NEW BRUNSWICK (dpa-AFX) - Johnson & Johnson (JNJ) on Tuesday announced new data from the investigational Phase 3 MajesTEC-3 study that demonstrate the potential of TECVAYLI plus DARZALEX FASPRO as early as second line for patients with relapsed/refractory multiple myeloma.
Results show an 83% reduction in the risk of disease progression or death compared to standard regimens at nearly three-years follow-up, 95 percent confidence interval. Ninety-one percent of patients who were progression-free at six months remained progression-free at three years.
The study evaluated the efficacy and safety of the investigational immunotherapy combination of TECVAYLI plus DARZALEX FASPRO versus DARZALEX FASPRO and dexamethasone with either pomalidomide or bortezomib in patients with RRMM who have received 1-3 prior lines of therapy.
'The combination of TECVAYLI and DARZALEX FASPRO offers remarkable efficacy, a well-characterized safety profile with robust infection management protocols, and 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 DARZALEX schedule,' said Maria-Victoria Mateos.
In the study, TECVAYLI plus DARZALEX FASPRO and standard of care comparators had similar rates of Grade 3/4 (95.1% vs. 96.6%) treatment-emergent adverse events (TEAE).
Infections were observed with TECVAYLI and DARZALEX FASPRO (any grade, 96.5%; Grade 3/4, 54.1%) and DPd/DVd control (any grade 84.1%; Grade 3/4 43.4%).
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