Lunsumio is a type of cancer treatment called immunotherapy. Immunotherapy works by using the body's immune system to fight cancer cells. Lunsumio is designed to help the immune system fight a type of lymphoma called follicular lymphoma (FL) that has either come back after previous therapy (relapsed) or did not go away after previous therapy (refractory). Lunsumio is a type of immunotherapy called a bispecific antibody.
How Does Lunsumio Work for FL?
Lunsumio 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 to CD3 proteins on T cells, a type of immune cell that can kill cancer cells. When Lunsumio attaches to CD20 and CD3, this activates the T cells, makes them multiply, and helps them release chemicals that destroy the lymphoma cells with CD20 on them.
How Will I Get Lunsumio?
Lunsumio is injected into a vein as an intravenous (IV) infusion. It will be given to you by a health care provider in a health care setting. Lunsumio is dosed on a “step-up” dosing schedule. You will receive 1 milligram for your first dose followed by a 2-milligram dose one week later. After this you will get two more weekly doses of 60 milligrams. This will be followed by 30 milligrams given every three weeks. Your health care provider may stop Lunsumio or adjust your dose if your cancer gets worse (progresses) or you have side effects that prevent you from tolerating the medicine.
How Well Does Lunsumio Work for FL?
Lunsumio was studied in people with relapsed or refractory FL who had already received at least two types of treatment for their lymphoma. People in this trial got the Lunsumio step up dosing as follows: 1 milligram for the first dose, a 2-milligram dose one week later, two more weekly doses of 60 milligrams, followed by 30 milligrams given every three weeks. There were 90 people in this study and 61% were men. The median age was 60 years old with a range of 29 to 90. Most people (77%) had stage III or IV cancer. Eighty-two percent of people were White, 9% were Asian, 4% were Black or African American, 1% were American Indian or Alaskan Native, and 3% were unknown. This study looked at objective response rate (ORR), which measured the amount of people who had a response to treatment. It also looked at duration of response (dOR), which measured the time between the start of a response and the time of cancer progression or death. The ORR for this study was 80%, which means that 80% of patients had either a partial or complete response to Lunsumio. The dOR for the patients that had a response was 22.8 months. This means that of the people that responded to Lunsumio, the average time that response lasted was almost 23 months. This showed that Lunsumio had a positive response in relapsed or refractory FL patients that had two or more prior treatments.
What Are Some Other Considerations to Be Aware Of?
Lunsumio can cause a serious side effect called cytokine release syndrome (CRS). CRS happens when your body has an exaggerated reaction to either an infection or immunotherapy. Your body responds by releasing cytokines, and sometimes these cytokines cause fevers and problems in some of your organs. To prevent CRS, the dose of Lunsumio will be gradually increased over your first three doses. Your health care provider will watch you for CRS symptoms, such as severe headache, fever, and increased heart rate. If you have any symptoms of CRS, you may need to receive your next dose in the hospital. You will get medicines to help prevent CRS with your first four doses and maybe longer. Your health care provider should give you a Lunsumio Wallet Card, which lists all the signs and symptoms of CRS. You should carry this with you all the time.
Lunsumio can cause harm to an unborn baby. Your health care provider will discuss options for contraception while you take Lunsumio. You should use an effective method of birth control while you are receiving Lunsumio and for three 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. Lunsumio may pass into your breast milk if you are breastfeeding. You should not breastfeed while you are getting Lunsumio and for three months after your last dose.
Lunsumio may cause other severe side effects such as neurologic problems and growth or worsening of your tumor called tumor flare. Contact your health care provider right away if you experience pain or swelling at the site of your tumor or signs of neurologic problems including dizziness, headache, numbness in hands and feet (peripheral neuropathy), or changes in your mental status.
What Are the Side Effects of Lunsumio, and How Can I Prevent or Manage Them?
Lunsumio can cause low blood counts, including low platelets (thrombocytopenia), low white blood cells (neutropenia), and low red blood cells (anemia). Thrombocytopenia can cause you to bruise or bleed easier than normal. Things you can do to prevent this include using an electric shaver instead of a razor, using a soft bristled toothbrush to brush your teeth, and avoiding contact sports. Neutropenia can cause severe infections. You can help reduce your risk of developing an infection by washing your hands often and staying away from people with infections, colds, or the flu. If you are at high risk for getting an infection, your health care provider may prescribe a medicine to help prevent infections. You should contact your health care provider right away if you develop a fever or any other signs of an infection such as a sore throat or cough. They may prescribe you medicine to treat your infection. Anemia can make you feel more tired than usual and have shortness of breath. Eating foods rich in iron such as spinach and red meat may help boost your energy. You should contact your health care provider if you have these symptoms so your blood counts can be monitored.
Lunsumio 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 experience diarrhea, your health care provider may recommend that you take diarrhea medicine and drink more fluids to avoid losing too much of your body water (dehydration).
Skin reactions are a common side effect of Lunsumio. If you develop a rash, you should contact your health care provider. They may recommend creams or antihistamines to help with your rash and itchiness. You may also be given a corticosteroid to treat your rash.
If you have certain side effects while you take Lunsumio, 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 that you have and what type of treatment it requires.
These are not all the possible side effects of Lunsumio. Contact your health care provider for medical advice about side effects if you are having symptoms that bother you. You can also report side effects to the FDA at 800-FDA-1088 (800-332-1088).
How Do I Know If Lunsumio Is Working?
Your health care provider will regularly check how well Lunsumio is working for your cancer through looking at results of tests such as blood tests, CT scans, or MRI scans. You may notice improvements within a few weeks to months after starting Lunsumio. The complete therapeutic effect can take longer, depending on individual factors and disease progression.
How Long Does Lunsumio Stay in My System?
Lunsumio remains in the body for several months after the last dose. Regular follow-up is essential to manage any lingering side effects and ensure a smooth transition off the treatment.
