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Momelotinib in Myelofibrosis Patients With Thrombocytopenia: Post Hoc Analysis From Three Randomized Phase 3 Trials
JJ. Kiladjian, AM. Vannucchi, AT. Gerds, V. Gupta, S. Verstovsek, M. Egyed, U. Platzbecker, J. Mayer, S. Grosicki, Á. Illés, T. Woźny, ST. Oh, D. McLornan, I. Kirgner, SS. Yoon, CN. Harrison, B. Klencke, M. Huang, J. Kawashima, R. Mesa
Status not-indexed Language English Country United States
Document type Journal Article
NLK
Directory of Open Access Journals
from 2017
PubMed Central
from 2017
Europe PubMed Central
from 2017
Wiley-Blackwell Open Access Titles
from 1997
- Publication type
- Journal Article MeSH
The oral activin A receptor type I, Janus kinase 1 (JAK1), and JAK2 inhibitor momelotinib demonstrated symptom, spleen, and anemia benefits in intermediate- and high-risk myelofibrosis (MF). Post hoc analyses herein evaluated the efficacy and safety of momelotinib in patients with MF and thrombocytopenia (platelet counts <100 × 109/L) from randomized phase 3 studies: MOMENTUM (momelotinib versus danazol; JAK inhibitor experienced); SIMPLIFY-1 (momelotinib versus ruxolitinib; JAK inhibitor naïve); and SIMPLIFY-2 (momelotinib versus best available therapy; JAK inhibitor experienced); these studies were not statistically powered to assess differences in thrombocytopenic subgroups, and these analyses are descriptive. The treatment effect of momelotinib versus ruxolitinib on week 24 response rates (spleen volume reduction ≥35%/Total Symptom Score reduction ≥50%/transfusion independence) was numerically comparable or better in thrombocytopenic patients versus the overall JAK inhibitor naive population; rates were preserved with momelotinib in thrombocytopenic patients but attenuated with ruxolitinib (momelotinib: 27%/28%/67% overall versus 39%/35%/61% in thrombocytopenic group; ruxolitinib: 29%/42%/49% overall versus 0%/22%/39% in thrombocytopenic group, respectively). In contrast to ruxolitinib, momelotinib maintained high dose intensity throughout the treatment. In the JAK inhibitor experienced population, thrombocytopenic patients had the following: (1) numerically higher symptom and transfusion independence response rates with momelotinib than in control arms; and (2) preserved spleen, symptom, and transfusion independence response rates with momelotinib relative to the overall study populations. The safety profile of momelotinib in thrombocytopenic patients was also consistent with the overall study population. In summary, momelotinib represents a safe and effective treatment option for patients with MF and moderate-to-severe thrombocytopenia.
Cancer Research Institute Seoul National University College of Medicine Seoul Korea
Cleveland Clinic Taussig Cancer Institute Cleveland OH USA
Clinic of Hematology Cellular Therapy and Hemostaseology University of Leipzig Germany
Department of Hematology Faculty of Medicine University of Debrecen Hungary
Department of Hematology Szpital MSWiA w Poznaniu Poznan Poland
Department of Internal Medicine Haematology and Oncology University Hospital Brno Czech Republic
Department of Internal Medicine Seoul National University College of Medicine Seoul Korea
Guy's and St Thomas' NHS Foundation Trust London United Kingdom
Hematology Institute Tel Aviv Sourasky Medical Center Tel Aviv Israel
Princess Margaret Cancer Center University of Toronto ON Canada
Sierra Oncology a GSK company San Mateo CA USA
Teaching Hospital Mór Kaposi Kaposvár Hungary
The Sackler Faculty of Medicine Tel Aviv University Ramat Aviv Israel
The University of Texas MD Anderson Cancer Center Houston TX USA
Université de Paris AP HP Hôpital Saint Louis Centre d'Investigations Cliniques INSERM Paris France
References provided by Crossref.org
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