ORCID: https://orcid.org/0000-0002-8411-8844; Nicolini, Franck E.; Coutre, Philipp le; Saussele, Susanne ORCID: https://orcid.org/0000-0003-0357-5785; Hochhaus, Andreas ORCID: https://orcid.org/0000-0003-0626-0834; Tuere, Evin; Metzelder, Stephan K.; Pauck, Kim; Garn, Holger; Raifer, Hartmann; Huber, Magdalena ORCID: https://orcid.org/0000-0002-2963-0693; Gattermann, Norbert; Crysandt, Martina; Schafhausen, Philippe; Bormann, Matthias; Radsak, Markus P. ORCID: https://orcid.org/0000-0002-3991-5721; Guerci-Bresler, Agnès; Illmer, Thomas; Goebeler, Maria E.; Herhaus, Peter; Teichmann, Lino L.; Franke, Georg-Nikolaus ORCID: https://orcid.org/0000-0001-8239-002X; Lang, Fabian; Krause, Stefan W. ORCID: https://orcid.org/0000-0002-5259-4651; Möhle, Robert; Klausmann, Martine; Stegelmann, Frank ORCID: https://orcid.org/0000-0003-2157-476X; Lutz, Christoph; Etienne, Gabriel; Stoltefuß, Andrea; Göthert, Joachim R.; Ernst, Thomas ORCID: https://orcid.org/0000-0003-2147-489X; Abu-Samra, Maisun; Höffkes, Heinz-Gert; Neubauer, Andreas ORCID: https://orcid.org/0000-0002-7606-8760; Wang, Ying; Weiland, Paul ORCID: https://orcid.org/0000-0003-3175-8271; Otto, Clara; Kiessler, Lea; Weber, Theresa; Kroning, Lea; Nist, Andrea; Stiewe, Thorsten ORCID: https://orcid.org/0000-0003-0134-7826; Hehlmann, Rüdiger; Aminossadati, Behnaz; Wittenberg, Michael ORCID: https://orcid.org/0000-0003-4526-1856; Winterstein, Kerstin; Oellerich, Thomas ORCID: https://orcid.org/0000-0001-6570-6125; Lechner, Marcus; Pfirrmann, Markus ORCID: https://orcid.org/0000-0002-8948-0690; Schade-Brittinger, Carmen; Klemm, Paul ORCID: https://orcid.org/0000-0002-3609-5713 und Michel, Christian
(2026):
Randomized phase 3 trial of Ropeginterferon alfa-2b versus surveillance after tyrosine kinase inhibitor discontinuation in chronic myeloid leukemia (ENDURE/CML-IX).
In: Leukemia, Vol. 40: pp. 410-417
[PDF, 1MB]
Abstract
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.
| Item Type: | Journal article |
|---|---|
| Faculties: | Medicine > Institute for Medical Information Processing, Biometry and Epidemiology |
| Subjects: | 600 Technology > 610 Medicine and health |
| URN: | urn:nbn:de:bvb:19-epub-135136-0 |
| ISSN: | 0887-6924 |
| Language: | English |
| Item ID: | 135136 |
| Date Deposited: | 17. Apr 2026 07:17 |
| Last Modified: | 17. Apr 2026 07:17 |
| DFG: | Gefördert durch die Deutsche Forschungsgemeinschaft (DFG) - 416910386 |
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