The combination of Tecvayli (teclistamab-cqyv), a bispecific T-cell engager antibody therapy, and Darzalex Faspro (daratumumab and hyaluronidase-fihj), a subcutaneous CD38-directed antibody, met the primary endpoint of progression-free survival and the results were statistically significant and superior to standard of care in relapsed/refractory multiple myeloma who received one to three prior lines of therapy, according to data from the phase III MajesTEC-3 study. This was compared to the investigator’s choice of Darzalex Faspro, pomalidomide, and dexamethasone or Darzalex Faspro, bortezomib, and dexamethasone.
In the phase II CAR-PRISM (PRecision Intervention Smoldering Myeloma) clinical trial, the first to investigate CAR T-cell therapy in patients with high-risk smoldering multiple myeloma, all 20 patients were negative for minimal residual disease within two months of treatment and remained MRD-negative after a median of 15.3 months of follow-up.
