In a plenary session at the 2026 European Hematology Association (EHA) annual meeting in Stockholm, Johnson & Johnson brought to the world stage a reminder of its status as a leading developer of multiple myeloma treatments.
The company spotlighted results from its MonumenTAL-3 phase 3 study, which added its GPRC5D bispecific antibody, Talvey, to the mainstay melanoma drug Darzalex Faspro in patients with relapsed or refractory multiple myeloma who had tried at least one prior line of therapy. When used with or without Bristol Myers Squibb’s Pomalyst (pomalidomide), the regimen cut the risk of disease progression or death by up to 72% and proved a clinically meaningful reduction of up to 53% in the risk of death compared with standard Darzalex Faspro, Pomalyst and dexamethasone (DPd), J&J said in a June 13 press release.
The trial showed a progression-free survival rate of up to 81.3% for the Talvey combos after 24 months compared with the standard-of-care regimen’s 51.2%, and an overall survival rate of up to 89.2% compared with 79.1% for DPd.
Those who added Pomalyst on top of their Darzalex-Talvey treatment combo experienced a higher progression-free survival rate of 81.3%, while the others who solely used J&J’s regimen experienced a progression-free survival rate of 77.6%, according to the company.
The different treatment arms were closer on the overall survival side, where Darzalex and Talvey made for an overall survival rate of 87.9% and Darzalex, Talvey and Pomalyst came in at 89.2% after around two years of follow-up. J&J also clocked statistically significant improvements across other secondary endpoints, such as the overall response rate and minimal residual disease measures.
The study is the first to prove superior progression-free survival with a GPRC5D bispecific antibody combo in earlier-line multiple myeloma, the company pointed out in its release. Along with its presentation at EHA, the results were also published in the New England Journal of Medicine.
“The MonumenTAL-3 findings underscore our commitment to bringing bispecific combinations into earlier lines of therapy, building on the strength and breadth of Johnson & Johnson’s multiple myeloma portfolio,” J&J’s global therapeutic head of oncology, Yusri Elsayed, M.D. Ph.D. explained in a statement. “These results add to our growing body of evidence across bispecific antibodies and reinforce our strategy of advancing differentiated immunotherapies to better match the right therapy to the right patient at each stage of disease.”
Given the phase 3 win, J&J said it is working with global regulatory authorities to bring the treatment option to eligible patients “as quickly as possible.” The drugmaker has already submitted a label expansion bid to move the regimen up to the earlier treatment line.
A potential earlier use for Talvey and Darzalex would mirror another multiple myeloma combo win for J&J in March, when the FDA approved Tecvayli and Darzalex for patients with released or refractory multiple myeloma after at least one prior line of therapy. That nod was ushered in by an “unsolicited” FDA Commissioner’s National Priority Voucher (CNPV) that was granted after the drug combo proved it can reduce the risk of death by 54% over Darzalex and dexamethasone, R&D chief John Reed said on a January call.
Tecvayli and Talvey are both newer multiple myeloma bispecific antibodies in J&J’s product portfolio, but Tecvayli targets the B-cell maturation antigen instead of GPRC5D. Talvey was the first GPRC5D-targeted therapy to win approval and followed Tecvalyi as J&J’s second bispecific multiple myeloma therapy. Both drugs were initially approved for heavily pre-treated patients.
Tecvalyi, with its recent expansion and another nod that allows its use under a biweekly dosing regimen, has so far proved itself more of a sales driver than Talvey, garnering $670 million in 2025 sales. Talvey, for its part, brought in $463 million for the year.
J&J has long held a focus on multiple myeloma, the second most common blood cancer. By the end of the decade, the company looks to have a treatment regimen in every line of multiple myeloma therapy, becoming “the only pharmaceutical company with the full spectrum of offerings” for the disease, J&J oncology exec Biljana Naumovic said in 2023.
Darzalex on its own has made a significant name for itself in myeloma, earning $14 billion in full-year sales last year through its multiple indications as part of combination therapies and as a monotherapy. Given its commercial success, the drug and its subcutaneous version, Darzalex Faspro, represent a core pillar in J&J’s ambitions to deliver $50 billion in oncology-specific sales by the end of the decade.