A phase 1 clinical trial of the selective BTK inhibitor ONO/GS-4059 in relapsed and refractory mature B-cell malignancies
Identifieur interne : 000121 ( Pmc/Curation ); précédent : 000120; suivant : 000122A phase 1 clinical trial of the selective BTK inhibitor ONO/GS-4059 in relapsed and refractory mature B-cell malignancies
Auteurs : Harriet S. Walter [Royaume-Uni] ; Simon A. Rule [Royaume-Uni] ; Martin J. S. Dyer [Royaume-Uni] ; Lionel Karlin [France] ; Ceri Jones [Royaume-Uni] ; Bruno Cazin [France] ; Philippe Quittet [France] ; Nimish Shah [Royaume-Uni] ; Claire V. Hutchinson [Royaume-Uni] ; Hideyuki Honda [Japon] ; Kevin Duffy [Royaume-Uni] ; Joseph Birkett [Royaume-Uni] ; Virginia Jamieson [Royaume-Uni] ; Nigel Courtenay-Luck [Royaume-Uni] ; Toshio Yoshizawa [Japon] ; John Sharpe [Royaume-Uni] ; Tomoya Ohno [Japon] ; Shinichiro Abe [Royaume-Uni] ; Akihisa Nishimura [Japon] ; Guillaume Cartron [France] ; Franck Morschhauser [France] ; Christopher Fegan [Royaume-Uni] ; Gilles Salles [France]Source :
- Blood [ 0006-4971 ] ; 2016.
Abstract
We report a first-in-human dose-escalation study in relapsed/refractory B-cell malignancies with the potent BTK inhibitor ONO/GS-4059. ONO/GS-4059 induced clinically durable responses in relapsed/refractory B-cell malignancies without significant toxicities.
Url:
DOI: 10.1182/blood-2015-08-664086
PubMed: 26542378
PubMed Central: 4731845
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Hutchinson</name><affiliation wicri:level="1"><nlm:aff id="aff1">Ernest and Helen Scott Haematological Research Institute, University of Leicester, Leicester, United Kingdom;</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Ernest and Helen Scott Haematological Research Institute, University of Leicester, Leicester</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff2">Department of Haematology, Plymouth Hospitals NHS Trust, Plymouth, United Kingdom;</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Haematology, Plymouth Hospitals NHS Trust, Plymouth</wicri:regionArea></affiliation></author><author><name sortKey="Honda, Hideyuki" sort="Honda, Hideyuki" uniqKey="Honda H" first="Hideyuki" last="Honda">Hideyuki Honda</name><affiliation wicri:level="1"><nlm:aff wicri:cut="; and" id="aff7">ONO Pharmaceuticals Co Ltd, Osaka, Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>ONO Pharmaceuticals Co Ltd, Osaka</wicri:regionArea></affiliation></author><author><name sortKey="Duffy, Kevin" sort="Duffy, Kevin" uniqKey="Duffy K" first="Kevin" last="Duffy">Kevin Duffy</name><affiliation wicri:level="1"><nlm:aff id="aff8">ONO Pharma UK Ltd, London, United Kingdom</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>ONO Pharma UK Ltd, London</wicri:regionArea></affiliation></author><author><name sortKey="Birkett, Joseph" sort="Birkett, Joseph" uniqKey="Birkett J" first="Joseph" last="Birkett">Joseph Birkett</name><affiliation wicri:level="1"><nlm:aff id="aff8">ONO Pharma UK Ltd, London, United Kingdom</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>ONO Pharma UK Ltd, London</wicri:regionArea></affiliation></author><author><name sortKey="Jamieson, Virginia" sort="Jamieson, Virginia" uniqKey="Jamieson V" first="Virginia" last="Jamieson">Virginia Jamieson</name><affiliation wicri:level="1"><nlm:aff id="aff8">ONO Pharma UK Ltd, London, United Kingdom</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>ONO Pharma UK Ltd, London</wicri:regionArea></affiliation></author><author><name sortKey="Courtenay Luck, Nigel" sort="Courtenay Luck, Nigel" uniqKey="Courtenay Luck N" first="Nigel" last="Courtenay-Luck">Nigel Courtenay-Luck</name><affiliation wicri:level="1"><nlm:aff id="aff8">ONO Pharma UK Ltd, London, United Kingdom</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>ONO Pharma UK Ltd, London</wicri:regionArea></affiliation></author><author><name sortKey="Yoshizawa, Toshio" sort="Yoshizawa, Toshio" uniqKey="Yoshizawa T" first="Toshio" last="Yoshizawa">Toshio Yoshizawa</name><affiliation wicri:level="1"><nlm:aff wicri:cut="; and" id="aff7">ONO Pharmaceuticals Co Ltd, Osaka, Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>ONO Pharmaceuticals Co Ltd, Osaka</wicri:regionArea></affiliation></author><author><name sortKey="Sharpe, John" sort="Sharpe, John" uniqKey="Sharpe J" first="John" last="Sharpe">John Sharpe</name><affiliation wicri:level="1"><nlm:aff id="aff8">ONO Pharma UK Ltd, London, United Kingdom</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>ONO Pharma UK Ltd, London</wicri:regionArea></affiliation></author><author><name sortKey="Ohno, Tomoya" sort="Ohno, Tomoya" uniqKey="Ohno T" first="Tomoya" last="Ohno">Tomoya Ohno</name><affiliation wicri:level="1"><nlm:aff wicri:cut="; and" id="aff7">ONO Pharmaceuticals Co Ltd, Osaka, Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>ONO Pharmaceuticals Co Ltd, Osaka</wicri:regionArea></affiliation></author><author><name sortKey="Abe, Shinichiro" sort="Abe, Shinichiro" uniqKey="Abe S" first="Shinichiro" last="Abe">Shinichiro Abe</name><affiliation wicri:level="1"><nlm:aff id="aff8">ONO Pharma UK Ltd, London, United Kingdom</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>ONO Pharma UK Ltd, London</wicri:regionArea></affiliation></author><author><name sortKey="Nishimura, Akihisa" sort="Nishimura, Akihisa" uniqKey="Nishimura A" first="Akihisa" last="Nishimura">Akihisa Nishimura</name><affiliation wicri:level="1"><nlm:aff wicri:cut="; and" id="aff7">ONO Pharmaceuticals Co Ltd, Osaka, Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>ONO Pharmaceuticals Co Ltd, Osaka</wicri:regionArea></affiliation></author><author><name sortKey="Cartron, Guillaume" sort="Cartron, Guillaume" uniqKey="Cartron G" first="Guillaume" last="Cartron">Guillaume Cartron</name><affiliation wicri:level="1"><nlm:aff id="aff6">Department of Clinical Hematology and Unité Mixte de Recherche (UMR)–Centre National de la Recherche Scientifique (CNRS) 5235, CHRU, Montpellier, France;</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Department of Clinical Hematology and Unité Mixte de Recherche (UMR)–Centre National de la Recherche Scientifique (CNRS) 5235, CHRU, Montpellier</wicri:regionArea></affiliation></author><author><name sortKey="Morschhauser, Franck" sort="Morschhauser, Franck" uniqKey="Morschhauser F" first="Franck" last="Morschhauser">Franck Morschhauser</name><affiliation wicri:level="1"><nlm:aff id="aff5">Department of Clinical Hematology, Centre Hospitalier Régional Universitaire (CHRU) de Lille, and Unité Groupe de Recherche sur les Formes Injectables et les Technologies Associées (GRITA), Université de Lille 2, Lille, France;</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Department of Clinical Hematology, Centre Hospitalier Régional Universitaire (CHRU) de Lille, and Unité Groupe de Recherche sur les Formes Injectables et les Technologies Associées (GRITA), Université de Lille 2, Lille</wicri:regionArea></affiliation></author><author><name sortKey="Fegan, Christopher" sort="Fegan, Christopher" uniqKey="Fegan C" first="Christopher" last="Fegan">Christopher Fegan</name><affiliation wicri:level="1"><nlm:aff id="aff4">Cardiff CLL Research Group, School of Medicine, Heath Park, Cardiff, Wales, United Kingdom;</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Cardiff CLL Research Group, School of Medicine, Heath Park, Cardiff, Wales</wicri:regionArea></affiliation></author><author><name sortKey="Salles, Gilles" sort="Salles, Gilles" uniqKey="Salles G" first="Gilles" last="Salles">Gilles Salles</name><affiliation wicri:level="1"><nlm:aff id="aff3">Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Service d’Hématologie, Pierre-Bénite, Université Claude Bernard Lyon 1, Lyon, France;</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Service d’Hématologie, Pierre-Bénite, Université Claude Bernard Lyon 1, Lyon</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">26542378</idno><idno type="pmc">4731845</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4731845</idno><idno type="RBID">PMC:4731845</idno><idno type="doi">10.1182/blood-2015-08-664086</idno><date when="2016">2016</date><idno type="wicri:Area/Pmc/Corpus">000121</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000121</idno><idno type="wicri:Area/Pmc/Curation">000121</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000121</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">A phase 1 clinical trial of the selective BTK inhibitor ONO/GS-4059 in relapsed and refractory mature B-cell malignancies</title><author><name sortKey="Walter, Harriet S" sort="Walter, Harriet S" uniqKey="Walter H" first="Harriet S." last="Walter">Harriet S. Walter</name><affiliation wicri:level="1"><nlm:aff id="aff1">Ernest and Helen Scott Haematological Research Institute, University of Leicester, Leicester, United Kingdom;</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Ernest and Helen Scott Haematological Research Institute, University of Leicester, Leicester</wicri:regionArea></affiliation></author><author><name sortKey="Rule, Simon A" sort="Rule, Simon A" uniqKey="Rule S" first="Simon A." last="Rule">Simon A. Rule</name><affiliation wicri:level="1"><nlm:aff id="aff2">Department of Haematology, Plymouth Hospitals NHS Trust, Plymouth, United Kingdom;</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Haematology, Plymouth Hospitals NHS Trust, Plymouth</wicri:regionArea></affiliation></author><author><name sortKey="Dyer, Martin J S" sort="Dyer, Martin J S" uniqKey="Dyer M" first="Martin J. S." last="Dyer">Martin J. S. Dyer</name><affiliation wicri:level="1"><nlm:aff id="aff1">Ernest and Helen Scott Haematological Research Institute, University of Leicester, Leicester, United Kingdom;</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Ernest and Helen Scott Haematological Research Institute, University of Leicester, Leicester</wicri:regionArea></affiliation></author><author><name sortKey="Karlin, Lionel" sort="Karlin, Lionel" uniqKey="Karlin L" first="Lionel" last="Karlin">Lionel Karlin</name><affiliation wicri:level="1"><nlm:aff id="aff3">Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Service d’Hématologie, Pierre-Bénite, Université Claude Bernard Lyon 1, Lyon, France;</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Service d’Hématologie, Pierre-Bénite, Université Claude Bernard Lyon 1, Lyon</wicri:regionArea></affiliation></author><author><name sortKey="Jones, Ceri" sort="Jones, Ceri" uniqKey="Jones C" first="Ceri" last="Jones">Ceri Jones</name><affiliation wicri:level="1"><nlm:aff id="aff4">Cardiff CLL Research Group, School of Medicine, Heath Park, Cardiff, Wales, United Kingdom;</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Cardiff CLL Research Group, School of Medicine, Heath Park, Cardiff, Wales</wicri:regionArea></affiliation></author><author><name sortKey="Cazin, Bruno" sort="Cazin, Bruno" uniqKey="Cazin B" first="Bruno" last="Cazin">Bruno Cazin</name><affiliation wicri:level="1"><nlm:aff id="aff5">Department of Clinical Hematology, Centre Hospitalier Régional Universitaire (CHRU) de Lille, and Unité Groupe de Recherche sur les Formes Injectables et les Technologies Associées (GRITA), Université de Lille 2, Lille, France;</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Department of Clinical Hematology, Centre Hospitalier Régional Universitaire (CHRU) de Lille, and Unité Groupe de Recherche sur les Formes Injectables et les Technologies Associées (GRITA), Université de Lille 2, Lille</wicri:regionArea></affiliation></author><author><name sortKey="Quittet, Philippe" sort="Quittet, Philippe" uniqKey="Quittet P" first="Philippe" last="Quittet">Philippe Quittet</name><affiliation wicri:level="1"><nlm:aff id="aff6">Department of Clinical Hematology and Unité Mixte de Recherche (UMR)–Centre National de la Recherche Scientifique (CNRS) 5235, CHRU, Montpellier, France;</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Department of Clinical Hematology and Unité Mixte de Recherche (UMR)–Centre National de la Recherche Scientifique (CNRS) 5235, CHRU, Montpellier</wicri:regionArea></affiliation></author><author><name sortKey="Shah, Nimish" sort="Shah, Nimish" uniqKey="Shah N" first="Nimish" last="Shah">Nimish Shah</name><affiliation wicri:level="1"><nlm:aff id="aff2">Department of Haematology, Plymouth Hospitals NHS Trust, Plymouth, United Kingdom;</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Haematology, Plymouth Hospitals NHS Trust, Plymouth</wicri:regionArea></affiliation></author><author><name sortKey="Hutchinson, Claire V" sort="Hutchinson, Claire V" uniqKey="Hutchinson C" first="Claire V." last="Hutchinson">Claire V. Hutchinson</name><affiliation wicri:level="1"><nlm:aff id="aff1">Ernest and Helen Scott Haematological Research Institute, University of Leicester, Leicester, United Kingdom;</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Ernest and Helen Scott Haematological Research Institute, University of Leicester, Leicester</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff2">Department of Haematology, Plymouth Hospitals NHS Trust, Plymouth, United Kingdom;</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Haematology, Plymouth Hospitals NHS Trust, Plymouth</wicri:regionArea></affiliation></author><author><name sortKey="Honda, Hideyuki" sort="Honda, Hideyuki" uniqKey="Honda H" first="Hideyuki" last="Honda">Hideyuki Honda</name><affiliation wicri:level="1"><nlm:aff wicri:cut="; and" id="aff7">ONO Pharmaceuticals Co Ltd, Osaka, Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>ONO Pharmaceuticals Co Ltd, Osaka</wicri:regionArea></affiliation></author><author><name sortKey="Duffy, Kevin" sort="Duffy, Kevin" uniqKey="Duffy K" first="Kevin" last="Duffy">Kevin Duffy</name><affiliation wicri:level="1"><nlm:aff id="aff8">ONO Pharma UK Ltd, London, United Kingdom</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>ONO Pharma UK Ltd, London</wicri:regionArea></affiliation></author><author><name sortKey="Birkett, Joseph" sort="Birkett, Joseph" uniqKey="Birkett J" first="Joseph" last="Birkett">Joseph Birkett</name><affiliation wicri:level="1"><nlm:aff id="aff8">ONO Pharma UK Ltd, London, United Kingdom</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>ONO Pharma UK Ltd, London</wicri:regionArea></affiliation></author><author><name sortKey="Jamieson, Virginia" sort="Jamieson, Virginia" uniqKey="Jamieson V" first="Virginia" last="Jamieson">Virginia Jamieson</name><affiliation wicri:level="1"><nlm:aff id="aff8">ONO Pharma UK Ltd, London, United Kingdom</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>ONO Pharma UK Ltd, London</wicri:regionArea></affiliation></author><author><name sortKey="Courtenay Luck, Nigel" sort="Courtenay Luck, Nigel" uniqKey="Courtenay Luck N" first="Nigel" last="Courtenay-Luck">Nigel Courtenay-Luck</name><affiliation wicri:level="1"><nlm:aff id="aff8">ONO Pharma UK Ltd, London, United Kingdom</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>ONO Pharma UK Ltd, London</wicri:regionArea></affiliation></author><author><name sortKey="Yoshizawa, Toshio" sort="Yoshizawa, Toshio" uniqKey="Yoshizawa T" first="Toshio" last="Yoshizawa">Toshio Yoshizawa</name><affiliation wicri:level="1"><nlm:aff wicri:cut="; and" id="aff7">ONO Pharmaceuticals Co Ltd, Osaka, Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>ONO Pharmaceuticals Co Ltd, Osaka</wicri:regionArea></affiliation></author><author><name sortKey="Sharpe, John" sort="Sharpe, John" uniqKey="Sharpe J" first="John" last="Sharpe">John Sharpe</name><affiliation wicri:level="1"><nlm:aff id="aff8">ONO Pharma UK Ltd, London, United Kingdom</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>ONO Pharma UK Ltd, London</wicri:regionArea></affiliation></author><author><name sortKey="Ohno, Tomoya" sort="Ohno, Tomoya" uniqKey="Ohno T" first="Tomoya" last="Ohno">Tomoya Ohno</name><affiliation wicri:level="1"><nlm:aff wicri:cut="; and" id="aff7">ONO Pharmaceuticals Co Ltd, Osaka, Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>ONO Pharmaceuticals Co Ltd, Osaka</wicri:regionArea></affiliation></author><author><name sortKey="Abe, Shinichiro" sort="Abe, Shinichiro" uniqKey="Abe S" first="Shinichiro" last="Abe">Shinichiro Abe</name><affiliation wicri:level="1"><nlm:aff id="aff8">ONO Pharma UK Ltd, London, United Kingdom</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>ONO Pharma UK Ltd, London</wicri:regionArea></affiliation></author><author><name sortKey="Nishimura, Akihisa" sort="Nishimura, Akihisa" uniqKey="Nishimura A" first="Akihisa" last="Nishimura">Akihisa Nishimura</name><affiliation wicri:level="1"><nlm:aff wicri:cut="; and" id="aff7">ONO Pharmaceuticals Co Ltd, Osaka, Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>ONO Pharmaceuticals Co Ltd, Osaka</wicri:regionArea></affiliation></author><author><name sortKey="Cartron, Guillaume" sort="Cartron, Guillaume" uniqKey="Cartron G" first="Guillaume" last="Cartron">Guillaume Cartron</name><affiliation wicri:level="1"><nlm:aff id="aff6">Department of Clinical Hematology and Unité Mixte de Recherche (UMR)–Centre National de la Recherche Scientifique (CNRS) 5235, CHRU, Montpellier, France;</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Department of Clinical Hematology and Unité Mixte de Recherche (UMR)–Centre National de la Recherche Scientifique (CNRS) 5235, CHRU, Montpellier</wicri:regionArea></affiliation></author><author><name sortKey="Morschhauser, Franck" sort="Morschhauser, Franck" uniqKey="Morschhauser F" first="Franck" last="Morschhauser">Franck Morschhauser</name><affiliation wicri:level="1"><nlm:aff id="aff5">Department of Clinical Hematology, Centre Hospitalier Régional Universitaire (CHRU) de Lille, and Unité Groupe de Recherche sur les Formes Injectables et les Technologies Associées (GRITA), Université de Lille 2, Lille, France;</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Department of Clinical Hematology, Centre Hospitalier Régional Universitaire (CHRU) de Lille, and Unité Groupe de Recherche sur les Formes Injectables et les Technologies Associées (GRITA), Université de Lille 2, Lille</wicri:regionArea></affiliation></author><author><name sortKey="Fegan, Christopher" sort="Fegan, Christopher" uniqKey="Fegan C" first="Christopher" last="Fegan">Christopher Fegan</name><affiliation wicri:level="1"><nlm:aff id="aff4">Cardiff CLL Research Group, School of Medicine, Heath Park, Cardiff, Wales, United Kingdom;</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Cardiff CLL Research Group, School of Medicine, Heath Park, Cardiff, Wales</wicri:regionArea></affiliation></author><author><name sortKey="Salles, Gilles" sort="Salles, Gilles" uniqKey="Salles G" first="Gilles" last="Salles">Gilles Salles</name><affiliation wicri:level="1"><nlm:aff id="aff3">Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Service d’Hématologie, Pierre-Bénite, Université Claude Bernard Lyon 1, Lyon, France;</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Service d’Hématologie, Pierre-Bénite, Université Claude Bernard Lyon 1, Lyon</wicri:regionArea></affiliation></author></analytic><series><title level="j">Blood</title><idno type="ISSN">0006-4971</idno><idno type="eISSN">1528-0020</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><title>Key Points</title><p><list list-type="bullet"><list-item><p>We report a first-in-human dose-escalation study in relapsed/refractory B-cell malignancies with the potent BTK inhibitor ONO/GS-4059.</p></list-item><list-item><p>ONO/GS-4059 induced clinically durable responses in relapsed/refractory B-cell malignancies without significant toxicities.</p></list-item></list></p></div></front></TEI><pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Blood</journal-id><journal-id journal-id-type="iso-abbrev">Blood</journal-id><journal-id journal-id-type="hwp">bloodjournal</journal-id><journal-id journal-id-type="pmc">blood</journal-id><journal-id journal-id-type="publisher-id">Blood</journal-id><journal-title-group><journal-title>Blood</journal-title></journal-title-group><issn pub-type="ppub">0006-4971</issn><issn pub-type="epub">1528-0020</issn><publisher><publisher-name>American Society of Hematology</publisher-name><publisher-loc>Washington, DC</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">26542378</article-id><article-id pub-id-type="pmc">4731845</article-id><article-id pub-id-type="publisher-id">2015/664086</article-id><article-id pub-id-type="doi">10.1182/blood-2015-08-664086</article-id><article-categories><subj-group subj-group-type="hwp-journal-coll"><subject>29</subject><subject>8</subject><subject>39</subject></subj-group><subj-group subj-group-type="heading"><subject>Clinical Trials and Observations</subject></subj-group></article-categories><title-group><article-title>A phase 1 clinical trial of the selective BTK inhibitor ONO/GS-4059 in relapsed and refractory mature B-cell malignancies</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Walter</surname><given-names>Harriet S.</given-names></name><xref ref-type="aff" rid="aff1">1</xref><contrib-id contrib-id-type="orcid">http://orcid.org/0000-0003-2618-711X</contrib-id></contrib><contrib contrib-type="author"><name><surname>Rule</surname><given-names>Simon A.</given-names></name><xref ref-type="aff" rid="aff2">2</xref></contrib><contrib contrib-type="author" corresp="yes"><name><surname>Dyer</surname><given-names>Martin J. S.</given-names></name><xref ref-type="aff" rid="aff1">1</xref><contrib-id contrib-id-type="orcid">http://orcid.org/0000-0002-5033-2236</contrib-id></contrib><contrib contrib-type="author"><name><surname>Karlin</surname><given-names>Lionel</given-names></name><xref ref-type="aff" rid="aff3">3</xref></contrib><contrib contrib-type="author"><name><surname>Jones</surname><given-names>Ceri</given-names></name><xref ref-type="aff" rid="aff4">4</xref></contrib><contrib contrib-type="author"><name><surname>Cazin</surname><given-names>Bruno</given-names></name><xref ref-type="aff" rid="aff5">5</xref></contrib><contrib contrib-type="author"><name><surname>Quittet</surname><given-names>Philippe</given-names></name><xref ref-type="aff" rid="aff6">6</xref></contrib><contrib contrib-type="author"><name><surname>Shah</surname><given-names>Nimish</given-names></name><xref ref-type="aff" rid="aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Hutchinson</surname><given-names>Claire V.</given-names></name><xref ref-type="aff" rid="aff1">1</xref><xref ref-type="aff" rid="aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Honda</surname><given-names>Hideyuki</given-names></name><xref ref-type="aff" rid="aff7">7</xref></contrib><contrib contrib-type="author"><name><surname>Duffy</surname><given-names>Kevin</given-names></name><xref ref-type="aff" rid="aff8">8</xref></contrib><contrib contrib-type="author"><name><surname>Birkett</surname><given-names>Joseph</given-names></name><xref ref-type="aff" rid="aff8">8</xref></contrib><contrib contrib-type="author"><name><surname>Jamieson</surname><given-names>Virginia</given-names></name><xref ref-type="aff" rid="aff8">8</xref></contrib><contrib contrib-type="author"><name><surname>Courtenay-Luck</surname><given-names>Nigel</given-names></name><xref ref-type="aff" rid="aff8">8</xref></contrib><contrib contrib-type="author"><name><surname>Yoshizawa</surname><given-names>Toshio</given-names></name><xref ref-type="aff" rid="aff7">7</xref></contrib><contrib contrib-type="author"><name><surname>Sharpe</surname><given-names>John</given-names></name><xref ref-type="aff" rid="aff8">8</xref></contrib><contrib contrib-type="author"><name><surname>Ohno</surname><given-names>Tomoya</given-names></name><xref ref-type="aff" rid="aff7">7</xref></contrib><contrib contrib-type="author"><name><surname>Abe</surname><given-names>Shinichiro</given-names></name><xref ref-type="aff" rid="aff8">8</xref></contrib><contrib contrib-type="author"><name><surname>Nishimura</surname><given-names>Akihisa</given-names></name><xref ref-type="aff" rid="aff7">7</xref></contrib><contrib contrib-type="author"><name><surname>Cartron</surname><given-names>Guillaume</given-names></name><xref ref-type="aff" rid="aff6">6</xref></contrib><contrib contrib-type="author"><name><surname>Morschhauser</surname><given-names>Franck</given-names></name><xref ref-type="aff" rid="aff5">5</xref></contrib><contrib contrib-type="author"><name><surname>Fegan</surname><given-names>Christopher</given-names></name><xref ref-type="aff" rid="aff4">4</xref></contrib><contrib contrib-type="author"><name><surname>Salles</surname><given-names>Gilles</given-names></name><xref ref-type="aff" rid="aff3">3</xref><contrib-id contrib-id-type="orcid">http://orcid.org/0000-0002-9541-8666</contrib-id></contrib><aff id="aff1"><label>1</label>Ernest and Helen Scott Haematological Research Institute, University of Leicester, Leicester, United Kingdom;</aff><aff id="aff2"><label>2</label>Department of Haematology, Plymouth Hospitals NHS Trust, Plymouth, United Kingdom;</aff><aff id="aff3"><label>3</label>Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Service d’Hématologie, Pierre-Bénite, Université Claude Bernard Lyon 1, Lyon, France;</aff><aff id="aff4"><label>4</label>Cardiff CLL Research Group, School of Medicine, Heath Park, Cardiff, Wales, United Kingdom;</aff><aff id="aff5"><label>5</label>Department of Clinical Hematology, Centre Hospitalier Régional Universitaire (CHRU) de Lille, and Unité Groupe de Recherche sur les Formes Injectables et les Technologies Associées (GRITA), Université de Lille 2, Lille, France;</aff><aff id="aff6"><label>6</label>Department of Clinical Hematology and Unité Mixte de Recherche (UMR)–Centre National de la Recherche Scientifique (CNRS) 5235, CHRU, Montpellier, France;</aff><aff id="aff7"><label>7</label>ONO Pharmaceuticals Co Ltd, Osaka, Japan; and</aff><aff id="aff8"><label>8</label>ONO Pharma UK Ltd, London, United Kingdom</aff></contrib-group><pub-date pub-type="ppub"><day>28</day><month>1</month><year>2016</year></pub-date><pub-date pub-type="epreprint"><day>05</day><month>11</month><year>2015</year></pub-date><pub-date pub-type="pmc-release"><day>28</day><month>1</month><year>2016</year></pub-date><pmc-comment> PMC Release delay is 0 months and 0 days and was based on the
<volume>127</volume><issue>4</issue><fpage>411</fpage><lpage>419</lpage><history><date date-type="received"><day>12</day><month>8</month><year>2015</year></date><date date-type="accepted"><day>22</day><month>10</month><year>2015</year></date></history><permissions><copyright-statement>© 2016 by The American Society of Hematology</copyright-statement><copyright-year>2016</copyright-year></permissions><self-uri xlink:title="pdf" xlink:type="simple" xlink:href="411.pdf"></self-uri><abstract abstract-type="executive-summary"><title>Key Points</title><p><list list-type="bullet"><list-item><p>We report a first-in-human dose-escalation study in relapsed/refractory B-cell malignancies with the potent BTK inhibitor ONO/GS-4059.</p></list-item><list-item><p>ONO/GS-4059 induced clinically durable responses in relapsed/refractory B-cell malignancies without significant toxicities.</p></list-item></list></p></abstract><abstract><p>We report the results of a multicenter phase 1 dose-escalation study of the selective Bruton tyrosine kinase (BTK) inhibitor ONO/GS-4059 in 90 patients with relapsed/refractory B-cell malignancies. There were 9 dose-escalation cohorts ranging from 20 mg to 600 mg once daily with twice-daily regimens of 240 mg and 300 mg. Twenty-four of 25 evaluable chronic lymphocytic leukemia (CLL) patients (96%) responded to ONO/GS-4059, with a median treatment duration of 80 weeks; 21 CLL patients remain on treatment. Lymph node responses were rapid and associated with a concurrent lymphocytosis. Eleven of 12 evaluable patients with mantle cell lymphoma (92%) responded (median treatment duration, 40 weeks). Eleven of 31 non–germinal center B-cell diffuse large B-cell lymphoma patients (35%) responded but median treatment duration was 12 weeks due to development of progressive disease. ONO/GS-4059 was very well tolerated with 75% of adverse events (AEs) being Common Toxicity Criteria for Adverse Events version 4.0 grade 1 or grade 2. Grade 3/4 AEs were mainly hematologic and recovered spontaneously during therapy. One CLL patient experienced a grade 3 treatment-related bleeding event (spontaneous muscle hematoma) but no clinically significant diarrhea, cardiac dysrhythmias, or arthralgia were observed. No maximal tolerated dose (MTD) was reached in the CLL cohort. In the non-Hodgkin lymphoma cohort, 4 patients developed a dose-limiting toxicity, yielding an MTD of 480 mg once daily. ONO/GS-4059 has significant activity in relapsed/refractory B-cell malignancies without major drug-related toxicity. The selectivity of ONO/GS-4059 should confer advantages in combination therapies. This trial was registered at <ext-link ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov">www.clinicaltrials.gov</ext-link> as #NCT01659255.</p></abstract><counts><page-count count="9"></page-count></counts><custom-meta-group><custom-meta><meta-name>access</meta-name><meta-value>free</meta-value></custom-meta></custom-meta-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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