. This means that at two years, 62.4% of people who received Keytruda had not had a cancer event, compared to 40.6% in the placebo group. There was no significant difference in OS rates at 24 months found between the Keytruda and placebo groups.
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 4 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 4 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 skin reactions, diarrhea, and high blood sugar levels.
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.
Your health care provider will tell you if you need to monitor your fasting blood sugar levels (blood sugar after an overnight fast) while you are taking Keytruda. Contact your health care provider if you notice your blood sugar rising or start having symptoms like feeling more thirsty than usual, needing to pee more often or in greater amounts, or have blurred vision or headaches. Your health care provider will have you get lab tests regularly and decide how to best manage your blood sugar levels.
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.
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.
