Data from Phase 3 MonumenTAL-3 study show "impressive results on talquetamab plus daratumumab as a potential new bispecific combination for patients with relapsed or refractory multiple myeloma," says Dr. Peter M. Voorhees, who presented the findings at the EHA 2026 Congress.
On Saturday, June 13, data and results of the MonumenTAL-3 trial (Abstract #S100) were presented during the Plenary Abstracts Session of the 2026 European Hematology Association (EHA) Congress. The study was simultaneously published in The New England Journal of Medicine.
Presenting the findings was Peter M. Voorhees, MD, Hematologist at the Atrium Health Levine Cancer Center and Professor of Medicine at Wake Forest University School of Medicine.
The Phase 3 MonumenTAL-3 study evaluated the efficacy and safety of talquetamab plus subcutaneous daratumumab, with or without pomalidomide (Tal-D and Tal-DP), compared with daratumumab, pomalidomide, and dexamethasone (DPd) in patients with relapsed or refractory multiple myeloma (RRMM) who had received at least one prior line of therapy.
Summary and results
The ongoing randomized Phase 3 trial enrolled 864 patients with RRMM previously treated with lenalidomide and a proteasome inhibitor. After a median follow-up of 24.6 months, results showed significant improvement in progression-free survival (PFS) with Tal-DP and Tal-D compared with DPd, with hazard ratios of 0.28 (95% CI, 0.20–0.40) and 0.33 (95% CI, 0.24–0.46), respectively (both p<0.0001). The 24-month PFS rates were 81.3% for Tal-DP and 77.6% for Tal-D.
Compared with DPd, both Tal-DP and Tal-D showed higher overall response rates (88.2% and 88.5% vs 77.6%), complete response or better rates (71.1% and 68.9% vs 34.5%), and MRD-negative complete response or better rates (52.3% and 46.3% vs 15.9%). Clinically meaningful improvement in overall survival was reported for Tal-DP (HR 0.47; 95% CI, 0.30–0.73) and Tal-D (HR 0.51; 95% CI, 0.33–0.78) compared with DPd. The 24-month overall survival rates were 89.2% for Tal-DP and 87.9% for Tal-D.
The overall safety profiles of the Tal-DP and Tal-D treatment arms were reported to be consistent with the known safety profiles of the individual monotherapies. Grade 3/4 treatment-emergent adverse events occurred in 94.9% of patients receiving Tal-DP, 74.8% receiving Tal-D, and 91.5% receiving DPd. Infections occurred in 87.3%, 84.3%, and 83.0% of patients in the Tal-DP, Tal-D, and DPd groups, respectively. Grade 3/4 infections occurred in 37.7%, 29.2%, and 42.2% of patients, respectively, and the study reported a reduced risk of severe infections in the Tal-D arm compared with DPd. Cytokine release syndrome occurred in 67.8% of Tal-DP-treated and 58.4% of Tal-D-treated patients and was predominantly Grade 1–2.
In the Phase 3 MonumenTAL-3 study, talquetamab plus daratumumab, with or without pomalidomide, showed significant improvement in progression-free survival compared with DPd in patients with relapsed or refractory multiple myeloma after at least one prior line of therapy. Both talquetamab-containing regimens also showed higher overall response rates, complete response or better rates, and MRD-negative complete response or better rates, and clinically meaningful improvement in overall survival compared with DPd. The overall safety profiles of the Tal-DP and Tal-D treatment arms were reported to be consistent with the known safety profiles of the individual monotherapies, and a reduced risk of severe infections was reported in the Tal-D arm compared with DPd.
“The impressive results from this study point to the promise of Talvey (talquetamab) plus Darzalex Faspro (daratumumab) as a potential new bispecific combination for patients with relapsed or refractory multiple myeloma,” said Dr. Voorhees, in a press release from Johnson & Johnson.
References:
Abstract EHA-2503 Short: S100. PHASE 3, RANDOMIZED STUDY OF TALQUETAMAB (TAL) PLUS DARATUMUMAB (DARA) ± POMALIDOMIDE (POM) VS DARA PLUS POM AND DEXAMETHASONE (DPD) IN RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM): MONUMENTAL-3. European Hematology Association (EHA) 2026 Congress. Plenary Abstracts Session, June 13, 2026.
Mina R, Beksac M, Rodríguez-Otero P, Chen W, Mateos MV, Li J, Moreau P, Cohen YC, Min CK, Jelinek T, Ye JC, Magen H, Rubinstein SM, Fu W, Hungria V, Cengiz Seval G, Farias JS, Radocha J, Maral S, Turgut M, Koh Y, O'Leary D, Schmidt Filho J, Thertulien R, An G, Huang SY, Grosicki S, Tyczyńska A, Banerjee R, Pianko MJ, Martínez-López J, Steckiewicz P, Maruyama D, Fukushima K, Oriol A, Lopez Pardo J, Goldschmidt H, Pawlyn C, Perrot A, Zamagni E, Dimopoulos MA, Rasche L, Tolbert J, Terry W, Courtoux C, Liu X, Vasey SY, Connors K, Festa M, Heuck C, Langlois A, O'Rourke L, Zhou J, Qin X, Lu J, Gong J, Vieyra D, Voorhees PM; MonumenTAL-3 Investigators. Talquetamab-Daratumumab in Relapsed or Refractory Myeloma. N Engl J Med. 2026 Jun 13. doi: 10.1056/NEJMoa2604657.
New TALVEY® (talquetamab-tgvs) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) data demonstrate the strength of a bispecific combination in earlier-line relapsed or refractory multiple myeloma. Johnson & Johnson press release. June 13, 2026.