Talvey Scores a Phase 3 Breakthrough; MonumenTAL-3 Meets Key Goals
During a plenary session at EHA 2026, Johnson & Johnson presented results from the phase 3 MonumenTAL-3 trial. Researchers evaluated Talvey alongside Darzalex Faspro in patients with relapsed or refractory multiple myeloma who had previously received at least one line of therapy.
The company tested the regimen both with and without Bristol Myers Squibb’s Pomalyst. According to Johnson & Johnson, the Talvey-based combinations reduced the risk of disease progression or death by up to 72% compared with Darzalex Faspro, pomalidomide, and dexamethasone. Furthermore, the treatment reduced the risk of death by as much as 53%.
Survival Gains Turn Heads; Talvey Combination Outperforms Standard Therapy
After approximately twenty four months of follow-up, investigators reported improvements in progression-free survival and overall survival.
Patients receiving Talvey-based combinations achieved progression-free survival rates of up to 81.3%, while patients receiving standard therapy reached 51.2%. Meanwhile, overall survival rates climbed to as high as 89.2% in the investigational groups compared with 79.1% in the control arm.
Among patients who received Darzalex Faspro, Talvey, and Pomalyst, progression-free survival reached 81.3%. In contrast, patients treated with Darzalex Faspro and Talvey without Pomalyst achieved a progression-free survival rate of 77.6%.
J&J Targets Earlier Disease Stages; Multiple Myeloma Strategy Expands
Johnson & Johnson also reported statistically significant improvements across several secondary endpoints. Researchers observed stronger overall response rates and improved minimal residual disease outcomes among patients receiving the Talvey-based regimens.
Importantly, the company said MonumenTAL-3 became the first study to demonstrate superior progression-free survival with a GPRC5D-targeting bispecific antibody combination in earlier-line multiple myeloma.
Positive Data Fuels Regulatory Push; Earlier-Line Approval Comes Into Focus
Yusri Elsayed, M.D., Ph.D., Johnson & Johnson’s Global Therapeutic Area Head of Oncology, said the findings support the company’s strategy of moving bispecific antibody combinations into earlier lines of therapy.
A $14 Billion Franchise Evolves; Darzalex Powers J&J’s Oncology Ambitions
The latest results follow another recent milestone for Johnson & Johnson. Earlier this year, the FDA approved Tecvayli plus Darzalex for patients with relapsed or refractory multiple myeloma after at least one previous line of treatment.
Tecvayli targets BCMA, while Talvey targets GPRC5D. Both therapies originally received approval for heavily pretreated patients, yet recent clinical data continue to support movement into earlier treatment settings.
Johnson & Johnson remains heavily invested in multiple myeloma, the second most common blood cancer. Darzalex generated approximately $14 billion in annual sales last year and remains central to the company’s oncology growth strategy. The MonumenTAL-3 results further reinforce the growing importance of bispecific antibody combinations in the future of multiple myeloma treatment.
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Source: Fiercepharma.Com