Bispecific T-Cell Engager (BiTE) Therapy

Bispecific T-cell engagers (BiTEs) are drugs used to treat cancer. Several BiTE therapies are approved to treat certain forms of blood cancer. BiTE therapies form a link between certain immune cells (T cells) and tumor cells. This helps T cells recognize and fight cancer cells.^1,2

Serious side effects of BiTEs are possible. Doctors may monitor you in the hospital for several days around the first couple of doses. You may take other drugs to reduce the risk of side effects. Talk to your doctor about the risks and benefits of BiTEs.²

How do bi-specific T-cell engagers work?

BiTEs are a type of targeted immunotherapy. They improve how your immune system fights cancer cells. They do this by forming a direct link between T cells and tumor cells.¹

T cells are immune cells that fight pathogens and harmful cells, like cancer cells. CAR T-cell therapy is another form of immunotherapy that improves how T cells fight cancer.^2-4

BiTEs are made up of two linked arms. Each arm has part of an antibody engineered to bind a specific protein. One arm is designed to bind a protein called CD3. CD3 is present on the surface of T cells.^1,3,5

The other arm can be changed to bind different types of cancer cells. For example, BiTEs that bind a protein called CD19 can treat acute lymphocytic leukemia. BiTEs that bind a protein called BCMA can treat multiple myeloma. BiTES that bind to a protein called CD20 can treat certain forms of non-Hodgkin lymphoma.^1-3,5,6

When both arms of the BiTE therapy bind their targets, T cells come very close to cancer cells. T cells then form pores on the surface of cancer cells. They release toxic molecules into the pores. This kills the cancer cells.^1,3,5,6

Examples of bi-specific T-cell engagers

BiTEs for blood cancer treatment are typically used for cancers that have come back (relapsed) or are not responding to therapy (refractory). As of early 2024, several BiTEs are approved to treat certain forms of multiple myeloma, including:^2,7-9

• Talvey^® (talquetamab-tgvs)
• Elrexfio^® (elranatamab-bcmm)
• Tecvayli^® (teclistamab-cqyv)

As of early 2024, one BiTE is approved to treat certain forms of acute lymphocytic leukemia:^1,10

• Blincyto^® (blinatumomab)

As of early 2024, several BiTEs are approved to treat certain forms of non-Hodgkin lymphoma:^5,11-13

• Columvi™ (glofitamab)
• Epkinly™ (epcoritamab)
• Lunsumio™ (mosunetuzumab)

Other BiTEs are approved for certain other forms of cancer, and others are under investigation in clinical trials.²

What are the possible side effects of bi-specific T-cell engagers?

Side effects depend on the specific BiTE. Some common side effects may include:^7-13

• Changes in sense of taste
• Nail problems
• Muscle and joint pain
• Tiredness
• Weight loss and low appetite
• Dry mouth or skin
• Fever
• Trouble swallowing
• Infections
• Diarrhea
• Nausea
• Headache

The following BiTE drugs have boxed warnings, the strictest warning from the US Food and Drug Administration (FDA):^7-13

• Talvey
• Elrexfio
• Tecvayli
• Blincyto
• Columvi
• Epkinly
• Lunsumio

They have this warning because of the risk of cytokine release syndrome (CRS). This is an aggressive immune response. CRS is common but can be serious or life-threatening. Talk to your doctor if you notice symptoms of CRS, such as:^7-10

• Fever
• Dizziness or lightheadedness
• Chills
• Difficulty breathing
• Feeling anxious
• Headache
• Fast heartbeat

Talvey, Elrexfio, Tecvayli, Blincyto, and Epkinly also have a boxed warning because of the risk of neurologic problems. Depending on the specific medicine, symptoms may include:^7-10,12

• Headache
• Confusion or disorientation
• Trouble speaking or writing
• Shaking
• Numbness or tingling
• Feeling sleepy or trouble sleeping
• Trouble thinking
• Seizures
• Muscle weakness
• Memory loss
• Burning or throbbing pain

Many BiTEs are only available through a restricted program. This program makes sure you and your doctor understand the risks.^7-9

These are not all the possible side effects of BiTEs used to treat multiple myeloma or acute lymphocytic leukemia. Talk to your doctor about what to expect. You should also call your doctor if you have any changes that concern you during treatment.

Other things to know about bi-specific T-cell engagers

Before starting treatment with any BiTE drugs, tell your doctor if you:^7-13

• Have any current infections
• Have a history of neurological problems
• Have a history of infusion reactions
• Have had previous radiation treatment
• Have any upcoming vaccine appointments
• Have any allergies
• Are pregnant or planning to become pregnant
• Are breastfeeding or planning to breastfeed

Receive BiTEs as your doctor prescribes. They will talk to you about your treatment schedule. Some BiTEs are given as an injection under your skin (subcutaneous injection). The injection may be in your stomach area or thigh. Depending on the specific medicine and schedule, you may get a dose every week or every few weeks.^7-13

Before beginning treatment, tell your doctor about all your health conditions. Tell them about other drugs, vitamins, or supplements you take. This includes over-the-counter drugs.