Janssen’s TECVAYLI® (teclistamab) Achieves Superior Progression-Free and Overall Survival Versus Standard of Care as Early as First Relapse in Multiple Myeloma

Janssen USA

Overview

New data from the MajesTEC-9 study revealed that TECVAYLI® (teclistamab) demonstrated superior progression-free and overall survival compared to standard of care in patients with relapsed/refractory multiple myeloma (RRMM). Teclistamab is an off-the-shelf bispecific T-cell engager antibody therapy for patients with 1–3 prior lines of therapy, including a CD38 monoclonal antibody and lenalidomide. These results further reinforce the role bispecific antibodies play in earlier decision-making for RRMM treatment.

In Depth

Key Findings

Janssen announced new data from the MajesTEC-9 study demonstrating that TECVAYLI® (teclistamab), a bispecific T-cell engager antibody, achieved superior progression-free survival (PFS) and overall survival (OS) compared to standard of care in patients with relapsed/refractory multiple myeloma (RRMM). These results underscore the significant role teclistamab can play in earlier treatment lines for multiple myeloma.

Technical / Clinical Details

TECVAYLI® (teclistamab) is an ‘off-the-shelf’ bispecific T-cell engager antibody that targets both B-cell maturation antigen (BCMA), expressed on multiple myeloma cells, and the CD3 receptor, expressed on T-cells. This bispecific engagement redirects T-cells to myeloma cells, activating a potent anti-tumor immune response that leads to tumor cell killing. The MajesTEC-9 study enrolled RRMM patients who had received 1–3 prior lines of therapy, including a CD38 monoclonal antibody and lenalidomide. Data showed a statistically significant improvement in PFS for the teclistamab arm compared to the standard of care arm (median XX months vs. XX months, HR XX), with a similar superiority in OS (median XX months vs. XX months, HR XX). The most common adverse events included cytokine release syndrome (CRS, mostly Grade 1/2) and infections, consistent with its known safety profile.

Background & Context

Multiple myeloma is a blood cancer characterized by the malignant proliferation of plasma cells, becoming difficult to treat as it progresses. Patients who are relapsed/refractory after multiple lines of therapy face a poor prognosis and urgently need new treatment options. Bispecific antibodies have shown remarkable efficacy in RRMM treatment through their innovative mechanism of redirecting T-cells to tumors. While TECVAYLI® is already approved for patients with multiple prior lines of therapy, these new data suggest its potential for use in earlier treatment lines, which could further improve patient outcomes.

Strategic Significance & Outlook

The positive results from the MajesTEC-9 study indicate that TECVAYLI® has the potential to further advance the treatment paradigm for patients with relapsed/refractory multiple myeloma. This data will support regulatory submissions to establish teclistamab as an earlier treatment option, which, if approved, would allow more patients to benefit from this innovative immunotherapy. This further raises expectations for the expanding role of bispecific antibodies in hematologic malignancies and for dramatic improvements in patient progression-free and overall survival.