Evidence map›Paper›PMID 39960615›Full record

Trial reportInternational journal of hematology2025

Zanubrutinib in Japanese treatment-naive and relapsed/refractory patients with Waldenström macroglobulinemia and CLL/SLL.

Koji Izutsu, Takayuki Ishikawa, Kazuyuki Shimada, Kohmei Kubo, Takeshi Kondo, Katsuya Fujimoto, Tomoaki Fujisaki, Shingo Kurahashi, Koji Nagafuji, Rika Sakai and 8 more

Abstract readClinical Trial, Phase IIClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of hematology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

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

3 citing papers in PubMed.

  1. Review
  2. Article
  3. 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

18 authors.

Koji IzutsuNational Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan. kizutsu@ncc.go.jp.ORCID http://orcid.org/0000-0001-9129-8057
Takayuki IshikawaKobe City Medical Center General Hospital, Kobe, Japan.
Kazuyuki ShimadaNagoya University Hospital, Nagoya, Japan.
Kohmei KuboAomori Prefectural Central Hospital, Aomori, Japan.
Takeshi KondoAiiku Hospital, Sapporo, Japan.
Katsuya FujimotoNHO Hokkaido Cancer Center, Sapporo, Japan.
Tomoaki FujisakiMatsuyama Red Cross Hospital, Matsuyama, Japan.
Shingo KurahashiToyohashi Municipal Hospital, Toyohashi, Japan.
Koji NagafujiKurume University Hospital, Kurume, Japan.
Rika SakaiKanagawa Cancer Center, Yokohama, Japan.
Tatsuro JoJapanese Red Cross Nagasaki Genbaku Hospital, Nagasaki, Japan.
Tomonori NakazatoYokohama Municipal Citizen's Hospital, Yokohama, Japan.
Kazutaka SunamiNational Hospital Organization Okayama Medical Center, Okayama, Japan.
Senji KasaharaGifu Municipal Hospital, Gifu, Japan.
Aileen CohenBeiGene USA, Inc., San Mateo, CA, USA.
Motohisa TakaiBeiGene USA, Inc., San Mateo, CA, USA.
Jinhua ZhongBeiGene (Shanghai) Co., Ltd., Shanghai, China.
Masahiro TakeuchiChiba-Ken Cancer Center, Chiba, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Zanubrutinib is a selective second-generation Bruton tyrosine kinase inhibitor approved in various B-cell malignancies globally. The phase 1/2 BGB-3111-111 study evaluated the efficacy and safety of zanubrutinib 160 mg twice daily orally in Japanese patients with treatment-naive or relapsed/refractory mature B-cell malignancies. Here, efficacy results from Part 2 in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL; n = 19) and Waldenström macroglobulinemia (WM; n = 19), and safety results from Parts 1 (N = 6) and 2 (N = 49) are presented, with the first dose between 30 January, 2020, and 31 October, 2022. As of 10 May, 2023, investigator-assessed overall response rates were 100% (19/19) and 94.7% (18/19) in CLL/SLL and WM, respectively, with median follow-up of 27.9 and 26.8 months; 24-month progression-free survival rates were 71.4% and 100% in treatment-naive and relapsed/refractory CLL/SLL and 83.9% and 100% in treatment-naive and relapsed/refractory WM, respectively. In patients with B-cell malignancies, any-grade treatment-emergent adverse events (TEAEs) occurred in 53 (96.4%) and serious TEAEs in 18 (32.7%). Common TEAEs were platelet count decreased (18.2%), pyrexia (18.2%), COVID-19 (14.5%), and neutrophil count decreased (12.7%). With median follow-up > 2 years, zanubrutinib demonstrated durable efficacy in Japanese patients with CLL/SLL or WM and a favorable safety profile consistent with global phase 3 studies.

Indexed as

Leukemia, Lymphocytic, Chronic, B-CellPiperidinesProtein Kinase InhibitorsPyrazolesPyrimidinesWaldenstrom MacroglobulinemiaAdultAgammaglobulinaemia Tyrosine KinaseAgedAged, 80 and overEast Asian PeopleFemaleHumansJapanMaleMiddle AgedAgammaglobulinaemia Tyrosine KinasePiperidinesProtein Kinase InhibitorsPyrazolesPyrimidineszanubrutinibBruton tyrosine kinaseChronic Lymphocytic Leukemia/Small Lymphocytic LymphomaJapaneseWaldenström MacroglobulinemiaZanubrutinib

Identifiers

PMID39960615
PMCPMC11922998

What OpenQuestion holds

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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.