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Ref Type Journal Article
PMID (31423336)
Authors Cejalvo JM, Jacob W, Fleitas Kanonnikoff T, Felip E, Navarro Mendivil A, Martinez Garcia M, Taus Garcia A, Leighl N, Lassen U, Mau-Soerensen M, Adessi C, Michielin F, James I, Ceppi M, Hasmann M, Weisser M, Cervantes A
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.
Journal Vol Issue Date Pages Journal Short Title
ESMO open 4 4 2019 e000532 ESMO Open
URL
Abstract Text 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.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.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.Lumretuzumab in combination with carboplatin and paclitaxel was well tolerated. Objective responses were enriched in tumours expressing higher heregulin mRNA levels.

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Lumretuzumab Lumretuzumab 0 0
Drug Name Trade Name Synonyms Drug Classes Drug Description
Lumretuzumab RG7116|RO5479599 HER3 (ERBB3) Antibody 23 Lumretuzumab (RO5479599) is a humanized anti-Her3 (ERBB3) antibody that binds to and inhibits human epidermal growth factor receptor signaling, leading to growth inhibition in tumors (PMID: 26463709, PMID: 31423336).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References