Johnson & Johnson's Phase 3 Study: TECVAYLI® and DARZALEX FASPRO® Show Promise for Relapsed/Refractory Multiple Myeloma
- Phase 3 MajesTEC-3 study shows TECVAYLI® plus DARZALEX FASPRO® reduces disease progression risk by 83% in RRMM.
- 91% of patients progression-free at six months remained so at three years.
- Study compares TECVAYLI® plus DARZALEX FASPRO® to DARZALEX FASPRO® with dexamethasone and either pomalidomide or bortezomib.
- TECVAYLI® plus DARZALEX FASPRO® shows higher complete response and overall survival rates at three years.
Study Overview
The Phase 3 MajesTEC-3 study evaluates the efficacy and safety of TECVAYLI® (teclistamab-cqyv) combined with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for patients with relapsed/refractory multiple myeloma (RRMM). The study compares this combination to DARZALEX FASPRO® with dexamethasone and either pomalidomide or bortezomib.
Key Findings
Results indicate an 83% reduction in the risk of disease progression or death with TECVAYLI® plus DARZALEX FASPRO® compared to standard regimens, with a hazard ratio of 0.17. At nearly three years of follow-up, 91% of patients who were progression-free at six months remained so at three years.
Secondary Endpoints
Significant improvements were observed in treatment response rates, minimal residual disease (MRD)-negativity, overall survival (OS), and time to worsening of symptoms. TECVAYLI® plus DARZALEX FASPRO® showed higher complete response rates (81.8% vs. 32.1%) and overall response rates (89.0% vs. 75.3%) compared to standard care.
Survival and Quality of Life
Overall survival favored the TECVAYLI® plus DARZALEX FASPRO® combination, with a hazard ratio of 0.46. At three years, OS rates were 83.3% for the combination versus 65.0% for standard care. Patients also remained symptom-free longer, indicating improved quality of life outcomes.
Source: J&J