Randomized Phase II Study of Duligotuzumab (MEHD7945A) vs. Cetuximab in Squamous Cell Carcinoma of the Head and Neck (MEHGAN Study)
Identifieur interne : 001852 ( Main/Exploration ); précédent : 001851; suivant : 001853Randomized Phase II Study of Duligotuzumab (MEHD7945A) vs. Cetuximab in Squamous Cell Carcinoma of the Head and Neck (MEHGAN Study)
Auteurs : Jérôme Fayette [France] ; Lori Wirth [États-Unis] ; Cristina Oprean [Roumanie] ; Anghel Udrea [Roumanie] ; Antonio Jimeno [États-Unis] ; Danny Rischin [Australie] ; Christopher Nutting [Royaume-Uni] ; Paul M. Harari [États-Unis] ; Tibor Csoszi [Hongrie] ; Dana Cernea [Roumanie] ; Paul O Rien [États-Unis] ; William D. Hanley [États-Unis] ; Amy V. Kapp [États-Unis] ; Maria Anderson [États-Unis] ; Elicia Penuel [États-Unis] ; Bruce Mccall [États-Unis] ; Andrea Pirzkall [États-Unis] ; Jan B. Vermorken [Belgique]Source :
- Frontiers in Oncology [ 2234-943X ] ; 2016.
Abstract
Duligotuzumab, a novel dual-action humanized IgG1 antibody that blocks ligand binding to epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3), inhibits signaling from all ligand-dependent HER dimers, and can elicit antibody-dependent cell-mediated cytotoxicity. High tumor-expression of neuregulin 1 (NRG1), a ligand to HER3, may enhance sensitivity to duligotuzumab.
This multicenter, open-label, randomized phase II study (MEHGAN) evaluated drug efficacy in patients with recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) progressive on/after chemotherapy and among patients with NRG1-high tumors. Patients received duligotuzumab (1100 mg IV, q2w) or cetuximab (400 mg/m2 load, 250 mg/m2 IV, q1w) until progression or intolerable toxicity. Tumor samples were assayed for biomarkers [
Patients (
While several lines of preclinical evidence had supported the premise that the blockade of HER3 in addition to that of EGFR may improve outcomes for patients with R/M SCCHN overall or specifically in those patients whose tumors express high levels of
Url:
DOI: 10.3389/fonc.2016.00232
PubMed: 27843803
PubMed Central: 5086582
Affiliations:
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Le document en format XML
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<author><name sortKey="Vermorken, Jan B" sort="Vermorken, Jan B" uniqKey="Vermorken J" first="Jan B." last="Vermorken">Jan B. Vermorken</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Randomized Phase II Study of Duligotuzumab (MEHD7945A) vs. Cetuximab in Squamous Cell Carcinoma of the Head and Neck (MEHGAN Study)</title>
<author><name sortKey="Fayette, Jerome" sort="Fayette, Jerome" uniqKey="Fayette J" first="Jérôme" last="Fayette">Jérôme Fayette</name>
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<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<author><name sortKey="Nutting, Christopher" sort="Nutting, Christopher" uniqKey="Nutting C" first="Christopher" last="Nutting">Christopher Nutting</name>
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<author><name sortKey="Cernea, Dana" sort="Cernea, Dana" uniqKey="Cernea D" first="Dana" last="Cernea">Dana Cernea</name>
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<author><name sortKey="O Rien, Paul" sort="O Rien, Paul" uniqKey="O Rien P" first="Paul" last="O Rien">Paul O Rien</name>
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<country xml:lang="fr">États-Unis</country>
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<author><name sortKey="Kapp, Amy V" sort="Kapp, Amy V" uniqKey="Kapp A" first="Amy V." last="Kapp">Amy V. Kapp</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<author><name sortKey="Anderson, Maria" sort="Anderson, Maria" uniqKey="Anderson M" first="Maria" last="Anderson">Maria Anderson</name>
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<country xml:lang="fr">États-Unis</country>
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<author><name sortKey="Penuel, Elicia" sort="Penuel, Elicia" uniqKey="Penuel E" first="Elicia" last="Penuel">Elicia Penuel</name>
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,<addr-line>South San Francisco, CA</addr-line>
,<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<author><name sortKey="Mccall, Bruce" sort="Mccall, Bruce" uniqKey="Mccall B" first="Bruce" last="Mccall">Bruce Mccall</name>
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,<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<author><name sortKey="Pirzkall, Andrea" sort="Pirzkall, Andrea" uniqKey="Pirzkall A" first="Andrea" last="Pirzkall">Andrea Pirzkall</name>
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,<addr-line>South San Francisco, CA</addr-line>
,<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<author><name sortKey="Vermorken, Jan B" sort="Vermorken, Jan B" uniqKey="Vermorken J" first="Jan B." last="Vermorken">Jan B. Vermorken</name>
<affiliation wicri:level="1"><nlm:aff id="aff13"><institution>Antwerp University Hospital</institution>
,<addr-line>Edegem</addr-line>
,<country>Belgium</country>
</nlm:aff>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<series><title level="j">Frontiers in Oncology</title>
<idno type="eISSN">2234-943X</idno>
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</teiHeader>
<front><div type="abstract" xml:lang="en"><sec id="ST1"><title>Background</title>
<p>Duligotuzumab, a novel dual-action humanized IgG1 antibody that blocks ligand binding to epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3), inhibits signaling from all ligand-dependent HER dimers, and can elicit antibody-dependent cell-mediated cytotoxicity. High tumor-expression of neuregulin 1 (NRG1), a ligand to HER3, may enhance sensitivity to duligotuzumab.</p>
</sec>
<sec id="ST2"><title>Methods</title>
<p>This multicenter, open-label, randomized phase II study (MEHGAN) evaluated drug efficacy in patients with recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) progressive on/after chemotherapy and among patients with NRG1-high tumors. Patients received duligotuzumab (1100 mg IV, q2w) or cetuximab (400 mg/m<sup>2</sup>
load, 250 mg/m<sup>2</sup>
IV, q1w) until progression or intolerable toxicity. Tumor samples were assayed for biomarkers [<italic>NRG1, ERBB3</italic>
, and human papillomavirus (HPV) status].</p>
</sec>
<sec id="ST3"><title>Results</title>
<p>Patients (<italic>N</italic>
= 121) were randomized (duligotuzumab:cetuximab; 59:62), median age 62 years; ECOG 0–2. Both arms (duligotuzumab vs. cetuximab, respectively) showed comparable progression-free survival [4.2 vs. 4.0 months; HR: 1.23 (90% confidence interval (CI): 0.89–1.70)], overall survival [7.2 vs. 8.7 months; HR 1.15 (90% CI: 0.81–1.63)], and objective response rate (12 vs. 14.5%), with no difference between patients with <italic>NRG1</italic>
-high tumors or <italic>ERBB3</italic>
-low tumors. Responses in both arms were confined to HPV-negative patients. Grade ≥3 adverse events (AEs) (duligotuzumab vs. cetuximab, respectively) included infections (22 vs. 11.5%) and GI disorders (17 vs. 7%), contributing to higher rates of serious AEs (41 vs. 29.5%). Metabolic disorders were less frequent with duligotuzumab (10 vs. 16%); any grade rash-related events were less with duligotuzumab (49 vs. 67%).</p>
</sec>
<sec id="ST4"><title>Conclusion</title>
<p>While several lines of preclinical evidence had supported the premise that the blockade of HER3 in addition to that of EGFR may improve outcomes for patients with R/M SCCHN overall or specifically in those patients whose tumors express high levels of <italic>NRG1</italic>
, this study provided definitive clinical evidence refuting this hypothesis. Duligotuzumab did not improve patient outcomes in comparison to cetuximab despite frequent expression of <italic>NRG1</italic>
. These data indicate that inhibition of EGFR alone is sufficient to block EGFR–HER3 signaling, suggesting that HER2 plays a minimal role in this disease. Extensive biomarker analyses further show that HPV-negative SCCHN but not HPV-positive SCCHN are most likely to respond to EGFR blockage by cetuximab or duligotuzumab.</p>
</sec>
</div>
</front>
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</back>
</TEI>
<affiliations><list><country><li>Australie</li>
<li>Belgique</li>
<li>France</li>
<li>Hongrie</li>
<li>Roumanie</li>
<li>Royaume-Uni</li>
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</country>
</list>
<tree><country name="France"><noRegion><name sortKey="Fayette, Jerome" sort="Fayette, Jerome" uniqKey="Fayette J" first="Jérôme" last="Fayette">Jérôme Fayette</name>
</noRegion>
</country>
<country name="États-Unis"><noRegion><name sortKey="Wirth, Lori" sort="Wirth, Lori" uniqKey="Wirth L" first="Lori" last="Wirth">Lori Wirth</name>
</noRegion>
<name sortKey="Anderson, Maria" sort="Anderson, Maria" uniqKey="Anderson M" first="Maria" last="Anderson">Maria Anderson</name>
<name sortKey="Hanley, William D" sort="Hanley, William D" uniqKey="Hanley W" first="William D." last="Hanley">William D. Hanley</name>
<name sortKey="Harari, Paul M" sort="Harari, Paul M" uniqKey="Harari P" first="Paul M." last="Harari">Paul M. Harari</name>
<name sortKey="Jimeno, Antonio" sort="Jimeno, Antonio" uniqKey="Jimeno A" first="Antonio" last="Jimeno">Antonio Jimeno</name>
<name sortKey="Kapp, Amy V" sort="Kapp, Amy V" uniqKey="Kapp A" first="Amy V." last="Kapp">Amy V. Kapp</name>
<name sortKey="Mccall, Bruce" sort="Mccall, Bruce" uniqKey="Mccall B" first="Bruce" last="Mccall">Bruce Mccall</name>
<name sortKey="O Rien, Paul" sort="O Rien, Paul" uniqKey="O Rien P" first="Paul" last="O Rien">Paul O Rien</name>
<name sortKey="Penuel, Elicia" sort="Penuel, Elicia" uniqKey="Penuel E" first="Elicia" last="Penuel">Elicia Penuel</name>
<name sortKey="Pirzkall, Andrea" sort="Pirzkall, Andrea" uniqKey="Pirzkall A" first="Andrea" last="Pirzkall">Andrea Pirzkall</name>
</country>
<country name="Roumanie"><noRegion><name sortKey="Oprean, Cristina" sort="Oprean, Cristina" uniqKey="Oprean C" first="Cristina" last="Oprean">Cristina Oprean</name>
</noRegion>
<name sortKey="Cernea, Dana" sort="Cernea, Dana" uniqKey="Cernea D" first="Dana" last="Cernea">Dana Cernea</name>
<name sortKey="Udrea, Anghel" sort="Udrea, Anghel" uniqKey="Udrea A" first="Anghel" last="Udrea">Anghel Udrea</name>
</country>
<country name="Australie"><noRegion><name sortKey="Rischin, Danny" sort="Rischin, Danny" uniqKey="Rischin D" first="Danny" last="Rischin">Danny Rischin</name>
</noRegion>
</country>
<country name="Royaume-Uni"><noRegion><name sortKey="Nutting, Christopher" sort="Nutting, Christopher" uniqKey="Nutting C" first="Christopher" last="Nutting">Christopher Nutting</name>
</noRegion>
</country>
<country name="Hongrie"><noRegion><name sortKey="Csoszi, Tibor" sort="Csoszi, Tibor" uniqKey="Csoszi T" first="Tibor" last="Csoszi">Tibor Csoszi</name>
</noRegion>
</country>
<country name="Belgique"><noRegion><name sortKey="Vermorken, Jan B" sort="Vermorken, Jan B" uniqKey="Vermorken J" first="Jan B." last="Vermorken">Jan B. Vermorken</name>
</noRegion>
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</record>
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