MajesTEC-3 Puts a New Immunotherapy Doublet in the Spotlight
Johnson & Johnson has reported what it describes as unprecedented phase 3 results from the MajesTEC-3 study, positioning TECVAYLI (teclistamab) in combination with DARZALEX subcutaneous (daratumumab SC) as a potentially practice-changing option as early as second-line therapy for patients living with relapsed or refractory multiple myeloma (RRMM).
In the headline findings, the company said the teclistamab–daratumumab SC combination delivered an 83.4% reduction in the risk of disease progression or death versus standard regimens, based on nearly three years of follow-up.
The durability signal stood out as well: more than 90% of patients who were progression-free at six months remained progression-free at three years, according to the reported data.
The phase 3 comparison pitted teclistamab plus daratumumab SC against established daratumumab-based combinations: daratumumab SC and dexamethasone alongside either pomalidomide or bortezomib.
Results were presented at the American Society of Hematology (ASH) Annual Meeting and published in The New England Journal of Medicine, underlining the weight the dataset is being given by the clinical community and the wider oncology field.
Clinical leaders involved in the conversation around the study are already framing the readout in practical terms – how it might fit into day-to-day care, not just academic discussion.
A Consultant Physician in Haematology at the University Hospital of Salamanca said the combination of teclistamab and daratumumab SC offers remarkable efficacy with safety that is consistent with the therapies’ known profiles.
Furthermore, the physician also highlighted the importance of robust infection management protocols, pointing to the potential for improved outcomes not only in specialist centres, but across both academic and community settings.
That focus on real-world delivery is also central to how Johnson & Johnson is describing the regimen’s possible role. The Salamanca consultant added that the data suggest the combination could change the standard of care as a steroid-sparing approach, suited to outpatient administration and delivered on the familiar daratumumab SC schedule – a detail that matters to patients and services alike, particularly when capacity and treatment burden are part of the equation.
From a company perspective, Johnson & Johnson Innovative Medicine is positioning MajesTEC-3 as more than another incremental improvement in a crowded treatment landscape.
The EMEA Therapeutic Area Head for Haematology at Johnson & Johnson Innovative Medicine said the results reflect the organisation’s commitment to get in front of cancer, and strengthen the evidence base for how the novel combination of teclistamab and daratumumab SC could broaden effective options for people with RRMM as early as second line – an earlier setting where, the company emphasised, the medical need for durable outcomes remains high.
Perhaps the boldest framing came from the company’s Vice President, Oncology Clinical Research at Johnson & Johnson Innovative Medicine, who said the data mark entry into a new era of multiple myeloma treatment – citing the combination as the first immunotherapy combination to demonstrate superior overall survival as early as second line compared with standard of care.
Regulators are already part of the story. Johnson & Johnson noted that the US Food and Drug Administration has granted Breakthrough Therapy Designation for the teclistamab and daratumumab SC regimen, and that applications have also been submitted to regulatory bodies in Brazil, signalling an intent to move quickly from conference presentation to broader patient access – subject, as always, to review outcomes and local decisions.
Conclusion
Taken together, the MajesTEC-3 readout places TECVAYLI (teclistamab) plus DARZALEX subcutaneous (daratumumab SC) firmly on the radar as a second-line contender in RRMM, backed by an 83.4% reported reduction in the risk of progression or death and a durability signal extending to three years for those progression-free at six months.
With publication in The New England Journal of Medicine, presentation at ASH, supportive clinician commentary on outpatient feasibility and infection management, and regulatory momentum led by FDA Breakthrough Therapy Designation, Johnson & Johnson is making the case that this steroid-sparing, schedule-familiar combination could help redefine expectations for earlier relapse treatment – where long-lasting benefit remains one of the biggest unmet needs. News Credits: Immunotherapy combination shows unprecedented results in multiple myeloma
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