Avid Bioservices Inc (CDMO)

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ASCO’14, Full Abstract – Gerber/Shan/8more, Bavi Ph.3 SUNRISE Trial. Only shows the Background & Methods sections – not the Results & Conclusions sections (obviously, since SUNRISE only began enrolling in Dec’13).

May30-June3 2014: ASCO 50th Annual Meeting, Chicago
http://am.asco.org
Home: http://iplanner.asco.org/am2014/AM2014.aspx
Peregrine Booth #19121/”E=Enhanced”(1 of 67), 400sf (see: http://tinyurl.com/ln5e96k )
…All ASCO exhibitors: http://events.jspargo.com/asco14/public/exhibitors.aspx
…Abstracts: http://abstracts.asco.org/144/IndexView_144.html
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Saturday, 5-31-14 1:15pm-5:00pm - General Poster Session
Track: Lung Cancer, Session: Lung Cancer - Non-small Cell Metastatic
Abstract #TPS8129 - poster board #304B
“Stimulating an Immune Response Through Bavituximab in a Phase III Lung Cancer Study”
David E. Gerber, MD (UTSW: http://tinyurl.com/n2powk4 ), Joe Shan (VP/Clin+Reg.Affairs, Peregrine), et al..
FULL ABSTRACT:
BACKGROUND: 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-B and IL-10 which 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-1B, 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 2nd-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 survival and secondary endpoints include overall response rate (modified RECIST 1.1), progression free survival (PFS) and safety.
Clinical trial information: NCT01999673 - http://www.clinicaltrials.gov/ct2/show/NCT01999673
AUTHORS:
David E. Gerber, Joseph Shan, Ulrich Keilholz, David R. Spigel, Leora Horn, Rebecca Suk Heist, Rachel E. Sanborn, Paul N. Mainwaring, Chandra Prakash Belani, Martin J. Edelman
UTSW-MC/Dallas; Peregrine Pharmaceuticals, Tustin, CA; Charité Comprehensive Cancer Center, Berlin, Germany; Sarah Cannon Research Institute, Nashville, TN; Vanderbilt-Ingram Cancer Center, Nashville, TN; Massachusetts General Hospital, Boston, MA; Providence Portland Medical Center, Portland, OR; ICON Cancer Care, South Brisbane, Australia; Penn State Hershey Cancer Institute, Hershey, PA; University of New Mexico Cancer Center, Albuquerque, NM

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BAVITUXIMAB PHASE III TRIAL: (see http://PeregrineTrials.com => http://www.SunriseTrial.com )
A. Phase III Bavi+Doce vs. 2nd-Line NSCLC "SUNRISE" (randomized, double-blind, placebo-ctl'd, n=582)
USA Protocol: http://www.clinicaltrials.gov/ct2/show/NCT01999673 - 25 sites a/o 5-2-14 (Start=Apr’14 Est PrimaryComp=Dec’16)
EU/EEA Registries: (pts world=582, pts/EU=345, planned EU sites=100)
• GER: http://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/DE (planned sites=14, pts=43)
• SPAIN: http://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/ES (planned sites=16, pts=100)
• HUNGARY: http://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/HU (planned sites=9, pts=28)
...EU= European Union (29 countries – see http://www.gov.uk/eu-eea ), EEA=European Economic Area (all the EU, plus Iceland, Liechtenstein, Norway)
…Regions where sites are planned: Australia, Belgium, France, Germany, Greece, Hungary, Italy, Korea, Romania, Russia., Spain, Taiwan, Ukraine, USA
...3-2014: Eur.Med.Assoc.(EMA) appears to approve Bavi/2L-NSCLC for possible future trial in Children: http://tinyurl.com/lqsjfj2
1-6-14: FDA grants FAST TRACK status to Bavi in 2ndLine NSCLC http://tinyurl.com/l799ukk
12-30-13: Pivotal Ph.3 ‘SUNRISE’ NSCLC Trial Initiated (n=~600, sites=~100) http://tinyurl.com/kdjb9qz
5-20-13: FDA Approves Bavituximab Ph.III Design for 2L/NSCLC; 600-pt trial to begin by y/e’13 http://tinyurl.com/n3dxtm6
...S.King: “We will now focus on starting the Ph.III trial while continuing ongoing partnering discussions.”
…R.Garnick: “This was a highly collaborative effort with the FDA; this trial, when combined with Bavi’s supporting data to date, could be sufficient to support a future BLA submission."