Lymphoma is a type of cancer that happens when certain white blood cells called lymphocytes grow and multiply in an uncontrolled way. Epkinly is a special medicine that helps the immune system fight lymphoma. This medicine works by connecting cancer cells with immune cells called T cells, enabling the T cells to attack and destroy the cancer. Epkinly is used to treat certain types of lymphoma that have come back or haven’t responded to other treatments. This medicine is given as a shot under the skin on a schedule that starts with smaller doses and increases over time.
How Does Epkinly Work to Treat Lymphoma?
Epkinly is a special type of molecule that can attach to two different types of cells. This is called a bispecific antibody. It attaches to CD20 proteins on lymphoma cells and healthy B cells, and to CD3 proteins on immune cells called T cells, binding them together. This activates the T cells, makes them multiply, and helps them release chemicals that destroy lymphoma cells.
What Types of Lymphoma Does Epkinly Treat?
Epkinly treats certain types of diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, and follicular lymphoma (FL) that have come back after other treatment (relapsed) or did not respond to other treatment (refractory), in patients who have been treated with at least two other types of treatment.
How Will I Get Epkinly?
Epkinly is a liquid medicine given as a shot under the skin (subcutaneous injection). It will be given to you by a health care provider in a health care setting. Epkinly is dosed on a “step-up” dosing schedule. A step-up dosing is when you get smaller doses before getting the full dose. The week after your last step-up dose, you will get your first full dose. This will be on day 15 or day 22, depending on what type of lymphoma you have.
You will usually get Epkinly weekly for the first three cycles, followed by every two weeks for the next six cycles, and then every four weeks. You may have to repeat step-up dosing if you have certain side effects.
Epkinly may be injected subcutaneously into the front of your thigh or lower stomach area. It should not be injected into areas where the skin is tender, red, bruised, hard, or affected by psoriasis. Also, it should not be injected within 2 inches of your navel (belly button). Each injection should be put into a different site. Your health care provider may stop Epkinly or change your dose if your cancer gets worse (progresses) or if you have side effects that prevent you from tolerating the medicine.
How Was Epkinly Studied for Lymphoma?
Epkinly was studied in patients with relapsed or refractory large B-cell lymphomas (LBCL) or follicular lymphoma (FL) who had received at least two prior treatments. People in the study got the step-up dosing schedule of Epkinly.
The study looked at objective response rate (ORR), which measured how many people had some type of response to their treatment. ORR is made up of partial response, which is when the lymphoma has shrunk but not disappeared, and complete response, which is when all signs of lymphoma have disappeared.
Follicular lymphoma
There were 127 patients with FL, aged 39-84 years. About half (52%) were 65 years of age or older, and 62% were male. Race was reported for 85 patients; of these patients, 89% were White, and 8% were Asian. There were no Black, African American, Hispanic, or Latino patients reported in this group.
The ORR was 82%. This means that 82% of people who got Epkinly had either a complete or partial response to the medicine. Of the people who responded, 60% had a complete response, which means that all signs of their lymphoma had disappeared (see Table 1).
Large B-cell lymphoma
There were 148 patients with LBCL, aged 22-83 years, and 62% were male. The median age was 65, meaning that about half were older and half were younger. Race was reported for 125 (84%) patients; of these patients, 61% were White, 20% were Asian, and 0.7% were Native Hawaiian or Other Pacific Islander. No Black, African American, Hispanic, or Latino patients were reported in this group.
The ORR was 61%. Of those people, 38% had a complete response to Epkinly (see Table 1).
Table 1
Follicular Lymphoma | Large B-cell Lymphoma | |
| Overall Response | 82% | 61% |
| Complete Response | 60% | 38% |
| Partial Response | 22% | 23% |
What Are Other Unique Considerations to Be Aware Of?
Epkinly can cause a serious side effect called cytokine release syndrome (CRS). CRS happens when your body has a very strong reaction to either an infection or immunotherapy. Your body responds by releasing substances that are used by your immune system (cytokines), and sometimes these cytokines cause fevers and problems in some of your organs. To prevent CRS, the dose of Epkinly will be gradually increased over your first three to four doses.
If you have DLBCL or high-grade B-cell lymphoma, you will get your first full dose of Epkinly in the hospital, and your health care provider will monitor you for 24 hours after your dose. If you have symptoms of CRS with any doses, you may need to get your next dose in the hospital.
For your first cycle of Epkinly, you will get medicines before and after your dose to help prevent CRS. Your health care provider should give you an Epkinly Wallet Card, which lists all the signs and symptoms of CRS. You should carry this with you all the time. Tell your health care provider right away if you have any of these symptoms, which include fever, chills, fast heartbeat, headache, dizziness, and shortness of breath.
Epkinly can cause a life-threatening problem that may make you less responsive. Make sure that anyone who is around you at home or work can get you to a hospital right away if you have a seizure or seem confused, sleepy, or hard to wake up. Get emergency help for yourself if you notice any problems writing, talking, thinking, or staying awake.
What Are the Possible Side Effects of Epkinly, and How Can I Prevent or Manage Them?
Severe infections can occur while taking Epkinly. You can help lower your risk of getting an infection by washing your hands often with soap and warm water and staying away from people who are sick. You may also consider wearing a mask in crowded spaces. Your health care provider may prescribe a medicine to help prevent infections. Be sure to finish any medicine given to you to treat an infection, even if you begin to feel better. Call your health care provider right away if you get a fever or any other signs of an infection, such as a sore throat or cough.
Low blood cell counts, such as low red blood cells (anemia), can be a common side effect of Epkinly. Anemia can make you feel more tired than usual, but there are some things you can do to help boost your energy. Exercising daily, even if 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. It is also important to get enough rest at night and take naps during the day, if needed.
Low blood cell counts, such as low platelet counts (thrombocytopenia), can be a common side effect of Epkinly. Low platelet counts can cause you to bruise or bleed more easily than normal. If you have a low number of platelets, consider using an electric shaver instead of a razor, a soft-bristled toothbrush to brush your teeth, and avoiding contact sports.
You may also have muscle or bone pain while taking Epkinly. Ask your health care provider about using an over-the-counter (OTC) pain reliever. Do not take or use any OTC medicine without first talking to your health care provider. You can apply ice or heat to help ease the pain in your muscles. Staying hydrated by drinking plenty of fluids can also help with muscle pain. Low-impact activities such as walking, swimming, and gentle stretching may help with muscle and bone pain. Call your health care provider if you have severe pain.
Epkinly may cause gastrointestinal (GI) side effects such as nausea and diarrhea. Your health care provider may give you certain medicines to prevent these side effects from happening, as well as medicines to treat them if they occur. Eating bland food and smaller meals throughout the day can help with symptoms of nausea. If you have diarrhea, your health care provider may recommend that you start antidiarrheal medicine and drink more fluids to avoid losing too much of your body water (dehydration).
How Do I Know if Epkinly Is Working?
Your health care provider will regularly check how well Epkinly is working for your cancer by looking at the results of tests such as CT scans or PET scans. You may notice improvements within a few weeks to months after starting Epkinly. The complete therapeutic effect can take longer, depending on individual factors and disease progression. In clinical trials, most people with large B-cell lymphomas saw a response in about one to eight months, and people with FL saw a response in one to three months. Your health care provider will look at how your tumor is responding and what kind of side effects you may have from this treatment to decide how long to use this medicine.
Is There a Cost Savings Program for Epkinly?
You may be able to get financial support to help with the cost of your Epkinly prescription. Whether or not you are eligible depends on your insurance coverage. You can find out more by visiting https://www.mynavcare.com/patient or calling 866-628-2271.
