Trial reportCancer science2022
Two-year outcomes of tirabrutinib monotherapy in Waldenström's macroglobulinemia.
Trial report in Cancer science, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled 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.
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.
Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it, 37 citations in OpenAlex.
- Efficacy and safety of tirabrutinib monotherapy in relapsed or refractory B-cell lymphomas/leukemia: a meta-analysis.Frontiers in pharmacology · 2025Pooled it
- Ibrutinib plus rituximab vs ibrutinib monotherapy in patients with Waldenström macroglobulinemia: a pooled analysis.Blood advances · 2025Trial
- Two-year outcomes of tirabrutinib monotherapy in Waldenström's macroglobulinemia.Cancer science · 2022Trial
- Post-marketing surveillance of tirabrutinib for Waldenström's macroglobulinemia/lymphoplasmacytic lymphoma in Japan.Journal of clinical and experimental hematopathology : JCEH · 2026Article
- Treatment of Anti-myelin-associated Glycoprotein Neuropathy with Tirabrutinib and a 3-year Follow-up.Internal medicine (Tokyo, Japan) · 2025Article
- Article
- Progression of IgM Monoclonal Gammopathy of Renal Significance (MGRS) to Symptomatic Waldenström Macroglobulinemia: A Case Report.Cancer reports (Hoboken, N.J.) · 2025Article
- Post-marketing surveillance of tirabrutinib in 189 patients with r/r primary central nervous system lymphoma.Future oncology (London, England) · 2025Observational
- Bruton tyrosine kinase inhibitor in non-IgM lymphoplasmacytic lymphoma: a case report and literature review.Journal of clinical and experimental hematopathology : JCEH · 2025Review
- New Means and Challenges in the Targeting of BTK.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024Review
- How I use genomics and BTK inhibitors in the treatment of Waldenström macroglobulinemia.Blood · 2024Article
- Article
- Optimal use of BTK inhibitors in Waldenström's macroglobulinemia: combination or single drug approach?Therapeutic advances in hematology · 2024Review
- Advances in Treatment of Waldenström Macroglobulinemia.Current oncology reports · 2023Review
- Bruton's Tyrosine Kinase Inhibitors (BTKIs): Review of Preclinical Studies and Evaluation of Clinical Trials.Molecules (Basel, Switzerland) · 2023Review
- Waldenström macroglobulinemia: 2023 update on diagnosis, risk stratification, and management.American journal of hematology · 2023Article
- The Impact of Tirabrutinib Monotherapy for Bing-Neel Syndrome in Waldenström's Macroglobulinemia.Internal medicine (Tokyo, Japan) · 2022Article
- Evaluation of orelabrutinib monotherapy in patients with relapsed or refractory Waldenström's macroglobulinemia in a single-arm, multicenter, open-label, phase 2 study.EClinicalMedicine · 2022Article
- Anti-myelin-associated-glycoprotein neuropathy successfully treated with tirabrutinib.Heliyon · 2022Article
- BTK inhibitors in the treatment of hematological malignancies and inflammatory diseases: mechanisms and clinical studies.Journal of hematology & oncology · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 14 institutions in 2 countries.
Funding
Abstract
The phase II study of tirabrutinib monotherapy at a daily dose of 480 mg under fasting conditions for treatment-naïve and relapsed/refractory Waldenström's macroglobulinemia (ONO-4059-05 study) demonstrated a promising efficacy and tolerable safety profile. We conducted an unplanned analysis with a median follow-up of 24.8 months to update the efficacy and safety results and to report patient-reported quality of life. Of 27 enrolled patients, 22 patients continued receiving the study drug. The major response assessed by an independent review committee was observed in 25 patients (93%), including one and five patients who newly achieved complete response and very good partial response, respectively, after the primary analysis. The progression-free and overall survival rates at 24 months were 92.6% and 100%, respectively. Serum IgM levels in all patients except one declined and were maintained at low levels, although transient increases occurred after temporal interruption of the study drug. The disease-related symptoms including recurrent fever and hyperviscosity mostly disappeared. Health-related quality of life, assessed by cancer-specific questionnaires, was mostly maintained. Grade 3-4 neutropenia, lymphopenia, and leukopenia were newly recognized in three, two, and one patient, respectively. Grade 3 treatment-related hypertriglyceridemia was also recognized. Nine patients experienced grade 1-2 bleeding events (33%), one patient experienced grade 2 treatment-related atrial fibrillation, and one patient experienced grade 1 treatment-related hypertension. Treatment-related skin adverse events were observed in 14 patients (52%). Taken together, tirabrutinib has durable efficacy with an acceptable safety profile for treatment-naïve and refractory/relapsed Waldenström's macroglobulinemia.
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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.