Evidence map›Paper›PMID 34159682›Full record

Trial reportCancer science2021

Phase II study of tazemetostat for relapsed or refractory B-cell non-Hodgkin lymphoma with EZH2 mutation in Japan.

Koji Izutsu, Kiyoshi Ando, Momoko Nishikori, Hirohiko Shibayama, Takanori Teshima, Junya Kuroda, Koji Kato, Yoshitaka Imaizumi, Kisato Nosaka, Rika Sakai and 3 more

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

Trial report in Cancer science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed
6.7field-weighted citation impact, top 2% 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

44 citing papers in PubMed, 58 citations in OpenAlex.

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  18. Epigenetics-targeted drugs: current paradigms and future challenges.Signal transduction and targeted therapy · 2024
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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

13 authors at 12 institutions in 1 country.

Koji IzutsuDepartment of Hematology, National Cancer Center Hospital, Tokyo, Japan.ORCID https://orcid.org/0000-0001-9129-8057
Kiyoshi AndoDepartment of Hematology and Oncology, Tokai University School of Medicine, Isehara, Japan.
Momoko NishikoriDepartment of Hematology and Oncology, Kyoto University, Kyoto, Japan.ORCID https://orcid.org/0000-0003-4171-2162
Hirohiko ShibayamaDepartment of Hematology and Oncology, Osaka University Hospital, Osaka, Japan.
Takanori TeshimaDepartment of Hematology, Hokkaido University Faculty of Medicine, Sapporo, Japan.
Junya KurodaDivision of Hematology and Oncology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Koji KatoDepartment of Hematology and Oncology, Kyushu University Hospital, Fukuoka, Japan.ORCID https://orcid.org/0000-0002-5815-4585
Yoshitaka ImaizumiDepartment of Hematology, Nagasaki University Hospital, Nagasaki, Japan.ORCID https://orcid.org/0000-0002-2954-5691
Kisato NosakaDepartment of Hematology, Rheumatology, and Infectious Diseases, Kumamoto University, Kumamoto, Japan.ORCID https://orcid.org/0000-0001-6682-2451
Rika SakaiDepartment of Hematology and Medical Oncology, Kanagawa Cancer Center, Yokohama, Japan.
Seiichiro HojoEisai Co., Ltd., Tokyo, Japan.
Tadashi NakanishiEisai Co., Ltd., Tokyo, Japan.
Shinya RaiDepartment of Hematology and Rheumatology, Kindai University Hospital, Osaka, Japan.ORCID https://orcid.org/0000-0003-3929-9751
Eisai (Japan) · JPHokkaido University · JPKanagawa Prefectural Hospital Organization · JPKindai University Hospital · JPKumamoto University · JPKyoto Prefectural University of Medicine · JPKyoto University · JPKyushu University Hospital · JPNagasaki University Hospital · JPOsaka University Hospital · JPTokai University · JPTokyo National Hospital · JP

Funding

Eisai
6 · The paper itself

Abstract

Tazemetostat is a selective, reversible, small-molecule inhibitor of the histone methyltransferase enzyme, enhancer of zest homolog 2 (EZH2). In this multicenter, open-label, phase II study, we assessed the efficacy and safety of tazemetostat in Japanese patients with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma harboring the EZH2 mutation. Tazemetostat (800 mg twice daily) was given orally (28-day cycle) until disease progression or unacceptable toxicity. Among the 20 eligible patients, 17 were enrolled in cohort 1 (follicular lymphoma [FL]), and three were enrolled in cohort 2 (diffuse large B-cell lymphoma). At data cut-off, the objective response rate in cohort 1 was 76.5%, including six patients (35.3%) with complete response and seven patients (41.2%) with partial response (PR). All three patients in cohort 2 achieved PR. In cohort 1, median progression-free survival (PFS) was not reached at the median follow-up of 12.9 months. The estimated PFS rate at 12 and 15 months was 94.1% and 73.2%, respectively. The most common grade 3 treatment-emergent adverse event (TEAE) was lymphopenia (n = 2). Grade 4 TEAEs included hypertriglyceridemia and pneumonia aspiration (n = 1 each), which were not related to tazemetostat. Treatment-emergent adverse events leading to study drug discontinuation were reported in four of the 20 patients, indicating that the safety profile of tazemetostat was acceptable and manageable. Tazemetostat 800 mg twice daily showed encouraging efficacy in patients with R/R EZH2 mutation-positive FL with a manageable safety profile in the overall population. Thus, tazemetostat could be a potential treatment for R/R EZH2 mutation-positive FL.

Indexed as

MutationAgedAged, 80 and overAntineoplastic AgentsBenzamidesBiphenyl CompoundsCohort StudiesEnhancer of Zeste Homolog 2 ProteinFemaleHumansJapanLymphoma, FollicularLymphoma, Large B-Cell, DiffuseMaleMiddle AgedMorpholinesAntineoplastic AgentsBenzamidesBiphenyl CompoundsEnhancer of Zeste Homolog 2 ProteinEZH2 protein, humanMorpholinesPyridonestazemetostatefficacyenhancer of zeste homolog 2follicular lymphomanon-Hodgkin lymphomasafetytazemetostattrimethylation of lysine 27 in histone 3

Identifiers

PMID34159682
PMCPMC8409398
OpenAlexW3175445752

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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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.