Phase IA/II, multicentre, open‐label study of the CD40 antagonistic monoclonal antibody lucatumumab in adult patients with advanced non‐Hodgkin or Hodgkin lymphoma
Summary Despite advancements in the treatment of non‐Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL), patients continue to relapse and thus a need for new targeted therapies remains. The CD40 receptor is highly expressed on neoplastic B cells and activation leads to enhanced proliferation and survi...
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| Veröffentlicht in: | British journal of haematology 2014-01, Vol.164 (2), p.258-265 |
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| creator | Fanale, Michelle Assouline, Sarit Kuruvilla, John Solal‐Céligny, Philippe Heo, Dae S. Verhoef, Gregor Corradini, Paolo Abramson, Jeremy S. Offner, Fritz Engert, Andreas Dyer, Martin J. S. Carreon, Daniel Ewald, Brett Baeck, Johan Younes, Anas Freedman, Arnold S. |
| description | Summary
Despite advancements in the treatment of non‐Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL), patients continue to relapse and thus a need for new targeted therapies remains. The CD40 receptor is highly expressed on neoplastic B cells and activation leads to enhanced proliferation and survival. Lucatumumab (HCD122) is a fully human antagonistic CD40 monoclonal antibody. A phase IA/II study was designed to determine the maximum tolerated dose (MTD) and activity of lucatumumab in patients with relapsed/refractory lymphoma. Determination of the MTD was the primary objective of the phase IA dose escalation portion and clinical response was the primary objective of the phase II dose expansion portion. Patients received escalating doses of lucatumumab administered intravenously once weekly for 4 weeks of an 8‐week cycle. MTD was determined at 4 mg/kg of lucatumumab. A total of 111 patients with NHL (n = 74) and HL (n = 37) were enrolled. Responses were observed across various lymphoma subtypes. The overall response rate by computed tomography among patients with follicular lymphoma (FL) and marginal zone lymphoma of mucosa‐associated lymphatic tissue (MZL/MALT) was 33·3% and 42·9%, respectively. Lucatumumab demonstrates modest activity in relapsed/refractory patients with advanced lymphoma, suggesting that targeting of CD40 warrants further investigation. |
| doi_str_mv | 10.1111/bjh.12630 |
| format | Article |
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Despite advancements in the treatment of non‐Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL), patients continue to relapse and thus a need for new targeted therapies remains. The CD40 receptor is highly expressed on neoplastic B cells and activation leads to enhanced proliferation and survival. Lucatumumab (HCD122) is a fully human antagonistic CD40 monoclonal antibody. A phase IA/II study was designed to determine the maximum tolerated dose (MTD) and activity of lucatumumab in patients with relapsed/refractory lymphoma. Determination of the MTD was the primary objective of the phase IA dose escalation portion and clinical response was the primary objective of the phase II dose expansion portion. Patients received escalating doses of lucatumumab administered intravenously once weekly for 4 weeks of an 8‐week cycle. MTD was determined at 4 mg/kg of lucatumumab. A total of 111 patients with NHL (n = 74) and HL (n = 37) were enrolled. Responses were observed across various lymphoma subtypes. The overall response rate by computed tomography among patients with follicular lymphoma (FL) and marginal zone lymphoma of mucosa‐associated lymphatic tissue (MZL/MALT) was 33·3% and 42·9%, respectively. Lucatumumab demonstrates modest activity in relapsed/refractory patients with advanced lymphoma, suggesting that targeting of CD40 warrants further investigation.</description><identifier>ISSN: 0007-1048</identifier><identifier>EISSN: 1365-2141</identifier><identifier>DOI: 10.1111/bjh.12630</identifier><identifier>PMID: 24219359</identifier><identifier>CODEN: BJHEAL</identifier><language>eng</language><publisher>Oxford: Blackwell</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal, Humanized - pharmacology ; Antibodies, Monoclonal, Humanized - therapeutic use ; Antineoplastic Agents - pharmacology ; Antineoplastic Agents - therapeutic use ; Biological and medical sciences ; CD40 Antigens - antagonists & inhibitors ; Female ; Hematologic and hematopoietic diseases ; Hodgkin Disease - drug therapy ; Hodgkin Disease - pathology ; Hodgkin lymphoma ; Humans ; Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis ; Lymphoma, Non-Hodgkin - drug therapy ; Lymphoma, Non-Hodgkin - pathology ; Male ; Medical sciences ; Middle Aged ; monoclonal antibodies ; Neoplasm Staging ; non‐Hodgkin lymphoma ; Treatment Outcome ; Tumors ; Young Adult</subject><ispartof>British journal of haematology, 2014-01, Vol.164 (2), p.258-265</ispartof><rights>2013 John Wiley & Sons Ltd</rights><rights>2015 INIST-CNRS</rights><rights>2013 John Wiley & Sons Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fbjh.12630$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fbjh.12630$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,314,776,780,881,1411,1427,27901,27902,45550,45551,46384,46808</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=28318667$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24219359$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Fanale, Michelle</creatorcontrib><creatorcontrib>Assouline, Sarit</creatorcontrib><creatorcontrib>Kuruvilla, John</creatorcontrib><creatorcontrib>Solal‐Céligny, Philippe</creatorcontrib><creatorcontrib>Heo, Dae S.</creatorcontrib><creatorcontrib>Verhoef, Gregor</creatorcontrib><creatorcontrib>Corradini, Paolo</creatorcontrib><creatorcontrib>Abramson, Jeremy S.</creatorcontrib><creatorcontrib>Offner, Fritz</creatorcontrib><creatorcontrib>Engert, Andreas</creatorcontrib><creatorcontrib>Dyer, Martin J. S.</creatorcontrib><creatorcontrib>Carreon, Daniel</creatorcontrib><creatorcontrib>Ewald, Brett</creatorcontrib><creatorcontrib>Baeck, Johan</creatorcontrib><creatorcontrib>Younes, Anas</creatorcontrib><creatorcontrib>Freedman, Arnold S.</creatorcontrib><title>Phase IA/II, multicentre, open‐label study of the CD40 antagonistic monoclonal antibody lucatumumab in adult patients with advanced non‐Hodgkin or Hodgkin lymphoma</title><title>British journal of haematology</title><addtitle>Br J Haematol</addtitle><description>Summary
Despite advancements in the treatment of non‐Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL), patients continue to relapse and thus a need for new targeted therapies remains. The CD40 receptor is highly expressed on neoplastic B cells and activation leads to enhanced proliferation and survival. Lucatumumab (HCD122) is a fully human antagonistic CD40 monoclonal antibody. A phase IA/II study was designed to determine the maximum tolerated dose (MTD) and activity of lucatumumab in patients with relapsed/refractory lymphoma. Determination of the MTD was the primary objective of the phase IA dose escalation portion and clinical response was the primary objective of the phase II dose expansion portion. Patients received escalating doses of lucatumumab administered intravenously once weekly for 4 weeks of an 8‐week cycle. MTD was determined at 4 mg/kg of lucatumumab. A total of 111 patients with NHL (n = 74) and HL (n = 37) were enrolled. Responses were observed across various lymphoma subtypes. The overall response rate by computed tomography among patients with follicular lymphoma (FL) and marginal zone lymphoma of mucosa‐associated lymphatic tissue (MZL/MALT) was 33·3% and 42·9%, respectively. Lucatumumab demonstrates modest activity in relapsed/refractory patients with advanced lymphoma, suggesting that targeting of CD40 warrants further investigation.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antibodies, Monoclonal, Humanized - pharmacology</subject><subject>Antibodies, Monoclonal, Humanized - therapeutic use</subject><subject>Antineoplastic Agents - pharmacology</subject><subject>Antineoplastic Agents - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>CD40 Antigens - antagonists & inhibitors</subject><subject>Female</subject><subject>Hematologic and hematopoietic diseases</subject><subject>Hodgkin Disease - drug therapy</subject><subject>Hodgkin Disease - pathology</subject><subject>Hodgkin lymphoma</subject><subject>Humans</subject><subject>Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis</subject><subject>Lymphoma, Non-Hodgkin - drug therapy</subject><subject>Lymphoma, Non-Hodgkin - pathology</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>monoclonal antibodies</subject><subject>Neoplasm Staging</subject><subject>non‐Hodgkin lymphoma</subject><subject>Treatment Outcome</subject><subject>Tumors</subject><subject>Young Adult</subject><issn>0007-1048</issn><issn>1365-2141</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFks1u1DAQxyMEokvhwAsgX5A4NN3xVz4uSGX52EWV4ABny3GcjYtjp3HSam99hL4F78WT4Gy3BU744tHMz3__NTNJ8hLDKY5nWV20p5hkFB4lC0wznhLM8ONkAQB5ioEVR8mzEC4AMAWOnyZHhBFcUl4ukp9fWxk02pwtN5sT1E12NEq7cdAnyPfa_bq5tbLSFoVxqnfIN2hsNVq9Z4CkG-XWOxPiC9R555X1Tto5byofYTspOU7d1MkKGYdkHcVRL0cT9QO6NmMbc1fSKV0j5-ev1r7e_oioH9B9aHdd3_pOPk-eNNIG_eJwHyffP374tlqn518-bVZn52nPgEHKeKWLpiF5wySBApiEWnEoC86rXKkm1xpnjOhCkQayyNVFRYiuSkazJlM5PU7e3un2U9Xpet8LaUU_mE4OO-GlEf9WnGnF1l8JTqHAZBZ4cxAY_OWkwyg6E5S2VjrtpyAwB045zjD9P8pKyIHGWUX01d-2HvzcDzICrw-ADEraZoh9NeEPV1BcZNlsb3nHXRurdw91DGLeJBE3Sew3Sbz7vN4H9Dd2ab9X</recordid><startdate>201401</startdate><enddate>201401</enddate><creator>Fanale, Michelle</creator><creator>Assouline, Sarit</creator><creator>Kuruvilla, John</creator><creator>Solal‐Céligny, Philippe</creator><creator>Heo, Dae S.</creator><creator>Verhoef, Gregor</creator><creator>Corradini, Paolo</creator><creator>Abramson, Jeremy S.</creator><creator>Offner, Fritz</creator><creator>Engert, Andreas</creator><creator>Dyer, Martin J. S.</creator><creator>Carreon, Daniel</creator><creator>Ewald, Brett</creator><creator>Baeck, Johan</creator><creator>Younes, Anas</creator><creator>Freedman, Arnold S.</creator><general>Blackwell</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope><scope>7T5</scope><scope>H94</scope><scope>5PM</scope></search><sort><creationdate>201401</creationdate><title>Phase IA/II, multicentre, open‐label study of the CD40 antagonistic monoclonal antibody lucatumumab in adult patients with advanced non‐Hodgkin or Hodgkin lymphoma</title><author>Fanale, Michelle ; Assouline, Sarit ; Kuruvilla, John ; Solal‐Céligny, Philippe ; Heo, Dae S. ; Verhoef, Gregor ; Corradini, Paolo ; Abramson, Jeremy S. ; Offner, Fritz ; Engert, Andreas ; Dyer, Martin J. S. ; Carreon, Daniel ; Ewald, Brett ; Baeck, Johan ; Younes, Anas ; Freedman, Arnold S.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p4040-45be8ff27f4a20804a0dc509855b7ccf7ee1642e8c2f06f27d8b22eb9436f6c73</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antibodies, Monoclonal, Humanized - pharmacology</topic><topic>Antibodies, Monoclonal, Humanized - therapeutic use</topic><topic>Antineoplastic Agents - pharmacology</topic><topic>Antineoplastic Agents - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>CD40 Antigens - antagonists & inhibitors</topic><topic>Female</topic><topic>Hematologic and hematopoietic diseases</topic><topic>Hodgkin Disease - drug therapy</topic><topic>Hodgkin Disease - pathology</topic><topic>Hodgkin lymphoma</topic><topic>Humans</topic><topic>Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis</topic><topic>Lymphoma, Non-Hodgkin - drug therapy</topic><topic>Lymphoma, Non-Hodgkin - pathology</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>monoclonal antibodies</topic><topic>Neoplasm Staging</topic><topic>non‐Hodgkin lymphoma</topic><topic>Treatment Outcome</topic><topic>Tumors</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Fanale, Michelle</creatorcontrib><creatorcontrib>Assouline, Sarit</creatorcontrib><creatorcontrib>Kuruvilla, John</creatorcontrib><creatorcontrib>Solal‐Céligny, Philippe</creatorcontrib><creatorcontrib>Heo, Dae S.</creatorcontrib><creatorcontrib>Verhoef, Gregor</creatorcontrib><creatorcontrib>Corradini, Paolo</creatorcontrib><creatorcontrib>Abramson, Jeremy S.</creatorcontrib><creatorcontrib>Offner, Fritz</creatorcontrib><creatorcontrib>Engert, Andreas</creatorcontrib><creatorcontrib>Dyer, Martin J. S.</creatorcontrib><creatorcontrib>Carreon, Daniel</creatorcontrib><creatorcontrib>Ewald, Brett</creatorcontrib><creatorcontrib>Baeck, Johan</creatorcontrib><creatorcontrib>Younes, Anas</creatorcontrib><creatorcontrib>Freedman, Arnold S.</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>British journal of haematology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Fanale, Michelle</au><au>Assouline, Sarit</au><au>Kuruvilla, John</au><au>Solal‐Céligny, Philippe</au><au>Heo, Dae S.</au><au>Verhoef, Gregor</au><au>Corradini, Paolo</au><au>Abramson, Jeremy S.</au><au>Offner, Fritz</au><au>Engert, Andreas</au><au>Dyer, Martin J. S.</au><au>Carreon, Daniel</au><au>Ewald, Brett</au><au>Baeck, Johan</au><au>Younes, Anas</au><au>Freedman, Arnold S.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase IA/II, multicentre, open‐label study of the CD40 antagonistic monoclonal antibody lucatumumab in adult patients with advanced non‐Hodgkin or Hodgkin lymphoma</atitle><jtitle>British journal of haematology</jtitle><addtitle>Br J Haematol</addtitle><date>2014-01</date><risdate>2014</risdate><volume>164</volume><issue>2</issue><spage>258</spage><epage>265</epage><pages>258-265</pages><issn>0007-1048</issn><eissn>1365-2141</eissn><coden>BJHEAL</coden><abstract>Summary
Despite advancements in the treatment of non‐Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL), patients continue to relapse and thus a need for new targeted therapies remains. The CD40 receptor is highly expressed on neoplastic B cells and activation leads to enhanced proliferation and survival. Lucatumumab (HCD122) is a fully human antagonistic CD40 monoclonal antibody. A phase IA/II study was designed to determine the maximum tolerated dose (MTD) and activity of lucatumumab in patients with relapsed/refractory lymphoma. Determination of the MTD was the primary objective of the phase IA dose escalation portion and clinical response was the primary objective of the phase II dose expansion portion. Patients received escalating doses of lucatumumab administered intravenously once weekly for 4 weeks of an 8‐week cycle. MTD was determined at 4 mg/kg of lucatumumab. A total of 111 patients with NHL (n = 74) and HL (n = 37) were enrolled. Responses were observed across various lymphoma subtypes. The overall response rate by computed tomography among patients with follicular lymphoma (FL) and marginal zone lymphoma of mucosa‐associated lymphatic tissue (MZL/MALT) was 33·3% and 42·9%, respectively. Lucatumumab demonstrates modest activity in relapsed/refractory patients with advanced lymphoma, suggesting that targeting of CD40 warrants further investigation.</abstract><cop>Oxford</cop><pub>Blackwell</pub><pmid>24219359</pmid><doi>10.1111/bjh.12630</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Aged Aged, 80 and over Antibodies, Monoclonal, Humanized - pharmacology Antibodies, Monoclonal, Humanized - therapeutic use Antineoplastic Agents - pharmacology Antineoplastic Agents - therapeutic use Biological and medical sciences CD40 Antigens - antagonists & inhibitors Female Hematologic and hematopoietic diseases Hodgkin Disease - drug therapy Hodgkin Disease - pathology Hodgkin lymphoma Humans Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis Lymphoma, Non-Hodgkin - drug therapy Lymphoma, Non-Hodgkin - pathology Male Medical sciences Middle Aged monoclonal antibodies Neoplasm Staging non‐Hodgkin lymphoma Treatment Outcome Tumors Young Adult |
| title | Phase IA/II, multicentre, open‐label study of the CD40 antagonistic monoclonal antibody lucatumumab in adult patients with advanced non‐Hodgkin or Hodgkin lymphoma |
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