Johnson & Johnson has reported encouraging Phase 3 results for a combination therapy featuring TALVEY (talquetamab-tgvs) and DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), highlighting the growing potential of bispecific antibody-based treatment strategies in earlier-line relapsed or refractory multiple myeloma (RRMM).
The findings come from the MonumenTAL-3 study, which evaluated TALVEY plus DARZALEX FASPRO, with or without pomalidomide, in patients who had previously received at least one line of therapy. According to the results, the investigational regimens significantly reduced the risk of disease progression or death by up to 72% compared with the current standard treatment regimen of daratumumab, pomalidomide, and dexamethasone. The combination also demonstrated a clinically meaningful reduction in the risk of death of up to 53%.
After 24 months of follow-up, progression-free survival rates reached as high as 81.3%, compared with 51.2% for standard therapy. Overall survival rates were also favorable, reaching 89.2% in the TALVEY-based treatment groups versus 79.1% in the control arm.
Researchers noted that the safety profile remained consistent with the known effects of the individual medicines, while severe infections were reduced compared with expectations for heavily treated myeloma populations. The data reinforce the possibility of moving potent bispecific antibody combinations into earlier stages of treatment, where they may provide greater long-term benefit for patients.
The MonumenTAL-3 trial marks an important milestone as the first Phase 3 study to demonstrate superior progression-free survival with a GPRC5D-targeting bispecific antibody combination in earlier-line multiple myeloma. The results were presented at the 2026 European Hematology Association (EHA) Congress and have prompted regulatory submissions in both the United States and Europe seeking expanded use of the regimen.
If approved, the TALVEY-DARZALEX combination could offer a new treatment option for patients whose disease has returned or stopped responding to previous therapies, further strengthening Johnson & Johnson’s expanding multiple myeloma portfolio.
