Johnson & Johnson has reported groundbreaking results from the phase 3 MajesTEC-3 study, highlighting the potential of TECVAYLI (teclistamab) combined with DARZALEX subcutaneous (daratumumab SC) as early as second line therapy for patients with relapsed/refractory multiple myeloma (RRMM).
The combination demonstrated an 83.4 percent reduction in risk of disease progression or death compared to standard regimens after nearly three years of follow-up. More than 90 percent of patients who were progression-free at six months remained progression-free at three years.
The study compared teclistamab plus daratumumab SC with daratumumab SC and dexamethasone alongside pomalidomide or bortezomib. Results were presented at the American Society of Hematology Annual Meeting and published in The New England Journal of Medicine.
Maria-Victoria Mateos, Consultant Physician in Hematology at University Hospital of Salamanca, said: “The combination of teclistamab and daratumumab SC offers remarkable efficacy and safety consistent with their known profiles, and, alongside robust infection management protocols, an opportunity to improve patient outcomes across academic and community settings.
“It has the potential to change the standard of care as a steroid-sparing combination regimen suited for outpatient administration on the familiar daratumumab SC schedule.”
Ester in ’t Groen, EMEA Therapeutic Area Head Haematology at Johnson & Johnson Innovative Medicine, explained: “The unprecedented results we’re seeing reflect our commitment to get in front of cancer, strengthening evidence on how the novel combination of teclistamab and daratumumab SC could broaden effective options for people living with relapsed/refractory multiple myeloma as early as second line, where the medical need for durable outcomes remains high.”
Sen Zhuang, Vice President, Oncology Clinical Research at Johnson & Johnson Innovative Medicine, said: “With these data, we are entering a new era in treating multiple myeloma with the first immunotherapy combination to demonstrate superior overall survival as early as second line versus standard of care.”
The US Food and Drug Administration has granted Breakthrough Therapy Designation for the regimen, with applications also submitted to regulatory bodies in Brazil.
