Johnson & Johnson's Phase 3 MajesTEC-3 Trial Becomes First To Show Statistically Significant Progression-Free And Overall Survival Benefit For Investigational TECVAYLI + DARZALEX FASPRO Combo In Relapsed/Refractory Multiple Myeloma As Early As Second Line; IDMC Recommended Unblinding The Study Based On Statistically Significant Results

Author: Benzinga Newsdesk | October 16, 2025 07:14am

First Phase 3 study (MajesTEC-3) of an investigational combination to show benefit in PFS and OS in relapsed/refractory multiple myeloma as early as second line

 

Independent Data Monitoring Committee (IDMC) recommended unblinding the study based on statistically significant results

RARITAN, N.J., Oct. 16, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ), the worldwide leader in multiple myeloma therapies, today announced positive topline results from the investigational Phase 3 MajesTEC-3 study. The study evaluates the efficacy and safety of TECVAYLI® (teclistamab-cqyv) in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) versus investigator's choice of DARZALEX FASPRO, pomalidomide, and dexamethasone (DPd) or DARZALEX FASPRO, bortezomib, and dexamethasone (DVd) in patients with relapsed/refractory multiple myeloma (RRMM) who received one to three prior lines of therapy.1

At almost three years follow-up, the combination of TECVAYLI and DARZALEX FASPRO met the primary endpoint of progression-free survival (PFS) (the time a treatment keeps a patient's cancer from progressing or death) and the results were statistically significant and superior to standard of care.2 The secondary endpoint of overall survival (OS) was also statistically significant at this first interim analysis.2

Posted In: JNJ