Johnson & Johnson’s Tecvayli regimen improves survival in multiple myeloma trial

Johnson & Johnson 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 or Darzalex Faspro, bortezomib, and dexamethasone in patients with relapsed/refractory multiple myeloma -or RRMM – who received one to three prior lines of therapy. At almost three years follow-up, the combination of Tecvayli and Darzalex Faspro met the primary endpoint of progression-free survival, or PFS, and the results were statistically significant and superior to standard of care. The secondary endpoint of overall survival – OS – was also statistically significant at this first interim analysis. MajesTEC-3 is the first Phase 3 study to show that the combination of Tecvayli and Darzalex Faspro offers better PFS and OS than current standards of care. Based on these statistically significant results at the interim analysis, the IDMC recommended unblinding the study. The overall safety profile of Tecvayli administered in combination with Darzalex Faspro was consistent with the known safety profiles of each monotherapy.