Tecvayli Cuts Progression Risk 71% and Deaths 40% in Phase 3 Myeloma Trial

Overview

• The MajesTEC-9 study randomized 614 patients whose disease worsened after Darzalex- or Revlimid-based frontline regimens to receive Tecvayli or standard combinations.
• At the first planned analysis, an independent committee confirmed benefit and recommended unblinding based on a PFS hazard ratio of 0.29 and an OS hazard ratio of 0.60.
• Tecvayli outperformed investigator-choice regimens such as pomalidomide/bortezomib/dexamethasone (PVd) or carfilzomib/dexamethasone (Kd) in a population largely refractory to anti-CD38 therapy and lenalidomide.
• Reported tolerability was manageable with established mitigation protocols, with no new safety signals observed compared with prior experience.
• Johnson & Johnson said it will present full Phase 3 results at upcoming medical meetings and engage the FDA and other regulators on potential earlier-line use.