Columvi is a type of cancer treatment called immunotherapy. Immunotherapy works by using the body's immune system to fight off cancer cells. Columvi is designed to help the immune system fight two types of lymphoma: diffuse large B-cell lymphoma (DLBCL) and large B-cell lymphoma (LBCL). Columvi is a type of immunotherapy called a bispecific antibody. Below you’ll find common questions and answers about Columvi to help decide whether it’s right for you.
How Does Columvi Work for DLBCL and LBCL?
Columvi 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 Columvi 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.
What Kinds of Lymphoma Does Columvi Treat?
Columbia treats certain types of DLBCL or LBCL that have come back after previous therapy (relapsed) or did not go away after previous therapy (refractory).
How Will I Get Columvi?
Columvi 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. Columvi is dosed on a “step-up” dosing schedule. You will receive 2.5 milligrams for your first dose followed by a 10-milligrams dose one week later. After your first two doses, you will receive Columvi 30 milligrams every three weeks. Your health care provider may stop Columvi 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 Columvi Work for Lymphoma?
Columvi was studied in people with relapsed or refractory DLBCL who already had two prior cancer treatments. The study had one treatment arm in which people received Columvi every 3 weeks for a total of 12 treatments. People were included if they had confirmed DLBCL (not otherwise specified), transformed follicular lymphoma, high-grade B-cell lymphoma, or primary mediastinal large B-cell lymphoma that had relapsed or was refractory to at least two prior therapies. People were not included in this trial if they received another immunotherapy medicine within four weeks of starting the trial. In this study, 77% of people were White, 4.5% were Asian, 0.8% were Black or African American, and 5% were Hispanic or Latino.
The study looked at complete response (CR), which happens when all signs of cancer have disappeared after treatment. It also looked at overall response rate (ORR) and duration of response (dOR), which measured how long people's responses lasted. There were 155 people in this study. The majority of the people had DLBCL (71%). The median age of the people in the study was 66, and the ages ranged from 21 to 90. More than half the people were male (65%). Seventy five percent of people had stage III or IV lymphoma that was refractory to treatment.
At 12.6 months, 39% of people achieved a CR. This means that a significant amount of people had no signs of cancer after they received Columvi. The median time it took for the people in the trial to achieve a CR was 42 days. This means it took about a month and a half for all signs of their cancer to disappear. Fifty two percent of people in this trial had an overall response to Columvi. The median time that their response lasted for was 18.4 months. This means that half of the people who responded to Columvi had a response that lasted at least 18.4 months.
What Are Other Unique Considerations to Be Aware Of?
Columvi 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 Columvi will be gradually increased over your first three doses. You will also be given another immunotherapy medicine called obinutuzumab before your first dose of Columvi to help prevent symptoms of CRS. You will get your first two doses of Columvi in the hospital, and your health care provider will monitor you for 24 hours after each dose. If you have symptoms of CRS with any doses, you may need to receive your next dose in the hospital. You will get medicines to help prevent CRS. Your health care provider should give you a Columvi Wallet Card, which lists all the signs and symptoms of CRS. You should carry this with you all the time.
Columvi can cause harm to a fetus. Your health care provider will discuss options for contraception while you take Columvi. You should use an effective method of birth control while you are receiving Columvi and for one month 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. Columvi may pass into your breast milk if you are breastfeeding. You should not breastfeed while you are getting Columvi and for one month after your last dose.
Columvi 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 Possible Side Effects of Columvi, and How Can I Prevent or Manage Them?
Columvi may cause gastrointestinal (GI) side effects such as nausea, diarrhea, and constipation. 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 start taking diarrhea medicine and drink more fluids to avoid losing too much of your body water (dehydration). Drinking more fluids can also help to prevent constipation, as well as eating foods that are high in fiber.
Skin reactions are a common side effect of Columvi. 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.
Severe infections can occur while taking Columvi. 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.
If you have certain side effects while you take Columvi, 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 Columvi. 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 Columvi Is Working?
Your health care provider will regularly check how well Columvi 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 Columvi. The complete therapeutic effect can take longer, depending on individual factors and disease progression.
How Long Does Columvi Stay in My System?
Columvi remains in the body for several weeks after the last dose. Regular follow-up is essential to manage any lingering side effects and ensure a smooth transition off the treatment.
