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Cancer Biomarkers: Enhancing Diagnostic, Therapeutic And Developmental Strategies

Published by: Datamonitor

Published: May. 24, 2006 - 73 Pages


Table of Contents


ABOUT DATAMONITOR HEALTHCARE




CHAPTER 1 EXECUTIVE SUMMARY




CHAPTER 2 BIOMARKER USE IN DRIVING EFFICIENCIES IN THE COMMERCIALIZATION OF NOVEL ONCOLOGY PHARMACOTHERAPY

Defining biomarkers in relation to the diagnosis and treatment of cancer

Using biomarkers to mitigate productivity-constraining challenges in oncology drug development


Early changes in PSA may predict efficacy of novel developmental agents targeting prostate cancer


Cancer biomarkers have the potential to greatly enhance the screening, diagnosis and treatment decision-making process

Ideal biomarker requirements vary with their proposed clinical use

Collaborative initiatives aim to facilitate biomarker discovery

Defining prognostic and predictive biomarkers


Prognostic biomarkers can be classified as 'biological progression biomarkers' or 'risk biomarkers'

Predictive biomarkers provide a measure of the impact of drug and non-drug interventions


FDA has designated 'Type 2' cancer biomarkers as valid surrogates of clinical benefit

Biomarker validation remains a major challenge for the scientific community


Lack of rigor and consistency in novel biomarker validation has resticted their acceptance among the scientific and clinical community


Current biomarkers and their clinical and commercial use


Many cancer biomarkers in current clinical use are used to guide the selection of novel targeted treatments

Four biomarker assays dominate the marketplace and collectively generated global sales of $860m in 2003




CHAPTER 3 IMAGING BIOMARKERS ARE BEING ADOPTED WITH INCREASING FREQUENCY

Functional imaging is generating the greatest interest as a tool to aid drug development


Focus on F-18-deoxyglucose Positron-Emission Tomography imaging to facilitate early assessment of cancer drug efficacy


Payer enthusiasm for PET scanning is shared by regulators


Dynamic contrast-enhanced magnetic resonance imaging may provide an valuable early assessment of the efficacy of angiogenesis inhibitors


Developers show early signs of adopting DCE-MRI to assess the antiangiogenic activity of novel developmental agents


Developers will need to partner with functional imaging experts to ensure quality assurance in functional imaging applications




CHAPTER 4 NEXT GENERATION BIOMARKERS WILL FOCUS ON GENOMIC- AND PROTEOMIC-BASED APPROACHES

Protein function rather than protein quantification may be the more salient approach


Early demonstration of how protein expression profiles may help guide pharmacotherapy decisions


Genomic biomarkers herald the future


Affymetrix-Roche's Amplichip represents the first FDA-approved genomic-based prognostic tool


Diagnostic biomarket market expected to reach $3 billion annually


Single DNA-based biomarkers likely to be of little prognostic or predictive value


Epigenetic changes and mutations in oncogenes, tumor suppressor genes and DNA mismatch repair genes are the focus of DNA-based biomarker approaches

Epigenetic biomarker have the potential to guide treatment decisions for a number of marketed and developmental agents

Viral biomarkers have clinical potential for predicting treatment response and prognosis following the diagnosis of virally-mediated tumors.

Mitochondrial DNA analysis has huge potential


Pattern-based RNA expression analysis has been demonstrated in a number of tumor types


Commercial potential of RNA-expression arrays demonstrated by Genomic Health's Oncotype DX

Predictive expression profiles also exist for diffuse large B-cell non-Hodgkins lymphoma

Advances in gene expression profiling need to be matched by improvements in patient outcomes

microRNA approaches offer a novel approach to molecular profiling

But challenges still cloud the path to the commerciazation of novel RNA-based biomarker approaches





CHAPTER 5 REGULATORY ISSUES PROVIDE CHALLENGES TO CANCER BIOMARKER DEVELOPMENT

Regulatory procedures for cancer biomarkers can be onerous


Anylate-specific reagent designation facilitates laboratory use of novel biomarkers but prohibits payer reimbursement

Case study of Affymetrix-Roche's AmpliChip illustrates impact of regulatory hurdles


Industry guidance on pharmacogenomics aims to build expertise and foundation for developing scientifically sound regulatory policies


Ambiguities and developer concerns persist despite guidance


New drug test co-development guidance aims to change existing paradigms


Scientific, business and regulatory challenges hinder drug-diagnostic co-launches

Drug-test co-development concept paper focuses on technical/analytical issues rather than clinical aspects

Drug-test co-development may ultimately be a mandatory rather than an elective path for developers to follow




CHAPTER 6 BENEFITS AND RISKS OF PURSUING INCREASED MARKET SEGMENTATION

Risk of increased market segmentation in the era of 'personalized medicine' countered by need for developers to demonstrate cost-effectiveness of new high-cost treatments


Case study of HER-2/neu testing illustrates potential commercial rewards of biomarker testing

Fragmentation of cancer staging sytems may limit their clinical utility


Industry anxiety related to relabelling of existing drugs


But could the availability of epidermal growth factor receptor mutational analysis have mitigated the failure of AstraZeneca's Iressa?


Pharmacoeconomic challenges to the implementation of biomarkers




CHAPTER 7 APPENDIX

Bibliography

Research methodology

About Datamonitor


About Datamonitor Healthcare

Datamonitor Healthcare's research and analysis methodologies


Datamonitor Healthcare's therapy area capabilities


About the Oncology analysis team

Key therapy team members


Nish Saini, Lead Oncology Analyst


Disclaimer




List of Tables

Table 1: Prognostic and predictive biomarkers used in oncology

Table 2: NIH-FDA classification of biomarkers

Table 3: FDA-approved cancer biomarkers

Table 4: Biomarkers to guide prognosis and treatment decisions

Table 5: Selected FDA-approved biomarker assays, test systems and kits for BTA, CEA, CA125 and CA27.19

Table 6: Medical imaging techniques in oncology

Table 7: DNA-based biomarkers

Table 8: Viral biomarkers in oncology

Table 9: Prognostic and predictive utility of RNA-expression analysis

Table 10: Selected HER-2 tests available in the US

Table 11: Crude incidence rates of female breast cancer (per 100,000) in the seven major markets, 2006

Table 12: Female breast cancer incidence forecast in the seven major markets, 2002-16

Table 13: Forecast sales of HER2/neu testing (FISH alone) in the 7 major pharmaceutical markets 2006-2016

Table 14: Forecast sales of HER2/neu testing (IHC followed by FISH in IHC positive patients) in the 7 major pharmaceutical markets, 2006-2016




List of Figures

Figure 1: Prognostic biomarkers

Figure 2: Predictive biomarkers

Figure 3: Development of biomarkers for clinical use

Abstract

Introduction
The current focus on biomarker discovery is a result of an improved understanding of the biologic basis for carcinogenesis. The increasing number of potential drug targets and a plethora of diverse, new developmental agents have stimulated the search for biomarkers that can reduce the time, cost and attrition rates prevalent in oncology drug development.

Scope
  • The role of biomarkers in optimizing patient selection and treatment outcomes and in expediting oncology drug development.
  • Biomarker classification in oncology.
  • Regulator opinion on the integration of novel, valid and relevant biomarker endpoints into the design of oncology clinical trials.
  • Key commercial benefits and risks of incorporating predictive biomarkers into oncology drug development.
Highlights
It is hoped that the increased adoption of biomarker use in oncology will enable early proof-of-concept studies for novel therapeutic targets; accelerate the adoption of population-enrichment strategies for clinical trial recruitment; and increase the use of biomarker endpoints as surrogates for clinical benefit in oncology clinical trials.

Advances in imaging analysis technology have shed new light on cancer progression by enabling the precise measurement of small changes in structure and function over time. Image-based biomarkers have been singled out by the FDA as promising tools for every stage of drug development, from preclinical research to the approval process.

While targeting specific genotypes in clinical trials increases the opportunity to demonstrate clinical benefit, developers are concerned about how an increasingly fragmented cancer market may limit a drug's commercial potential. There is already skepticism among physicians about how readily Pharma will adopt a more 'personalized' approach.

Reasons to Purchase
  • Understand how tumor biomarkers will impact on oncology drug development as the paradigm to targeted treatment evolves.
  • Assess opportunities and risks for novel oncology biomarker development and commercialization.
  • Drive drug development strategies that incorporate prognostic or predictive biomarkers.


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