What is TECVAYLI?
TECVAYLI, also known as teclistamab, is a B-cell maturation antigen (BCMA)–directed bispecific T-cell engaging antibody. TECVAYLI is manufactured by Janssen Biotech.
Uses
How is TECVAYLI used?
TECVAYLI is used as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
What patients can benefit from TECVAYLI?
In a phase 1/2 clinical trial, TECVAYLI was shown to be effective in:
TECVAYLI redirects CD3-positive T cells to BCMA-expressing myeloma cells to induce the killing of myeloma cells.
TECVAYLI is used as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
What patients can benefit from TECVAYLI?
In a phase 1/2 clinical trial, TECVAYLI was shown to be effective in:
- Patients who received at least four prior therapies
- Patients who were refractory to a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody (also known as triple-class refractory)
- Patients who previously received high-dose chemotherapy and stem cell transplant
TECVAYLI redirects CD3-positive T cells to BCMA-expressing myeloma cells to induce the killing of myeloma cells.
Dosing and Administration
How is TECVAYLI administered?
TECVAYLI is given under the skin (subcutaneously) in two step-up doses on day 1 and day 4, followed by the first treatment on day 7 at a dose of 1.5 mg/kg. TECVAYLI is given once weekly thereafter until disease progression.
TECVAYLI is given under the skin (subcutaneously) in two step-up doses on day 1 and day 4, followed by the first treatment on day 7 at a dose of 1.5 mg/kg. TECVAYLI is given once weekly thereafter until disease progression.
Side Effects
What are TECVAYLI side effects?
The most common side effects seen in a clinical study with TECVAYLI included:
How are side effects of TECVAYLI managed?
Approximately 1 to 3 hours before each TECVAYLI step-up dose, patients receive corticosteroids, diphenhydramine (antihistamine), and acetaminophen (fever reducer). Because of the risk of side effects, patients should be hospitalized for 48 hours after administration of each dose in the TECVAYLI step-up dosing schedule.
Management guidelines will be followed if cytokine release syndrome or neurologic toxicity is suspected.
The most common side effects seen in a clinical study with TECVAYLI included:
- Fever
- Cytokine release syndrome
- Musculoskeletal pain
- Injection-site reaction
- Fatigue
- Upper respiratory infection
- Nausea
- Headache
- Pneumonia
- Diarrhea
- Low lymphocyte counts
- Low neutrophil counts (neutropenia)
- Low white blood cell counts
- Low hemoglobin (anemia)
- Low platelets
- Hypogammaglobulinemia
- Immune effector cell–associated neurotoxicity syndrome
- Cytokine release syndrome
- Neurotoxicity, called immune effector cell-associated neurotoxicity syndrome (ICANS)
- Infections
- Liver toxicity
- Low neutrophil counts (neutropenia)
How are side effects of TECVAYLI managed?
Approximately 1 to 3 hours before each TECVAYLI step-up dose, patients receive corticosteroids, diphenhydramine (antihistamine), and acetaminophen (fever reducer). Because of the risk of side effects, patients should be hospitalized for 48 hours after administration of each dose in the TECVAYLI step-up dosing schedule.
Management guidelines will be followed if cytokine release syndrome or neurologic toxicity is suspected.
Clinical Studies
What have TECVAYLI clinical trials shown?
The approval of TECVAYLI was based on results from the MajesTEC-1 study, a single-arm, multicenter study to determine the efficacy of TECVAYLI in patients with relapsed or refractory multiple myeloma who had received at least three prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.
The MajesTEC-1 study enrolled 165 patients who received step-up doses of 0.06 mg/kg and 0.3 mg/kg of TECVAYLI followed by TECVAYLI at 1.5 mg/kg subcutaneously once weekly thereafter until disease progression or unacceptable toxicity. The overall response rate was 63%. The median time to first response was 1.2 months, and the median duration of response was 18.4 months.
How is TECVAYLI currently being studied in myeloma?
TECVAYLI is being evaluated in several clinical trials in the U.S.
Created October 2022
Please visit the sponsor’s official patient site for up-to-date information on TECVAYLI.
The approval of TECVAYLI was based on results from the MajesTEC-1 study, a single-arm, multicenter study to determine the efficacy of TECVAYLI in patients with relapsed or refractory multiple myeloma who had received at least three prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.
The MajesTEC-1 study enrolled 165 patients who received step-up doses of 0.06 mg/kg and 0.3 mg/kg of TECVAYLI followed by TECVAYLI at 1.5 mg/kg subcutaneously once weekly thereafter until disease progression or unacceptable toxicity. The overall response rate was 63%. The median time to first response was 1.2 months, and the median duration of response was 18.4 months.
How is TECVAYLI currently being studied in myeloma?
TECVAYLI is being evaluated in several clinical trials in the U.S.
- Phase 3 trial includes:
- TECVAYLI in combination with Darzalex (Janssen Biotech) and Revlimid (Bristol Myers Squibb) in patients with newly diagnosed multiple myeloma (MajesTEC-7; NCT05552222)
- TECVAYLI in combination with Darzalex vs Darzalex-Pomalyst (Bristol Myers Squibb)-dex or Darzalex-Velcade (Takeda Oncology)-dex in patients with relapsed or refractory multiple myeloma (MajesTEC-3; NCT05083169)
- Phase 2 trial includes:
- TECVAYLI vs Revlimid-dex in patients with high-risk smoldering multiple myeloma (Immuno-PRISM; NCT05469893)
Created October 2022
Please visit the sponsor’s official patient site for up-to-date information on TECVAYLI.
