Pipeline Insight: Colorectal Cancer - Growing trend towards personalized medicine
Datamonitor
October 21, 2009 51 Pages - SKU: DFMN2482221
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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.
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- 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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