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Author Notes:

Corresponding author: Ruben A. Mesa, MD, Mayo Clinic Cancer Center, 5777 E Mayo Blvd, Phoenix, AZ; e-mail: mesa.ruben@mayo.edu

Conception and design: Ruben A. Mesa, Wei Deng, Jason Gotlib

Provision of study materials or patients: Ruben A. Mesa, John V. Catalano, Timothy Devos

Collection and assembly of data: Timothy Devos, Miklos Egyed, Andrzei Hellmann, Donal McLornan Kazuya Shimoda, Wei Deng, Julia D. Maltzman, Francisco Cervantes

Data analysis and interpretation: Jean-Jacques Kiladjian, John V. Catalano, Miklos Egyed, Kazuya Shimoda, Elliott F. Winton, Wei Deng, Ronald L. Dubowy, Julia D. Maltzman, Francisco Cervantes

Manuscript writing; Final approval of manuscript; Accountable for all aspects of the work: All authors

Professional medical writing assistance was provided by Beth Sesler, CMPP, at Impact Communications (New York, NY).

See publication for full list of disclosures.

Subjects:

Research Funding:

Supported by Gilead Sciences, Foster City, CA.

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Oncology
  • INTERNATIONAL WORKING GROUP
  • POLYCYTHEMIA-VERA
  • ESSENTIAL THROMBOCYTHEMIA
  • RESPONSE CRITERIA
  • JAK2 INHIBITOR
  • THERAPY
  • RATIONALE
  • CYT387

SIMPLIFY-1: A Phase III Randomized Trial of Momelotinib Versus Ruxolitinib in Janus Kinase Inhibitor-Naive Patients With Myelofibrosis

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Journal Title:

Journal of Clinical Oncology

Volume:

Volume 35, Number 34

Publisher:

, Pages 3844-+

Type of Work:

Article | Final Publisher PDF

Abstract:

Purpose We evaluated the efficacy and safety of momelotinib, a potent and selective Janus kinase 1 and 2 inhibitor (JAKi), compared with ruxolitinib, in JAKi-naïve patients with myelofibrosis. Patients and Methods Patients (N = 432) with high risk or intermediate-2 risk or symptomatic intermediate-1 risk myelofibrosis were randomly assigned to receive 24 weeks of treatment with momelotinib 200 mg once daily or ruxolitinib 20 mg twice a day (or per label), after which all patients could receive open-label momelotinib. The primary end point was a $ 35% reduction in spleen volume at 24 weeks of therapy. Secondary end points were rates of symptom response and effects on RBC transfusion requirements. Results A $ 35% reduction in spleen volume at week 24 was achieved by a similar proportion of patients in both treatment arms: 26.5% of the momelotinib group and 29% of the ruxolitinib group (noninferior; P = .011). A $ 50% reduction in the total symptom score was observed in 28.4% and 42.2% of patients who received momelotinib and ruxolitinib, respectively, indicating that noninferiority was not met (P = .98). Transfusion rate, transfusion independence, and transfusion dependence were improved with momelotinib (all with nominal P # .019). The most common grade $ 3 hematologic abnormalities in either group were thrombocytopenia and anemia. Grade $ 3 infections occurred in 7% of patients who received momelotinib and 3% of patients who received ruxolitinib. Treatment-emergent peripheral neuropathy occurred in 10% of patients who received momelotinib (all grade # 2) and 5% of patients who received ruxolitinib (all grade # 3). Conclusion In JAKi-naïve patients with myelofibrosis, 24 weeks of momelotinib treatment was noninferior to ruxolitinib for spleen response but not for symptom response. Momelotinib treatment was associated with a reduced transfusion requirement.

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© 2017 American Society of Clinical Oncology. All rights reserved.

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