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<p>LINKER-MM1 (NCT03761108) is a Phase 1/2 study of linvoseltamab, a human BCMA×CD3 bispecific antibody for patients with relapsed/refractory multiple myeloma (RRMM) who are triple-class exposed (TCE) with ≥ 3 prior lines of therapy (3L+), or triple-class refractory (TCR). To contextualize efficacy data from LINKER-MM1, the Phase 2 linvoseltamab 200 mg cohort (<i>N</i> = 105) was compared with an international external control arm (ECA) comprising 203 patients from participating International Myeloma Working Group sites who met LINKER-MM1 eligibility criteria based on chart reviews. The ECA reflected real-world standard-of-care (RW SOC). An independent data review committee assessed data relevance, quality, and cohort comparability, while a separate independent central review committee evaluated response data. Inverse probability of treatment weighting was used to balance baseline characteristics between the linvoseltamab arm and the ECA. Linvoseltamab had a higher objective response rate (weighted odds ratio 3.0 [95% confidence interval (CI): 1.9–4.1]) and longer median progression-free survival (weighted hazard ratio [wHR] 0.33 [95% CI: 0.28–0.40]), time to next treatment (wHR 0.34 [95% CI: 0.29–0.44]), and overall survival (wHR 0.72 [95% CI: 0.58–0.98]) than RW SOC. These findings highlight linvoseltamab’s potential as an effective treatment for 3L+ and TCE/TCR RRMM.</p>

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Linvoseltamab versus real-world International Myeloma Working Group standard-of-care in triple-class exposed relapsed/refractory multiple myeloma

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月25日

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  • Shaji Kumar,
  • Sundar Jagannath,
  • Katja C. Weisel,
  • Laura Rosiñol,
  • Xavier Leleu,
  • Meletios-Athanasios Dimopoulos,
  • Efstathios Kastritis,
  • David S. Siegel,
  • Jorge Monge,
  • Juan Du,
  • Javier de la Rubia,
  • Pedro Asensi Cantó,
  • Jae Hoon Lee,
  • María-Victoria Mateos,
  • Borja Puertas,
  • Alessandro Gozzetti,
  • Dominik Dytfeld,
  • Enrique M. Ocio,
  • Joan Blade,
  • Shuji Ozaki,
  • Meral Beksac,
  • Fernando Escalante,
  • Madhu Nagaraj,
  • Rafla Hassan,
  • Nicolle Bonar,
  • Paul Spin,
  • Mostafa Shokoohi,
  • Muhaimen Siddiqui,
  • Di Wang,
  • Kevin Hou,
  • Michael E. D. West,
  • Christian Hampp,
  • Jeannette Green,
  • Olivier Humblet,
  • Alexander Breskin,
  • James Harnett,
  • Wenzhen Ge,
  • Rachel E. Sobel,
  • Jessica J. Jalbert,
  • Glenn S. Kroog,
  • Karen Rodriguez Lorenc,
  • Qiufei Ma,
  • Brian G. M. Durie

摘要

LINKER-MM1 (NCT03761108) is a Phase 1/2 study of linvoseltamab, a human BCMA×CD3 bispecific antibody for patients with relapsed/refractory multiple myeloma (RRMM) who are triple-class exposed (TCE) with ≥ 3 prior lines of therapy (3L+), or triple-class refractory (TCR). To contextualize efficacy data from LINKER-MM1, the Phase 2 linvoseltamab 200 mg cohort (N = 105) was compared with an international external control arm (ECA) comprising 203 patients from participating International Myeloma Working Group sites who met LINKER-MM1 eligibility criteria based on chart reviews. The ECA reflected real-world standard-of-care (RW SOC). An independent data review committee assessed data relevance, quality, and cohort comparability, while a separate independent central review committee evaluated response data. Inverse probability of treatment weighting was used to balance baseline characteristics between the linvoseltamab arm and the ECA. Linvoseltamab had a higher objective response rate (weighted odds ratio 3.0 [95% confidence interval (CI): 1.9–4.1]) and longer median progression-free survival (weighted hazard ratio [wHR] 0.33 [95% CI: 0.28–0.40]), time to next treatment (wHR 0.34 [95% CI: 0.29–0.44]), and overall survival (wHR 0.72 [95% CI: 0.58–0.98]) than RW SOC. These findings highlight linvoseltamab’s potential as an effective treatment for 3L+ and TCE/TCR RRMM.