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Case Studies in Cancer Drug Development
May 14, 2009
11:00 a.m. –1:00 p.m. EST

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11:00-11:10 Chairperson’s Opening Remarks

11:10-11:35 VANDETANIB 
Pretreatment Circulating VEGF Levels as A Predictive Biomarker of Efficacy in NSCLC Patients Treated with Vandetanib
Anderson Ryan, Ph.D., Principle Translational Scientist, Cancer BioScience, Global Discovery Science Lead and Translational Science Strategist for ZACTIMA (vandetanib) project, AstraZeneca
Vandetanib has demonstrated improvements in progression-free survival (PFS) in advanced NSCLC in three randomized phase II studies: vandetanib versus gefitinib; docetaxel ± vandetanib; carboplatin and paclitaxel (CP) ± vandetanib. We performed an exploratory analysis of the relationship between baseline circulating VEGF concentrations and PFS and OS. These analyses suggest that low baseline circulating VEGF may be predictive of PFS and OS advantage in patients with advanced NSCLC receiving vandetanib versus gefitinib, or vandetanib + docetaxel versus docetaxel. Notably, patients with low VEGF levels had similar outcome with either vandetanib monotherapy or CP doublet chemotherapy raising the possibility that this test could be used to select patients for treatment with a targeted therapy instead of treatment with a standard cytotoxic chemotherapy regimen.

11:35-12:00 IRESSA
Detecting EGFR Mutations in NSCLC as A Predictive Factor for IRESSA

Georgina Speake, Ph.D., Translational Science Strategist, Cancer BioScience, Global Discovery Science Lead and Translational Science Strategist for IRESSA (gefitinib) project, AstraZeneca
IPASS was a Phase III, randomized, open-label study of gefitinib versus carboplatin / paclitaxel in clinically selected patients with advanced NSCLC.  Multiple, non-comparative studies have demonstrated superior efficacy of EGFR TKIs in patients of Asian origin, never / light smokers and in patients with adenocarcinoma histology when compared to other patient groups.  A known higher incidence of EGFR mutations in patients with these characteristics made analysis of efficacy by biomarker status particularly interesting.  We therefore hypothesized that a clinically selected group of patients with these characteristics treated with an EGFR TKI as first-line therapy would have efficacy at least as good as carboplatin / paclitaxel with benefits in tolerability and quality of life.  The study exceeded its primary objective and demonstrated superiority of gefitinib relative to carboplatin / paclitaxel in terms of PFS, and EGFR mutation status was a strong predictive biomarker for the effect of gefitinib compared to carboplatin / paclitaxel.  There are a number of different technologies that can be used to identify EGFR mutation status, all with different potential benefits and issues.  Our experience of EGFR mutation testing will be discussed.

12:00-12:10 Sponsored Presentation
Opportunity available. Contact Ilana Quigley, Business Development, 781-972-5457 or iquigley@healthtech.com.

12:10-12:35 VECTIBIX
The KRAS Signaling Pathway Biomarker in Oncology: From Prognostic to Predictive

Scott D. Patterson, Ph.D., Executive Director, Medical Sciences, Amgen, Inc.
There are a number of biomarkers that are considered to be prognostic, although the difficulty in proving this with the array of treatment options available makes confirmation difficult. In some cases these same biomarkers may be predictive of response to specific therapies. Demonstration of this requires analysis of samples from clinical studies with control arms – often not employed until phase 3. Our experience in the elucidation of KRAS as a patient stratification biomarker will be presented.

12:35-1:00 TARCEVA
Incorporation of Biomarkers into Tarceva Clinical Trials
Frank Richardson, Ph.D., Senior Director, Safety Assessment & Molecular Markers, OSI Pharmaceuticals
Tarceva® is an EGFR tyrosine kinase inhibitor approved as monotherapy for the treatment of 2nd-3rd-line advance non-small cell lung cancer (NSCLC) and in combination with Gemzar for the treatment of 1st –line advanced pancreatic cancer.  There is intense interest in finding and validating new biomarkers that predict outcome to Tarceva and thus enhance clinical benefit.   The development of biomarkers is a challenging process in which the promise of a specific biomarker can grow or diminish as new information becomes available.  This talk will discuss and present preliminary results of two biomarker-selected trials in NSCLC as case examples that highlight ongoing efforts to incorporate and clinically validate emerging biomarkers in an ever-shifting landscape.


About the Speakers:

Scott D. Patterson, Ph.D., Executive Director, Medical Sciences, Amgen, Inc.
Dr. Patterson returned to Amgen Inc., California in 2003 and is an Executive Director in the Medical Sciences function leading the Molecular Sciences department (with the Computational Biology department also reporting to him). Medical Sciences is responsible for conducting first-in-human studies through to Phase 2a for all therapeutic areas in the company, and Molecular Sciences is part of this function to enable biochemical determination of whether the targeted pathway is being interdicted, whether exposure:response relationships can be generated (to inform dose ranging), and in which patient populations the therapeutic may be more efficacious (should that be necessary). He is well known in the field of protein chemistry, and a pioneer in the field of proteomics. He has published extensively and is a frequent guest lecturer. After leaving Amgen in 2000, he served as Vice President of Proteomics at the Celera Genomics Group and then as Chief Scientific Officer of Farmal Biomedicines, LLC. While at Celera, he established the company's initial foray into protein-based drug target discovery and validation in oncology, building a large group of cell biologists, protein chemists and mass spectrometrists whose efforts resulted in the identification of cell surface targets for therapeutic development and diagnostics, a number of which have been licensed to Pharma and Biotechnology companies. Dr. Patterson first worked at Amgen from 1993–2000 progressing from a Research Scientist to Department Head, ultimately leading the Department of Biochemistry and Genetics. He received his Ph.D. and B.Sc. from The University of Queensland, where he held positions of increasing responsibility over a period of 11 years, culminating in that of Senior Research Officer. In 1991 he joined the faculty of Cold Spring Harbor Laboratory, New York where he established a program in apoptosis and pursued his technical interests in analytical protein chemistry applications.

Frank Richardson, Ph.D., Senior Director, Safety Assessment & Molecular Markers, OSI Pharmaceuticals
Dr. Richardson received his B.S. degree from the Massachusetts Institute of Technology, his D.V.M from Iowa State University, and his Ph.D. in Experimental Pathology from Duke University.  His early research focused on mechanisms of carcinogenesis evaluating the relationships between molecular dosimeters and cancer.  He was a Visiting Scientist at the Chemical Industries Institute of Toxicology before taking a toxicology position at Eli Lilly in a newly created carcinogenesis/mutagenesis research laboratory that conducted and published research on mutational and proteomic analyses of carcinogenic mechanisms. In addition, he was involved in early work on implementing biomarker analysis in preclinical and clinical trials. Dr. Richardson moved to Nexstar Pharmaceuticals in Boulder Colorado as Toxicologist responsible for evaluating mechanism of mitochondrial toxicities of nucleoside analogues.  He has been employed by OSI Pharmaceuticals since 2001. He is responsible for preclinical development safety assessment and helped instigate biomarker sample collection, biomarker assay development and biomarker assay implementation in OSI preclinical and clinical trials. Current research is focused on identifying and conducting biomarker analysis that may aid in the selection of patients who will respond to OSI oncology compounds. In collaboration with partners Genentech and Roche, some of this research has focused on Tarceva®, the TKI inhibitor approved for treatment of 2nd and 3rd line NSCLC and advanced pancreatic cancer in combination with gemcitabine.


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