Teclistamab in Multiple Myeloma with One to Three Previous Lines of Therapy

BACKGROUND: The efficacy of teclistamab, a bispecific antibody targeting B-cell maturation antigen and CD3, as early-line monotherapy in relapsed or refractory multiple myeloma is unclear. METHODS: We randomly assigned patients with relapsed or refractory multiple myeloma who had previously received one, two, or three lines of therapy, including an anti-CD38 monoclonal antibody and lenalidomide, to receive teclistamab or the investigator's choice of pomalidomide, bortezomib, and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd). Antimicrobial prophylaxis and immune globulin replacement were recommended. The primary end point was progression-free survival as assessed by an independent review committee. RESULTS: A total of 296 patients were assigned to teclistamab and 297 to PVd or Kd. At the interim analysis (median follow-up, 17.3 months), teclistamab significantly improved progression-free survival as compared with PVd or Kd (estimated 18-month progression-free survival, 69.8% vs. 26.9%; hazard ratio for disease progression or death, 0.29; 95% confidence interval [CI], 0.23 to 0.38; P<0.001). The percentage of patients with a complete response or better was higher with teclistamab than with PVd or Kd (65.9% vs. 16.8%, P<0.001). Overall survival was improved with teclistamab as compared with PVd or Kd (estimated 18-month overall survival, 79.2% vs. 68.6%; hazard ratio for death, 0.60; 95% CI, 0.43 to 0.83; P = 0.002). Adverse events of grade 3 or 4 occurred in 84.9% of teclistamab recipients and in 76.3% of PVd or Kd recipients, with grade 5 adverse events in 6.5% and 3.5%, respectively. Cytokine release syndrome, mostly of grade 1 or 2, occurred in 66.0% of teclistamab recipients, and immune effector cell-associated neurotoxicity syndrome occurred in 4.1%. Grade 3 or 4 infection occurred in 41.6% of teclistamab recipients and in 29.0% of PVd or Kd recipients. CONCLUSIONS: Among patients with multiple myeloma and one to three previous lines of therapy, teclistamab significantly improved progression-free and overall survival as compared with PVd or Kd. Infections of grade 3 or 4 were common. (Funded by Johnson & Johnson; MajesTEC-9 ClinicalTrials.gov number, NCT05572515.).

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Publication Details

Journal
New England Journal of Medicine
Published
2026-05-29
DOI
https://doi.org/10.1056/nejmoa2603870
Citations
1
Primary Topic
Multiple Myeloma Research and Treatments
Type
article
Field-Weighted Citation Impact
15.21

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article

Teclistamab in Multiple Myeloma with One to Three Previous Lines of Therapy

Tatiana Perova, Meir Preis, H Quach, Gabriele Buda et al.
1 citations
New England Journal of Medicine
Multiple Myeloma Research and Treatments
15.21
article

Teclistamab in Multiple Myeloma with One to Three Previous Lines of Therapy

Tatiana Perova, Meir Preis, H Quach, Gabriele Buda, W Roeloffzen, Véronique Vanquickelberghe, Jayr Schmidt Filho, Ombretta Annibali, D Wang, Ingrid M. Ariës, Max Flogegård, Albert Oriol, Rachel Kobos, Raphael Teipel, Katherine Chastain, Natalia A. Quijano Cardé, M Delforge, Ola Landgren, T Melchardt, Lixia Pei, Yu Hu, Priya Shah, Divaya Bhutani, Emmanuelle Bourgeois, Meletios Athanasios Dimopoulos, Nizar J. Bahlis, S Satheesh Kumar, Tertia de Jager, Niels W.C.J. van de Donk, Chakra Chaulagain, Senem Maral, Miki Ando, Wenming Chen, Ludek Pour, Meral Beksac, Khalid Saja, Vania Hungria, Sarah Farmer, Roberto Mina, Tzu-Min Yeh, Aurore Perrot, Cyrille Touzeau, Marek Hus, Susan Wroblewski, Cirino Botta, Marta Nunes, Robin Carson, Bradley Augustson
article en
1 citations

Abstract

BACKGROUND: The efficacy of teclistamab, a bispecific antibody targeting B-cell maturation antigen and CD3, as early-line monotherapy in relapsed or refractory multiple myeloma is unclear. METHODS: We randomly assigned patients with relapsed or refractory multiple myeloma who had previously received one, two, or three lines of therapy, including an anti-CD38 monoclonal antibody and lenalidomide, to receive teclistamab or the investigator's choice of pomalidomide, bortezomib, and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd). Antimicrobial prophylaxis and immune globulin replacement were recommended. The primary end point was progression-free survival as assessed by an independent review committee. RESULTS: A total of 296 patients were assigned to teclistamab and 297 to PVd or Kd. At the interim analysis (median follow-up, 17.3 months), teclistamab significantly improved progression-free survival as compared with PVd or Kd (estimated 18-month progression-free survival, 69.8% vs. 26.9%; hazard ratio for disease progression or death, 0.29; 95% confidence interval [CI], 0.23 to 0.38; P<0.001). The percentage of patients with a complete response or better was higher with teclistamab than with PVd or Kd (65.9% vs. 16.8%, P<0.001). Overall survival was improved with teclistamab as compared with PVd or Kd (estimated 18-month overall survival, 79.2% vs. 68.6%; hazard ratio for death, 0.60; 95% CI, 0.43 to 0.83; P = 0.002). Adverse events of grade 3 or 4 occurred in 84.9% of teclistamab recipients and in 76.3% of PVd or Kd recipients, with grade 5 adverse events in 6.5% and 3.5%, respectively. Cytokine release syndrome, mostly of grade 1 or 2, occurred in 66.0% of teclistamab recipients, and immune effector cell-associated neurotoxicity syndrome occurred in 4.1%. Grade 3 or 4 infection occurred in 41.6% of teclistamab recipients and in 29.0% of PVd or Kd recipients. CONCLUSIONS: Among patients with multiple myeloma and one to three previous lines of therapy, teclistamab significantly improved progression-free and overall survival as compared with PVd or Kd. Infections of grade 3 or 4 were common. (Funded by Johnson & Johnson; MajesTEC-9 ClinicalTrials.gov number, NCT05572515.).

New England Journal of Medicine
University of Pisa (IT), Medical University of Lublin (PL), Union Hospital (HK), Johnson & Johnson (United States) (US), University Medical Center Groningen (NL), Emory University (US), The University of Melbourne (AU), University of Calgary (CA), University of Groningen (NL), Capital Medical University (CN), Korea University (KR), National and Kapodistrian University of Athens (GR), Masaryk University (CZ), Paracelsus Medical University (AT), Columbia University Irving Medical Center (US), Beijing Chao-Yang Hospital, Capital Medical University (CN), Cancer Institute (WIA) (IN), Sir Charles Gairdner Hospital (AU), AC Camargo Hospital (BR), Centre Hospitalier Universitaire de Nantes (FR), Centre Hospitalier Universitaire de Toulouse (FR), Istanbul Medipol University (TR), Juntendo University (JP), Azienda Ospedaliera Citta' della Salute e della Scienza di Torino (IT), St Vincent's Hospital Melbourne (AU), Falun Hospital (SE), Institute of Cancer Research (CA), Vejle Sygehus (DK), Institut universitaire du cancer de Toulouse Oncopole (FR), East Suffolk and North Essex NHS Foundation Trust (GB), University Hospital Brno (CZ), Institut Català d'Oncologia (ES), Amsterdam Neuroscience (NL), Amyloidosis Foundation (US), Administração Regional de Saúde de Lisboa e Vale do Tejo (PT), Department of Health (ES), São Germano Oncologia (BR), Carmel Medical Center (IL), Johnson & Johnson (Germany) (DE), Groupe Hospitalier de l'Institut Catholique de Lille (FR), Johnson & Johnson (United Kingdom) (GB), Centro Hospitalar de Vila Nova de Gaia (PT), Campus Bio Medico University Hospital (IT), Amsterdam University Medical Centers (NL), Liv Hospital (TR), Sylvester Comprehensive Cancer Center (US), Johnson & Johnson (Netherlands) (NL), Huazhong University of Science and Technology (CN), UConn Health (US), Technische Universität Dresden (DE), Vrije Universiteit Amsterdam (NL), University of Palermo (IT), University of Haifa (IL), KU Leuven (BE)
Johnson and Johnson
Good health and well-being
Openalex Percentile: Top 1%
Multiple Myeloma Research and Treatments
15.21
DOISourceOpenAlex
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