Pipeline Insight: Colorectal Cancer - Growing trend towards personalized medicine

Date: October 1, 2009
Pages: 51
Price:
US$ 11,400.00
Publisher: Datamonitor
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: PFF0443E33AEN
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Pipeline Insight: Colorectal Cancer - Growing trend towards personalized medicine
Introduction

CRC incidence will be over 490,000 cases by 2018 in the seven major markets. This large patient base will translate into a high commercial potential for the development of novel, more effective therapies. Currently, there are 77 agents in development for CRC, 4 of which are in late-phase development. Collectively, they are forecast to achieve sales of $1,398m by 2018.

Scope

*Examination of the CRC pipeline with in-depth clinical and commercial profiles of Phase III candidates

*Seven major pharmaceutical market sales forecasts for Phase III pipeline products through to 2018

*Segmentation and analysis of the current CRC pipeline by developmental phase, drug class and company

*Insight and analysis of market potential including commercial opportunity, epidemiology and discussion of unmet needs

Highlights

The CRC pipeline consists of 77 drugs, of which 60% are molecular targeted therapies (MTTs), 22% are immunotherapies, and 17% are cytotoxic therapies. MTTs constitute the bulk of the CRC pipeline. This is in line with R&D in other tumor types, where there is a shift away from standard cytotoxic therapies towards MTTs and personalized medicine.

The late-phase CRC pipeline consists only of MTTs. Except for one agent; all the others are being investigated in previously-treated patients. Drug developers appear to be pursuing approval for treatment in the second-line setting where barriers to market entry are lower and the high level of unmet need may facilitate a drug's uptake and approval.

Aflibercept (VEGF-Trap; Regeneron/Sanofi-Aventis) is forecast to achieve the highest level of sales among the late-phase pipeline candidates in the CRC market, generating £604m by 2018 in the seven major pharmaceutical markets.

Reasons to Purchase

*Identify key drugs and companies within the CRC pipeline based on sales forecasts to 2018 and Datamonitor drug assessment.

*Characterize unmet need and poorly served patient subsets within the CRC market and assess the potential for pipeline products to fulfil them.

*Segmentation and analysis of the current CRC pipeline by developmental phase, drug class, company and indication.

OVERVIEW

Catalyst
Summary

ABOUT DATAMONITOR HEALTHCARE

About the Oncology pharmaceutical analysis team
Executive Summary
Strategic scoping and focus
Datamonitor insight into the colorectal cancer market
Datamonitor pipeline assessment summary
Related reports
Upcoming related reports
Table of Contents

1. PIPELINE OVERVIEW AND DYNAMICS

Key findings
Pipeline overview
Pipeline summary
Novel molecular targeted therapies dominate the current late-phase colorectal cancer pipeline
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
Colorectal cancer is one of the 'big four' tumors and numbers are set to rise over the next decade
Histology
Risk factors
CRC is predominantly a disease of the elderly
People with CRC in the family have a high risk of developing the disease
Western style diets contribute to CRC incidence
Rise of CRC in the migrant population
Symptoms
Screening and diagnosis
Fecal occult blood test is the most commonly used screening method
Endoscopic methods are not ideal for CRC screening
CRC screening remains fragmented between countries
Patient segmentation
Proper staging is essential to the design of treatment plans
Epidemiology
Seven major markets
CRC cases are expected to rise in line with the aging world population
Low detection in the early stages of the disease results in a high mortality rate
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
Avastin is used predominantly in the US in the first-line setting
Erbitux is indicated for use in patients with wild-type KRAS status
Vectibix has limited uptake in the treatment of the 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
Overall survival
Disease-free survival
Overall response rates
Progression-free survival
Disease control
Toxicity

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
Phase II studies show aflibercept to be well tolerated in metastatic CRC
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
The combination of brivanib with Erbitux is tolerable and shows signs of clinical activity
Retrospective study shows that efficacy of brivanib with Erbitux is driven by wild-type KRAS patients
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
Recentin shows disappointing results in a Phase II head-to-head trial against Avastin
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
Phase II shows MK-0646 to be tolerable in metastatic patients with wild-type KRAS
Clinical attractiveness
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
About Datamonitor
About Datamonitor Healthcare
About the Oncology analysis team
Datamonitor consulting
Disclaimer

LIST OF TABLES

Table 1: Sales forecasts for late-phase colorectal cancer (CRC) pipeline products in the seven major markets ($m), 2009-2018
Table 2: Drugs in late-phase development for colorectal cancer (CRC), 2009
Table 3: Sales forecasts for late-stage colorectal cancer (CRC) pipeline products in the seven major markets ($m), 2009-2018
Table 4: Amgen's marketed and pipeline oncology portfolio, 2009
Table 5: AstraZeneca's marketed and pipeline oncology portfolio, 2009
Table 6: Roche's marketed and pipeline oncology portfolio, 2009
Table 7: Forecast incidence of colorectal cancer (CRC) in the seven major pharmaceutical markets, 2009-2018
Table 8: Molecular targeted therapies (MTTs) approved for use in metastatic colorectal cancer (CRC), 2009
Table 9: Eloxatin (oxaliplatin) - drug profile, 2009
Table 10: Ability of Eloxatin to meet unmet needs in the first-line treatment of metastatic colorectal cancer (CRC), 2009
Table 11: Ability of Eloxatin to meet unmet needs in the second-line treatment of metastatic colorectal cancer (CRC), 2009
Table 12: Drugs in late-phase development for colorectal cancer (CRC) , 2009
Table 15: Sales forecasts for late-phase colorectal cancer (CRC) pipeline products in the seven major markets ($m), 2009-2018
Table 16: Aflibercept - drug profile, 2009
Table 17: Aflibercept: key historical events
Table 18: Clinical development of aflibercept in colorectal cancer (CRC), 2009
Table 19: Ability of aflibercept to meet unmet needs in colorectal cancer (CRC), 2009
Table 20: Sales forecast for aflibercept in colorectal cancer (CRC) across the seven major markets ($m), 2009-2018
Table 21: Brivanib - drug profile, 2009
Table 22: Brivanib: key historical events
Table 23: Clinical development of brivanib in colorectal cancer (CRC), 2009
Table 24: Phase I results investigating a second-line or higher combination of Erbitux and brivanib in advanced gastrointestinal malignancies
Table 25: Ability of brivanib to meet unmet needs in colorectal cancer (CRC), 2009
Table 26: Sales forecast for brivanib in colorectal cancer (CRC) across the seven major markets($m), 2009-2018
Table 27: Recentin (cediranib) - drug profile, 2009
Table 28: Recentin: key historical events
Table 29: Clinical development of Recentin in colorectal cancer (CRC), 2009
Table 30: Ability of Recentin to meet unmet needs in colorectal cancer (CRC), 2009
Table 31: Sales forecast for Recentin in colorectal cancer (CRC) across the seven major markets ($m), 2009-2018
Table 32: MK-0646 - drug profile, 2009
Table 33: MK-0646: key historical events
Table 34: Clinical development of MK-0646 in colorectal cancer (CRC), 2009
Table 35: Ability of MK-0646 to meet unmet needs in colorectal cancer (CRC), 2009
Table 36: Sales forecast for MK-0646 in colorectal cancer (CRC) across the seven major markets, 2009-2018 ($m)
Table 37: Top 10 early-stage colorectal cancer (CRC) drug targets, 2009
Table 38: Datamonitor drug assessment parameters

LIST OF FIGURES

Figure 1: Datamonitor drug assessment summary for molecular targeted therapies (MTTs) in development for colorectal cancer (CRC), 2009
Figure 2: Colorectal cancer (CRC) pipeline split by development phase and drug class, 2009
Figure 3: Datamonitor drug assessment summary for molecular targeted therapies (MTTs) in development for colorectal cancer (CRC), 2009
Figure 4: Incidence and mortality from colorectal cancer (CRC) in the seven major pharmaceutical markets, 2009 and 2018
Figure 5: Incidence of colorectal cancer (CRC) in the rest of the world, 2009 and 2019
Figure 6: Datamonitor drug assessment summary for molecular targeted therapies in development for colorectal cancer (CRC), 2009
Table 13: Forecast assumptions for molecular targeted therapy colorectal cancer (CRC) pipeline products across the seven major markets, 2009
Table 14: Forecast assumptions for molecular targeted therapy colorectal cancer (CRC) pipeline products across the seven major markets, 2009
Figure 7: SWOT analysis for aflibercept, 2009
Figure 8: Phase II data on the second-line treatment of aflibercept in recurrent metastatic colorectal cancer (CRC) patients following failure of standard therapy
Figure 9: Datamonitor drug assessment summary for aflibercept in colorectal cancer (CRC), 2009
Figure 10: Brivanib SWOT analysis, 2009
Figure 11: 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 12: Datamonitor drug assessment summary for brivanib in colorectal cancer (CRC), 2009
Figure 13: SWOT analysis for Recentin, 2009
Figure 14: Phase II results for second-line FOLFOX + Recentin versus FOLFOX + Avastin in metastatic colorectal cancer (CRC) (HORIZON I)
Figure 15: Datamonitor drug assessment summary for Recentin in colorectal cancer (CRC), 2009
Figure 16: SWOT analysis for MK-0646, 2009
Figure 17: Phase II study of MK-0646 in second-line or higher metastatic colorectal cancer (CRC) patients with wild-type KRAS
Figure 18: Datamonitor drug assessment summary for MK-0646 in colorectal cancer (CRC), 2009
Figure 19: Early-stage colorectal cancer pipeline (CRC) split by drug class, 2009
Figure 20: Datamonitor drug assessment summary for molecular targeted therapies in development for colorectal cancer (CRC), 2009

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