Johnson & Johnson Announces Positive Phase 3 Results for TECVAYLI® Monotherapy in Early Relapse Multiple Myeloma
Johnson & Johnson a global leader in oncology innovation and multiple myeloma treatment, has announced encouraging topline results from the Phase 3 MajesTEC-9 clinical trial evaluating TECVAYLI® (teclistamab-cqyv) as a standalone therapy. The study demonstrated a substantial clinical benefit for patients with relapsed or refractory multiple myeloma, particularly those whose disease no longer responds to widely used anti-CD38 therapies and lenalidomide.
According to the topline findings, TECVAYLI® monotherapy reduced the risk of disease progression or death by 71 percent compared with standard-of-care regimens. In addition, treatment with TECVAYLI® resulted in a 40 percent reduction in the risk of death. These outcomes translate into significantly improved progression-free survival (PFS) and overall survival (OS), with benefits observed as early as the second line of therapy—an important milestone for patients facing limited treatment options after early relapse.
Multiple myeloma is a chronic and incurable blood cancer characterized by repeated cycles of remission and relapse. Although treatment advances over the past decade have improved outcomes, many patients eventually become resistant to cornerstone therapies, including anti-CD38 monoclonal antibodies and immunomodulatory drugs such as lenalidomide. Once resistance develops, prognosis worsens considerably, underscoring the urgent need for new, effective, and tolerable therapies that can be used earlier in the disease course.
The MajesTEC-9 study was specifically designed to address this unmet need. It evaluated TECVAYLI® monotherapy in patients with relapsed or refractory multiple myeloma who had received one to three prior lines of therapy. All participants had previously been treated with both an anti-CD38 monoclonal antibody and lenalidomide, reflecting a real-world population with high-risk disease features. Importantly, the majority of patients enrolled were refractory to these prior therapies, with 85 percent resistant to anti-CD38 agents and 79 percent refractory to lenalidomide. More than 90 percent of participants were refractory to their most recent treatment regimen.
In the randomized trial, TECVAYLI® was compared with established standard-of-care combinations, including pomalidomide, bortezomib, and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd). Patients receiving TECVAYLI® experienced a statistically significant and clinically meaningful improvement in outcomes. The hazard ratio for progression or death was 0.29, indicating a strong protective effect, while the hazard ratio for overall survival was 0.60, confirming a meaningful reduction in mortality risk.
TECVAYLI® is a bispecific T-cell engager antibody that redirects the body’s immune system to target and destroy multiple myeloma cells by binding both CD3 on T cells and BCMA on malignant plasma cells. Its off-the-shelf availability distinguishes it from more complex cellular therapies, making it accessible to a broader range of patients, including those treated in community oncology settings.
The safety profile observed in MajesTEC-9 was consistent with prior studies of TECVAYLI®. Adverse events were manageable using established monitoring and mitigation protocols, and no new safety signals were identified. Based on the strength and consistency of the efficacy and safety data, the Independent Data Monitoring Committee recommended unblinding the study following the first pre-specified interim analysis.
Experts believe these results reinforce TECVAYLI®’s potential to reshape the multiple myeloma treatment landscape. Clinicians emphasize that having a highly effective immunotherapy option available earlier in the disease course could significantly improve long-term outcomes for patients who relapse after first-line treatment.
The MajesTEC-9 findings also complement earlier results from the Phase 3 MajesTEC-3 trial, published in The New England Journal of Medicine. That study demonstrated significant improvements in progression-free and overall survival when TECVAYLI® was used in combination with DARZALEX FASPRO® in patients who were naïve or sensitive to anti-CD38 therapy. Together, the MajesTEC-3 and MajesTEC-9 studies span a broad spectrum of disease stages, addressing critical gaps across the multiple myeloma treatment continuum.
Johnson & Johnson noted that the MajesTEC-9 results highlight the company’s ongoing commitment to advancing innovative immunotherapies for hematologic malignancies. TECVAYLI® represents a cornerstone of the company’s multiple myeloma portfolio, alongside other transformational therapies aimed at extending survival and improving quality of life for patients.
The full dataset from the MajesTEC-9 trial will be presented at an upcoming major medical conference and submitted to global regulatory authorities. If confirmed in final analyses, these findings could support expanded use of TECVAYLI® as a monotherapy option earlier in the treatment pathway, offering new hope to patients facing relapse after standard therapies.
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