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Upcoming Event
May 31, 2014 2014 ASCO Annual Meeting
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Abstract: #TPS8129
Title: Stimulating an immune response through bavituximab in a phase III lung cancer study.
Presenter: David E. Gerber, MD, Associate Professor, Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas
Track(s): Lung Cancer
Session Type: General Poster Session
Date, Time and Location:: Saturday, May 31, 1:15 PM - 5:00 PM CDT; S Hall A2
Poster Board: #304B
Link to Abstract:
Abstract: Escape from immune surveillance is a frequent mechanism of tumor initiation, proliferation, and resistance to treatment. Bavituximab is a chimeric monoclonal antibody with immune modulating properties. Bavituximab targets exposed phosphatidylserine (PS) on tumor vascular endothelium, tumor cells and tumor derived exosomes. Exposed PS in the tumor microenvironment suppresses immune and inflammatory responses by binding to PS receptors on myeloid derived suppressor cells (MDSC) and M2 macrophages, which leads to production of anti-inflammatory cytokines such as TGF-ß and IL-10which inhibits the development of an adaptive immune response. In preclinical models, PS-targeting antibodies counter these effects, resulting in production of pro-inflammatory cytokines such as TNF-a and IL-1ß, maturation of dendritic cells and induction of tumor specific cytotoxic T lymphocyte immunity. Administration of docetaxel increases PS exposure within the tumor microenvironment and also suppresses MDSCs, thereby enhancing bavituximab's effects. In a double-blind Phase II clinical trial, bavituximab 3 mg/kg plus docetaxel was well-tolerated and demonstrated 60% improvement (11.7 vs 7.3 month) in median overall survival (OS) compared to control. Methods: In this randomized, double-blind, global Phase III clinical trial, approximately 600 pts with second-line stage IIIb/IV non-squamous NSCLC will be randomized 1:1 to receive up to six 21-day cycles of docetaxel 75 mg/m2 with placebo or bavituximab 3 mg/kg weekly until disease progression or unacceptable toxicity. Patients must have one progression on platinum doublet therapy for advanced disease. Prior maintenance or targeted therapy is allowed if only 1 progression occurred. Within each geographic region, patients will be stratified by disease stage and prior maintenance/targeted therapy. The primary endpoint is overall survivaland secondary endpoints include overall response rate (modified RECIST 1.1), progression free survival (PFS) and safety. Clinical trial information: NCT01999673.
