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Cancer Biomarkers: Enhancing diagnostic, therapeutic and developmental strategies

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.

Report 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.

Table of Contents

• ABOUT DATAMONITOR HEALTHCARE - page 2
• CHAPTER 1 EXECUTIVE SUMMARY - page 7
• CHAPTER 2 BIOMARKER USE IN DRIVING EFFICIENCIES IN THE COMMERCIALIZATION OF NOVEL ONCOLOGY PHARMACOTHERAPY - page 10
  • Defining biomarkers in relation to the diagnosis and treatment of cancer - page 10
  • Using biomarkers to mitigate productivity-constraining challenges in oncology drug development - page 10
    • Early changes in PSA may predict efficacy of novel developmental agents targeting prostate cancer - page 11
  • Cancer biomarkers have the potential to greatly enhance the screening, diagnosis and treatment decision-making process - page 11
  • Ideal biomarker requirements vary with their proposed clinical use - page 12
  • Collaborative initiatives aim to facilitate biomarker discovery - page 14
  • Defining prognostic and predictive biomarkers - page 15
    • Prognostic biomarkers can be classified as 'biological progression biomarkers' or 'risk biomarkers' - page 16
    • Predictive biomarkers provide a measure of the impact of drug and non-drug interventions - page 17
  • FDA has designated 'Type 2' cancer biomarkers as valid surrogates of clinical benefit - page 19
  • Biomarker validation remains a major challenge for the scientific community - page 21
    • Lack of rigor and consistency in novel biomarker validation has resticted their acceptance among the scientific and clinical community - page 22
  • Current biomarkers and their clinical and commercial use - page 23
    • Many cancer biomarkers in current clinical use are used to guide the selection of novel targeted treatments - page 25
    • Four biomarker assays dominate the marketplace and collectively generated global sales of $860m in 2003 - page 25
• CHAPTER 3 IMAGING BIOMARKERS ARE BEING ADOPTED WITH INCREASING FREQUENCY - page 30
  • Functional imaging is generating the greatest interest as a tool to aid drug development - page 31
    • Focus on F-18-deoxyglucose Positron-Emission Tomography imaging to facilitate early assessment of cancer drug efficacy - page 31
      • Payer enthusiasm for PET scanning is shared by regulators - page 33
    • Dynamic contrast-enhanced magnetic resonance imaging may provide an valuable early assessment of the efficacy of angiogenesis inhibitors - page 33
      • Developers show early signs of adopting DCE-MRI to assess the antiangiogenic activity of novel developmental agents - page 34
    • Developers will need to partner with functional imaging experts to ensure quality assurance in functional imaging applications - page 35
• CHAPTER 4 NEXT GENERATION BIOMARKERS WILL FOCUS ON GENOMIC- AND PROTEOMIC-BASED APPROACHES - page 36
  • Protein function rather than protein quantification may be the more salient approach - page 36
    • Early demonstration of how protein expression profiles may help guide pharmacotherapy decisions - page 37
  • Genomic biomarkers herald the future - page 37
    • Affymetrix-Roche's Amplichip represents the first FDA-approved genomic-based prognostic tool - page 38
      • Diagnostic biomarket market expected to reach $3 billion annually - page 38
    • Single DNA-based biomarkers likely to be of little prognostic or predictive value - page 38
      • Epigenetic changes and mutations in oncogenes, tumor suppressor genes and DNA mismatch repair genes are the focus of DNA-based biomarker approaches - page 39
      • Epigenetic biomarker have the potential to guide treatment decisions for a number of marketed and developmental agents - page 42
      • Viral biomarkers have clinical potential for predicting treatment response and prognosis following the diagnosis of virally-mediated tumors. - page 42
      • Mitochondrial DNA analysis has huge potential - page 43
    • Pattern-based RNA expression analysis has been demonstrated in a number of tumor types - page 44
      • Commercial potential of RNA-expression arrays demonstrated by Genomic Health's Oncotype DX - page 46
      • Predictive expression profiles also exist for diffuse large B-cell non-Hodgkins lymphoma - page 47
      • Advances in gene expression profiling need to be matched by improvements in patient outcomes - page 49
      • microRNA approaches offer a novel approach to molecular profiling - page 50
      • But challenges still cloud the path to the commerciazation of novel RNA-based biomarker approaches - page 50
• CHAPTER 5 REGULATORY ISSUES PROVIDE CHALLENGES TO CANCER BIOMARKER DEVELOPMENT - page 51
  • Regulatory procedures for cancer biomarkers can be onerous - page 51
    • Anylate-specific reagent designation facilitates laboratory use of novel biomarkers but prohibits payer reimbursement - page 51
    • Case study of Affymetrix-Roche's AmpliChip illustrates impact of regulatory hurdles - page 52
  • Industry guidance on pharmacogenomics aims to build expertise and foundation for developing scientifically sound regulatory policies - page 52
    • Ambiguities and developer concerns persist despite guidance - page 54
  • New drug test co-development guidance aims to change existing paradigms - page 55
    • Scientific, business and regulatory challenges hinder drug-diagnostic co-launches - page 55
    • Drug-test co-development concept paper focuses on technical/analytical issues rather than clinical aspects - page 56
    • Drug-test co-development may ultimately be a mandatory rather than an elective path for developers to follow - page 57
• CHAPTER 6 BENEFITS AND RISKS OF PURSUING INCREASED MARKET SEGMENTATION - page 58
  • 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 - page 58
    • Case study of HER-2/neu testing illustrates potential commercial rewards of biomarker testing - page 59
    • Fragmentation of cancer staging sytems may limit their clinical utility - page 63
  • Industry anxiety related to relabelling of existing drugs - page 64
    • But could the availability of epidermal growth factor receptor mutational analysis have mitigated the failure of AstraZeneca's Iressa? - page 64
  • Pharmacoeconomic challenges to the implementation of biomarkers - page 65
• CHAPTER 7 APPENDIX - page 67
  • Bibliography - page 67
  • Research methodology - page 70
  • About Datamonitor - page 70
    • About Datamonitor Healthcare - page 70
    • Datamonitor Healthcare's research and analysis methodologies - page 71
  • Datamonitor Healthcare's therapy area capabilities - page 71
    • About the Oncology analysis team - page 72
    • Key therapy team members - page 73
      • Nish Saini, Lead Oncology Analyst - page 73
    • Disclaimer - page 73


• List of Tables
• Table 1: Prognostic and predictive biomarkers used in oncology - page 18
• Table 2: NIH-FDA classification of biomarkers - page 20
• Table 3: FDA-approved cancer biomarkers - page 23
• Table 4: Biomarkers to guide prognosis and treatment decisions - page 25
• Table 5: Selected FDA-approved biomarker assays, test systems and kits for BTA, CEA, CA125 and CA27.19 - page 27
• Table 6: Medical imaging techniques in oncology - page 30
• Table 7: DNA-based biomarkers - page 40
• Table 8: Viral biomarkers in oncology - page 43
• Table 9: Prognostic and predictive utility of RNA-expression analysis - page 45
• Table 10: Selected HER-2 tests available in the US - page 60
• Table 11: Crude incidence rates of female breast cancer (per 100,000) in the seven major markets, 2006 - page 61
• Table 12: Female breast cancer incidence forecast in the seven major markets, 2002-16 - page 62
• Table 13: Forecast sales of HER2/neu testing (FISH alone) in the 7 major pharmaceutical markets 2006-2016 - page 62
• Table 14: Forecast sales of HER2/neu testing (IHC followed by FISH in IHC positive patients) in the 7 major pharmaceutical markets, 2006-2016 - page 63


• List of Figures
• Figure 1: Prognostic biomarkers - page 15
• Figure 2: Predictive biomarkers - page 16
• Figure 3: Development of biomarkers for clinical use - page 56

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