- The Phase 3 MajesTEC-3 study evaluates TECVAYLI® and DARZALEX FASPRO® in relapsed/refractory multiple myeloma.
- The study met primary and secondary endpoints for progression-free and overall survival.
- The combination targets BCMA and CD38, enhancing immune response against myeloma cells.
- The safety profile aligns with known monotherapy profiles.
Study Overview
The Phase 3 MajesTEC-3 study investigates the efficacy and safety of TECVAYLI® (teclistamab-cqyv) combined with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in patients with relapsed/refractory multiple myeloma (RRMM) who have undergone one to three prior lines of therapy. The study compares this combination to standard treatments involving DARZALEX FASPRO with either pomalidomide and dexamethasone (DPd) or bortezomib and dexamethasone (DVd).
Key Findings
After nearly three years of follow-up, the combination of TECVAYLI and DARZALEX FASPRO met the primary endpoint of progression-free survival (PFS) and showed statistically significant results superior to standard care. The secondary endpoint of overall survival (OS) was also statistically significant at the first interim analysis.
Mechanism of Action
TECVAYLI and DARZALEX FASPRO work together to target BCMA and CD38, enhancing the immune system's ability to eliminate myeloma cells. This combination is the first in a Phase 3 study to demonstrate improved PFS and OS over current standards of care.
Safety Profile
The safety profile of the TECVAYLI and DARZALEX FASPRO combination is consistent with the known safety profiles of each drug when used as monotherapy.
Next Steps
The results of the MajesTEC-3 study will be presented at a future major medical meeting and shared with health authorities. The Independent Data Monitoring Committee (IDMC) has recommended unblinding the study based on these significant interim results.
