Pharmacokinetic and pharmacodynamic analysis of circulating biomarkers of anti-NRP1, a novel anti-angiogenesis agent, in two phase I trials in patients with advanced solid tumors.

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Pharmacokinetic and pharmacodynamic analysis of circulating biomarkers of anti-NRP1, a novel anti-angiogenesis agent, in two phase I trials in patients with advanced solid tumors.

Xin Y, Li J, Wu J, Kinard R, Weekes CD, Patnaik A, Lorusso PM, Brachmann R, Tong RK, Yan Y, Watts R, Bai S, Hegde PS.

Journal		Clin Cancer Res.
Species
Analytes Measured		PlGF , Flt-1 VEGFR1
Matrix Tested		Plasma

Year		2012
Volume
Page Numbers
Application		Angiogenesis and Vascular

Abstract

PURPOSE: MNRP1685A is a monoclonal antibody to neuropilin-1 (NRP1). We evaluated blood-based pharmacodynamic (PD) biomarkers of MNRP1685A in two Phase I studies to assess exposure/response relationships to inform target dose and regimen selection.

EXPERIMENTAL DESIGN: The Phase I studies evaluated escalating doses of MNRP1685A as a single agent or in combination with bevacizumab. Plasma Placental Growth Factor (P1GF), VEGF and circulating NRP1 (cNRP1) were evaluated at multiple time-points using meso-scale discovery (MSD) assays and ELISA, respectively. Plasma PlGF was also measured in a Phase I/II trial of bevacizumab in metastatic breast cancer (AVF0776). The association between PlGF and MNRP1685A dose was described by a sigmoid Emax model. cNRP1 and MNRP1685A PK profiles were described using a two-target quasi-steady state (QSS) model.

RESULTS: A dose and time dependent increase in plasma PlGF and cNRP1 was observed in all patients treated with MNRP1685A. PK/PD analysis showed that bevacizumab and MNRP1685A had an additive effect in elevating P1GF. Predictions based on the two-target QSS model showed that the free drug concentration to maintain greater than 90% saturation of membrane NRP1 (mNRP1) and cNRP1 is about 8 µg/mL.

CONCLUSIONS: These data show that MNRP1685A inhibits the VEGF pathway in humans as assessed by an increase in plasma PlGF. MNRP1685A appears to enhance bevacizumab-mediated VEGF pathway blockade, as demonstrated by an increase in the magnitude of PlGF elevation when combined with bevacizumab. PK/PD analysis of biomarkers in the Phase I population allowed identification of doses at which apparent maximal pathway modulation was observed.

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Pharmacokinetic and pharmacodynamic analysis of circulating biomarkers of anti-NRP1, a novel anti-angiogenesis agent, in two phase I trials in patients with advanced solid tumors.

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