Please use this identifier to cite or link to this item: https://doi.org/10.1002/cpdd.427
Title: Phase 1b Trial of Ficlatuzumab, a Humanized Hepatocyte Growth Factor Inhibitory Monoclonal Antibody, in Combination With Gefitinib in Asian Patients With NSCLC
Authors: Tan, Eng-Huat 
Lim, Wan-Teck 
Ahn, Myung-Ju
Ng, Quan-Sing 
Ahn, Jin Seok
Tan, Daniel Shao-Weng 
Sun, Jong-Mu
Han, May
Payumo, Francis C
Mckee, Krista
Yin, Wei
Credi, Marc
Agarwal, Shefali
Jac, Jaroslaw
Park, Keunchil
Keywords: Science & Technology
Life Sciences & Biomedicine
Pharmacology & Pharmacy
ficlatuzumab
NSCLC
gefitinib
lung adenocarcinoma
non-small cell lung cancer
CELL LUNG-CANCER
ADVANCED SOLID TUMORS
FACTOR RECEPTOR
CLINICAL-SIGNIFICANCE
SCATTER-FACTOR
RESISTANCE
MET
MUTATIONS
ERLOTINIB
ADENOCARCINOMA
Issue Date: 1-Jun-2018
Publisher: WILEY
Citation: Tan, Eng-Huat, Lim, Wan-Teck, Ahn, Myung-Ju, Ng, Quan-Sing, Ahn, Jin Seok, Tan, Daniel Shao-Weng, Sun, Jong-Mu, Han, May, Payumo, Francis C, Mckee, Krista, Yin, Wei, Credi, Marc, Agarwal, Shefali, Jac, Jaroslaw, Park, Keunchil (2018-06-01). Phase 1b Trial of Ficlatuzumab, a Humanized Hepatocyte Growth Factor Inhibitory Monoclonal Antibody, in Combination With Gefitinib in Asian Patients With NSCLC. CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT 7 (5) : 532-542. ScholarBank@NUS Repository. https://doi.org/10.1002/cpdd.427
Abstract: Hepatocyte growth factor (HGF)/c-Met pathway dysregulation is a mechanism for epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs). Ficlatuzumab (AV-299; SCH 900105), a humanized IgG 1 κ HGF inhibitory monoclonal antibody, prevents HGF/c-Met pathway ligand–mediated activation. This phase 1b study assessed the safety/tolerability, pharmacokinetics/pharmacodynamics, and antitumor activity of ficlatuzumab plus gefitinib in Asian patients with previously treated advanced non–small cell lung cancer (NSCLC). Patients received intravenous ficlatuzumab either 10 mg/kg (cohort 1; n = 3) or 20 mg/kg (cohort 2; n = 12) every 2 weeks plus oral gefitinib 250 mg daily. Patients tolerated the drug combination well. Four treatment-related grade 3/4 adverse events were reported in 3 patients (cohort 2). Pharmacokinetic profiles for ficlatuzumab and gefitinib were consistent with prior single-agent trials. Partial responses were achieved in 5 patients (4 confirmed), all in cohort 2; objective response rate (ORR) was 33% (duration, 1.9–6.4 months). Responding patients had no prior EGFR TKI treatment, 2 without an EGFR mutation. Four additional patients had disease stabilization (cohort 2; duration, 2.7–9.1 months; 42% ORR). The recommended phase 2 dose for ficlatuzumab plus gefitinib 250 mg/day was 20 mg/kg every 2 weeks. This drug combination has shown preliminary dose-related antitumor activity in advanced NSCLC.
Source Title: CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT
URI: https://scholarbank.nus.edu.sg/handle/10635/218636
ISSN: 21607648
DOI: 10.1002/cpdd.427
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