Polivy is a type of targeted therapy called an antibody-drug conjugate. This antibody-drug conjugate is made up of an antibody that is attached to an anti-cancer medicine. Polivy is used to treat a type of non-Hodgkin's lymphoma called diffuse large B-cell lymphoma (DLBCL). Below you'll find common questions and answers about Polivy to help decide whether it's right for you.
How Does Polivy Work for Lymphoma?
Polivy works by targeting a certain type of white blood cell in your body, called a B cell. Polivy targets B cells that have become cancerous, but it may affect healthy B cells in your body too. Polivy is made up of two parts: an antibody and an anti-cancer medicine. The antibody attaches to a protein on the B cell called CD79b, and then the anti-cancer medicine enters the B cell. The anti-cancer medicine stops the lymphoma cells from growing and causes them to die.
What Kinds of Lymphoma Does Polivy Treat?
- DLBCL that has not been treated before
- DLBCL that has come back (relapsed) or does not go away (refractory) after two types of treatment
How Will I Get Polivy?
Polivy 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. Polivy doses are usually 1.8 mg/kg given every three weeks. Your health care provider will decide the dose that is right for you and how often you will need to receive Polivy. You will get Polivy along with one of two combinations: a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) or bendamustine and a rituximab product (BR). Your health care provider may stop your Polivy doses if your cancer gets worse (progresses), or they may pause treatment, adjust your dose, or stop Polivy if you have certain side effects.
Your health care provider may need to stop Polivy if you have problems with your liver. Talk to your health care provider about all of your medical history so they can decide if Polivy is right for you.
How Was Polivy Studied?
Polivy was studied in people who had DLBCL that was positive for CD-20 protein and who had not received any prior treatment for their lymphoma. People in this study got Polivy plus R-CHP or another combination of chemotherapy plus rituximab called R-CHOP. This study looked at progression-free survival (PFS) which measured how long people lived without their lymphoma growing (progressing) or coming back. There were 879 people in this trial, and they were divided evenly between the two groups. The median age was 65 years (range 19 to 80 years), and 54% were male. Fifty-four percent of people in this study were White, 19% were Asian, 1.8% were Black or African American, and 6% were Hispanic or Latino. At two years, the PFS rate was 6.5% higher in the Polivy group, at 76.7%, versus 70.2% in the R-CHOP group. This means that more people in the Polivy group were alive without disease progression at two years than in the R-CHOP group. The risk of death or lymphoma progression or relapse was reduced by 27% in the people who got Polivy. This means that the people who got Polivy had a 27% lower chance of dying than those not getting Polivy.
Polivy was also studied in people with DLBCL that had relapsed or was refractory to at least one other treatment. People in this study got either Polivy plus bendamustine and rituximab (BR) or BR alone. This study looked at complete response (CR). CR means that after treatment, there are no signs of cancer. This study also looked at how long people had a response to treatment (DOR) and best overall response, which measures how many people had either a CR or partial response (PR) to therapy. There were 80 people in this study, and half were in each group. The median age was 69 years (range: 30-86 years), and 66% were male. Seventy-one percent were White, 4% were Black or African American, 13% were Asian, 1% were American Indian or Alaska Native, and the rest were "Unknown." People who got Polivy-BR had a CR of 40%, versus 18% for people who got BR. This means that at the end of the trial, a higher percentage of patients who received Polivy showed no signs of cancer, compared to those who did not receive Polivy. Of the people who had a response in the Polivy group, 64% had a response that lasted six months and 48% had a response that lasted 12 months.
What Are Some Unique Considerations to Be Aware Of?
Polivy can harm a fetus. Your health care provider will discuss options for contraception while you take Polivy. You should use an effective method of birth control while you are receiving Polivy. You should also use effective birth control for three months after your last dose if you are female and five months after your last dose if you are male. If you and your partner are or are planning to become pregnant, talk with your health care provider about your options. It is unknown if Polivy will pass into your breast milk if you are breastfeeding. But you should not breastfeed while you are getting Polivy and for two months after your last dose.
Polivy may cause other severe side effects such as tumor lysis syndrome (TLS) and infusion reactions. Call your health care provider right away if you have any infusion reaction symptoms, including a fever, rash, chills, dizziness, hives, breathing problems, or low blood pressure; or symptoms of TLS such as nausea, vomiting, or diarrhea.
What Are the Possible Side Effects of Polivy, and How Can I Prevent or Manage Them?
You may have the following side effects when you take Polivy along with R-CHP or BR.
Feeling tired is a common side effect of Polivy, 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 pain or low blood counts, which may help with your fatigue.
Polivy 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 do happen. Eating bland food and smaller meals throughout the day can help with symptoms of nausea. If you get diarrhea, your health care provider may recommend that you start anti-diarrhea medicine and drink more fluids to keep your body from losing too much water (dehydration). Drinking more fluids can also help prevent constipation, and so can eating foods that are high in fiber.
Polivy may cause oral toxicity, such mucositis (inflammation of the mouth and digestive tract). 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 get 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 health care provider may give you something to treat your pain if it becomes severe.
Severe infections can happen while taking Polivy. You can help reduce your risk of an infection by washing your hands often and staying away from people with infections, colds, or the flu. If you are at high risk of 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 get a fever or any other signs of an infection such as a sore throat or cough.
Polivy 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 an infection by washing your hands often and staying away from people with infections, colds, or the flu. If you are at high risk of 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 get 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.
If you are receiving Polivy, you may have 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.
How Do I Know if Polivy Is Working?
Your health care provider will regularly check how well Polivy is working for your cancer by looking at results of tests such as blood tests and computed tomography (CT) scans or positron emission tomography (PET) scans. You may notice improvements within a few weeks to months after starting Polivy. The complete therapeutic effect can take longer, depending on individual factors and disease progression.
How Long Does Polivy Stay in My System?
Polivy remains in the body for several weeks to months after the last dose. Even after stopping Polivy, some side effects may continue. Regular follow-up is essential to manage any lingering side effects and ensure a smooth transition off the treatment.
Is there a Cost Savings Program?
There is a copay savings program available from the drugmaker that may cost you as little as $0 for your monthly copay for your Polivy prescription. Whether or not you are eligible depends on your insurance coverage. You can find out more by visiting https://www.polivy.com/newly-diagnosed/rchp/financial-support/assistance-options.html#copaycard or by calling 888-249-4918.
