STOCKHOLM, Sweden, June 13, 2026
Johnson & Johnson has announced groundbreaking results from the pivotal Phase 3 MonumenTAL-3 clinical trial, demonstrating that the combination of TALVEY® (talquetamab-tgvs) and DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj), with or without pomalidomide, significantly improved outcomes for patients with relapsed or refractory multiple myeloma (RRMM). Presented at the 2026 European Hematology Association (EHA) Annual Meeting and simultaneously published in the New England Journal of Medicine, the findings represent the first Phase 3 evidence showing a GPRC5D-targeting bispecific antibody combination can outperform current standards of care in earlier-line multiple myeloma treatment. The study reinforces the growing role of bispecific immunotherapies in reshaping cancer treatment and could lead to expanded treatment options for patients whose disease has returned or become resistant to therapy.
Phase 3 Trial Delivers Significant Survival Benefits
The MonumenTAL-3 study evaluated two investigational regimens: TALVEY plus DARZALEX FASPRO (Tal-D) and TALVEY plus DARZALEX FASPRO with pomalidomide (Tal-DP), compared with the established regimen of daratumumab, pomalidomide, and dexamethasone (DPd). Results showed that the TALVEY-based combinations reduced the risk of disease progression or death by up to 72%, while reducing the risk of death by as much as 53% compared with the standard treatment approach.
After a median follow-up of approximately two years, patients receiving Tal-DP achieved a progression-free survival rate of 81.3%, while those receiving Tal-D achieved 77.6%, compared with only 51.2% in the standard treatment group. Overall survival rates were equally impressive, reaching 89.2% for Tal-DP and 87.9% for Tal-D, compared with 79.1% for DPd. Researchers also reported significantly higher overall response rates, complete response rates, and minimal residual disease negativity, indicating deeper and more durable treatment responses among patients receiving the investigational combinations.
Bispecific Antibody Strategy Advances Earlier-Line Treatment
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The results highlight the growing importance of bispecific antibodies in the management of multiple myeloma. TALVEY targets GPRC5D, a protein highly expressed on myeloma cells while showing limited expression on healthy B cells, allowing the therapy to direct immune responses toward cancer cells while minimizing broader immune system damage.
By combining TALVEY with the established anti-CD38 therapy DARZALEX FASPRO, researchers created a dual-targeted immunotherapy approach capable of producing stronger anti-cancer activity. Importantly, the study enrolled 864 heavily pretreated patients who had previously received lenalidomide and proteasome inhibitors, making the strong efficacy results particularly meaningful for a difficult-to-treat population. Experts believe these findings could accelerate the movement of bispecific therapies into earlier stages of treatment, where achieving deeper remissions may significantly improve long-term outcomes.
Regulatory Submissions Underway Following Positive Results
Safety findings remained generally consistent with the known profiles of the individual therapies, with manageable rates of cytokine release syndrome and neurotoxicity. Most adverse events were low grade and rarely led to treatment discontinuation. Johnson & Johnson reported that severe infections were lower in the Tal-D treatment arm than in the standard-care group, further supporting the regimen’s favorable benefit-risk profile.
Following the positive Phase 3 data, the company has already submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration and a Type II variation application to the European Medicines Agency seeking approval of the combination for patients with RRMM after at least one prior line of therapy. If approved, the regimen could become a new standard treatment option, further strengthening Johnson & Johnson’s leadership in multiple myeloma and advancing the use of innovative bispecific immunotherapies in clinical oncology.
Source: Johnson and Johnson press release
