Evidence map›Paper›PMID 38824917›Full record

ArticleActa haematologica2025

Safety of Extended Pirtobrutinib Exposure in Relapsed and/or Refractory B-Cell Malignancies.

Lindsey E Roeker, Catherine C Coombs, Nirav N Shah, Wojciech Jurczak, Jennifer A Woyach, Chan Y Cheah, Krish Patel, Kami Maddocks, Yucai Wang, Pier Luigi Zinzani and 11 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Acta haematologica, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. 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

21 authors.

Lindsey E RoekerMemorial Sloan Kettering Cancer Center, New York, New York, USA.
Catherine C CoombsDepartment of Medicine, University of California Irvine Health, Orange, California, USA.
Nirav N ShahDepartment of Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
Wojciech JurczakMaria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland.
Jennifer A WoyachThe Ohio State University Comprehensive Cancer Center, Columbus, Ohio, USA.
Chan Y CheahLinear Clinical Research and Sir Charles Gairdner Hospital, Perth, Washington, Australia.
Krish PatelCenter for Blood Disorders and Cellular Therapy, Swedish Cancer Institute, Seattle, Washington, USA.
Kami MaddocksThe Ohio State University Comprehensive Cancer Center, Columbus, Ohio, USA.
Yucai WangDivision of Hematology, Mayo Clinic, Rochester, Minnesota, USA.
Pier Luigi ZinzaniIRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia Seràgnoli, Bologna, Italy.
Talha MunirDepartment of Haematology, St. James's University Hospital, Leeds, UK.
Youngil KohDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
Meghan C ThompsonMemorial Sloan Kettering Cancer Center, New York, New York, USA.
Catherine E MuehlenbeinLoxo@Lilly, Indianapolis, Indiana, USA.
Chunxiao WangEli Lilly and Company, Indianapolis, Indiana, USA.
Richard SizeloveEli Lilly and Company, Indianapolis, Indiana, USA.
Sarang AbhyankarEli Lilly and Company, Indianapolis, Indiana, USA.
Safarulla HasanabbaEli Lilly and Company, Indianapolis, Indiana, USA.
Donald E TsaiLoxo@Lilly, Indianapolis, Indiana, USA.
Toby A EyreOxford University Hospitals NHS Foundation Trust, Churchill Cancer Center, Oxford, UK.
Michael WangMD Anderson Cancer Center, Houston, Texas, USA.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

introductionPirtobrutinib, a highly selective, noncovalent (reversible) Bruton tyrosine kinase inhibitor, has demonstrated promising efficacy in B-cell malignancies and is associated with low rates of discontinuation and dose reduction. Pirtobrutinib is administered until disease progression or toxicity, necessitating an understanding of the safety profile in patients with extended treatment.

methodsHere we report the safety of pirtobrutinib in patients with relapsed/refractory B-cell malignancies with extended (≥12 months) drug exposure from the BRUIN trial. Assessments included median time-to-first-occurrence of adverse events (AEs), dose reductions, and discontinuations due to treatment-emergent AEs (TEAEs) and select AEs of interest (AESIs).

resultsOf 773 patients enrolled, 326 (42%) received treatment for ≥12 months. In the extended exposure cohort, the median time-on-treatment was 19 months. The most common all-cause TEAEs were fatigue (32%) and diarrhea (31%). TEAEs leading to dose reduction occurred in 23 (7%) and discontinuations in 11 (3%) extended exposure patients. One patient had a fatal treatment-related AE (COVID-19 pneumonia). Infections (73.0%) were the most common AESI with a median time-to-first-occurrence of 7.4 months. Majority of TEAEs and AESIs occurred during the first year of therapy.

conclusionsPirtobrutinib therapy continues to demonstrate an excellent safety profile amenable to long-term administration without evidence of new or worsening toxicity signals.

introductionPirtobrutinib, a highly selective, noncovalent (reversible) Bruton tyrosine kinase inhibitor, has demonstrated promising efficacy in B-cell malignancies and is associated with low rates of discontinuation and dose reduction. Pirtobrutinib is administered until disease progression or toxicity, necessitating an understanding of the safety profile in patients with extended treatment.

methodsHere we report the safety of pirtobrutinib in patients with relapsed/refractory B-cell malignancies with extended (≥12 months) drug exposure from the BRUIN trial. Assessments included median time-to-first-occurrence of adverse events (AEs), dose reductions, and discontinuations due to treatment-emergent AEs (TEAEs) and select AEs of interest (AESIs).

resultsOf 773 patients enrolled, 326 (42%) received treatment for ≥12 months. In the extended exposure cohort, the median time-on-treatment was 19 months. The most common all-cause TEAEs were fatigue (32%) and diarrhea (31%). TEAEs leading to dose reduction occurred in 23 (7%) and discontinuations in 11 (3%) extended exposure patients. One patient had a fatal treatment-related AE (COVID-19 pneumonia). Infections (73.0%) were the most common AESI with a median time-to-first-occurrence of 7.4 months. Majority of TEAEs and AESIs occurred during the first year of therapy.

conclusionsPirtobrutinib therapy continues to demonstrate an excellent safety profile amenable to long-term administration without evidence of new or worsening toxicity signals.

Indexed as

Antineoplastic AgentsLymphoma, B-CellProtein Kinase InhibitorsPyrazolesPyrimidinesAdenineAdultAgammaglobulinaemia Tyrosine KinaseAgedAged, 80 and overClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicFemaleHumansMaleMiddle AgedAdenineAgammaglobulinaemia Tyrosine KinaseAntineoplastic AgentsBTK protein, humanpirtobrutinibProtein Kinase InhibitorsPyrazolesPyrimidinesB-cell malignanciesBruton tyrosine kinase inhibitorLong-term safetyToxicity

Identifiers

PMID38824917
PMCPMC11617602

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