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A Randomized Study of Ruxolitinib Tablets Compared to Best Available Therapy in Subjects With Primary Myelofibrosis, Post-Polycythemia Vera-Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis

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Trial Profile

A Randomized Study of Ruxolitinib Tablets Compared to Best Available Therapy in Subjects With Primary Myelofibrosis, Post-Polycythemia Vera-Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Jul 2023

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At a glance

  • Drugs Ruxolitinib (Primary)
  • Indications Essential thrombocythaemia; Myelofibrosis; Polycythaemia vera
  • Focus Registrational; Therapeutic Use
  • Acronyms COMFORT-II
  • Sponsors Incyte Corporation; Novartis

    • Most Recent Events

    • 15 Jun 2023 Results of post-hoc analysis of two studies COMFORT-1 & COMFORT-II assessing the impact of new or worsening anemia induced by ruxolitinib treatment on spleen volume response and total symptom score in patients with myelofibrosis, presented at the 28th Congress of the European Haematology Association.
    • 25 Feb 2023 Results of post hoc, pooled analysis of COMFORT-I and COMFORT-II examining relevant disease outcomes based on the disease duration before ruxolitinib initiation, published in the Cancer
    • 17 Jun 2022 Results assessing MAICs conducted to correct for potential imbalances in baseline characteristics, comparing the primary endpoint SVR35 and secondary endpoint TSS50 at Week 24 for the combination of pelabresib and ruxo (MANIFEST Arm 3) with Phase 3 ruxo monotherapy (COMFORT-I and II, SIMPLIFY-1) and fedratinib monotherapy (JAKARTA) data, presented at the 27th Congress of the European Haematology Association.
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