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Resistance in CPCML while on a prior kinase inhibitor was defined as failure to achieve either a complete hematologic response (by 3 months), a minor cytogenetic response (by 6 months), or a major cytogenetic response (by 12 months), or development of a new BCRABL1 kinase domain mutation or new clonal evolution. Patients were required to have > 1% BCRABL1IS (by realtime polymerase chain reaction) at trial entry. Patients received one of three starting dosages: 45 mg orally once daily, 30 mg orally once daily, or 15 mg orally once daily. Patients who received a starting dose of 45 mg or 30 mg had a mandatory dose reduction to 15 mg once daily upon achieving ≤ 1% BCRABL1IS. The primary efficacy endpoint was a molecular response based on the achievement of ≤ 1% BCRABL1IS at 12 months. All patients reached the 12month time point (primary endpoint) by the primary analysis data cutoff. The median duration of followup for the 45 mg cohort (N = 94) was 77.9 months (95% CI: 72.4, 84.0). 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{"after": {"end": 828, "start": 0, "text": "L’essai avait inclus 449 patients, parmi lesquels 444 avaient satisfait aux critères requis pour l’analyse : 267 patients atteints de LMC-PC (cohorte R/I : n = 203, cohorte T315I : n = 64), 83 patients atteints de LMC-PA (cohorte R/I : n = 65, cohorte T315I : n = 18), 62 patients atteints de LMC-PB (cohorte R/I : n = 38, cohorte T315I : n = 24), et 32 patients atteints de LAL Ph+ (cohorte R/I : n = 10, cohorte T315I : n = 22). Une RCyM antérieure au minimum (RCyM, RMM ou RMC) au dasatinib ou au nilotinib n’a été obtenue que chez 26 % des patients atteints de LMC-PC et une RHMa antérieure au minimum (RHMa, RCyM, RMM ou RMC) n'a été obtenue que chez 21 % et 24 % des patients atteints de LMC-PA et de LMC-PB/LAL Ph+, respectivement. Les caractéristiques démographiques initiales sont décrites dans le Tableau 9 ci-dessous.", "truncated": false}, "after_length": 828, "after_sha256": "40c488f446254fc54ee2b3eb0be17dd155f533be8d55dd7c1cd4c2607a9905b5", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 828, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 828}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8ec94c7cb3391a98a2a2e346", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002695", "medicine_name": "Iclusig", "medicine_slug": "iclusig", "observed_at": "2026-10-12T13:29:40Z", "pipeline_version": "2.0.0", "presentation_label": "Iclusig 5 mg, gélules", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "835939e8841a039c75ad2b71ddde4acef2e5acd9a5e0a25b63e6774a75837088", "source_snapshot_id": "source-fc7809f4cbc58386db5fb631", "source_updated_at": "2026-07-31", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/iclusig-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3125}
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{"after": {"end": 1005, "start": 0, "text": "Chez les patients atteints de LMC-PC qui ont obtenu une RCyM, le délai médian d’obtention de la réponse était de 2,8 mois (intervalle : 1,6 à 11,3 mois) et chez ceux ayant obtenu une RMM, le délai médian d’obtention de la réponse était de 5,5 mois (intervalle : 1,8 à 55,5 mois). Au moment de la soumission du rapport d’étude actualisé avec un suivi minimum de 64 mois pour tous les patients encore inclus dans l’étude, les durées médianes de RCyM et de RMM n'avaient pas encore été atteintes. D’après les estimations selon la méthode de KaplanMeier, 82 % (IC à 95 % : [74 % 88 %]) des patients atteints de LMC-PC (durée médiane de traitement : 32,2 mois) qui ont obtenu une RCyM devraient maintenir cette réponse à 48 mois et 61 % (IC à 95 % : [51 % 70 %]) des patients atteints de LMC-PC ayant obtenu une RMM devraient maintenir cette réponse à 36 mois. La probabilité que les patients atteints de LMC-PC maintiennent leur RCyM et leur RMM n’a pas changé lorsque l’analyse a été prolongée jusqu’à 5 ans.", "truncated": false}, "after_length": 1005, "after_sha256": "4d6ef85de5e5a456adb419296c4920255395374df7996199dd073beaab86d2e5", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 1005, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1005}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ec26ebffdc736838795b2515", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002695", "medicine_name": "Iclusig", "medicine_slug": "iclusig", "observed_at": "2026-10-12T13:29:40Z", "pipeline_version": "2.0.0", "presentation_label": "Iclusig 5 mg, gélules", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "835939e8841a039c75ad2b71ddde4acef2e5acd9a5e0a25b63e6774a75837088", "source_snapshot_id": "source-fc7809f4cbc58386db5fb631", "source_updated_at": "2026-07-31", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/iclusig-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3250}
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{"after": {"end": 1900, "start": 400, "text": "que complète (à 3 mois), l’obtention d’une réponse cytogénétique mineure (à 6 mois) ou d’une réponse cytogénétique majeure (à 12 mois), ou le développement d’une nouvelle mutation du domaine de kinase BCR::ABL1 ou d’une nouvelle évolution clonale. Les patients devaient présenter une BCR::ABL1> 1 % (réaction en chaîne par polymérase en temps réel) à l’entrée dans l’étude. Les patients ont reçu une des trois doses initiales : 45 mg une fois par jour par voie orale, 30 mg une fois par jour par voie orale ou 15 mg une fois par jour par voie orale. Les patients ayant reçu une dose initiale de 45 mg ou 30 mg ont fait l’objet d’une réduction de dose obligatoire à 15 mg une fois par jour jusqu’à l’obtention d’une BCR::ABL1 ≤ 1 %. Le critère d’évaluation principal était la réponse moléculaire basée sur l’obtention d’une BCR::ABL1 ≤ 1 % à 12 mois. Tous les patients avaient atteint le point-temps de 12 mois (critère d’évaluation principal) à la date limite d’analyse des données primaires. La durée médiane du suivi pour la cohorte 45 mg (N = 94) était de 77,9 mois (IC à 95 % : 72,4, 84,0). Seuls les résultats d’efficacité pour la dose initiale recommandée de 45 mg sont présentés ci-dessous. En tout, 282 patients ont reçu Iclusig : 94 ont reçu une dose initiale de 45 mg, 94 ont reçu une dose initiale de 30 mg et 94 ont reçu une dose initiale de 15 mg. 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Les patients ayant reçu une dose initiale de 45 mg ou 30 mg ont fait l’objet d’une réduction de dose obligatoire à 15 mg une fois par jour jusqu’à l’obtention d’une BCR::ABL1 ≤ 1 %. Le critère d’évaluation principal était la réponse moléculaire basée sur l’obtention d’une BCR::ABL1 ≤ 1 % à 12 mois. Tous les patients avaient atteint le point-temps de 12 mois (critère d’évaluation principal) à la date limite d’analyse des données primaires. La durée médiane du suivi pour la cohorte 45 mg (N = 94) était de 77,9 mois (IC à 95 % : 72,4, 84,0). Seuls les résultats d’efficacité pour la dose initiale recommandée de 45 mg sont présentés ci-dessous. En tout, 282 patients ont reçu Iclusig : 94 ont reçu une dose initiale de 45 mg, 94 ont reçu une dose initiale de 30 mg et 94 ont reçu une dose initiale de 15 mg. 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