CHICAGO, Illinois, May 29, 2026
Johnson & Johnson has reported landmark results from the pivotal Phase 3 MajesTEC-9 study, demonstrating that TECVAYLI® (teclistamab-cqyv) significantly improved both progression-free survival (PFS) and overall survival (OS) compared with standard-of-care regimens in patients with relapsed or refractory multiple myeloma (RRMM). Presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in the New England Journal of Medicine, the findings reinforce TECVAYLI’s growing role in earlier treatment settings and further establish bispecific antibody therapies as a transformative force in hematologic oncology. The study showed remarkable survival benefits in heavily pretreated patients, including those resistant to anti-CD38 therapies and lenalidomide, highlighting the potential for TECVAYLI to reshape treatment strategies as early as the second line of therapy.
Phase 3 MajesTEC-9 Delivers Significant Survival Benefits
The randomized Phase 3 MajesTEC-9 study compared TECVAYLI monotherapy against investigator-selected standard treatments, including pomalidomide, bortezomib and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd), in patients who had received one to three prior lines of therapy. The enrolled population represented a particularly challenging treatment group, with 85% of patients refractory to anti-CD38 monoclonal antibodies, 79% refractory to lenalidomide, and more than 90% resistant to their most recent therapy.
Despite these challenges, TECVAYLI demonstrated exceptional efficacy. The treatment achieved a 71% reduction in the risk of disease progression or death, corresponding to a hazard ratio of 0.29, while also reducing the risk of death by 40% compared with standard therapies. These improvements in both progression-free survival and overall survival represent a significant advance for patients facing limited treatment options after relapse. Researchers also reported statistically significant improvements across all major secondary endpoints, reinforcing the robustness of the clinical benefit observed in the study.
Deep and Durable Responses Strengthen Clinical Profile
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One of the most compelling findings from MajesTEC-9 was the depth and durability of responses achieved with TECVAYLI. Nearly two-thirds of treated patients (65.9%) achieved a complete response or better, compared with only 16.8% in the standard-of-care group. These findings suggest that TECVAYLI not only delays disease progression but also delivers profound disease control capable of driving long-term clinical benefit.
TECVAYLI is a first-in-class bispecific T-cell engager antibody that simultaneously targets B-cell maturation antigen (BCMA) on myeloma cells and CD3 receptors on T cells, enabling the immune system to identify and destroy malignant plasma cells. The innovative mechanism has already transformed treatment options for advanced multiple myeloma, and the latest data suggest that its benefits can be extended into earlier stages of disease management. Importantly, the median duration of treatment for TECVAYLI was nearly double that of standard therapies, indicating sustained disease control and prolonged patient benefit.
Expanding the Role of Bispecific Antibodies in Myeloma Care
Safety findings from the study remained generally consistent with the known profile of TECVAYLI. While infections and cytokine release syndrome were observed, most events were manageable using established monitoring and mitigation strategies. The majority of cytokine release syndrome cases were low grade, resolved successfully, and did not lead to treatment discontinuation. These results support the feasibility of integrating TECVAYLI into broader clinical practice settings while maintaining an acceptable benefit-risk profile.
The positive MajesTEC-9 data arrive shortly after the approval of TECVAYLI plus DARZALEX FASPRO®, further strengthening Johnson & Johnson’s leadership position in multiple myeloma treatment. Regulatory submissions are already under review by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to expand TECVAYLI’s use into earlier treatment lines. As multiple myeloma remains one of the most complex hematologic malignancies worldwide, the ability to deliver meaningful survival improvements at first relapse could significantly alter treatment paradigms and provide new hope for thousands of patients facing disease progression after initial therapy.
Source: Johnson & Johnson press release
