- TECVAYLI® monotherapy shows a 71% reduction in disease progression risk and 40% reduction in death risk.
- The MajesTEC-9 study involved patients refractory to anti-CD38 and lenalidomide therapies.
- TECVAYLI® is a bispecific T-cell engager antibody therapy.
- The study's interim analysis led to unblinding based on strong data.
Study Overview
The Phase 3 MajesTEC-9 study evaluated TECVAYLI® (teclistamab-cqyv) monotherapy in patients with relapsed/refractory multiple myeloma, predominantly refractory to anti-CD38 therapy and lenalidomide. The study compared TECVAYLI® to standard care regimens, including pomalidomide, bortezomib, and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd).
Key Findings
TECVAYLI® demonstrated a 71% reduction in the risk of disease progression or death and a 40% reduction in the risk of death. The safety profile was manageable with no new safety concerns identified. The study's interim analysis confirmed these results, leading to the recommendation to unblind the study.
Patient Population
Participants in the study had received 1 to 3 prior lines of therapy and were predominantly refractory to anti-CD38 monoclonal antibodies (85%) and lenalidomide (79%). Over 90% were refractory to their last line of therapy.
Implications
The results suggest TECVAYLI® could transform treatment for multiple myeloma, offering significant progression-free and overall survival benefits. The findings build on previous MajesTEC-3 study results, which showed benefits of TECVAYLI® combined with DARZALEX FASPRO® in patients sensitive to anti-CD38 therapy.
