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Rigshospitalet - en del af Københavns Universitetshospital
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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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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  • Juan-Miguel Cejalvo
  • Wolfgang Jacob
  • Tania Fleitas Kanonnikoff
  • Enriqueta Felip
  • Alejandro Navarro Mendivil
  • Maria Martinez Garcia
  • Alvaro Taus Garcia
  • Natasha Leighl
  • Ulrik Lassen
  • Morten Mau-Soerensen
  • Celine Adessi
  • Francesca Michielin
  • Ian James
  • Maurizio Ceppi
  • Max Hasmann
  • Martin Weisser
  • Andrés Cervantes
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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.

OriginalsprogEngelsk
TidsskriftESMO Open
Vol/bind4
Udgave nummer4
Sider (fra-til)e000532
ISSN2059-7029
DOI
StatusUdgivet - 2019

ID: 58968146