Bispecific T-Cell engager (BiTE) therapy is a novel immunotherapy approach that helps the body’s immune system target cancer cells.
Antibodies are naturally produced by the body in response to infections, neutralizing the foreign agents by binding to and destroying them in a specific key/lock fashion. Because antibodies have a two-arm structure, they can be modified to attach to two different cell markers at once. In the case of bispecific T-Cell engagers, the therapy is designed in the lab to leverage the antibodies two arm-structure in order to bind to both malignant cells and T-cells in the body.
T-cells are part of the immune system and help the body fight infection and cancer. Cancer often hides by becoming invisible to the T-cells. Unmodified or natural antibodies are unable to recruit T-cells to directly fight the cancer, so these artificially developed antibodies provide a workaround to assist in this process.
After being created in the lab, BiTEs are typically infused into the body. In BiTEs designed to treat myeloma, one end of the antibody binds to the myeloma cells and the other binds to the T-cells.
Once infused, the BiTEs can grab onto both the myeloma cells and the body’s own immune cells, helping to activate them to kill the myeloma cells. One way to think about it is that the BiTEs act like keys that open up specific locks in the body, activating an immune response.
The process of using cell markers and the immune system is a form of precision medicine which can allow targeted treatments to be delivered directly where they are needed, avoiding areas where they are not.
FDA Approval and Clinical Trials
In October 2022, the U.S. Food and Drug Administration (FDA) approved the first bispecific t-cell engager for patients with relapsed or refractory multiple myeloma. This drug, known as teclistamab (TECVAYLI), is given via a subcutaneous injection (under the skin) for patients who previously received four or more prior lines of therapy.
In August 2023, the FDA approved two more BiTE therapies, talquetamab (Talvey) and elranatanab (Elrexfio), for patients with relapsed or refractory multiple myeloma patients who have received at least four prior lines of therapy. These therapies are both also given via a subcutaneous injection.
Research and clinical trials for other BiTE therapies is ongoing in an effort to continue to evaluate other potential alternative treatments for patients. We have a number of these clinical trials open at Weill Cornell Medicine and NewYork-Presbyterian Hospital. Learn more about our open trials here.
While treatment with BiTE therapy is promising, there are certain risks associated with this approach. Currently, those who receive BiTE therapy will be monitored for any side effects. Possible side effects include:
Cytokine release syndrome (CRS): Sometimes T cells release chemicals called cytokines that ramp up the immune system. Noticing high fever, chills, trouble breathing, severe nausea, dizziness, headaches, a fast heartbeat, or extreme fatigue after receiving BiTE therapy, may indicate CRS and should be communicated to the care team.
Other side effects: Fever, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea have also been noted in some patients.