Pipeline Insight: Colorectal Cancer - Growing trend towards personalized medicine

Table of Contents

OVERVIEW

• Catalyst
• Summary

EXECUTIVE SUMMARY

• Strategic scoping and focus
• Datamonitor insight into the colorectal cancer market
• Datamonitor pipeline assessment summary
• Related reports
• Upcoming related reports

1. PIPELINE OVERVIEW AND DYNAMICS

• Key findings
• Pipeline overview
  • Pipeline summary
  • Comparative forecasts
  • Datamonitor pipeline assessment summary

• Key companies involved in the colorectal cancer (CRC) pipeline
  • Amgen
  • AstraZeneca
  • Roche

• Key R&D company strategies
  • Ongoing shift towards molecular targeted therapies in colorectal cancer
  • Line extensions of already marketed drugs

2. COLORECTAL CANCER - MARKET POTENTIAL

• Key findings
• Definition
  • Introduction
  • Histology
  • Risk factors
  • Symptoms
  • Screening and diagnosis
  • Patient segmentation

• Epidemiology
  • Seven major markets
  • Rest of the world

• Current treatment options
  • Surgery remains the primary treatment choice for early-stage CRC
  • Adjuvant therapy extends disease-free survival in Stage III patients
  • Combination chemotherapy is the standard of care in metastatic disease

• Current comparator therapy
  • Eloxatin (oxaliplatin; Sanofi-aventis)

• Unmet need in colorectal cancer (CRC)
  • Better screening approaches needed to decrease mortality rates
  • There is a need for more effective therapies in both early-stage and advanced disease
  • Biomarkers and the selection of patients may help improve outcomes
  • Target product profile versus current level of attainment

3. R&D APPROACH

• Key findings
• Clinical trial design in colorectal cancer (CRC)
  • Patient selection
  • Clinical trial endpoints in oncology

4. PIPELINE ANALYSIS & FORECASTS: MOLECULAR TARGETED THERAPIES

• Key findings
• Overview of the molecular targeted therapies
  • Pipeline summary
  • Comparative forecasts

• Aflibercept (VEGF-Trap; Regeneron/Sanofi-aventis)
  • Drug overview
  • Drug profile
  • Key historical events
  • SWOT analysis
  • Clinical trial data
  • Clinical attractiveness
  • Commercial attractiveness
  • Datamonitor drug assessment summary
  • Satisfaction of unmet needs
  • Forecasts to 2018

• Brivanib (Bristol-Myers Squibb)
  • Drug overview
  • Drug profile
  • Key historical events
  • SWOT analysis
  • Clinical trial data
  • Clinical attractiveness
  • Commercial attractiveness
  • Datamonitor drug assessment summary
  • Satisfaction of unmet needs
  • Forecasts to 2018

• Recentin (cediranib; AstraZeneca)
  • Drug overview
  • Drug profile
  • Key historical events
  • SWOT analysis
  • Clinical trial data
  • Clinical attractiveness
  • Commercial attractiveness
  • Datamonitor drug assessment summary
  • Satisfaction of unmet needs
  • Forecasts to 2018

• MK-0646 (Merck/Pierre Fabre)
  • Drug overview
  • Drug profile
  • Key historical events
  • SWOT analysis
  • Clinical trial data
  • Commercial attractiveness
  • Datamonitor drug assessment summary
  • Satisfaction of unmet needs
  • Forecasts to 2018

5. INNOVATIVE EARLY-STAGE APPROACHES

• Key findings
• Overview of early-stage innovative projects
  • TRAIL
  • Insulin-like growth factor receptor (IGFR)
  • MAP kinase pathway

• The future of treatment of colorectal cancer (CRC)
  • Molecular markers will become an important part of therapy for patient selection
  • The future will see more combination therapies to target multiple pathways
  • Increased understanding of cancer evolution should result in a large range of potential drug targets

BIBLIOGRAPHY

• Journals
• Websites
• Datamonitor reports

APPENDIX

• Methodology
  • Epidemiology forecasts
  • Product forecasts
  • Datamonitor drug assessment scorecard

• Contributing experts

TABLES

• Table: Sales forecasts for late-phase colorectal cancer (CRC) pipeline products in the seven major markets ($m), 2009 - 2018
• Table: Drugs in late-phase development for colorectal cancer (CRC), 2009
• Table: Sales forecasts for late-stage colorectal cancer (CRC) pipeline products in the seven major markets ($m), 2009 - 2018
• Table: Amgen' s marketed and pipeline oncology portfolio, 2009
• Table: AstraZeneca' s marketed and pipeline oncology portfolio, 2009
• Table: Roche' s marketed and pipeline oncology portfolio, 2009
• Table: Forecast incidence of colorectal cancer (CRC) in the seven major pharmaceutical markets, 2009 - 2018
• Table: Molecular targeted therapies (MTTs) approved for use in metastatic colorectal cancer (CRC), 2009
• Table: Eloxatin (oxaliplatin) - drug profile, 2009
• Table: Ability of Eloxatin to meet unmet needs in the first-line treatment of metastatic colorectal cancer (CRC), 2009
• Table: Ability of Eloxatin to meet unmet needs in the second-line treatment of metastatic colorectal cancer (CRC), 2009
• Table: Drugs in late-phase development for colorectal cancer (CRC) , 2009
• Table: Forecast assumptions for molecular targeted therapy colorectal cancer (CRC) pipeline products across the seven major markets, 2009
• Table: Forecast assumptions for molecular targeted therapy colorectal cancer (CRC) pipeline products across the seven major markets, 2009
• Table: Sales forecasts for late-phase colorectal cancer (CRC) pipeline products in the seven major markets ($m), 2009 - 2018
• Table: Aflibercept - drug profile, 2009
• Table: Aflibercept: key historical events
• Table: Clinical development of aflibercept in colorectal cancer (CRC), 2009
• Table: Ability of aflibercept to meet unmet needs in colorectal cancer (CRC), 2009
• Table: Sales forecast for aflibercept in colorectal cancer (CRC) across the seven major markets ($m), 2009 - 2018
• Table: Brivanib - drug profile, 2009
• Table: Brivanib: key historical events
• Table: Clinical development of brivanib in colorectal cancer (CRC), 2009
• Table: Phase I results investigating a second-line or higher combination of Erbitux and brivanib in advanced gastrointestinal malignancies
• Table: Ability of brivanib to meet unmet needs in colorectal cancer (CRC), 2009
• Table: Sales forecast for brivanib in colorectal cancer (CRC) across the seven major markets($m), 2009 - 2018
• Table: Recentin (cediranib) - drug profile, 2009
• Table: Recentin: key historical events
• Table: Clinical development of Recentin in colorectal cancer (CRC), 2009
• Table: Ability of Recentin to meet unmet needs in colorectal cancer (CRC), 2009
• Table: Sales forecast for Recentin in colorectal cancer (CRC) across the seven major markets ($m), 2009 - 2018
• Table: MK-0646 - drug profile, 2009
• Table: MK-0646: key historical events
• Table: Clinical development of MK-0646 in colorectal cancer (CRC), 2009
• Table: Ability of MK-0646 to meet unmet needs in colorectal cancer (CRC), 2009
• Table: Sales forecast for MK-0646 in colorectal cancer (CRC) across the seven major markets, 2009 - 2018 ($m)
• Table: Top 10 early-stage colorectal cancer (CRC) drug targets, 2009
• Table: Datamonitor drug assessment parameters

FIGURES

• Figure: Datamonitor drug assessment summary for molecular targeted therapies (MTTs) in development for colorectal cancer (CRC), 2009
• Figure: Colorectal cancer (CRC) pipeline split by development phase and drug class, 2009
• Figure: Datamonitor drug assessment summary for molecular targeted therapies (MTTs) in development for colorectal cancer (CRC), 2009
• Figure: Incidence and mortality from colorectal cancer (CRC) in the seven major pharmaceutical markets, 2009 and 2018
• Figure: Incidence of colorectal cancer (CRC) in the rest of the world, 2009 and 2019
• Figure: Datamonitor drug assessment summary for molecular targeted therapies in development for colorectal cancer (CRC), 2009
• Figure: SWOT analysis for aflibercept, 2009
• Figure: Phase II data on the second-line treatment of aflibercept in recurrent metastatic colorectal cancer (CRC) patients following failure of standard therapy
• Figure: Datamonitor drug assessment summary for aflibercept in colorectal cancer (CRC), 2009
• Figure: Brivanib SWOT analysis, 2009
• Figure: Retrospective analysis evaluating correlation between KRAS status and efficacy from a Phase I/II study of brivanib in combination with Erbitux in patients with advanced or metastatic colorectal cancer (CRC)
• Figure: Datamonitor drug assessment summary for brivanib in colorectal cancer (CRC), 2009
• Figure: SWOT analysis for Recentin, 2009
• Figure: Phase II results for second-line FOLFOX + Recentin versus FOLFOX + Avastin in metastatic colorectal cancer (CRC) (HORIZON I)
• Figure: Datamonitor drug assessment summary for Recentin in colorectal cancer (CRC), 2009
• Figure: SWOT analysis for MK-0646, 2009
• Figure: Phase II study of MK-0646 in second-line or higher metastatic colorectal cancer (CRC) patients with wild-type KRAS
• Figure: Datamonitor drug assessment summary for MK-0646 in colorectal cancer (CRC), 2009
• Figure: Early-stage colorectal cancer pipeline (CRC) split by drug class, 2009
• Figure: Datamonitor drug assessment summary for molecular targeted therapies in development for colorectal cancer (CRC), 2009