Evidence map›Paper›PMID 42179186›Full record

Trial reportThe oncologist2026

Add-on parsaclisib for patients with myelofibrosis and suboptimal response to ruxolitinib: a randomized phase 3 study.

Jean-Jacques Kiladjian, Uma Borate, Elisabetta Abruzzese, Valerio De Stefano, Tiejun Gong, Massimo Breccia, Francesca Palandri, Fabrizio Pane, Andrea Patriarca, Hakon Reikvam and 6 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The oncologist, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04551053 (A Randomized, Double-Blind, Placebo-Controlled Study of the PI3Kδ Inhibitor Parsaclisib Plus Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT04551053 phase3terminatednot on this map

A Randomized, Double-Blind, Placebo-Controlled Study of the PI3Kδ Inhibitor Parsaclisib Plus Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib

TypeinterventionalSponsorIncyte CorporationRan2021 to 2024Enrolled177ConditionsMyelofibrosis, Primary Myelofibrosis, Post Essential Thrombocythemia Myelofibrosis, Post Polycythemia Vera MyelofibrosisArmsparsaclisib, ruxolitinib, placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
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

16 authors.

Jean-Jacques KiladjianSaint-Louis Hospital, Paris Cité University, INSERM, Paris 75010, France.
Uma BorateDivision of Hematology, The Ohio State University Comprehensive Cancer Center, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, The James Outpatient Care, Columbus, OH 43210, United States.
Elisabetta AbruzzeseS. Eugenio Hospital, Tor Vergata University, Rome 00144, Italy.
Valerio De StefanoSection of Hematology, Department of Radiological and Hematological Sciences, Catholic University, Fondazione Policlinico Gemelli IRCCS, Rome 00168, Italy.
Tiejun GongHarbin Institute of Hematology and Oncology, Harbin the First Hospital, Harbin, Heilongjiang 150010, China.
Massimo BrecciaDepartment of Translational and Precision Medicine, Azienda Policlinico Umberto I, Sapienza University, Rome 00161, Italy.
Francesca PalandriDepartment of Medical and Surgical Sciences, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna 40138, Italy.
Fabrizio PaneDepartment of Clinical Medicine and Surgery, University Federico II, Naples 80131, Italy.
Andrea PatriarcaDivision of Hematology, Department of Translational Medicine, Università del Piemonte Orientale, Novara 28100, Italy.
Hakon ReikvamDepartment of Clinical Science, K.G. Jebsen Center for Myeloid Blood Cancer, University of Bergen, Bergen 5009, Norway.
Lindsay ReinDepartment of Medicine, Duke University School of Medicine, Durham, NC 27710, United States.
Abdulraheem YacoubDepartment of Internal Medicine, University of Kansas Medical Center, Westwood Campus, Westwood, KS 66205, United States.
Feng ZhouIncyte Corporation, Wilmington, DE 19803, United States.
Michael StouffsIncyte Corporation, Wilmington, DE 19803, United States.
Albert AssadIncyte Corporation, Wilmington, DE 19803, United States.ORCID 0009-0008-3705-0585
Alessandro Maria VannucchiDepartment of Experimental and Clinical Medicine, University of Florence, Azienda Ospedaliero-Universitaria Careggi, Florence 50134, Italy.

Funding

Incyte Corporation, Wilmington, DE, USA
6 · The paper itself

Abstract

backgroundRuxolitinib (JAK1/JAK2 inhibitor) is indicated for adults with intermediate or high-risk myelofibrosis; however, a subset of patients may exhibit a suboptimal response due to persistent PI3K/AKT activation. The phase 3, randomized, double-blind, placebo-controlled LIMBER-304 study (NCT04551053) investigated the efficacy and safety of add-on parsaclisib (highly selective PI3Kδ inhibitor) in patients with myelofibrosis and suboptimal or declining response to stable ruxolitinib monotherapy. PATIENTS AND

methodsAdults with primary or secondary myelofibrosis who received ruxolitinib with palpable spleen and Myelofibrosis Symptom Assessment Form (MFSAF) total symptom score (TSS) ≥10 were eligible. Primary end point was proportion of patients achieving ≥25% spleen volume reduction (SVR; baseline to week 24); key secondary end point was proportion of patients with ≥50% MFSAF-TSS reduction (baseline to week 24).

resultsIn total, 90 patients received parsaclisib/ruxolitinib; 87 received placebo/ruxolitinib. At week 24, 16.7% of patients receiving parsaclisib/ruxolitinib achieved ≥25% SVR vs 9.7% for placebo/ruxolitinib; this difference was not statistically significant. By week 24, ≥50% reduction in MFSAF-TSS was observed in 17.1% of patients receiving parsaclisib/ruxolitinib vs 14.1% for placebo/ruxolitinib. Higher rates of infections (including cytomegalovirus) and gastrointestinal disorders were observed with parsaclisib/ruxolitinib. Grade ≥3 treatment-emergent adverse events occurred in 60.0% of patients receiving parsaclisib/ruxolitinib vs 42.5% with placebo/ruxolitinib. The study was terminated early based on efficacy findings.

conclusionsStudy results suggested adding parsaclisib to stable-dose ruxolitinib was unlikely to offer clinically meaningful benefits. Further research is needed on the potential of JAK and PI3K inhibitor-based combination therapy for patients with myelofibrosis.

Indexed as

Primary MyelofibrosisPyrazolesAdultAgedAged, 80 and overDouble-Blind MethodFemaleHumansMaleMiddle AgedNitrilesPyrimidinesNitrilesPyrazolesPyrimidinesruxolitinibparsaclisibprimary myelofibrosisruxolitinibspleen

Identifiers

PMID42179186
PMCPMC13257860

What Socratic holds

Textmetadata
LicenceCC BY
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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 Socratic graph.