A phase 1/2a dose-finding study and biomarker assessment of oral lisavanbulin in patients with high-grade glioma or glioblastoma
Lisavanbulin is a prodrug of the microtubule-targeting agent avanbulin. Both avanbulin and lisavanbulin have demonstrated significant antitumor activity in several preclinical tumor models including glioblastoma. Previous human studies demonstrated that 48-h infusions of intravenous lisavanbulin wer...
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| Vydané v: | Cell reports. Medicine Ročník 6; číslo 6; s. 102165 |
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| Hlavní autori: | , , , , , , , , , , , , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | English |
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United States
Elsevier Inc
17.06.2025
Elsevier |
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| ISSN: | 2666-3791, 2666-3791 |
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| Abstract | Lisavanbulin is a prodrug of the microtubule-targeting agent avanbulin. Both avanbulin and lisavanbulin have demonstrated significant antitumor activity in several preclinical tumor models including glioblastoma. Previous human studies demonstrated that 48-h infusions of intravenous lisavanbulin were well tolerated with preliminary activity in recurrent glioblastoma. The current phase 1/2a study evaluates the safety and tolerability of once-daily oral lisavanbulin in patients with solid tumors or recurrent glioblastoma or high-grade glioma. Lisavanbulin is associated with profound, durable responses in a subset of patients with recurrent refractory grade 4 astrocytoma or glioblastoma. We present here the clinical and translational results from this trial, including a description of a response-predictive molecular signature that warrants further exploration in these tumor types of significant unmet need. The study is registered at ClinicalTrials.gov (NCT02490800).
[Display omitted]
•Lisavanbulin is an orally dosed brain-penetrant mitotic spindle checkpoint inhibitor•Our study assesses lisavanbulin in refractory astrocytoma or glioblastoma•Lisavanbulin is tolerable in patients with these tumors•A subset of patients have durable efficacy responses to lisavanbulin
Lopez et al. report a phase 1/2a study evaluating once-daily oral lisavanbulin, a brain-penetrant microtubule-targeting agent in patients with solid tumors or recurrent high-grade glioma. Lisavanbulin is tolerable in these patients and is associated with profound, durable responses in a subset of patients with grade 4 astrocytoma or glioblastoma. |
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| AbstractList | SummaryLisavanbulin is a prodrug of the microtubule-targeting agent avanbulin. Both avanbulin and lisavanbulin have demonstrated significant antitumor activity in several preclinical tumor models including glioblastoma. Previous human studies demonstrated that 48-h infusions of intravenous lisavanbulin were well tolerated with preliminary activity in recurrent glioblastoma. The current phase 1/2a study evaluates the safety and tolerability of once-daily oral lisavanbulin in patients with solid tumors or recurrent glioblastoma or high-grade glioma. Lisavanbulin is associated with profound, durable responses in a subset of patients with recurrent refractory grade 4 astrocytoma or glioblastoma. We present here the clinical and translational results from this trial, including a description of a response-predictive molecular signature that warrants further exploration in these tumor types of significant unmet need. The study is registered at ClinicalTrials.gov (NCT02490800). Lisavanbulin is a prodrug of the microtubule-targeting agent avanbulin. Both avanbulin and lisavanbulin have demonstrated significant antitumor activity in several preclinical tumor models including glioblastoma. Previous human studies demonstrated that 48-h infusions of intravenous lisavanbulin were well tolerated with preliminary activity in recurrent glioblastoma. The current phase 1/2a study evaluates the safety and tolerability of once-daily oral lisavanbulin in patients with solid tumors or recurrent glioblastoma or high-grade glioma. Lisavanbulin is associated with profound, durable responses in a subset of patients with recurrent refractory grade 4 astrocytoma or glioblastoma. We present here the clinical and translational results from this trial, including a description of a response-predictive molecular signature that warrants further exploration in these tumor types of significant unmet need. The study is registered at ClinicalTrials.gov (NCT02490800).Lisavanbulin is a prodrug of the microtubule-targeting agent avanbulin. Both avanbulin and lisavanbulin have demonstrated significant antitumor activity in several preclinical tumor models including glioblastoma. Previous human studies demonstrated that 48-h infusions of intravenous lisavanbulin were well tolerated with preliminary activity in recurrent glioblastoma. The current phase 1/2a study evaluates the safety and tolerability of once-daily oral lisavanbulin in patients with solid tumors or recurrent glioblastoma or high-grade glioma. Lisavanbulin is associated with profound, durable responses in a subset of patients with recurrent refractory grade 4 astrocytoma or glioblastoma. We present here the clinical and translational results from this trial, including a description of a response-predictive molecular signature that warrants further exploration in these tumor types of significant unmet need. The study is registered at ClinicalTrials.gov (NCT02490800). Lisavanbulin is a prodrug of the microtubule-targeting agent avanbulin. Both avanbulin and lisavanbulin have demonstrated significant antitumor activity in several preclinical tumor models including glioblastoma. Previous human studies demonstrated that 48-h infusions of intravenous lisavanbulin were well tolerated with preliminary activity in recurrent glioblastoma. The current phase 1/2a study evaluates the safety and tolerability of once-daily oral lisavanbulin in patients with solid tumors or recurrent glioblastoma or high-grade glioma. Lisavanbulin is associated with profound, durable responses in a subset of patients with recurrent refractory grade 4 astrocytoma or glioblastoma. We present here the clinical and translational results from this trial, including a description of a response-predictive molecular signature that warrants further exploration in these tumor types of significant unmet need. The study is registered at ClinicalTrials.gov (NCT02490800). [Display omitted] •Lisavanbulin is an orally dosed brain-penetrant mitotic spindle checkpoint inhibitor•Our study assesses lisavanbulin in refractory astrocytoma or glioblastoma•Lisavanbulin is tolerable in patients with these tumors•A subset of patients have durable efficacy responses to lisavanbulin Lopez et al. report a phase 1/2a study evaluating once-daily oral lisavanbulin, a brain-penetrant microtubule-targeting agent in patients with solid tumors or recurrent high-grade glioma. Lisavanbulin is tolerable in these patients and is associated with profound, durable responses in a subset of patients with grade 4 astrocytoma or glioblastoma. Lisavanbulin is a prodrug of the microtubule-targeting agent avanbulin. Both avanbulin and lisavanbulin have demonstrated significant antitumor activity in several preclinical tumor models including glioblastoma. Previous human studies demonstrated that 48-h infusions of intravenous lisavanbulin were well tolerated with preliminary activity in recurrent glioblastoma. The current phase 1/2a study evaluates the safety and tolerability of once-daily oral lisavanbulin in patients with solid tumors or recurrent glioblastoma or high-grade glioma. Lisavanbulin is associated with profound, durable responses in a subset of patients with recurrent refractory grade 4 astrocytoma or glioblastoma. We present here the clinical and translational results from this trial, including a description of a response-predictive molecular signature that warrants further exploration in these tumor types of significant unmet need. The study is registered at ClinicalTrials.gov (NCT02490800). Lisavanbulin is a prodrug of the microtubule-targeting agent avanbulin. Both avanbulin and lisavanbulin have demonstrated significant antitumor activity in several preclinical tumor models including glioblastoma. Previous human studies demonstrated that 48-h infusions of intravenous lisavanbulin were well tolerated with preliminary activity in recurrent glioblastoma. The current phase 1/2a study evaluates the safety and tolerability of once-daily oral lisavanbulin in patients with solid tumors or recurrent glioblastoma or high-grade glioma. Lisavanbulin is associated with profound, durable responses in a subset of patients with recurrent refractory grade 4 astrocytoma or glioblastoma. We present here the clinical and translational results from this trial, including a description of a response-predictive molecular signature that warrants further exploration in these tumor types of significant unmet need. The study is registered at ClinicalTrials.gov (NCT02490800). •Lisavanbulin is an orally dosed brain-penetrant mitotic spindle checkpoint inhibitor•Our study assesses lisavanbulin in refractory astrocytoma or glioblastoma•Lisavanbulin is tolerable in patients with these tumors•A subset of patients have durable efficacy responses to lisavanbulin Lopez et al. report a phase 1/2a study evaluating once-daily oral lisavanbulin, a brain-penetrant microtubule-targeting agent in patients with solid tumors or recurrent high-grade glioma. Lisavanbulin is tolerable in these patients and is associated with profound, durable responses in a subset of patients with grade 4 astrocytoma or glioblastoma. |
| ArticleNumber | 102165 |
| Author | Beebe, Kirk Tabatabai, Ghazaleh Haefliger, Simon Clement, Paul M. Steinbach, Joachim Hundsberger, Thomas Eisner, Joel Robert Kaindl, Thomas Läubli, Heinz Engelhardt, Marc Roth, Patrick Brazil, Lucy Wick, Antje Kristeleit, Rebecca Lopez, Juanita Suzanne Jeffry Evans, Thomas R. Wunderlich, Benjamin Lane, Heidi Plummer, Ruth Hau, Peter |
| Author_xml | – sequence: 1 givenname: Juanita Suzanne surname: Lopez fullname: Lopez, Juanita Suzanne email: juanita.lopez@icr.ac.uk organization: Drug Development Unit at the Royal Marsden NHS Foundation Trust and the Institute of Cancer Research, Sutton, UK – sequence: 2 givenname: Simon surname: Haefliger fullname: Haefliger, Simon organization: Inselspital, Bern University Hospital, University of Bern, Department of Medical Oncology, Bern, Switzerland – sequence: 3 givenname: Ruth surname: Plummer fullname: Plummer, Ruth organization: Newcastle University and Northern Centre for Cancer Care, Freeman Hospital, Newcastle upon Tyne, UK – sequence: 4 givenname: Paul M. surname: Clement fullname: Clement, Paul M. organization: UZ Leuven - Department of Oncology, Leuven Cancer Institute - KU Leuven, Leuven, Belgium – sequence: 5 givenname: Thomas R. surname: Jeffry Evans fullname: Jeffry Evans, Thomas R. organization: University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow, UK – sequence: 6 givenname: Heinz surname: Läubli fullname: Läubli, Heinz organization: Department of Oncology, University Hospital Basel, Basel, Switzerland – sequence: 7 givenname: Patrick surname: Roth fullname: Roth, Patrick organization: Department of Neurology, University Hospital Zurich and University of Zurich, Zürich, Switzerland – sequence: 8 givenname: Rebecca surname: Kristeleit fullname: Kristeleit, Rebecca organization: Guy’s and St Thomas’ NHS Foundation Trust and King’s College London, London, UK – sequence: 9 givenname: Lucy surname: Brazil fullname: Brazil, Lucy organization: Guy’s Hospital, Cancer Centre, London, UK – sequence: 10 givenname: Ghazaleh surname: Tabatabai fullname: Tabatabai, Ghazaleh organization: Department of Neurology & Interdisciplinary Neuro-Oncology, University Hospital Tübingen, Hertie Institute for Clinical Brain Research, Eberhard Karls Uninversity Tübingen, Tübingen, Germany – sequence: 11 givenname: Antje surname: Wick fullname: Wick, Antje organization: Neurology Department, University Clinic Universitätsklinikum, Heidelberg, Germany – sequence: 12 givenname: Benjamin surname: Wunderlich fullname: Wunderlich, Benjamin organization: Discovery Life Sciences Biomarker Services GmbH, Kassel, Germany – sequence: 13 givenname: Kirk surname: Beebe fullname: Beebe, Kirk organization: GeneCentric Therapeutics Inc., Durham, NC, USA – sequence: 14 givenname: Joel Robert surname: Eisner fullname: Eisner, Joel Robert organization: GeneCentric Therapeutics Inc., Durham, NC, USA – sequence: 15 givenname: Heidi surname: Lane fullname: Lane, Heidi organization: Basilea Pharmaceutica International Ltd, Allschwil, Switzerland – sequence: 16 givenname: Marc surname: Engelhardt fullname: Engelhardt, Marc organization: Basilea Pharmaceutica International Ltd, Allschwil, Switzerland – sequence: 17 givenname: Thomas orcidid: 0000-0001-9640-7937 surname: Kaindl fullname: Kaindl, Thomas email: thomas.kaindl@basilea.com organization: Basilea Pharmaceutica International Ltd, Allschwil, Switzerland – sequence: 18 givenname: Peter surname: Hau fullname: Hau, Peter organization: Wilhelm Sander NeuroOncology Unit and Department of Neurology - Neurooncology, University Hospital Regensburg, Regensburg, Germany – sequence: 19 givenname: Thomas surname: Hundsberger fullname: Hundsberger, Thomas organization: Department of Neurology and Medical Oncology, Cantonal Hospital St. Gallen, Sankt Gallen, Switzerland – sequence: 20 givenname: Joachim surname: Steinbach fullname: Steinbach, Joachim organization: Dr. Senckenberg Institute of Neurooncology, University Hospital, Goethe University Frankfurt, Frankfurt, Germany |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/40532659$$D View this record in MEDLINE/PubMed |
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| Keywords | glioma glioblastoma lisavanbulin astrocytoma |
| Language | English |
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| Snippet | Lisavanbulin is a prodrug of the microtubule-targeting agent avanbulin. Both avanbulin and lisavanbulin have demonstrated significant antitumor activity in... SummaryLisavanbulin is a prodrug of the microtubule-targeting agent avanbulin. Both avanbulin and lisavanbulin have demonstrated significant antitumor activity... |
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| SubjectTerms | Administration, Oral Adult Advanced Basic Science Aged Antineoplastic Agents - administration & dosage Antineoplastic Agents - therapeutic use astrocytoma Biomarkers, Tumor - metabolism Brain Neoplasms - drug therapy Brain Neoplasms - pathology Dose-Response Relationship, Drug Female glioblastoma Glioblastoma - drug therapy Glioblastoma - metabolism Glioblastoma - pathology glioma Glioma - drug therapy Glioma - metabolism Glioma - pathology Humans lisavanbulin Male Middle Aged Neoplasm Grading |
| Title | A phase 1/2a dose-finding study and biomarker assessment of oral lisavanbulin in patients with high-grade glioma or glioblastoma |
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