Scholarlink

<p>Treatment-free remission (TFR) after discontinuation of ABL tyrosine kinase inhibitors (TKIs) is an important therapeutic goal in chronic myeloid leukemia (CML). Interferon-α (IFN) has been suggested to promote durable TFR. The phase 3 ENDURE trial (NCT03117816; EUDRA-CT 2016-001030-94) prospectively tested this hypothesis in patients with stable deep molecular remission after TKI therapy. A total of 203 patients were randomised 1:1 to receive ropeginterferon alfa-2b (ropeg-IFN; 100 µg subcutaneously every two weeks for 15 months, n = 95) or observation alone (n = 108) after TKI discontinuation. The primary endpoint was molecular relapse-free survival (MRFS), defined as time to loss of major molecular response (MMR) or death. At a median follow-up of 36 months, 25-month MRFS was 56% (95% confidence interval (CI), 45–66) with ropeg-IFN and 59% (95% CI, 49–68) with observation (hazard ratio (HR), 1.02; 95% CI, 0.68–1.55; P = 0.91). Among 83 patients with molecular data after TKI restart, 79 (95%) regained at least MMR, 78 within 12 months (median 3 months, interquartile range: 2-4 months). Ropeg-IFN was well tolerated (median administered dose of 92 µg, range 3–104), and no new safety signals were observed. Ropeg-IFN maintenance did not improve the probability of sustained TFR after TKI discontinuation.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Randomized phase 3 trial of Ropeginterferon alfa-2b versus surveillance after tyrosine kinase inhibitor discontinuation in chronic myeloid leukemia (ENDURE/CML-IX)

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年1月12日

查看全文
  • Andreas Burchert,
  • Franck E. Nicolini,
  • Philipp le Coutre,
  • Susanne Saussele,
  • Andreas Hochhaus,
  • Evin Tuere,
  • Stephan K. Metzelder,
  • Kim Pauck,
  • Holger Garn,
  • Hartmann Raifer,
  • Magdalena Huber,
  • Norbert Gattermann,
  • Martina Crysandt,
  • Philippe Schafhausen,
  • Matthias Bormann,
  • Markus P. Radsak,
  • Agnès Guerci-Bresler,
  • Thomas Illmer,
  • Maria E. Goebeler,
  • Peter Herhaus,
  • Lino L. Teichmann,
  • Georg-Nikolaus Franke,
  • Fabian Lang,
  • Stefan W. Krause,
  • Robert Möhle,
  • Martine Klausmann,
  • Frank Stegelmann,
  • Christoph Lutz,
  • Gabriel Etienne,
  • Andrea Stoltefuß,
  • Joachim R. Göthert,
  • Thomas Ernst,
  • Maisun Abu-Samra,
  • Heinz-Gert Höffkes,
  • Andreas Neubauer,
  • Ying Wang,
  • Paul Weiland,
  • Clara Otto,
  • Lea Kiessler,
  • Theresa Weber,
  • Lea Kroning,
  • Andrea Nist,
  • Thorsten Stiewe,
  • Rüdiger Hehlmann,
  • Behnaz Aminossadati,
  • Michael Wittenberg,
  • Kerstin Winterstein,
  • Thomas Oellerich,
  • Marcus Lechner,
  • Markus Pfirrmann,
  • Carmen Schade-Brittinger,
  • Paul Klemm,
  • Christian Michel

摘要

Treatment-free remission (TFR) after discontinuation of ABL tyrosine kinase inhibitors (TKIs) is an important therapeutic goal in chronic myeloid leukemia (CML). Interferon-α (IFN) has been suggested to promote durable TFR. The phase 3 ENDURE trial (NCT03117816; EUDRA-CT 2016-001030-94) prospectively tested this hypothesis in patients with stable deep molecular remission after TKI therapy. A total of 203 patients were randomised 1:1 to receive ropeginterferon alfa-2b (ropeg-IFN; 100 µg subcutaneously every two weeks for 15 months, n = 95) or observation alone (n = 108) after TKI discontinuation. The primary endpoint was molecular relapse-free survival (MRFS), defined as time to loss of major molecular response (MMR) or death. At a median follow-up of 36 months, 25-month MRFS was 56% (95% confidence interval (CI), 45–66) with ropeg-IFN and 59% (95% CI, 49–68) with observation (hazard ratio (HR), 1.02; 95% CI, 0.68–1.55; P = 0.91). Among 83 patients with molecular data after TKI restart, 79 (95%) regained at least MMR, 78 within 12 months (median 3 months, interquartile range: 2-4 months). Ropeg-IFN was well tolerated (median administered dose of 92 µg, range 3–104), and no new safety signals were observed. Ropeg-IFN maintenance did not improve the probability of sustained TFR after TKI discontinuation.