Evidence map›Paper›PMID 28930494›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2017

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

Ruben A Mesa, Jean-Jacques Kiladjian, John V Catalano, Timothy Devos, Miklos Egyed, Andrzei Hellmann, Donal McLornan, Kazuya Shimoda, Elliott F Winton, Wei Deng and 4 more

Abstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 212 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
212citing papers in PubMed, 6 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

212 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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  17. MANIFEST: Pelabresib in Combination With Ruxolitinib for Janus Kinase Inhibitor Treatment-Naïve Myelofibrosis.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
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152 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Ruben A MesaRuben A. Mesa, Mayo Clinic Cancer Center, Scottsdale, AZ; Jean-Jacques Kiladjian, Saint-Louis Hospital (Assistance Publique-Hôpitaux de Paris) and Paris Diderot University, Paris, France; John V. Catalano, Frankston Hospital and Monash University, Melbourne, Victoria, Australia; Timothy Devos, University Hospital Leuven and Katholieke Universiteit Leuven, Leuven, Belgium; Miklos Egyed, Kaposi Mor Teaching Hospital, Kaposvar, Hungary; Andrzei Hellmann, Medical University of Gdańsk, Gdańsk, Poland; Donal McLornan, Guy's and St Thomas' National Health Service Foundation Trust, London, United Kingdom; Kazuya Shimoda, University of Miyazaki, Miyazaki, Japan; Elliott F. Winton, Emory University School of Medicine, Atlanta, GA; Wei Deng, Ronald L. Dubowy, and Julia D. Maltzman, Gilead Sciences, Foster City; Jason Gotlib, Stanford Cancer Institute, Stanford, CA; and Francisco Cervantes, Hospital Clinic, Institut D'Investigacions Biomèdiques August Pi I Sunyer, University of Barcelona, Barcelona, Spain.
Jean-Jacques KiladjianRuben A. Mesa, Mayo Clinic Cancer Center, Scottsdale, AZ; Jean-Jacques Kiladjian, Saint-Louis Hospital (Assistance Publique-Hôpitaux de Paris) and Paris Diderot University, Paris, France; John V. Catalano, Frankston Hospital and Monash University, Melbourne, Victoria, Australia; Timothy Devos, University Hospital Leuven and Katholieke Universiteit Leuven, Leuven, Belgium; Miklos Egyed, Kaposi Mor Teaching Hospital, Kaposvar, Hungary; Andrzei Hellmann, Medical University of Gdańsk, Gdańsk, Poland; Donal McLornan, Guy's and St Thomas' National Health Service Foundation Trust, London, United Kingdom; Kazuya Shimoda, University of Miyazaki, Miyazaki, Japan; Elliott F. Winton, Emory University School of Medicine, Atlanta, GA; Wei Deng, Ronald L. Dubowy, and Julia D. Maltzman, Gilead Sciences, Foster City; Jason Gotlib, Stanford Cancer Institute, Stanford, CA; and Francisco Cervantes, Hospital Clinic, Institut D'Investigacions Biomèdiques August Pi I Sunyer, University of Barcelona, Barcelona, Spain.
John V CatalanoRuben A. Mesa, Mayo Clinic Cancer Center, Scottsdale, AZ; Jean-Jacques Kiladjian, Saint-Louis Hospital (Assistance Publique-Hôpitaux de Paris) and Paris Diderot University, Paris, France; John V. Catalano, Frankston Hospital and Monash University, Melbourne, Victoria, Australia; Timothy Devos, University Hospital Leuven and Katholieke Universiteit Leuven, Leuven, Belgium; Miklos Egyed, Kaposi Mor Teaching Hospital, Kaposvar, Hungary; Andrzei Hellmann, Medical University of Gdańsk, Gdańsk, Poland; Donal McLornan, Guy's and St Thomas' National Health Service Foundation Trust, London, United Kingdom; Kazuya Shimoda, University of Miyazaki, Miyazaki, Japan; Elliott F. Winton, Emory University School of Medicine, Atlanta, GA; Wei Deng, Ronald L. Dubowy, and Julia D. Maltzman, Gilead Sciences, Foster City; Jason Gotlib, Stanford Cancer Institute, Stanford, CA; and Francisco Cervantes, Hospital Clinic, Institut D'Investigacions Biomèdiques August Pi I Sunyer, University of Barcelona, Barcelona, Spain.
Timothy DevosRuben A. Mesa, Mayo Clinic Cancer Center, Scottsdale, AZ; Jean-Jacques Kiladjian, Saint-Louis Hospital (Assistance Publique-Hôpitaux de Paris) and Paris Diderot University, Paris, France; John V. Catalano, Frankston Hospital and Monash University, Melbourne, Victoria, Australia; Timothy Devos, University Hospital Leuven and Katholieke Universiteit Leuven, Leuven, Belgium; Miklos Egyed, Kaposi Mor Teaching Hospital, Kaposvar, Hungary; Andrzei Hellmann, Medical University of Gdańsk, Gdańsk, Poland; Donal McLornan, Guy's and St Thomas' National Health Service Foundation Trust, London, United Kingdom; Kazuya Shimoda, University of Miyazaki, Miyazaki, Japan; Elliott F. Winton, Emory University School of Medicine, Atlanta, GA; Wei Deng, Ronald L. Dubowy, and Julia D. Maltzman, Gilead Sciences, Foster City; Jason Gotlib, Stanford Cancer Institute, Stanford, CA; and Francisco Cervantes, Hospital Clinic, Institut D'Investigacions Biomèdiques August Pi I Sunyer, University of Barcelona, Barcelona, Spain.
Miklos EgyedRuben A. Mesa, Mayo Clinic Cancer Center, Scottsdale, AZ; Jean-Jacques Kiladjian, Saint-Louis Hospital (Assistance Publique-Hôpitaux de Paris) and Paris Diderot University, Paris, France; John V. Catalano, Frankston Hospital and Monash University, Melbourne, Victoria, Australia; Timothy Devos, University Hospital Leuven and Katholieke Universiteit Leuven, Leuven, Belgium; Miklos Egyed, Kaposi Mor Teaching Hospital, Kaposvar, Hungary; Andrzei Hellmann, Medical University of Gdańsk, Gdańsk, Poland; Donal McLornan, Guy's and St Thomas' National Health Service Foundation Trust, London, United Kingdom; Kazuya Shimoda, University of Miyazaki, Miyazaki, Japan; Elliott F. Winton, Emory University School of Medicine, Atlanta, GA; Wei Deng, Ronald L. Dubowy, and Julia D. Maltzman, Gilead Sciences, Foster City; Jason Gotlib, Stanford Cancer Institute, Stanford, CA; and Francisco Cervantes, Hospital Clinic, Institut D'Investigacions Biomèdiques August Pi I Sunyer, University of Barcelona, Barcelona, Spain.
Andrzei HellmannRuben A. Mesa, Mayo Clinic Cancer Center, Scottsdale, AZ; Jean-Jacques Kiladjian, Saint-Louis Hospital (Assistance Publique-Hôpitaux de Paris) and Paris Diderot University, Paris, France; John V. Catalano, Frankston Hospital and Monash University, Melbourne, Victoria, Australia; Timothy Devos, University Hospital Leuven and Katholieke Universiteit Leuven, Leuven, Belgium; Miklos Egyed, Kaposi Mor Teaching Hospital, Kaposvar, Hungary; Andrzei Hellmann, Medical University of Gdańsk, Gdańsk, Poland; Donal McLornan, Guy's and St Thomas' National Health Service Foundation Trust, London, United Kingdom; Kazuya Shimoda, University of Miyazaki, Miyazaki, Japan; Elliott F. Winton, Emory University School of Medicine, Atlanta, GA; Wei Deng, Ronald L. Dubowy, and Julia D. Maltzman, Gilead Sciences, Foster City; Jason Gotlib, Stanford Cancer Institute, Stanford, CA; and Francisco Cervantes, Hospital Clinic, Institut D'Investigacions Biomèdiques August Pi I Sunyer, University of Barcelona, Barcelona, Spain.
Donal McLornanRuben A. Mesa, Mayo Clinic Cancer Center, Scottsdale, AZ; Jean-Jacques Kiladjian, Saint-Louis Hospital (Assistance Publique-Hôpitaux de Paris) and Paris Diderot University, Paris, France; John V. Catalano, Frankston Hospital and Monash University, Melbourne, Victoria, Australia; Timothy Devos, University Hospital Leuven and Katholieke Universiteit Leuven, Leuven, Belgium; Miklos Egyed, Kaposi Mor Teaching Hospital, Kaposvar, Hungary; Andrzei Hellmann, Medical University of Gdańsk, Gdańsk, Poland; Donal McLornan, Guy's and St Thomas' National Health Service Foundation Trust, London, United Kingdom; Kazuya Shimoda, University of Miyazaki, Miyazaki, Japan; Elliott F. Winton, Emory University School of Medicine, Atlanta, GA; Wei Deng, Ronald L. Dubowy, and Julia D. Maltzman, Gilead Sciences, Foster City; Jason Gotlib, Stanford Cancer Institute, Stanford, CA; and Francisco Cervantes, Hospital Clinic, Institut D'Investigacions Biomèdiques August Pi I Sunyer, University of Barcelona, Barcelona, Spain.
Kazuya ShimodaRuben A. Mesa, Mayo Clinic Cancer Center, Scottsdale, AZ; Jean-Jacques Kiladjian, Saint-Louis Hospital (Assistance Publique-Hôpitaux de Paris) and Paris Diderot University, Paris, France; John V. Catalano, Frankston Hospital and Monash University, Melbourne, Victoria, Australia; Timothy Devos, University Hospital Leuven and Katholieke Universiteit Leuven, Leuven, Belgium; Miklos Egyed, Kaposi Mor Teaching Hospital, Kaposvar, Hungary; Andrzei Hellmann, Medical University of Gdańsk, Gdańsk, Poland; Donal McLornan, Guy's and St Thomas' National Health Service Foundation Trust, London, United Kingdom; Kazuya Shimoda, University of Miyazaki, Miyazaki, Japan; Elliott F. Winton, Emory University School of Medicine, Atlanta, GA; Wei Deng, Ronald L. Dubowy, and Julia D. Maltzman, Gilead Sciences, Foster City; Jason Gotlib, Stanford Cancer Institute, Stanford, CA; and Francisco Cervantes, Hospital Clinic, Institut D'Investigacions Biomèdiques August Pi I Sunyer, University of Barcelona, Barcelona, Spain.
Elliott F WintonRuben A. Mesa, Mayo Clinic Cancer Center, Scottsdale, AZ; Jean-Jacques Kiladjian, Saint-Louis Hospital (Assistance Publique-Hôpitaux de Paris) and Paris Diderot University, Paris, France; John V. Catalano, Frankston Hospital and Monash University, Melbourne, Victoria, Australia; Timothy Devos, University Hospital Leuven and Katholieke Universiteit Leuven, Leuven, Belgium; Miklos Egyed, Kaposi Mor Teaching Hospital, Kaposvar, Hungary; Andrzei Hellmann, Medical University of Gdańsk, Gdańsk, Poland; Donal McLornan, Guy's and St Thomas' National Health Service Foundation Trust, London, United Kingdom; Kazuya Shimoda, University of Miyazaki, Miyazaki, Japan; Elliott F. Winton, Emory University School of Medicine, Atlanta, GA; Wei Deng, Ronald L. Dubowy, and Julia D. Maltzman, Gilead Sciences, Foster City; Jason Gotlib, Stanford Cancer Institute, Stanford, CA; and Francisco Cervantes, Hospital Clinic, Institut D'Investigacions Biomèdiques August Pi I Sunyer, University of Barcelona, Barcelona, Spain.
Wei DengRuben A. Mesa, Mayo Clinic Cancer Center, Scottsdale, AZ; Jean-Jacques Kiladjian, Saint-Louis Hospital (Assistance Publique-Hôpitaux de Paris) and Paris Diderot University, Paris, France; John V. Catalano, Frankston Hospital and Monash University, Melbourne, Victoria, Australia; Timothy Devos, University Hospital Leuven and Katholieke Universiteit Leuven, Leuven, Belgium; Miklos Egyed, Kaposi Mor Teaching Hospital, Kaposvar, Hungary; Andrzei Hellmann, Medical University of Gdańsk, Gdańsk, Poland; Donal McLornan, Guy's and St Thomas' National Health Service Foundation Trust, London, United Kingdom; Kazuya Shimoda, University of Miyazaki, Miyazaki, Japan; Elliott F. Winton, Emory University School of Medicine, Atlanta, GA; Wei Deng, Ronald L. Dubowy, and Julia D. Maltzman, Gilead Sciences, Foster City; Jason Gotlib, Stanford Cancer Institute, Stanford, CA; and Francisco Cervantes, Hospital Clinic, Institut D'Investigacions Biomèdiques August Pi I Sunyer, University of Barcelona, Barcelona, Spain.
Ronald L DubowyRuben A. Mesa, Mayo Clinic Cancer Center, Scottsdale, AZ; Jean-Jacques Kiladjian, Saint-Louis Hospital (Assistance Publique-Hôpitaux de Paris) and Paris Diderot University, Paris, France; John V. Catalano, Frankston Hospital and Monash University, Melbourne, Victoria, Australia; Timothy Devos, University Hospital Leuven and Katholieke Universiteit Leuven, Leuven, Belgium; Miklos Egyed, Kaposi Mor Teaching Hospital, Kaposvar, Hungary; Andrzei Hellmann, Medical University of Gdańsk, Gdańsk, Poland; Donal McLornan, Guy's and St Thomas' National Health Service Foundation Trust, London, United Kingdom; Kazuya Shimoda, University of Miyazaki, Miyazaki, Japan; Elliott F. Winton, Emory University School of Medicine, Atlanta, GA; Wei Deng, Ronald L. Dubowy, and Julia D. Maltzman, Gilead Sciences, Foster City; Jason Gotlib, Stanford Cancer Institute, Stanford, CA; and Francisco Cervantes, Hospital Clinic, Institut D'Investigacions Biomèdiques August Pi I Sunyer, University of Barcelona, Barcelona, Spain.
Julia D MaltzmanRuben A. Mesa, Mayo Clinic Cancer Center, Scottsdale, AZ; Jean-Jacques Kiladjian, Saint-Louis Hospital (Assistance Publique-Hôpitaux de Paris) and Paris Diderot University, Paris, France; John V. Catalano, Frankston Hospital and Monash University, Melbourne, Victoria, Australia; Timothy Devos, University Hospital Leuven and Katholieke Universiteit Leuven, Leuven, Belgium; Miklos Egyed, Kaposi Mor Teaching Hospital, Kaposvar, Hungary; Andrzei Hellmann, Medical University of Gdańsk, Gdańsk, Poland; Donal McLornan, Guy's and St Thomas' National Health Service Foundation Trust, London, United Kingdom; Kazuya Shimoda, University of Miyazaki, Miyazaki, Japan; Elliott F. Winton, Emory University School of Medicine, Atlanta, GA; Wei Deng, Ronald L. Dubowy, and Julia D. Maltzman, Gilead Sciences, Foster City; Jason Gotlib, Stanford Cancer Institute, Stanford, CA; and Francisco Cervantes, Hospital Clinic, Institut D'Investigacions Biomèdiques August Pi I Sunyer, University of Barcelona, Barcelona, Spain.
Francisco CervantesRuben A. Mesa, Mayo Clinic Cancer Center, Scottsdale, AZ; Jean-Jacques Kiladjian, Saint-Louis Hospital (Assistance Publique-Hôpitaux de Paris) and Paris Diderot University, Paris, France; John V. Catalano, Frankston Hospital and Monash University, Melbourne, Victoria, Australia; Timothy Devos, University Hospital Leuven and Katholieke Universiteit Leuven, Leuven, Belgium; Miklos Egyed, Kaposi Mor Teaching Hospital, Kaposvar, Hungary; Andrzei Hellmann, Medical University of Gdańsk, Gdańsk, Poland; Donal McLornan, Guy's and St Thomas' National Health Service Foundation Trust, London, United Kingdom; Kazuya Shimoda, University of Miyazaki, Miyazaki, Japan; Elliott F. Winton, Emory University School of Medicine, Atlanta, GA; Wei Deng, Ronald L. Dubowy, and Julia D. Maltzman, Gilead Sciences, Foster City; Jason Gotlib, Stanford Cancer Institute, Stanford, CA; and Francisco Cervantes, Hospital Clinic, Institut D'Investigacions Biomèdiques August Pi I Sunyer, University of Barcelona, Barcelona, Spain.
Jason GotlibRuben A. Mesa, Mayo Clinic Cancer Center, Scottsdale, AZ; Jean-Jacques Kiladjian, Saint-Louis Hospital (Assistance Publique-Hôpitaux de Paris) and Paris Diderot University, Paris, France; John V. Catalano, Frankston Hospital and Monash University, Melbourne, Victoria, Australia; Timothy Devos, University Hospital Leuven and Katholieke Universiteit Leuven, Leuven, Belgium; Miklos Egyed, Kaposi Mor Teaching Hospital, Kaposvar, Hungary; Andrzei Hellmann, Medical University of Gdańsk, Gdańsk, Poland; Donal McLornan, Guy's and St Thomas' National Health Service Foundation Trust, London, United Kingdom; Kazuya Shimoda, University of Miyazaki, Miyazaki, Japan; Elliott F. Winton, Emory University School of Medicine, Atlanta, GA; Wei Deng, Ronald L. Dubowy, and Julia D. Maltzman, Gilead Sciences, Foster City; Jason Gotlib, Stanford Cancer Institute, Stanford, CA; and Francisco Cervantes, Hospital Clinic, Institut D'Investigacions Biomèdiques August Pi I Sunyer, University of Barcelona, Barcelona, Spain.

Funding

TISSUE CULTURE---COREP30CA054174 · NCI · UNIVERSITY OF TEXAS HLTH SCIENCE CENTER · PI Robin Jean Leach · 1991 to 2026
$59.1M
NCI NIH HHS P30 CA054174
6 · The paper itself

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.

Indexed as

AgedBenzamidesDisease-Free SurvivalDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleHumansJanus Kinase InhibitorsMaleMaximum Tolerated DoseMiddle AgedNitrilesPatient SafetyPrimary MyelofibrosisPrognosisBenzamidesJanus Kinase InhibitorsN-(cyanomethyl)-4-(2-((4-(4-morpholinyl)phenyl)amino)-4-pyrimidinyl)benzamideNitrilesPyrazolesPyrimidinesruxolitinib

Identifiers

PMID28930494
PMCPMC6553796

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.