Tecvayli Associated With Reduced Risk of Myeloma Progression or Death

Among patients with relapsed or refractory multiple myeloma, Tecvayli (teclistamab-cqyv) monotherapy was associated with a 71% reduction in the risk of disease progression or death compared with those receiving standard of care, as well as a 40% reduction in the risk of death, it has been announced.

Johnson & Johnson announced in a news release that the phase 3 MajesTEC-9 study of Tecvayli successfully met its goals, showing that the monotherapy significantly reduced the risk of death and disease worsening for patients with relapsed or refractory multiple myeloma as early as the second line of treatment.

Data from MajesTEC-9 with Tecvayli in Myeloma

These findings were confirmed during the first pre-specified interim analysis. The data were considered so strong that an independent data monitoring committee recommended unblinding the study.

The study focused on a population that is often difficult to treat. Among the participants, 85% were refractory to anti-CD38 monoclonal antibodies and 79% were refractory to Revlimid (lenalidomide). Furthermore, more than 90% of the patients enrolled were refractory to their most recent line of therapy. The results suggest that Tecvayli may help address the significant unmet need for effective therapies in earlier stages of the disease, specifically for those whose cancer has become resistant to standard first-line medications.

MajesTEC-9 Trial Details

The MajesTEC-9 study is a phase 3 trial that is designed to evaluate the efficacy and safety of Tecvayli monotherapy. It compared this treatment against two different standard-of-care regimens: Pomalyst (pomalidomide), Velcade (bortezomib) and dexamethasone (PVd) or Kyprolis (carfilzomib) and dexamethasone (Kd).

The trial enrolled patients with relapsed or refractory multiple myeloma who had previously received between one and three lines of therapy. To participate, all patients must have previously received an anti-CD38 monoclonal antibody and Revlimid.

Tecvayli is a bispecific T-cell engager antibody. This type of therapy works by binding to two different targets: the CD3 receptor on T cells (part of the immune system) and the B-cell maturation antigen (BCMA) found on the surface of multiple myeloma cells. By connecting these two, the therapy activates the immune system to target the cancer cells. It is administered as a subcutaneous treatment and is considered an "off-the-shelf" or ready-to-use therapy.

The study builds on previous research, such as the MajesTEC-3 trial, which looked at Tecvayli in combination with other drugs for patients who had not yet been treated with anti-CD38 therapy. Together, these studies aim to show how the treatment can be used across different stages of a patient's experience with multiple myeloma.

Safety of Tecvayli Monotherapy

According to the topline results, the safety profile of Tecvayli monotherapy in the MajesTEC-9 study was consistent with what has been observed in previous studies of the drug. No new safety concerns were identified during the trial.

Researchers reported that the side effects associated with the treatment were clinically manageable when using established medical protocols. This is an important consideration for patients and caregivers, as multiple myeloma often requires long-term management and well-tolerated therapy options.

Previously, the U.S. Food and Drug Administration (FDA) approved a reduced dosing schedule for certain patients using Tecvayli. Patients who achieve and maintain a complete response for at least six months may be eligible for a dose of 1.5 mg/kg every two weeks. More than 20,800 patients worldwide have been treated with the therapy since its initial approval in 2022. The full safety and efficacy data from the MajesTEC-9 trial will be presented at an upcoming medical meeting and submitted to global health authorities for review.

Reference

1. “TECVAYLI® monotherapy demonstrates superior progression-free and overall survival versus standard of care as early as first relapse in patients with multiple myeloma predominantly refractory to anti-CD38 therapy and lenalidomide,” by Johnson & Johnson. News release; July 14, 2026.

Editor's note: This article is for informational purposes only and is not a substitute for professional medical advice, as your own experience will be unique. Use this article to guide discussions with your oncologist. Content was generated with AI, reviewed by a human editor, but not independently verified by a medical professional.

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