Romidepsin for the treatment of relapsed/refractory peripheral T-cell lymphoma: pivotal study update demonstrates durable responses
Identifieur interne : 001356 ( Pmc/Checkpoint ); précédent : 001355; suivant : 001357Romidepsin for the treatment of relapsed/refractory peripheral T-cell lymphoma: pivotal study update demonstrates durable responses
Auteurs : Bertrand Coiffier [France] ; Barbara Pro [États-Unis] ; H Miles Prince [Australie] ; Francine Foss [États-Unis] ; Lubomir Sokol [États-Unis] ; Matthew Greenwood [Australie] ; Dolores Caballero [Espagne] ; Franck Morschhauser [France] ; Martin Wilhelm [Allemagne] ; Lauren Pinter-Brown [États-Unis] ; Swaminathan Padmanabhan Iyer [États-Unis] ; Andrei Shustov [États-Unis] ; Tina Nielsen [États-Unis] ; Jean Nichols [États-Unis] ; Julie Wolfson [États-Unis] ; Barbara Balser [États-Unis] ; Steven Horwitz [États-Unis]Source :
- Journal of Hematology & Oncology [ 1756-8722 ] ; 2014.
Abstract
Romidepsin is a structurally unique, potent, bicyclic class 1 selective histone deacetylase inhibitor approved by the US Food and Drug Administration for the treatment of patients with cutaneous T-cell lymphoma who have received ≥ 1 prior systemic therapy and patients with peripheral T-cell lymphoma (PTCL) who have received ≥ 1 prior therapy. Approval for PTCL was based on results (n = 130; median follow-up, 13.4 months) from the pivotal study of romidepsin for the treatment of relapsed/refractory PTCL. The objective is to present updated data (median follow-up, 22.3 months) and to characterize patients who achieved long-term responses (≥ 12 months) to romidepsin.
Patients with PTCL who relapsed from or were refractory to ≥ 1 prior systemic therapy received romidepsin 14 mg/m2 as a 4-hour intravenous infusion on days 1, 8, and 15 every 28 days for up to 6 cycles; patients with response or stable disease could continue romidepsin beyond 6 cycles. The primary endpoint was rate of confirmed/unconfirmed complete response (CR/CRu) determined by an Independent Review Committee. Secondary endpoints included objective response rate (ORR) and duration of response (DOR). For patients who achieved CR/CRu, baseline characteristics by DOR (≥ 12 vs < 12 months) were examined.
The ORR to romidepsin was 25%, including 15% with CR/CRu. The median DOR for all responders was 28 months (range, < 1-48+) and was not reached for those who achieved CR/CRu. Patients with lack of response or transient response to prior therapy achieved durable responses with romidepsin. Of the 19 patients who achieved CR/CRu, 10 had long-term (≥ 12 months) responses; none of the baseline characteristics examined—including heavy pretreatment, response to prior therapy, or advanced disease—precluded long-term responses to romidepsin. With a median progression-free survival of 29 months, patients who achieved CR/CRu for ≥ 12 months had significantly longer survival vs those with CR/CRu for < 12 months or < CR/CRu. Extended treatment and longer follow-up did not affect the reported safety profile of romidepsin.
Treatment with romidepsin leads to highly durable responses in a subset of patients with relapsed/refractory PTCL, with responses ongoing as long as 48 months.
Url:
DOI: 10.1186/1756-8722-7-11
PubMed: 24456586
PubMed Central: 4016573
Affiliations:
- Allemagne, Australie, Espagne, France, États-Unis
- Auvergne-Rhône-Alpes, Californie, Connecticut, Floride, Hauts-de-France, Massachusetts, New Jersey, Nord-Pas-de-Calais, Nouvelle-Galles du Sud, Pennsylvanie, Rhône-Alpes, Texas, Victoria (État), Washington (État), État de New York
- Lille, Lyon, Melbourne, Seattle, Sydney
- Université de Melbourne, Université de Washington
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<author><name sortKey="Padmanabhan Iyer, Swaminathan" sort="Padmanabhan Iyer, Swaminathan" uniqKey="Padmanabhan Iyer S" first="Swaminathan" last="Padmanabhan Iyer">Swaminathan Padmanabhan Iyer</name>
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<author><name sortKey="Nielsen, Tina" sort="Nielsen, Tina" uniqKey="Nielsen T" first="Tina" last="Nielsen">Tina Nielsen</name>
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<author><name sortKey="Wolfson, Julie" sort="Wolfson, Julie" uniqKey="Wolfson J" first="Julie" last="Wolfson">Julie Wolfson</name>
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<author><name sortKey="Balser, Barbara" sort="Balser, Barbara" uniqKey="Balser B" first="Barbara" last="Balser">Barbara Balser</name>
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<author><name sortKey="Horwitz, Steven" sort="Horwitz, Steven" uniqKey="Horwitz S" first="Steven" last="Horwitz">Steven Horwitz</name>
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<country xml:lang="fr">États-Unis</country>
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<placeName><region type="state">État de New York</region>
</placeName>
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<series><title level="j">Journal of Hematology & Oncology</title>
<idno type="eISSN">1756-8722</idno>
<imprint><date when="2014">2014</date>
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<front><div type="abstract" xml:lang="en"><sec><title>Background</title>
<p>Romidepsin is a structurally unique, potent, bicyclic class 1 selective histone deacetylase inhibitor approved by the US Food and Drug Administration for the treatment of patients with cutaneous T-cell lymphoma who have received ≥ 1 prior systemic therapy and patients with peripheral T-cell lymphoma (PTCL) who have received ≥ 1 prior therapy. Approval for PTCL was based on results (n = 130; median follow-up, 13.4 months) from the pivotal study of romidepsin for the treatment of relapsed/refractory PTCL. The objective is to present updated data (median follow-up, 22.3 months) and to characterize patients who achieved long-term responses (≥ 12 months) to romidepsin.</p>
</sec>
<sec><title>Methods</title>
<p>Patients with PTCL who relapsed from or were refractory to ≥ 1 prior systemic therapy received romidepsin 14 mg/m<sup>2</sup>
as a 4-hour intravenous infusion on days 1, 8, and 15 every 28 days for up to 6 cycles; patients with response or stable disease could continue romidepsin beyond 6 cycles. The primary endpoint was rate of confirmed/unconfirmed complete response (CR/CRu) determined by an Independent Review Committee. Secondary endpoints included objective response rate (ORR) and duration of response (DOR). For patients who achieved CR/CRu, baseline characteristics by DOR (≥ 12 vs < 12 months) were examined.</p>
</sec>
<sec><title>Results</title>
<p>The ORR to romidepsin was 25%, including 15% with CR/CRu. The median DOR for all responders was 28 months (range, < 1-48+) and was not reached for those who achieved CR/CRu. Patients with lack of response or transient response to prior therapy achieved durable responses with romidepsin. Of the 19 patients who achieved CR/CRu, 10 had long-term (≥ 12 months) responses; none of the baseline characteristics examined—including heavy pretreatment, response to prior therapy, or advanced disease—precluded long-term responses to romidepsin. With a median progression-free survival of 29 months, patients who achieved CR/CRu for ≥ 12 months had significantly longer survival vs those with CR/CRu for < 12 months or < CR/CRu. Extended treatment and longer follow-up did not affect the reported safety profile of romidepsin.</p>
</sec>
<sec><title>Conclusions</title>
<p>Treatment with romidepsin leads to highly durable responses in a subset of patients with relapsed/refractory PTCL, with responses ongoing as long as 48 months.</p>
</sec>
<sec><title>Trial registration</title>
<p><ext-link ext-link-type="uri" xlink:href="http://clinicaltrials.gov/show/NCT00426764">NCT00426764</ext-link>
</p>
</sec>
</div>
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</TEI>
<pmc article-type="research-article" xml:lang="en"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">J Hematol Oncol</journal-id>
<journal-id journal-id-type="iso-abbrev">J Hematol Oncol</journal-id>
<journal-title-group><journal-title>Journal of Hematology & Oncology</journal-title>
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<issn pub-type="epub">1756-8722</issn>
<publisher><publisher-name>BioMed Central</publisher-name>
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</journal-meta>
<article-meta><article-id pub-id-type="pmid">24456586</article-id>
<article-id pub-id-type="pmc">4016573</article-id>
<article-id pub-id-type="publisher-id">1756-8722-7-11</article-id>
<article-id pub-id-type="doi">10.1186/1756-8722-7-11</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Research</subject>
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</article-categories>
<title-group><article-title>Romidepsin for the treatment of relapsed/refractory peripheral T-cell lymphoma: pivotal study update demonstrates durable responses</article-title>
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</contrib>
<contrib contrib-type="author" id="A6"><name><surname>Greenwood</surname>
<given-names>Matthew</given-names>
</name>
<xref ref-type="aff" rid="I6">6</xref>
<email>mgreenwood@health.nsw.gov.au</email>
</contrib>
<contrib contrib-type="author" id="A7"><name><surname>Caballero</surname>
<given-names>Dolores</given-names>
</name>
<xref ref-type="aff" rid="I7">7</xref>
<email>cabarri@usal.es</email>
</contrib>
<contrib contrib-type="author" id="A8"><name><surname>Morschhauser</surname>
<given-names>Franck</given-names>
</name>
<xref ref-type="aff" rid="I8">8</xref>
<email>fmorschhauser@gmail.com</email>
</contrib>
<contrib contrib-type="author" id="A9"><name><surname>Wilhelm</surname>
<given-names>Martin</given-names>
</name>
<xref ref-type="aff" rid="I9">9</xref>
<email>Martin.wilhelm@klinikum-nuernberg.de</email>
</contrib>
<contrib contrib-type="author" id="A10"><name><surname>Pinter-Brown</surname>
<given-names>Lauren</given-names>
</name>
<xref ref-type="aff" rid="I10">10</xref>
<email>lpb@ucla.edu</email>
</contrib>
<contrib contrib-type="author" id="A11"><name><surname>Padmanabhan Iyer</surname>
<given-names>Swaminathan</given-names>
</name>
<xref ref-type="aff" rid="I11">11</xref>
<email>spiyer@houstonmethodist.org</email>
</contrib>
<contrib contrib-type="author" id="A12"><name><surname>Shustov</surname>
<given-names>Andrei</given-names>
</name>
<xref ref-type="aff" rid="I12">12</xref>
<email>ashustov@seattlecca.org</email>
</contrib>
<contrib contrib-type="author" id="A13"><name><surname>Nielsen</surname>
<given-names>Tina</given-names>
</name>
<xref ref-type="aff" rid="I13">13</xref>
<email>tnielsen@celgene.com</email>
</contrib>
<contrib contrib-type="author" id="A14"><name><surname>Nichols</surname>
<given-names>Jean</given-names>
</name>
<xref ref-type="aff" rid="I14">14</xref>
<email>jn@jnichols.com</email>
</contrib>
<contrib contrib-type="author" id="A15"><name><surname>Wolfson</surname>
<given-names>Julie</given-names>
</name>
<xref ref-type="aff" rid="I15">15</xref>
<email>julie.wolfson@veristat.com</email>
</contrib>
<contrib contrib-type="author" id="A16"><name><surname>Balser</surname>
<given-names>Barbara</given-names>
</name>
<xref ref-type="aff" rid="I15">15</xref>
<email>barbara.balser@veristat.com</email>
</contrib>
<contrib contrib-type="author" id="A17"><name><surname>Horwitz</surname>
<given-names>Steven</given-names>
</name>
<xref ref-type="aff" rid="I16">16</xref>
<email>horwitzs@MSKCC.ORG</email>
</contrib>
</contrib-group>
<aff id="I1"><label>1</label>
Hospices Civils de Lyon, Lyon, France</aff>
<aff id="I2"><label>2</label>
Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA, USA</aff>
<aff id="I3"><label>3</label>
Peter MacCallum Cancer Centre and University of Melbourne, Melbourne, Australia</aff>
<aff id="I4"><label>4</label>
Yale Cancer Center, New Haven, CT, USA</aff>
<aff id="I5"><label>5</label>
Moffitt Cancer Center, Tampa, FL, USA</aff>
<aff id="I6"><label>6</label>
Royal North Shore Hospital, Sydney, Australia</aff>
<aff id="I7"><label>7</label>
Hospital Universitario de Salamanca, Salamanca, Spain</aff>
<aff id="I8"><label>8</label>
Hôpital Claude Huriez, CHRU de Lille, Lille, France</aff>
<aff id="I9"><label>9</label>
Klinikum Nürnberg Nord, Nürnberg, Germany</aff>
<aff id="I10"><label>10</label>
UCLA Medical Center, Los Angeles, CA, USA</aff>
<aff id="I11"><label>11</label>
The Methodist Hospital, Houston, TX, USA</aff>
<aff id="I12"><label>12</label>
University of Washington, Seattle, WA, USA</aff>
<aff id="I13"><label>13</label>
Celgene Corporation, Summit, NJ, USA</aff>
<aff id="I14"><label>14</label>
JNichols LLC, Swampscott, MA, USA</aff>
<aff id="I15"><label>15</label>
Veristat, LLC, Holliston, MA, USA</aff>
<aff id="I16"><label>16</label>
Memorial Sloan-Kettering Cancer Center, New York, NY, USA</aff>
<pub-date pub-type="collection"><year>2014</year>
</pub-date>
<pub-date pub-type="epub"><day>23</day>
<month>1</month>
<year>2014</year>
</pub-date>
<volume>7</volume>
<fpage>11</fpage>
<lpage>11</lpage>
<history><date date-type="received"><day>26</day>
<month>11</month>
<year>2013</year>
</date>
<date date-type="accepted"><day>18</day>
<month>1</month>
<year>2014</year>
</date>
</history>
<permissions><copyright-statement>Copyright © 2014 Coiffier et al.; licensee BioMed Central Ltd.</copyright-statement>
<copyright-year>2014</copyright-year>
<copyright-holder>Coiffier et al.; licensee BioMed Central Ltd.</copyright-holder>
<license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by/2.0"><license-p>This is an open access article distributed under the terms of the Creative Commons Attribution License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/2.0">http://creativecommons.org/licenses/by/2.0</ext-link>
), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
</license>
</permissions>
<self-uri xlink:href="http://www.jhoonline.org/content/7/1/11"></self-uri>
<abstract><sec><title>Background</title>
<p>Romidepsin is a structurally unique, potent, bicyclic class 1 selective histone deacetylase inhibitor approved by the US Food and Drug Administration for the treatment of patients with cutaneous T-cell lymphoma who have received ≥ 1 prior systemic therapy and patients with peripheral T-cell lymphoma (PTCL) who have received ≥ 1 prior therapy. Approval for PTCL was based on results (n = 130; median follow-up, 13.4 months) from the pivotal study of romidepsin for the treatment of relapsed/refractory PTCL. The objective is to present updated data (median follow-up, 22.3 months) and to characterize patients who achieved long-term responses (≥ 12 months) to romidepsin.</p>
</sec>
<sec><title>Methods</title>
<p>Patients with PTCL who relapsed from or were refractory to ≥ 1 prior systemic therapy received romidepsin 14 mg/m<sup>2</sup>
as a 4-hour intravenous infusion on days 1, 8, and 15 every 28 days for up to 6 cycles; patients with response or stable disease could continue romidepsin beyond 6 cycles. The primary endpoint was rate of confirmed/unconfirmed complete response (CR/CRu) determined by an Independent Review Committee. Secondary endpoints included objective response rate (ORR) and duration of response (DOR). For patients who achieved CR/CRu, baseline characteristics by DOR (≥ 12 vs < 12 months) were examined.</p>
</sec>
<sec><title>Results</title>
<p>The ORR to romidepsin was 25%, including 15% with CR/CRu. The median DOR for all responders was 28 months (range, < 1-48+) and was not reached for those who achieved CR/CRu. Patients with lack of response or transient response to prior therapy achieved durable responses with romidepsin. Of the 19 patients who achieved CR/CRu, 10 had long-term (≥ 12 months) responses; none of the baseline characteristics examined—including heavy pretreatment, response to prior therapy, or advanced disease—precluded long-term responses to romidepsin. With a median progression-free survival of 29 months, patients who achieved CR/CRu for ≥ 12 months had significantly longer survival vs those with CR/CRu for < 12 months or < CR/CRu. Extended treatment and longer follow-up did not affect the reported safety profile of romidepsin.</p>
</sec>
<sec><title>Conclusions</title>
<p>Treatment with romidepsin leads to highly durable responses in a subset of patients with relapsed/refractory PTCL, with responses ongoing as long as 48 months.</p>
</sec>
<sec><title>Trial registration</title>
<p><ext-link ext-link-type="uri" xlink:href="http://clinicaltrials.gov/show/NCT00426764">NCT00426764</ext-link>
</p>
</sec>
</abstract>
<kwd-group><kwd>Romidepsin</kwd>
<kwd>Relapsed/refractory peripheral T-cell lymphoma</kwd>
<kwd>Duration of response</kwd>
</kwd-group>
</article-meta>
</front>
</pmc>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>Espagne</li>
<li>France</li>
<li>États-Unis</li>
</country>
<region><li>Auvergne-Rhône-Alpes</li>
<li>Californie</li>
<li>Connecticut</li>
<li>Floride</li>
<li>Hauts-de-France</li>
<li>Massachusetts</li>
<li>New Jersey</li>
<li>Nord-Pas-de-Calais</li>
<li>Nouvelle-Galles du Sud</li>
<li>Pennsylvanie</li>
<li>Rhône-Alpes</li>
<li>Texas</li>
<li>Victoria (État)</li>
<li>Washington (État)</li>
<li>État de New York</li>
</region>
<settlement><li>Lille</li>
<li>Lyon</li>
<li>Melbourne</li>
<li>Seattle</li>
<li>Sydney</li>
</settlement>
<orgName><li>Université de Melbourne</li>
<li>Université de Washington</li>
</orgName>
</list>
<tree><country name="France"><region name="Auvergne-Rhône-Alpes"><name sortKey="Coiffier, Bertrand" sort="Coiffier, Bertrand" uniqKey="Coiffier B" first="Bertrand" last="Coiffier">Bertrand Coiffier</name>
</region>
<name sortKey="Morschhauser, Franck" sort="Morschhauser, Franck" uniqKey="Morschhauser F" first="Franck" last="Morschhauser">Franck Morschhauser</name>
</country>
<country name="États-Unis"><region name="Pennsylvanie"><name sortKey="Pro, Barbara" sort="Pro, Barbara" uniqKey="Pro B" first="Barbara" last="Pro">Barbara Pro</name>
</region>
<name sortKey="Balser, Barbara" sort="Balser, Barbara" uniqKey="Balser B" first="Barbara" last="Balser">Barbara Balser</name>
<name sortKey="Foss, Francine" sort="Foss, Francine" uniqKey="Foss F" first="Francine" last="Foss">Francine Foss</name>
<name sortKey="Horwitz, Steven" sort="Horwitz, Steven" uniqKey="Horwitz S" first="Steven" last="Horwitz">Steven Horwitz</name>
<name sortKey="Nichols, Jean" sort="Nichols, Jean" uniqKey="Nichols J" first="Jean" last="Nichols">Jean Nichols</name>
<name sortKey="Nielsen, Tina" sort="Nielsen, Tina" uniqKey="Nielsen T" first="Tina" last="Nielsen">Tina Nielsen</name>
<name sortKey="Padmanabhan Iyer, Swaminathan" sort="Padmanabhan Iyer, Swaminathan" uniqKey="Padmanabhan Iyer S" first="Swaminathan" last="Padmanabhan Iyer">Swaminathan Padmanabhan Iyer</name>
<name sortKey="Pinter Brown, Lauren" sort="Pinter Brown, Lauren" uniqKey="Pinter Brown L" first="Lauren" last="Pinter-Brown">Lauren Pinter-Brown</name>
<name sortKey="Shustov, Andrei" sort="Shustov, Andrei" uniqKey="Shustov A" first="Andrei" last="Shustov">Andrei Shustov</name>
<name sortKey="Sokol, Lubomir" sort="Sokol, Lubomir" uniqKey="Sokol L" first="Lubomir" last="Sokol">Lubomir Sokol</name>
<name sortKey="Wolfson, Julie" sort="Wolfson, Julie" uniqKey="Wolfson J" first="Julie" last="Wolfson">Julie Wolfson</name>
</country>
<country name="Australie"><region name="Victoria (État)"><name sortKey="Prince, H Miles" sort="Prince, H Miles" uniqKey="Prince H" first="H Miles" last="Prince">H Miles Prince</name>
</region>
<name sortKey="Greenwood, Matthew" sort="Greenwood, Matthew" uniqKey="Greenwood M" first="Matthew" last="Greenwood">Matthew Greenwood</name>
</country>
<country name="Espagne"><noRegion><name sortKey="Caballero, Dolores" sort="Caballero, Dolores" uniqKey="Caballero D" first="Dolores" last="Caballero">Dolores Caballero</name>
</noRegion>
</country>
<country name="Allemagne"><noRegion><name sortKey="Wilhelm, Martin" sort="Wilhelm, Martin" uniqKey="Wilhelm M" first="Martin" last="Wilhelm">Martin Wilhelm</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>
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