{
  "abstract": "Background: Tal (anti-GPRC5D bispecific antibody) has shown deep, durable responses in late-line RRMM with a favorable infection profile. Its B-cell–sparing mechanism supports combination with Dara and Pom, potentially enhancing efficacy in earlier lines. We report efficacy and safety from a pre-planned interim analysis of MonumenTAL-3 (NCT05455320) comparing Tal-DP and Tal-D vs DPd in RRMM after ≥1 prior LOT. Methods: Phase 3 study randomizing pts with RRMM after ≥1 prior LOT including lenalidomide (Len) and a proteasome inhibitor 1:1:1 to Tal-DP, Tal-D, or DPd. Primary endpoint was IRC-assessed PFS for Tal-DP vs DPd and Tal-D vs DPd. Secondary endpoints included response, ≥CR, MRD-negative ≥CR (10−5; NGS), OS, and safety. Results: Overall, 864 pts were randomized (Tal-DP, N=287; Tal-D, N=287; DPd, N=290). Baseline characteristics were balanced across arms. Median age was 64.0 yrs (range 30–88), median prior LOT was 2 (range 1–8); 11.8% were anti-CD38 (nearly all Dara) exposed; 85.1% and 93.4% were refractory to Len or last LOT, respectively; 30.9% had high risk cytogenetics. At 24.6 mo median follow-up, Tal-DP and Tal-D significantly improved PFS vs DPd (HRs 0.28 [0.20–0.40], P<0.0001 and 0.33 [0.24–0.46], P<0.0001. 24-mo PFS rates favored Tal-DP (81.3% [75.8–85.7]) and Tal-D (77.6% [71.7–82.5]) vs DPd (51.2% [44.8–57.1]) PFS benefit was consistent across clinically relevant subgroups. ORRs (88.2%, 88.5%, 77.6%) ≥CR rates (71.1%, 69.0%, 34.5%) and MRD-negative ≥CR rates (52.3%, 46.3%, 15.9%) were significantly higher for Tal-DP and Tal-D vs DPd, respectively. OS HRs (95% CI) vs DPd were 0.47 (0.30–0.73; P=0.0006) for Tal-DP and 0.51 (0.33–0.78; P=0.0015) for Tal-D. At data cutoff, 70.3% (Tal-DP), 69.7% (Tal-D) and 47.3% (DPd) of pts remained on study tx. AEs were manageable and consistent with expectations for each agent; overall AE rates (gr 3-4, gr 5) Tal-DP (96.7%, 1.8%), Tal-D (78.8%, 4.0%), DPd (95.8%, 4.6%). AEs leading to discontinuation (d/c) of all study tx occurred in 10.5% (Tal-DP), 8.0% (Tal-D), and 6.7% (DPd). Rates of cytopenias (any gr, gr 3-4) were: Tal-DP (91.7%, 87.7%), Tal-D (68.2%, 51.8%) and DPd (91.9%, 89.0%). Infection rates (any gr, gr 3-4, gr 5) were: Tal-DP (87.3%, 37.0%, 0.7%) Tal-D (84.3%, 27.7%, 1.5%), and DPd (83.0%, 41.0%, 1.8%). With Tal-DP and Tal-D, respectively, CRS (any gr: 67.8%; 58.4%) and ICANS (any gr: 2.9%; 1.8%) were mostly gr 1-2. Any gr GPRC5D-related AEs with Tal-DP, Tal-D and DPd, respectively, included taste changes (72.8%; 74.8%; 3.9%) and decreased weight (45.7%; 38.3%; 7.4%); most events were gr 1-2 and did not lead to Tal d/c. Ataxia/balance disorders (gr 1-2, gr 3) with Tal-DP (11.6%, 2.9%), Tal-D (10.2%, 2.2%) and DPd (0.4%, 0%) were primarily low gr (none gr ≥4); events led to Tal d/c in 4.7% (Tal-DP) and 2.2% (Tal-D). Conclusions: Tal-DP and Tal-D demonstrated a significant and profound PFS benefit vs DPd, clinically meaningful OS improvements and gr ≥3 infection rates similar to or lower than DPd. Tal was combinable, with low rates of tx d/c. Efficacy appeared numerically better with Tal-DP vs Tal-D but with a higher gr 3-4 cytopenia rate, as expected with Pom. Tal-D with or without Pom represents a new standard of care for RRMM as early as 2L across all practice settings.",
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  "affiliations": [
    "Atrium Health/Levine Cancer Institute, Wake Forest University School of Medicine, Charlotte, NC, United States",
    "Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, United States",
    "Cancer Center Clínica Universidad de Navarra, Cima, Pamplona, Spain",
    "Beijing Chaoyang Hospital, Capital Medical University, Chaoyang District, Beijing, China",
    "Hospital Clínico Universitario de Salamanca, Servicio de Salud de Castilla y León (SACYL), Salamanca, Castile and León, Spain",
    "Department of Hematology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China",
    "Hematology Clinic, University Hospital Hôtel-Dieu, Nantes, France",
    "Tel-Aviv Sourasky (Ichilov) Medical Center, Tel Aviv, Israel; Gray Faculty of Medical & Health Sciences, Tel Aviv University, Tel Aviv, Israel",
    "Seoul St. Mary’s Hospital, The Catholic University of Korea, Seoul, South Korea",
    "Department of Hematooncology, University Hospital Ostrava, Ostrava, Czech Republic; Department of Hematooncology, Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic",
    "MD Anderson Cancer Center, University of Texas, Houston, TX, United States",
    "Chaim Sheba Medical Center, Ramat-Gan, Israel; Sackler Faculty of Medical and Health Sciences, Tel Aviv University, Israel",
    "Division of Hematology and Oncology, Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, United States",
    "Department of Hematology, Shanghai Fourth People’s Hospital, School of Medicine, Tongji University, 200434 Shanghai, China",
    "Clínica Médica São Germano, São Paulo, SP, Brazil",
    "Ankara University Faculty of Medicine, Department of Hematology and Oncology, Ankara University, Ankara, Türkiye",
    "Liga Paranaense de Combate ao Câncer (LPCC), Curitiba, PA, Brazil",
    "Hematology, University Hospital Hradec Kralove, Faculty of Medicine in Hradec Kralove, Charles University, Czech Republic",
    "Medipol Mega University Hospital, Bağcılar, İstanbul, Türkiye",
    "Ondokuz Mayıs University, Samsun, Türkiye",
    "Seoul National University Hospital, Seoul National University, Jongno-gu, Seoul, South Korea",
    "University of Minnesota, Minneapolis, MN, United States",
    "A.C. Camargo Cancer Center, São Paulo, SP, Brazil",
    "Novant Health Cancer Institute, Winston-Salem, NC, United States",
    "Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China",
    "National Taiwan University Hospital, National Taiwan University College of Medicine, Zhongzheng District, Taipei, Taiwan",
    "Department of Cancer Prevention, Medical University of Silesia, Katowice, Poland",
    "Medical University of Gdańsk, Department of Hematology and Transplantology, University Clinical Center Gdańsk, Department of Hematology and Transplantology, Gdańsk, Poland",
    "Fred Hutchinson Cancer Center, Seattle, United States",
    "University of Michigan Health, Ann Arbor, United States",
    "Hospital Universitario 12 de Octubre, imas12/Complutense University of Madrid/CNIO/Madrid, Spain",
    "Holy Cross Cancer Center, Department of Hematology and Bone Marrow Transplantation, Kielce, Poland",
    "Cancer Institute Hospital, Japanese Foundation for Cancer Research (JFCR), Koto-ku, Tokyo, Japan",
    "The University of Osaka Graduate School of Medicine, Suita, Japan",
    "Hospital Universitari Germans Trias i Pujol (HUGTiP), Institut Català de la Salut (ICS), Badalona, Barcelona, Spain",
    "l’Hospital de la Santa Creu i Sant Pau, Barcelona, Catalonia, Spain",
    "Internal Medicine V, Hematology, Oncology and Rheumatology, GMMG Study Group, Heidelberg University Hospital and National Center for Tumor Diseases, Heidelberg, Germany",
    "The Institute of Cancer Research, London, UK, and The Royal Marsden NHS Foundation Trust, London, United Kingdom",
    "Université de Toulouse, Centre Hospitalier Universitaire de Toulouse, Service Hématologie, IUCT Oncopole, Toulouse, France",
    "University of Bologna, Bologna, Italy"
  ],
  "article_type": null,
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  "author_total": 59,
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  "doi": "10.1016/j.htct.2026.107913",
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  "published": "2026-10-23",
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  "title": "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",
  "title_text": "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",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T13:43:37Z",
  "url": "https://research.draconitic.com/paper/53bvk78va8qbf",
  "venue": "Hematology, Transfusion and Cell Therapy",
  "versions": []
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