Evidence map›Paper›PMID 38990433›Full record

Trial reportAdvances in therapy2024

Momelotinib versus Continued Ruxolitinib or Best Available Therapy in JAK Inhibitor-Experienced Patients with Myelofibrosis and Anemia: Subgroup Analysis of SIMPLIFY-2.

Claire N Harrison, Alessandro M Vannucchi, Christian Recher, Francesco Passamonti, Aaron T Gerds, Juan Carlos Hernandez-Boluda, Abdulraheem Yacoub, Shireen Sirhan, Catherine Ellis, Bharat Patel and 2 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIComparative Study
In one paragraph

Trial report in Advances in therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02101268 (A Phase 3, Randomized Study To Evaluate the Efficacy of Momelotinib Versus Best Available Therapy in Anemic or Thrombocytopenic Subjects With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis Who Were Treated With Ruxolitinib), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
–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.

NCT02101268 phase3completednot on this map

A Phase 3, Randomized Study To Evaluate the Efficacy of Momelotinib Versus Best Available Therapy in Anemic or Thrombocytopenic Subjects With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis Who Were Treated With Ruxolitinib

TypeinterventionalSponsorSierra Oncology LLC - a GSK companyRan2014 to 2019Enrolled156ConditionsPrimary Myelofibrosis (PMF), Post-polycythemia Vera (Post-PV), Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)ArmsMomelotinib, Best Available Therapy (BAT)
3 · Its place in the literature

Who cites it

14 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Pharmacologic Inhibition of JAK1/2 Potentiates Aminoglycoside-Induced Ototoxicity.Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology · 2026
    Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Emerging Therapeutic Approaches for Anemia in Myelofibrosis.Current hematologic malignancy reports · 2025
    Review
  11. Article
  12. Article
  13. Review
  14. Review
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

12 authors.

Claire N HarrisonGuy's and St Thomas' NHS Foundation Trust, Great Maze Pond, London, SE1 9RT, UK. claire.harrison@gstt.nhs.uk.ORCID 0000-0002-3212-920X
Alessandro M VannucchiUniversity of Florence, Florence, Italy.
Christian RecherUniversity Hospital Center (CHU) of Toulouse, Toulouse, France.
Francesco PassamontiFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Dipartimento di Oncologia ed Onco-Ematologia, Università degli Studi di Milano, Milan, Italy.
Aaron T GerdsCleveland Clinic Taussig Cancer Institute, Cleveland, OH, USA.
Juan Carlos Hernandez-BoludaHospital Clìnico de Valencia-INCLIVA, University of Medicine, Valencia, Spain.
Abdulraheem YacoubUniversity of Kansas, Kansas City, KS, USA.
Shireen SirhanJewish General Hospital, McGill University, Montreal, QC, Canada.
Catherine EllisGSK plc, Philadelphia, PA, USA.
Bharat PatelGSK plc, Philadelphia, PA, USA.
Bryan StrouseGSK plc, Philadelphia, PA, USA.
Uwe PlatzbeckerUniversity Hospital Leipzig, Leipzig, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSome Janus kinase (JAK) inhibitors such as ruxolitinib and fedratinib do not address and may worsen anemia in patients with myelofibrosis. In these cases, the JAK inhibitor may be continued at a reduced dose in an effort to maintain splenic and symptom control, with supportive therapy and/or red blood cell (RBC) transfusions added to manage anemia. This post hoc descriptive analysis of the phase 3 SIMPLIFY-2 trial evaluated the relative benefits of this approach versus switching to the JAK1/JAK2/activin A receptor type 1 inhibitor momelotinib in patients for whom anemia management is a key consideration.

methodsSIMPLIFY-2 was a randomized (2:1), open-label, phase 3 trial of momelotinib versus best available therapy (BAT; 88.5% continued ruxolitinib) in JAK inhibitor-experienced patients with myelofibrosis (n = 156). Patient subgroups (n = 105 each) were defined by either baseline (1) hemoglobin (Hb) of < 100 g/L or (2) non-transfusion independence (not meeting the criteria of no transfusions and no Hb of < 80 g/L for the previous 12 weeks); outcomes have been summarized descriptively.

resultsIn both subgroups of interest, week 24 transfusion independence rates were higher with momelotinib versus BAT/ruxolitinib: baseline Hb of < 100 g/L, 22 (33.3%) versus 5 (12.8%); baseline non-transfusion independent, 25 (34.7%) versus 1 (3.0%). Mean Hb levels over time were also generally higher in both subgroups with momelotinib, despite median transfusion rates through week 24 with momelotinib being comparable to or lower than with BAT/ruxolitinib. Spleen and symptom response rates with momelotinib in these subgroups were comparable to the intent-to-treat population, while rates with BAT/ruxolitinib were lower.

conclusionIn patients with moderate-to-severe anemia and/or in need of RBC transfusions, outcomes were improved by switching to momelotinib rather than continuing ruxolitinib and using anemia supportive therapies.

trial registrationClinicalTrials.gov: NCT02101268.

Indexed as

AnemiaJanus Kinase InhibitorsNitrilesPrimary MyelofibrosisPyrazolesPyrimidinesAgedAged, 80 and overBenzamidesErythrocyte TransfusionFemaleHumansJanus Kinase 1Janus Kinase 2MaleMiddle AgedBenzamidesJanus Kinase 1Janus Kinase 2Janus Kinase InhibitorsN-(cyanomethyl)-4-(2-((4-(4-morpholinyl)phenyl)amino)-4-pyrimidinyl)benzamideNitrilesPyrazolesPyrimidinesruxolitinibAnemiaAnemia supportive therapyErythropoiesis-stimulating agentsHemoglobinMomelotinibMyelofibrosisRed blood cell transfusionsRuxolitinibTransfusion independence

Identifiers

PMID38990433
PMCPMC11349857

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Registered trials

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.