{
  "abstract": "Background: Tec-Dara demonstrated significant improvement in PFS (primary endpoint) and all key secondary endpoints (including ≥ CR, minimal residual disease [MRD] negativity [neg], and OS) vs Dara + dexamethasone + pomalidomide or bortezomib (DPd/DVd) in the primary analysis of the phase 3 MajesTEC-3 trial (NCT05083169) in early-line RRMM. PFS/OS favored Tec-Dara across all subgroups, and the safety profile was well-managed. Aims: We report in-depth, post-hoc subgroup analyses of MajesTEC-3 (PFS, MRD-neg CR rate) in pts with and without high-risk cytogenetic abnormalities (HRCAs) and functional high-risk (FHR) status. Methods: Pts had 1-3 prior lines of therapy (LOT) including a proteasome inhibitor and lenalidomide (lenalidomide refractory if only 1 prior LOT) with progressive disease (PD) on/after last LOT. Pts were randomized 1:1 to Tec-Dara or DPd/DVd. Tec-Dara pts received 28-day cycles (C) of Tec (C1-2: 1.5 mg/kg QW [C1 dose preceded by approved step-up dose schedule]; C3-6: 3 mg/kg Q2W; C7+: 3 mg/kg Q4W) with Dara; steroid-sparing after C1 Day 8. Tec and Dara dosing were aligned with the approved Dara schedule. DPd/DVd were administered per approved schedules. The prespecified definition of high risk included ≥ 1 of the following HRCAs: t(4;14), t(14;16), or del(17p); a revised high-risk definition also included gain(1q21) or amp(1q21) (3 and ≥ 4 copies, respectively). Risk subgroups reported include: standard (std.) or high (0 or ≥ 1 HRCAs, respectively, per prespecified definition); revised std. or high (0 or ≥ 1 HRCAs per revised definition); and 1 or ≥ 2 HRCAs (per revised definition). FHR was defined as 1 prior LOT with PD ≤ 18 mo post-ASCT or start of initial therapy. MRD-neg CR rate was defined as the percentage of pts in the NGS analysis set (all randomized pts except those in China [only NGF cytometry available]) who achieved both ≥ CR and MRD neg (10–5 or 10–6). Results: 587 pts were randomized (Tec-Dara, n = 291; DPd/DVd, n = 296). At 34.5 mo median follow-up, PFS favored Tec-Dara vs DPd/DVd across all cytogenetic subgroups (Figure). Estimated 36-mo PFS rates were higher with Tec-Dara vs DPd/DVd for both prespecified std. (87.4% vs 37.1%) and high-risk cytogenetics (77.7% vs 11.5%). Among pts with 1 prior LOT, PFS also favored Tec-Dara vs DPd/DVd both in pts with FHR (estimated 36-mo PFS rate, 77.3% vs 0%; HR, 0.22 [95% CI, 0.08-0.62]) and without FHR (89.9% vs 35.9%; HR, 0.11 [95% CI, 0.05-0.23]). MRD-neg CR rates were higher with Tec-Dara vs DPd/DVd across all risk subgroups: std. (10–5: 62.6% vs 24.8%; 10–6: 58.9% vs 14.7%; both P < 0.0001), high (57.9% vs 9.7%; 54.7% vs 5.4%; both P < 0.0001), revised std. (67.4% vs 18.8%; 67.4% vs 6.3%; both P<0.0001), revised high (57.5% vs 17.5%; 53.4% vs 11.3%; both P < 0.0001), 1 HRCA (53.9% vs 21.4%; 48.3% vs 14.3%; both P < 0.0001), ≥ 2 HRCAs (63.2% vs 11.3%; 61.4% vs 6.5%; both P<0.0001). MRD-neg CR rates were also higher with Tec-Dara in pts with FHR MM (10–5: 42.9% vs 5.6%, P = 0.0106; 10–6: 38.1% vs 0%, P = 0.0040). Additional data and high-risk subgroups will be presented. Conclusion: Tec-Dara substantially improved PFS and MRD-neg CR rates vs DPd/DVd regardless of cytogenetic risk and FHR status. The 36-mo PFS rates of 87.4% and 89.9% in pts with std. risk and non-FHR MM, respectively, and attenuation of the adverse prognosis associated with high-risk disease support Tec-Dara as a steroid-sparing standard-of-care as early as the 2nd LOT, across all practice settings and regardless of risk status.",
  "abstract_shown": true,
  "affiliations": [
    "Fred Hutchinson Cancer Center, Seattle, United States",
    "Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Netherlands",
    "Winship Cancer Institute, Emory University, Atlanta, Georgia, States",
    "Hospital Universitario de Salamanca, Instituto de Investigación Biomédica de Salamanca, Instituto de Biología Molecular y Celular del Cáncer Salamanca, Spain",
    "Arnie Charbonneau Cancer Institute, University of Calgary, Calgary, Canada",
    "Universite de Toulouse, Centre Hospitalier Universitaire, Service d’Hematologie, IUCT Oncopole CRCT, Toulouse, France",
    "Emory University, Winship Cancer Institute, Atlanta, GA, United States",
    "Peking University People’s Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing, China",
    "The Royal Marsden NHS Foundation Trust, London, United Kingdom",
    "Hospital Privado Centro Medico de Córdoba SA, Córdoba, Argentina",
    "Department of Hematology, Hôpital de Jolimont, Haine-Saint-Paul, Belgium",
    "Clínica São Germano, São Paulo, SP, Brazil",
    "Department of Hematology, Rigshospitalet, Copenhagen, Denmark",
    "16Department of Hematology, Odense University Hospital, Odense, Denmark",
    "Medizinische Klinik und Poliklinik I Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Dresden, Germany",
    "Department of Internal Medicine II, University Tübingen, Tübinge, Germany",
    "Department of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece",
    "IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia “Seràgnoli,” Bologna, Italy",
    "Division of Hematology-Oncology, Department of Medicine, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South Korea",
    "Department of Internal Medicine, Isala Klinieken, Zwolle, The Netherlands",
    "Department of Hematology, St. Antonius Hospital Nieuwegein, Nieuwegein, Netherlands",
    "Department of Hematology and Transplantology, Medical University of Gdansk;, Poland",
    "Sahlgrenska University Hospital, Göteborg, Sweden",
    "The Lancashire Haematology Centre, Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool Victoria Hospital, Blackpool, United Kingdom",
    "Stanford University School of Medicine, Palo Alto, California, United States",
    "Cancer Center Clínica Universidad de Navarra, University of Navarra, Pamplona, Spain",
    "Hematology Department, Hospital 12 de Octubre, Universidad Complutense, Spain",
    "Memorial Sloan Kettering Cancer Center, New York, United States",
    "Hematologic Malignancies and Cellular Therapy Program, Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, TX, United States",
    "Hematology Unit, Istituto Romagnolo per lo Studio dei Tumori ''Dino Amadori, Italy",
    "Hematology, CHU Lille, University of Lille, France",
    "Cancer Center Clinica Universidad de Navarra, CIMA, IDISNA, Pamplona, Spain",
    "Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, United States",
    "Johnson & Johnson, Spring House, PA, United States",
    "Johnson & Johnson, Los Angeles, CA, United States",
    "Johnson & Johnson, Spring House, PA, United State",
    "Johnson & Johnson, High Wycombe, United Kingdom",
    "Johnson & Johnson, Yorba Linda, CA, United States",
    "Johnson & Johnson, Raritan, NJ, United States",
    "Johnson & Johnson, Shanghai, China"
  ],
  "article_type": null,
  "arxiv": null,
  "author_total": 47,
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      "name": "Raphael TEIPEL,"
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      "name": "Britta BESEMER"
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      "name": "Paul GEERTS"
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      "name": "Elena VAN LEEUWEN-SEGARCEANU"
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      "name": "Agata TYCZYNSKA"
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      "name": "Markus HANSSON"
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      "name": "Mark GREY"
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        24
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      "name": "Surbhi SIDANA"
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        25
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      "name": "Paula RODRIGUEZ-OTERO"
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        26
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      "name": "Joaquin MARTINEZ-LOPEZ"
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        27
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      "name": "Hamza HASHMI"
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    {
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        28
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      "name": "Larry D. ANDERSON"
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      "name": "Claudio CERCHIONE"
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      "name": "Saloman MANIER"
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      "name": "Jesús SAN-MIGUEL"
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      "name": "Muhamed BALJEVIC"
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      "name": "Robin CARSON"
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      "name": "Weili SUN"
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      "name": "Kristen LANTZ"
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      "name": "Deborah BRISENO-TOOMEY"
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      "name": "Lisa O'ROURKE"
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      "name": "Ricardo ATTAR"
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  "bibtex": "https://research.draconitic.com/paper/079s6cfem22pw.bib",
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  "doi": "10.1016/j.htct.2026.107938",
  "fulltext_url": "http://www.sciencedirect.com/science/article/pii/S2531137926016858",
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    "2531-1387"
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  "landing_url": "https://doi.org/10.1016/j.htct.2026.107938",
  "language": "en",
  "licence": "CC-BY",
  "licence_label": "CC BY",
  "licence_source": "journal",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
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  "native_subjects": [
    [
      "lcc",
      "RC633-647.5"
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      "openalex",
      "2720|Multiple Myeloma Research and Treatments"
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  "openalex": "W7223156160",
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  "published": "2026-10-23",
  "publisher": "Elsevier",
  "ris": "https://research.draconitic.com/paper/079s6cfem22pw.ris",
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      "first_seen": "2026-10-30T13:43:19Z",
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      "field": "medicine",
      "origin": "lcc:RC633-647.5",
      "subfield": "endocrinology-metabolism"
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  ],
  "title": "TECLISTAMAB PLUS DARATUMUMAB (TEC-DARA) IN PATIENTS (PTS) WITH RELAPSED REFRACTORY MULTIPLE MYELOMA (RRMM): ANALYSIS OF MAJESTEC-3 BASED ON CYTOGENETIC AND FUNCTIONAL RISK",
  "title_text": "TECLISTAMAB PLUS DARATUMUMAB (TEC-DARA) IN PATIENTS (PTS) WITH RELAPSED REFRACTORY MULTIPLE MYELOMA (RRMM): ANALYSIS OF MAJESTEC-3 BASED ON CYTOGENETIC AND FUNCTIONAL RISK",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T13:43:19Z",
  "url": "https://research.draconitic.com/paper/079s6cfem22pw",
  "venue": "Hematology, Transfusion and Cell Therapy",
  "versions": []
}