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<p>Acalabrutinib is a second-generation BTK inhibitor approved for the treatment of chronic lymphocytic leukemia (CLL) after demonstrating efficacy and safety in clinical trials. NAOS, a real-world study, complements these trials with real-world (rw) acalabrutinib data generated from clinical practice.&#xa0;This retrospective, non-interventional, longitudinal study was conducted in 59 sites in France in adult patients initiating acalabrutinib for CLL in 2021–2022.The study assessed rw use (time to discontinuation, TTD) and effectiveness (rw progression free survival, rwPFS) in first line (L1) and relapsed/refractory setting (L2+). At the time of the analysis, data were collected from routine medical records since the treatment start up to the end of 2022. Of the 485 enrolled patients, 58.8% were in L1 and 41.2% in L2+. Median age was 73 (L1) and 77 (L2+) years. Of them, 55.1% had a prior cardiovascular history, 25.1% del(17p)/<i>TP53</i>m, and 67.4% were u<i>IGHV</i>. Among 188 patients initiated in 2021 (119 L1; 69 L2+), 31.4% discontinued treatment, 14.9% of whom due to adverse event (AE). The 12-month rwPFS rate was 93.1% (88.5–97.7) in L1 and 87% (79.0-94.9) in L2 + patients with no significant difference based on del17p/<i>TP53</i>m (<i>p</i> = 0.21) and on <i>IGHV</i> status (<i>p</i> = 0.34). AEs leading to treatment changes occurred in 40 patients (21.3%), grade 3/4 AE in 9.6%, while cardiac disorders occurred in only 2.1% of patients.&#xa0;NAOS, one of the largest real-world cohorts of acalabrutinib-treated CLL patients in Europe, showed effectiveness and safety consistent with clinical trials, despite an older population with more cardiovascular comorbidities.</p>

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Real-world efficacy and safety outcomes of acalabrutinib in chronic lymphocytic leukemia: primary results of a French multicentre observational study (NAOS)

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年7月30日

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  • Anne Quinquenel,
  • Stéphane Leprêtre,
  • Marie Sarah Dilhuydy,
  • Lucile Bussot,
  • Zora Marjanovic,
  • Omar Benbrahim,
  • Romain Guièze,
  • Alberto Santagostino,
  • Caroline Dartigeas,
  • Pierre Feugier,
  • Damien Roos-Weil,
  • Ghandi Damaj,
  • Kamel Laribi,
  • Loic Ysebaert,
  • Vincent Levy

摘要

Acalabrutinib is a second-generation BTK inhibitor approved for the treatment of chronic lymphocytic leukemia (CLL) after demonstrating efficacy and safety in clinical trials. NAOS, a real-world study, complements these trials with real-world (rw) acalabrutinib data generated from clinical practice. This retrospective, non-interventional, longitudinal study was conducted in 59 sites in France in adult patients initiating acalabrutinib for CLL in 2021–2022.The study assessed rw use (time to discontinuation, TTD) and effectiveness (rw progression free survival, rwPFS) in first line (L1) and relapsed/refractory setting (L2+). At the time of the analysis, data were collected from routine medical records since the treatment start up to the end of 2022. Of the 485 enrolled patients, 58.8% were in L1 and 41.2% in L2+. Median age was 73 (L1) and 77 (L2+) years. Of them, 55.1% had a prior cardiovascular history, 25.1% del(17p)/TP53m, and 67.4% were uIGHV. Among 188 patients initiated in 2021 (119 L1; 69 L2+), 31.4% discontinued treatment, 14.9% of whom due to adverse event (AE). The 12-month rwPFS rate was 93.1% (88.5–97.7) in L1 and 87% (79.0-94.9) in L2 + patients with no significant difference based on del17p/TP53m (p = 0.21) and on IGHV status (p = 0.34). AEs leading to treatment changes occurred in 40 patients (21.3%), grade 3/4 AE in 9.6%, while cardiac disorders occurred in only 2.1% of patients. NAOS, one of the largest real-world cohorts of acalabrutinib-treated CLL patients in Europe, showed effectiveness and safety consistent with clinical trials, despite an older population with more cardiovascular comorbidities.