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Interferon-\u03b1 (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\u2009\u00b5g subcutaneously every two weeks for 15 months, n\u2009=\u200995) or observation alone (n\u2009=\u2009108) 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\u201366) with ropeg-IFN and 59% (95% CI, 49\u201368) with observation (hazard ratio (HR), 1.02; 95% CI, 0.68\u20131.55; P\u2009=\u20090.91). 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\u2009\u00b5g, range 3\u2013104), and no new safety signals were observed. Ropeg-IFN maintenance did not improve the probability of sustained TFR after TKI discontinuation.<\/jats:p>","DOI":"10.1038\/s41375-025-02859-1","type":"journal-article","created":{"date-parts":[[2026,1,12]],"date-time":"2026-01-12T10:55:21Z","timestamp":1768215321000},"page":"410-417","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Randomized phase 3 trial of Ropeginterferon alfa-2b versus surveillance after tyrosine kinase inhibitor discontinuation in chronic myeloid leukemia (ENDURE\/CML-IX)"],"prefix":"10.1038","volume":"40","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8411-8844","authenticated-orcid":false,"given":"Andreas","family":"Burchert","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Franck E.","family":"Nicolini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philipp","family":"le 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