On October 25, 2022, the US Food and Drug Administration (FDA) granted approval for Johnson & Johnson’s Tecvayli® (teclistamab-cqyv) for the treatment of adult patients with relapsed or refractory multiple myeloma. This approval is specifically for patients who have previously received four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug, and anti-CD38 monoclonal antibody.

An additional indication was approved on February 20, 2024, when the FDA approved the supplemental Biologics License Application (sBLA) for Tecvayli. This approval allows for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W) in patients with relapsed or refractory multiple myeloma who have achieved and maintained a complete response (CR) or better for a minimum of six months. This approval provides increased flexibility in dosing schedules for appropriate patients with a weight-based regimen.

Multiple myeloma is an incurable cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow. In multiple myeloma, these plasma cells proliferate rapidly, replacing normal cells in the bone marrow with tumors.

According to the National Cancer Institute, it is estimated that there will be 35,780 new cases of multiple myeloma in 2024, with a 5-year survival rate of 61.1%. The rate of new cases of myeloma is 7.2 per 100,000 men and women per year, with a death rate of 3.0 per 100,000 men and women per year. These rates are age-adjusted and based on cases from 2017-2021 and deaths from 2018-2022.

In light of the urgent demand for effective treatments, we will be examining the findings from the MajesTEC-5 Phase II trial and MajesTEC-4 Phase III trial. These two research studies focus on patients who have recently been diagnosed with multiple myeloma and are undergoing treatment to both induce remission and maintain it. The results of these trials demonstrate the potential of Tecvaldi as a viable option for newly diagnosed patients, showing promising effectiveness and a manageable safety profile. These significant findings were presented as oral presentations at the 2024 American Society of Hematology (ASH) Annual Meeting.

Below is a brief overview of the studies:

A Phase 2 Study to Evaluate Safety and Efficacy of Teclistamab- and Talquetamab-based Combination Regimens in Participants with Newly Diagnosed Transplant Eligible Multiple Myeloma

GMMG-HD10 /​ DSMM-XX /​ 64007957MMY2003, MajesTEC-5 (HD10/DSMMXX)

Study Details | Source

  • Sponsor: University of Heidelberg Medical Center
  • Phase 2 Study to Evaluate Safety and Efficacy of Teclistamab- and Talquetamab-based Combination Regimens in Participants with Newly Diagnosed Transplant Eligible Multiple Myeloma
  • Interventions:
    • Drug: Teclistamab (Tec)
    • Drug: Daratumumab
    • Drug: Dexamethasone
    • Drug: Lenalidomide
    • Drug: Bortezomib
    • Drug: Talquetamab
  • Primary Outcomes Measures:
    • Number of incidence and severity of adverse events [safety and tolerability]
      • through study completion, up to 28 months

Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation (MajesTEC-4)

Study Details | Source

  • Sponsor: Stichting European Myeloma Network
  • This is a multicenter, randomized, open-label, Phase 3 study in participants with newly diagnosed multiple myeloma to evaluate the benefits of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.
  • Interventions:
    • Drug: Teclistamab
    • Drug: Lenalidomide
  • Primary Outcomes Measures:
    • Progression Free Survival (PFS)
      • PFS is defined as the time from the date of randomization to the date of disease progression (as assessed by IMWG criteria) or death due to any cause, whichever occurs first.
      • Timing: from randomization to the date of disease progression or death (approximately up to 8 years)

The data suggests that Tecvayli can enhance current standard treatment regimens when used in combination, particularly in earlier stages of treatment. Ongoing research in the Phase 3 MajesTEC-7 study aims to further explore the benefits of combination therapies, with enrollment currently open to participants. The implications of these trials are significant, as they have the potential to influence future guidelines and clinical practices in the field of multiple myeloma treatment. We are excited about the possibilities that Tecvayli presents and look forward to further advancements in the field.

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