A phase Ib/II study of HER3-targeting lumretuzumab in combination with carboplatin and paclitaxel as first-line treatment in patients with advanced or metastatic squamous non-small cell lung cancer
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- dc.contributor.author Cejalvo, Juan M.
- dc.contributor.author Jacob, Wolfgang
- dc.contributor.author Fleitas Kanonnikoff, Tania
- dc.contributor.author Felip, Enriqueta
- dc.contributor.author Navarro Mendivil, Alejandro
- dc.contributor.author Martínez-García, Maria
- dc.contributor.author Taus García, Álvaro
- dc.contributor.author Leighl, Natasha
- dc.contributor.author Lassen, Ulrik
- dc.contributor.author Mau-Soerensen, Morten
- dc.contributor.author Adessi, Celine
- dc.contributor.author Michielin, Francesca
- dc.contributor.author James, Ian
- dc.contributor.author Ceppi, Maurizio
- dc.contributor.author Hasmann, Max
- dc.contributor.author Weisser, Martin
- dc.contributor.author Cervantes, Andrés
- dc.date.accessioned 2019-12-18T11:37:19Z
- dc.date.available 2019-12-18T11:37:19Z
- dc.date.issued 2019
- dc.description.abstract PURPOSE:This study investigated the safety and clinical activity of lumretuzumab, a humanised antihuman epidermal growth factor receptor 3 (HER3) monoclonal antibody, in combination with carboplatin and paclitaxel in first-line treatment of patients with squamous non-small cell lung cancer (sqNSCLC). HER3 ligand heregulin and HER3 protein expression were evaluated as potential biomarkers of clinical activity. PATIENTS AND METHODS: This open-label, phase Ib/II study enrolled patients receiving lumretuzumab at 800 mg (flat) in combination with carboplatin (area under the curve (AUC) 6 mg/mL×min) and paclitaxel (200 mg/m2) administered intravenously on a every 3-week schedule. Adverse event (AE) rates and tumour responses were determined. Heregulin messenger RNA (mRNA) and HER3 protein expression were investigated in archival tumour biopsies. RESULTS: Altogether, 12 patients received lumretuzumab in combination with carboplatin and paclitaxel. The most frequent AEs were gastrointestinal, haematological and nervous system toxicities, which were generally mild and manageable. Partial responses were observed in 3 of 12 patients lasting 81, 177 and 207 days. All responses were achieved in tumours expressing higher heregulin mRNA levels. CONCLUSION: Lumretuzumab in combination with carboplatin and paclitaxel was well tolerated. Objective responses were enriched in tumours expressing higher heregulin mRNA levels.
- dc.format.mimetype application/pdf
- dc.identifier.citation Cejalvo JM, Jacob W, Fleitas Kanonnikoff T, Felip E, Navarro Mendivil A, Martinez Garcia M. et al. A phase Ib/II study of HER3-targeting lumretuzumab in combination with carboplatin and paclitaxel as first-line treatment in patients with advanced or metastatic squamous non-small cell lung cancer. ESMO Open. 2019 Jul 22;4(4):e000532. DOI 10.1136/esmoopen-2019-000532
- dc.identifier.doi http://dx.doi.org/10.1136/esmoopen-2019-000532
- dc.identifier.issn 2059-7029
- dc.identifier.uri http://hdl.handle.net/10230/43198
- dc.language.iso eng
- dc.publisher BMJ Publishing Group
- dc.rights © Cejalvo, Juan M.“This article was published in BMJ Open following peer review and can also be viewed on the journal’s website at http://bmjopen.bmj.com”. http://creativecommons.org/licenses/by-nc/4.0/.
- dc.rights.accessRights info:eu-repo/semantics/openAccess
- dc.rights.uri http://creativecommons.org/licenses/by-nc/4.0/
- dc.subject.keyword ErbB3
- dc.subject.keyword Biomarker
- dc.subject.keyword Heregulin
- dc.subject.keyword Human epidermal growth factor receptor 3 (HER3)
- dc.subject.keyword Non-small cell lung cancer (NSCLC)
- dc.subject.keyword Phase I
- dc.subject.keyword Squamous
- dc.title A phase Ib/II study of HER3-targeting lumretuzumab in combination with carboplatin and paclitaxel as first-line treatment in patients with advanced or metastatic squamous non-small cell lung cancer
- dc.type info:eu-repo/semantics/article
- dc.type.version info:eu-repo/semantics/publishedVersion