Johnson & Johnson has reported strong phase 3 results combining its bispecific antibody Talvey with Darzalex Faspro in earlier-stage multiple myeloma patients.
The data emerged from J&J’s MonumenTAL-3 phase 3 study, which earned a plenary presentation spot at the European Haematology Association congress in June 2026.
The trial enrolled patients with relapsed or refractory multiple myeloma who had received at least one prior line of therapy, representing an earlier treatment population than previous studies.
Talvey, J&J’s GPRC5D bispecific antibody, was combined with Darzalex Faspro with or without Bristol Myers Squibb’s Pomalyst, a drug also known as pomalidomide.
The regimen cut the risk of disease progression or death by up to 72% compared with standard Darzalex Faspro, Pomalyst and dexamethasone, known as DPd.
The combination also demonstrated a clinically meaningful reduction of up to 53% in the risk of death compared with the standard DPd regimen, according to J&J’s press release.
Progression-free survival after 24 months reached up to 81.3% for the Talvey-based combinations, against 51.2% for the standard-of-care comparator arm.
Overall survival rates also favoured the new combinations, with the three-drug Talvey regimen delivering an 89.2% rate compared with 79.1% for the DPd control group after approximately two years of follow-up.
The Darzalex and Talvey doublet without Pomalyst produced an overall survival rate of 87.9%, while adding Pomalyst pushed that figure to 89.2%, with the two arms performing more closely on this measure than on progression-free survival.
J&J reported statistically significant improvements across secondary endpoints including overall response rate and minimal residual disease measures, further reinforcing the dataset’s clinical breadth.
The company described MonumenTAL-3 as the first trial to demonstrate superior progression-free survival with a GPRC5D bispecific antibody combination in earlier-line multiple myeloma, marking a notable competitive milestone.
Johnson & Johnson has submitted a supplemental biologics licence application to the FDA and a Type II variation to the European Medicines Agency, signalling its ambition to expand approved indications for the combination.