Johnson and Johnson, a global leader in therapies for multiple myeloma, has reported positive topline findings from the Phase three MajesTEC nine clinical study evaluating TECVAYLI, also known as teclistamab cqyv, as a standalone treatment. The study showed that TECVAYLI significantly lowered the risk of disease progression or death by 71 percent and reduced the risk of death by 40 percent when compared with commonly used standard treatments. The results were observed in patients whose disease no longer responded to anti CD38 therapies and lenalidomide, two widely used treatments in multiple myeloma. Data also confirmed that TECVAYLI delivered better progression free survival and overall survival outcomes than standard care as early as second line therapy.

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Multiple myeloma is a complex blood cancer that frequently returns despite treatment advances. While outcomes have improved in recent years, many patients still face limited options, particularly those whose disease becomes resistant to commonly prescribed therapies. This challenge is especially pronounced earlier in the treatment pathway for patients who no longer respond to anti CD38 antibodies and lenalidomide, highlighting the need for additional effective and tolerable therapies.

The MajesTEC nine study focused on patients with relapsed or refractory multiple myeloma who had previously received one to three lines of treatment. All participants had been treated with both an anti CD38 monoclonal antibody and lenalidomide, and the majority were resistant to these therapies. Most patients were also refractory to their most recent line of treatment. The study compared TECVAYLI monotherapy with standard regimens that included pomalidomide, bortezomib, and dexamethasone or carfilzomib and dexamethasone.

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These findings build on earlier Phase three MajesTEC three results published in The New England Journal of Medicine, which demonstrated strong survival benefits when TECVAYLI was combined with DARZALEX FASPRO in patients who were either new to or still responsive to anti CD38 therapy. Together, the two studies address treatment needs across different stages of disease resistance.

Roberto Mina, M.D., Associate Professor at the Winship Cancer Institute of Emory University and formerly Assistant Professor at the University of Turin in Italy, explained that the MajesTEC nine results highlight the potential of TECVAYLI to change how multiple myeloma is treated earlier in the disease course. He noted that the therapy shows meaningful improvements in both progression free and overall survival as a single agent, even in patients with difficult to treat disease, and supports its role as a key option as early as first relapse.

Patients treated with TECVAYLI experienced a statistically significant reduction in the risk of progression or death, as well as a notable reduction in the risk of death alone. The safety profile of TECVAYLI remained consistent with previous findings and was considered manageable using established treatment guidelines. No new safety concerns were identified, and the strength of the interim data led the independent monitoring committee to recommend unblinding the study.

Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Head of Oncology at Johnson and Johnson Innovative Medicine, stated that the MajesTEC nine results reflect the company’s continued focus on expanding treatment options for patients at every stage of multiple myeloma. He emphasized that TECVAYLI, as a first in class bispecific T cell engager therapy, represents another step toward improving long term outcomes and redefining what is possible for patients living with this disease.

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