Evidence map›Paper›PMID 33877856›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2021

ROCK2 Inhibition With Belumosudil (KD025) for the Treatment of Chronic Graft-Versus-Host Disease.

Madan Jagasia, Aleksandr Lazaryan, Carlos R Bachier, Amandeep Salhotra, Daniel J Weisdorf, Behyar Zoghi, James Essell, Laurie Green, Olivier Schueller, Jeegar Patel and 7 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 100 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
100citing papers in PubMed, 2 pooled it
17.4field-weighted citation impact, top 1% of its field
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

100 citing papers in PubMed, 2 syntheses or guidelines pooled it, 178 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. A Multicenter Phase II Trial of Ruxolitinib for Treatment of Corticosteroid Refractory Sclerotic Chronic Graft-Versus-Host Disease.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
    Trial
  7. Trial
  8. Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. Review
  16. Article
  17. Chronic graft-versus-host disease.Nature reviews. Disease primers · 2026
    Review
  18. Review
  19. Review
  20. Review

40 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 9 institutions in 1 country.

Madan JagasiaPrior affiliation: Vanderbilt-Ingram Cancer Center, Nashville, TN.ORCID 0000-0001-5757-5604
Aleksandr LazaryanMoffitt Cancer Center, Tampa, FL.ORCID 0000-0001-9605-6436
Carlos R BachierTriStar Centennial Medical Center, Nashville, TN.
Amandeep SalhotraCity of Hope Comprehensive Cancer Center, Duarte, CA.
Daniel J WeisdorfMasonic Cancer Center, University of Minnesota, Minneapolis, MN.ORCID 0000-0001-8078-8579
Behyar ZoghiTexas Transplant Institute, Methodist Hospital, San Antonio, TX.
James EssellOncology Hematology Care, Inc, Cincinnati, OH.
Laurie GreenKadmon Corporation, LLC, New York, NY.
Olivier SchuellerKadmon Corporation, LLC, New York, NY.
Jeegar PatelKadmon Corporation, LLC, New York, NY.
Alexandra Zanin-ZhorovKadmon Corporation, LLC, New York, NY.
Jonathan M WeissKadmon Corporation, LLC, New York, NY.
Zhongming YangKadmon Corporation, LLC, New York, NY.
David EiznhamerKadmon Corporation, LLC, New York, NY.
Sanjay K AggarwalKadmon Corporation, LLC, New York, NY.
Bruce R BlazarUniversity of Minnesota, Minneapolis, MN.ORCID 0000-0002-9608-9841
Stephanie J LeeFred Hutchinson Cancer Research Center, Seattle, WA.ORCID 0000-0003-2600-6390
Eon Corporation (United States) · USUniversity of Minnesota · USCentennial Medical Center · USCity of Hope · USFred Hutch Cancer Center · USHouston Methodist · USMoffitt Cancer Center · USOncology Hematology Care · USVanderbilt University · US

Funding

Project 3: Humoral Targets and B Cell Biology in Chronic Graft-vs.-Host DiseaseP01CA142106 · NCI · DANA-FARBER CANCER INST · PI RITZ, JEROME · 2009 to 2019
$17.5M
Nongenotoxic conditioning for gene therapy and allogeneic transplantation in Fanconi anemiaR01HL147324 · NHLBI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Bruce R Blazar, HANS-PETER KIEM · 2020 to 2026
$4.1M
NCI NIH HHS P01 CA142106NHLBI NIH HHS R01 HL147324
6 · The paper itself

Abstract

purposeThe rho-associated coiled-coil-containing protein kinase-2 (ROCK2) signaling pathway regulates the Th17/regulatory T cells balance and controls profibrotic pathways. Selective ROCK2 inhibition with belumosudil (KD025) may offer a novel approach to the management of chronic graft-versus-host disease (cGVHD). PATIENTS AND

methodsA phase IIa, open-label, dose-finding study of belumosudil enrolled 54 patients with cGVHD who had received one to three prior lines of therapy (LOTs). The primary end point was overall response rate (ORR).

resultsThe median time from cGVHD diagnosis to enrollment was 20 months. Seventy-eight percent of patients had severe cGVHD, 50% had ≥ 4 organs involved, 73% had cGVHD refractory to their last LOT, and 50% had received ≥ 3 prior LOTs. With an overall median follow-up of 29 months, the ORR (95% CI) with belumosudil 200 mg once daily, 200 mg twice daily, and 400 mg once daily was 65% (38% to 86%), 69% (41% to 89%), and 62% (38% to 82%), respectively. Responses were clinically meaningful, with a median duration of response of 35 weeks, and were associated with quality-of-life improvements and corticosteroid (CS) dose reductions. CS treatment was discontinued in 19% of patients. The failure-free survival rate was 76% (62% to 85%) and 47% (33% to 60%) at 6 and 12 months, respectively. The 2-year overall survival rate was 82% (69% to 90%). Belumosudil was well-tolerated, with low rates of cytopenia. There were no unexpected adverse events and no apparent increased risk of infection, including cytomegalovirus infection and reactivation.

conclusionBelumosudil treatment resulted in a high ORR and overall survival rate and demonstrated quality-of-life improvements, CS dose reductions, and limited toxicity. Data from the study indicated that belumosudil may prove to be an effective therapy for patients with treatment-refractory cGVHD.

Indexed as

AcetamidesAdultAgedCohort StudiesFemaleGraft vs Host DiseaseHematopoietic Stem Cell TransplantationHumansMaleMiddle AgedProtein Kinase Inhibitorsrho-Associated KinasesYoung AdultAcetamidesbelumosudilProtein Kinase Inhibitorsrho-Associated KinasesROCK2 protein, human

Identifiers

PMID33877856
PMCPMC8189612
OpenAlexW3153469960

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.