Evidence map›Paper›PMID 37165840›Full record

Trial reportHaematologica2023

Safety and efficacy of zinpentraxin alfa as monotherapy or in combination with ruxolitinib in myelofibrosis: stage I of a phase II trial.

Srdan Verstovsek, Lynda Foltz, Vikas Gupta, Robert Hasserjian, Taghi Manshouri, John Mascarenhas, Ruben Mesa, Olga Pozdnyakova, Ellen Ritchie, Ivo Veletic and 10 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Haematologica, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01981850 (A Phase 2, Prospective Study Of PRM-151 In Subjects With Primary Myelofibrosis), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
4.9field-weighted citation impact, top 5% 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.

NCT01981850 phase2completednot on this map

A Phase 2, Prospective Study Of PRM-151 In Subjects With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV MF), Or Post-Essential Thrombocythemia MF (Post-ET MF)

TypeinterventionalSponsorHoffmann-La RocheRan2013 to 2020Enrolled125ConditionsPrimary Myelofibrosis, Polycythemia Vera, Post-Essential Thrombocythemia MyelofibrosisArmsRO7490677, Ruxolitinib
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 17 citations in OpenAlex.

  1. Trial
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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

20 authors at 11 institutions in 4 countries.

Srdan VerstovsekDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX. sverstovsek@kartosthera.com.
Lynda FoltzSt Paul's Hospital, University of British Columbia, Vancouver.
Vikas GuptaPrincess Margaret Cancer Centre, University of Toronto, Toronto.
Robert HasserjianMassachusetts General Hospital, Harvard Medical School, Boston, MA.
Taghi ManshouriDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.
John MascarenhasTisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY.
Ruben MesaMays Cancer Center at UT Health San Antonio MD Anderson, San Antonio, TX.
Olga PozdnyakovaBrigham and Women's Hospital, Harvard Medical School, Boston, MA.
Ellen RitchieWeill Cornell Medicine, New York, NY.
Ivo VeleticDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.
Katia GamelF. Hoffmann-La Roche, Ltd., Basel.
Habib HamidiGenentech Inc, South San Francisco, CA.
Lyrialle HanGenentech Inc, South San Francisco, CA.
Brian HigginsGenentech Inc, South San Francisco, CA.
Kerstin TrunzerF. Hoffmann-La Roche, Ltd., Basel.
Marianne UguenF. Hoffmann-La Roche, Ltd., Basel.
Dao WangF. Hoffmann-La Roche, Ltd., Basel.
Tarec Christoffer El-GalalyF. Hoffmann-La Roche, Ltd., Basel, Switzerland; Current affiliation: Department of Hematology, Aalborg University Hospital, Aalborg.
Boyan TodorovF. Hoffmann-La Roche, Ltd., Basel.
Jason GotlibStanford Cancer Institute/Stanford University School of Medicine, Stanford, CA.
Roche (Switzerland) · CHThe University of Texas MD Anderson Cancer Center · USAalborg University Hospital · DKBrigham and Women's Hospital · USCornell University · USIcahn School of Medicine at Mount Sinai · USMassachusetts General Hospital · USPrincess Margaret Cancer Centre · CAStanford University · USThe University of Texas Health Science Center at San Antonio · USUniversity of British Columbia · CA

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI DIANE BODURKA · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

Pentraxin 2 (PTX-2; serum amyloid P component), a circulating endogenous regulator of the inflammatory response to tissue injury and fibrosis, is reduced in patients with myelofibrosis (MF). Zinpentraxin alfa (RO7490677, PRM-151) is a recombinant form of PTX-2 that has shown preclinical antifibrotic activity and no dose-limiting toxicities in phase I trials. We report results from stage 1 of a phase II trial of zinpentraxin alfa in patients with intermediate-1/2 or high-risk MF. Patients (n=27) received intravenous zinpentraxin α weekly (QW) or every 4 weeks (Q4W), as monotherapy or an additional therapy for patients on stable-dose ruxolitinib. The primary endpoint was overall response rate (ORR; investigatorassessed) adapted from International Working Group-Myeloproliferative Neoplasms Research and Treatment criteria. Secondary endpoints included modified Myeloproliferative Neoplasm-Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) change, bone marrow (BM) MF grade reduction, pharmacokinetics, and safety. ORR at week 24 was 33% (n=9/27) and varied across individual cohorts (QW: 38% [3/8]; Q4W: 14% [1/7]; QW+ruxolitinib: 33% [2/6]; Q4W+ruxolitinib: 50% [3/6]). Five of 18 evaluable patients (28%) experienced a ≥50% reduction in MPN-SAF TSS, and six of 17 evaluable patients (35%) had a ≥1 grade improvement from baseline in BM fibrosis at week 24. Most treatment-emergent adverse events (AE) were grade 1-2, most commonly fatigue. Among others, anemia and thrombocytopenia were infrequent (n=3 and n=1, respectively). Treatment-related serious AE occurred in four patients (15%). Overall, zinpentraxin alfa showed evidence of clinical activity and tolerable safety as monotherapy and in combination with ruxolitinib in this open-label, non-randomized trial (clinicaltrials gov. Identifier: NCT01981850).

Indexed as

Primary MyelofibrosisRecombinant ProteinsAnemiaDrug Therapy, CombinationFibrosisHumansNitrilesPyrazolesPyrimidinesTreatment OutcomeNitrilesPyrazolesPyrimidinesRecombinant Proteinsruxolitinib

Identifiers

PMID37165840
PMCPMC10543197
OpenAlexW4376133764

What OpenQuestion holds

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LicenceCC BY-NC
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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.