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Schema {🗺️}

WebPage:
      mainEntity:
         headline:Phase 1b/2a study of galunisertib, a small molecule inhibitor of transforming growth factor-beta receptor I, in combination with standard temozolomide-based radiochemotherapy in patients with newly diagnosed malignant glioma
         description:Purpose Galunisertib, a TGF-β inhibitor, has demonstrated antitumor effects in preclinical and radiographic responses in some patients with malignant glioma. This Phase 1b/2a trial investigated the clinical benefit of combining galunisertib with temozolomide-based radiochemotherapy (TMZ/RTX) in patients with newly diagnosed malignant glioma (NCT01220271). Methods This is an open-label, 2-arm Phase 1b/2a study (N = 56) of galunisertib (intermittent dosing: 14 days on/14 days off per cycle of 28 days) in combination with TMZ/RTX (n = 40), versus a control arm (TMZ/RTX, n = 16). The primary objective of Phase 1b was to determine the safe and tolerable Phase 2 dose of galunisertib. The primary objective of Phase 2a was to confirm the tolerability and pharmacodynamic profile of galunisertib with TMZ/RTX, and the secondary objectives included determining the efficacy and pharmacokinetic (PK) profile of galunisertib with TMZ/RTX in patients with glioblastoma. This study also characterized the changes in the major T-cell subsets during TMZ/RTX plus galunisertib treatment. Results In the Phase 2a study, efficacy results for patients treated with galunisertib plus TMZ/RTX or TMZ/RTX were: median overall survival (18.2 vs 17.9 months), median progression-free survival (7.6 vs 11.5 months), and disease control rate (80% [32/40] vs 56% [9/16] patients) respectively. PK profile of galunisertib plus TMZ/RTX regimen was consistent with previously published PK data of galunisertib. The overall safety profile across treatment arms was comparable. Conclusion No differences in efficacy, safety or pharmacokinetic variables were observed between the two treatment arms.
         datePublished:2020-03-05T00:00:00Z
         dateModified:2020-03-05T00:00:00Z
         pageStart:1570
         pageEnd:1579
         license:http://creativecommons.org/licenses/by/4.0/
         sameAs:https://doi.org/10.1007/s10637-020-00910-9
         keywords:
            Glioblastoma
            Galunisertib
            Radiochemotherapy
            T cells
            Biomarkers
            Oncology
            Pharmacology/Toxicology
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               1573-0646
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            volumeNumber:38
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            logo:
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         author:
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               affiliation:
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                     address:
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ScholarlyArticle:
      headline:Phase 1b/2a study of galunisertib, a small molecule inhibitor of transforming growth factor-beta receptor I, in combination with standard temozolomide-based radiochemotherapy in patients with newly diagnosed malignant glioma
      description:Purpose Galunisertib, a TGF-β inhibitor, has demonstrated antitumor effects in preclinical and radiographic responses in some patients with malignant glioma. This Phase 1b/2a trial investigated the clinical benefit of combining galunisertib with temozolomide-based radiochemotherapy (TMZ/RTX) in patients with newly diagnosed malignant glioma (NCT01220271). Methods This is an open-label, 2-arm Phase 1b/2a study (N = 56) of galunisertib (intermittent dosing: 14 days on/14 days off per cycle of 28 days) in combination with TMZ/RTX (n = 40), versus a control arm (TMZ/RTX, n = 16). The primary objective of Phase 1b was to determine the safe and tolerable Phase 2 dose of galunisertib. The primary objective of Phase 2a was to confirm the tolerability and pharmacodynamic profile of galunisertib with TMZ/RTX, and the secondary objectives included determining the efficacy and pharmacokinetic (PK) profile of galunisertib with TMZ/RTX in patients with glioblastoma. This study also characterized the changes in the major T-cell subsets during TMZ/RTX plus galunisertib treatment. Results In the Phase 2a study, efficacy results for patients treated with galunisertib plus TMZ/RTX or TMZ/RTX were: median overall survival (18.2 vs 17.9 months), median progression-free survival (7.6 vs 11.5 months), and disease control rate (80% [32/40] vs 56% [9/16] patients) respectively. PK profile of galunisertib plus TMZ/RTX regimen was consistent with previously published PK data of galunisertib. The overall safety profile across treatment arms was comparable. Conclusion No differences in efficacy, safety or pharmacokinetic variables were observed between the two treatment arms.
      datePublished:2020-03-05T00:00:00Z
      dateModified:2020-03-05T00:00:00Z
      pageStart:1570
      pageEnd:1579
      license:http://creativecommons.org/licenses/by/4.0/
      sameAs:https://doi.org/10.1007/s10637-020-00910-9
      keywords:
         Glioblastoma
         Galunisertib
         Radiochemotherapy
         T cells
         Biomarkers
         Oncology
         Pharmacology/Toxicology
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      affiliation:
            name:Universitat Autònoma de Barcelona
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      name:Ivelina Gueorguieva
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            address:
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      name:Tiana Burkholder
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            name:Eli Lilly and Company
            address:
               name:Eli Lilly and Company, Erl Wood, UK
               type:PostalAddress
            type:Organization
      name:Shawn T. Estrem
      affiliation:
            name:Eli Lilly and Company
            address:
               name:Eli Lilly and Company, Indianapolis, USA
               type:PostalAddress
            type:Organization
      name:Shuaicheng Wang
      affiliation:
            name:BioStat Solutions, Inc
            address:
               name:BioStat Solutions, Inc, Frederick, USA
               type:PostalAddress
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      affiliation:
            name:Eli Lilly and Company
            address:
               name:Eli Lilly and Company, Indianapolis, USA
               type:PostalAddress
            type:Organization
      name:Susan C. Guba
      affiliation:
            name:Eli Lilly and Company
            address:
               name:Eli Lilly and Company, Indianapolis, USA
               type:PostalAddress
            type:Organization
      name:David Capper
      affiliation:
            name:Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health
            address:
               name:Department of Neuropathology, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany
               type:PostalAddress
            type:Organization
      name:Jordi Rodon
      affiliation:
            name:Universitat Autònoma de Barcelona
            address:
               name:Vall d’Hebron University Hospital and Institute of Oncology, Universitat Autònoma de Barcelona, Barcelona, Spain
               type:PostalAddress
            type:Organization
            name:U. T. M. D. Anderson Cancer Center
            address:
               name:Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, U. T. M. D. Anderson Cancer Center, Houston, USA
               type:PostalAddress
            type:Organization
PostalAddress:
      name:Clinical Cooperation Unit Neuro-oncology, German Cancer Research Center, Heidelberg University Medical Center, Heidelberg, Germany
      name:The Preston Robert Tisch Brain Tumor Center at Duke, Duke University, Durham, USA
      name:Vall d’Hebron University Hospital and Institute of Oncology, Universitat Autònoma de Barcelona, Barcelona, Spain
      name:H. Lee Moffitt Cancer Center and Research Institute, Tampa, USA
      name:Eli Lilly and Company, Erl Wood, UK
      name:Eli Lilly and Company, Indianapolis, USA
      name:Eli Lilly and Company, Erl Wood, UK
      name:Eli Lilly and Company, Indianapolis, USA
      name:BioStat Solutions, Inc, Frederick, USA
      name:Eli Lilly and Company, Indianapolis, USA
      name:Eli Lilly and Company, Indianapolis, USA
      name:Department of Neuropathology, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany
      name:Vall d’Hebron University Hospital and Institute of Oncology, Universitat Autònoma de Barcelona, Barcelona, Spain
      name:Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, U. T. M. D. Anderson Cancer Center, Houston, USA

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