A phase I open-label dose-escalation study of the anti-HER3 monoclonal antibody LJM716 in patients with advanced squamous cell carcinoma of the esophagus or head and neck and HER2-overexpressing breast or gastric cancer

Table 4 Biomarker inhibition in paired tumor biopsies of individual patients treated with LJM716 40 mg/kg QW

Patient biopsy	Best response	t-HER3	p-HER3	HER3 ratio (P/T)	t-AKT	p-AKT	AKT ratio (P/T)
1	PD	−86% ↑	81% ↓	90% ↓	7% ↓	84% ↓	83% ↓
2	SD	ND	−157% ↑	ND	−249% ↑	−84% ↑	47% ↓
3	PD	ND	63% ↓	ND	ND	ND	ND
4	SD	25% ↓	ND	ND	−33% ↑	0%	25% ↓
5	SD	72% ↓	82% ↓	34% ↓	70% ↓	ND	ND
Median		25%	72% ↓	62% ↓	−13% ↑	0%	47% ↓

Percentages represent changes in the post-baseline sample against the baseline value
Positive and negative values represent biomarker inhibition (↓) and stimulation (↑), respectively
HER3 human epidermal growth factor receptor 3, ND not determined, PD progressive disease, p-AKT phosphor-AKT, p-HER3 phospho-HER3, Q2W once every two weeks, QW once weekly, SD stable disease, t-AKT total AKT, t-HER3 total HER3

ISSN: 1471-2407