How it Works
Teclistamab is the first bispecific antibody BCMA-directed CD3 T cell engager to be used in relapsed or refractory multiple myeloma. An off-the-shelf product given by subcutaneous injection (a shot) that links BCMA, a target on myeloma cells, with T cells (one type of white blood cell) to kill myeloma cells. The drug was approved based on results from the Phase II MajesTEC-1 clinical trial that included 110 patients.
How it’s Administered
For subcutaneous injection only. The recommended dosage to reduce the risk of CRS and other adverse reactions is step-up doses of 0.06 mg/kg (Day 1) and 0.3 mg/kg (day 4), followed by 1.5 mg/kg, starting day 7, once weekly until disease progression or unacceptable toxicity.
Who Should Take Teclistamab
Teclistamab (TECVAYLI®) was approved as a single drug therapy for patients who have demonstrated disease progression on the last therapy and received four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody.
Who Shouldn’t Take Teclistamab
- Allergic reactions may occur with the infusion of Teclistamab.
- Teclistamab should not be administered to patients with active infections or inflammatory disorders.
- Based on the mechanism of action Teclistamab can cause severe congenital disabilities or embryo-fetal death. Teclistamab should not be used by pregnant women or those who could become pregnant while taking the drug. It's advised for women with reproductive potential to use effective contraception during treatment with Teclistamab and for 5 months after the last dose.
The most common side effects of taking Teclistamad in the Phase I/II study include:
- Cytokine release syndrome (72% with .6% being Grade 3, with no occurrences with higher severity). Teclistamab can cause a very common side effect called cytokine release syndrome or CRS, which can be severe or fatal. Symptoms of CRS include fever, difficulty breathing, dizziness or light-headedness, nausea, headache, fast heartbeat, low blood pressure, or fatigue.
- Neutropenia (64%)
- Anemia (55%)
- Infection (37% with respiratory tract infections being most common)
- Liver toxicity (34%, with Grade 3 or 4 AST elevations in 1.2% and ALT elevations in 1.8%)
- Neurotoxic events were low grade (15% total with 14% being Grade 1 or 2)
- Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) (2.43%). Watch this video to better understand ICANS.
Because there is a possibility of CRS and neurological toxicity, the drug will include a Risk Evaluation and Mitigation Strategy (REMS) program.
Commonly Being Tested With
- Immunomodulators agents: Lenalidomide (as induction and maintenance), and Pomalidomide.
- Proteasome Inhibitors: Bortezomib.
- Monoclonal Antibodies: Daratumumab.
- Bispecific Antibodies: Talquetamab.
- Other therapies: PD-1 inhibitors.
Date last updated: 11/8/22