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.
NIH announced Jan. 29 that “Basic Experimental Studies Involving Humans,” also called BESH, will no longer be considered clinical trials and will therefore no longer be subject to the requirements under the NIH definition of a clinical trial, including registration and reporting requirements in ClinicalTrials.gov.
