Introduction
A convergence of scientific advances has enabled the identification of
molecular targets specific to cancer cells, resulting in therapies with enhanced
selectivity, efficacy and reduced toxicity. Developers can rise to the clinical,
regulatory and economic challenges to commercialization by improving strategic
decision-making in progressing drugs through the developmental pipeline.
Scope of this report
- Review of key innovatives in development including apoptosis stimulators
and inhibitors of angiogenesis, signal transduction and histone
deacetylation
- Analysis of trial data and marketing factors, with sales forecasts for key
technologies in late-stage clinical development
- Cancer overview including epidemiology, unmet needs, disease segmentation
and how innovative therapies will shift existing treatment paradigms
- Clinical, regulatory and pharmacoeconomic challenges and strategies for
commercialization
Research and analysis highlights
The cytostatic nature of many molecular-targeted treatments means that
significant tumor regressions are only likely to be seen in the context of
combinatorial treatment approaches alongside 'classic' cytotoxic treatments and
alternate molecular-targeted treatments.
The financial impact of adopting novel molecular-targeted treatments may be
prohibitive to market uptake. Mitigating this, improved diagnostic and
predictive analysis will facilitate predictive targeting of treatments to
patient populations most likely to respond.
Datamonitor believes the angiogenesis and signal transduction inhibitor
classes will provide the greatest revenue potential, congruent with their
combined clinical and commercial appeal. The crowded and competitive signal
transduction class will result in a high degree of fragmentation and
cannibalization, limiting potential revenue generation.
Key reasons to read this report
- Identify the key molecular-targeted anticancer drugs in clinical
development
- Assess opportunities and risks for innovative molecular targeted
treatments within the oncology market
- Adopt knowledge from this report to drive strategic planning for the
development of future treatments directed against unprecedented molecular
targets
ABOUT DATAMONITOR HEALTHCARE
- About the oncology pharmaceutical analysis team
CHAPTER 1 KEY FINDINGS
- Datamonitor insight into the innovative market
- Key metrics
- Summary of research/clinical and commercial attractiveness of molecular
-targeted treatments in clinical development
CHAPTER 2 CANCER OVERVIEW
- Cancer treatment
- Cancer epidemiology
- Incidence
- Prevalence
- Unmet need in cancer
- Long-term control of advanced tumors
- Decreased relapse for early-stage patients
- Less toxic therapies
- Improved diagnostics and prognostic analysis
- Enhanced preventative strategies
- Segmentation of cancer
- Incident patients/year
- Patient split (metastatic/non-metastatic)
- Screening
- Surgical viability
- Usefulness of pharmacotherapy
- Appeal as target drug market
CHAPTER 3 R&D APPROACH
- Classification of pipeline products
- Development of targeted therapies
- Angiogenesis inhibitors
- Angiogenesis
- THE PROCESS OF TUMOR ANGIOGENESIS
- SIGNALING INHIBITORS
- ENDOTHELIAL CELL INHIBITORS
- MATRIX BREAKDOWN INHIBITORS
- OTHERS
- Apoptosis stimulators
- Signal transduction inhibitors
- Cell cycle inhibitors
- Histone deacetylase inhibitors (HDAC-Is)
- Monoclonal antibodies
- Unprecedented molecular targets
- Summary of molecular-targeted drugs in the developmental pipeline
CHAPTER 4 STRATEGIES FOR COMMERCIALIZATION: THE GENENTECH EXAMPLE
- Established, respected oncology franchise
- Strengths and weaknesses of a highly innovative portfolio
- Reliance on out-licensing and royalty payments
CHAPTER 5 APOPTOSIS STIMULATORS LATE-STAGE DRUG ANALYSIS & FORECASTS
- Overview of apoptosis stimulators
- Pipeline summary
- Genasense (oblimersen sodium)
- Profile
- Drug overview
- Clinical trial data
- MALIGNANT MELANOMA
- MULTIPLE MYELOMA
- CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
- NSCLC
- SCLC
- PROSTATE CANCER
- OTHER TRIALS
- Datamonitor comments
- Marketing factors
- Genasense forecast to 2012
- Datamonitor drug assessment summary
- Affinitak (aprinocarsen, ISIS-3521, LY-900003)
- Profile
- Drug overview
- Clinical trial data
- NSCLC
- NHL
- BREAST CANCER
- Datamonitor comments
- Marketing factors
- Affinitak forecasts to 2012
- Datamonitor drug assessment summary
- LDI-200
- Profile
- Drug overview
- Clinical trial data
- MYELODYSPLATIC SYNDROME (MDS)
- ACUTE MYELOID LEUKEMIA (AML)
- PROSTATE CANCER
- Datamonitor comments
- Aptosyn (exisulind)
- Profile
- Drug overview
- Clinical trial data
- FAMILIAL ADENOMATOUS POLYPOSIS (FAP)
- NON-SMALL-CELL LUNG CANCER
- PROSTATE CANCER
- BREAST CANCER
- Datamonitor comments
- Marketing factors
- Aptosyn forecasts to 2012
- Datamonitor drug assessment summary
- Summary of research/clinical and commercial attractiveness of apoptosis
stimulators
CHAPTER 6 ANGIOGENESIS INHIBITORS LATE-STAGE DRUG ANALYSIS AND FORECASTS
- Overview for angiogenesis inhibitors
- Pipeline summary
- Neovastat (AE-941)
- Profile
- Drug overview
- Clinical trial data
- NSCLC
- RENAL CELL CARCINOMA
- Datamonitor comments
- Marketing factors
- Neovastat forecasts to 2012
- Datamonitor drug assessment summary
- Avastin (bevacizumab)
- Profile
- Drug overview
- Clinical trial data
- BREAST CANCER
- NSCLC
- RENAL CELL CANCER
- PROSTATE CANCER
- PANCREATIC CANCER
- MELANOMA
- Datamonitor comments
- Marketing factors
- Avastin sales forecasts to 2012
- Datamonitor drug assessment summary
- CAI (L-651582)
- Profile
- Drug overview
- Clinical trial data
- NSCLC
- RENAL CALL CANCER
- OVARIAN CANCER
- Datamonitor comments
- Marketing factors
- Datamonitor drug assessment summary
- Vatalanib (PTK787, ZK222582)
- Profile
- Drug overview
- Clinical trial data
- COLORECTAL CANCER
- OTHER TUMORS
- Datamonitor comments
- Marketing factors
- Vatalanib forecasts to 2012
- Datamonitor drug assessment summary
- Selected angiogenesis targets in early-stage development
- Selective MMP inhibitors
- BMS-275291
- Datamonitor comments:
- Integrin inhibition
- Vitaxin
- Cilengitide (EMD-121974)
- Datamonitor comments
- VEGF trap
- Summary of research/clinical and commercial attractiveness of apoptosis
stimulators
CHAPTER 7 HISTONE DEACETYLASE INHIBITORS DRUG ANALYSIS AND FORECASTS
- Overview of histone deacetylase inhibitors (HDAC-Is)
- Pipeline summary
- FK-228 (depsipeptide, FR-901228)
- Profile
- Drug overview
- Clinical trial data
- Datamonitor comments
- Marketing factors
- FK-228 forecasts to 2012
- Datamonitor drug assessment summary
- Suberanilohydroxyamic acid (SAHA)
- Profile
- Drug overview
- Clinical trial data
- Datamonitor comments
- SAHA forecasts to 2012
- Datamonitor drug assessment summary
- Pivanex (AN-9)
- Profile
- Drug overview
- Clinical trial data
- Datamonitor comments
- Marketing factors
- Datamonitor drug assessment summary
- Summary of research/clinical and commercial attractiveness of HDAC
inhibitors
CHAPTER 8 SIGNAL TRANSDUCTION INHIBITORS
- Overview of signal transduction inhibitors
- Pipeline summary
- Erbitux (cetuximab)
- Profile
- Drug overview
- Clinical trial data
- COLORECTAL CANCER
- NSCLC
- HEAD AND NECK CANCER
- PANCREATIC CANCER
- Datamonitor comments
- Marketing factors
- PROHIBITIVE COST?
- Erbitux forecast to 2012
- Datamonitor drug assessment
- Iressa (gefitinib)
- Profile
- Drug overview
- Clinical trial data
- NSCLC
- BREAST CANCER
- HEAD AND NECK CANCER
- COLORECTAL CANCER
- PROSTATE CANCER
- Datamonitor comments
- Marketing factors
- Iressa forecast to 2012
- Datamonitor drug assessment
- Tarceva (erlotinib)
- Profile
- Drug overview
- Clinical trial data
- NSCLC
- PANCREATIC CANCER
- GLIOBLASTOMA
- BREAST CANCER
- OTHER TUMOR TYPES
- TOXICITY
- Datamonitor comments
- Marketing factors
- Tarceva forecasts to 2012
- Datamonitor drug assessment summary
- ABX-EGF (panitumumab)
- Profile
- Drug overview
- Clinical trial data
- COLORECTAL CANCER
- RENAL CELL CARCINOMA
- NON-SMALL -CELL LUNG CANCER
- PROSTATE CANCER
- Datamonitor comments
- Marketing factors
- ABX-EGF forecasts to 2012
- Datamonitor drug assessment summary
- Lapatinib (GW-572016)
- Profile
- Drug overview
- BREAST CANCER
- NON-SMALL-CELL LUNG CANCER
- COLORECTAL CANCER
- UROTHELIAL TUMORS
- Datamonitor comments
- Marketing factors
- Lapatinib forecasts to 2012
- Datamonitor drug assessment summary
- SU11248
- Profile
- Drug overview
- Clinical trial data
- GIST
- RENAL CELL CARCINOMA
- Datamonitor comments
- SU22148 forecasts to 2012
- Datamonitor drug assessment summary
- BAY 43-9006
- Profile
- Drug overview
- Clinical trial data
- MALIGNANT MELANOMA
- RENAL CELL CARCINOMA (RCC)
- OTHER TUMOR TYPES
- Datamonitor comments
- Sales forecast for BAY 43-9006
- Datamonitor drug assessment summary
- Zarnestra (tipifarnib)
- Profile
- Drug overview
- Clinical trial data
- PHASE I TRIALS
- PANCREATIC CANCER
- COLORECTAL CANCER
- BREAST CANCER
- PROSTATE CANCER
- SMALL -CELL LUNG CANCER (SCLC)
- NON-SMALL-CELL LUNG CANCER (NSCLC)
- GLIOMAS
- ACUTE MYELOID LEUKEMIA (AML)
- OTHER TRIALS
- Datamonitor comments
- Marketing factors
- Zarnestra sales forecasts to 2012
- Datamonitor drug assessment summary
- Sarasar (lonafarnib)
- Profile
- Drug overview
- Clinical trial data
- PHASE I TRIALS
- NSCLC
- UROTHELIAL TRACT CARCINOMA
- PANCREATIC CANCER
- COLORECTAL CANCER
- HEAD AND NECK CANCER
- MYELODYSPLASTIC SYNDROME & CHRONIC MYELOID LEUKEMIA
- OTHER TRIALS
- Datamonitor comments
- Marketing factors
- Datamonitor drug assessment summary
- Summary of research/clinical and commercial attractiveness of signal
transduction inhibitors
CHAPTER 9 CELL CYCLE REGULATORS
- Overview of the cyclin dependent kinase inhibitors
- Pipeline summary
- CYC-202 (R-roscovitine)
- Clinical data
- Indisulam (E-7070)
- Clinical data
- UCN-01
- Clinical data
- Datamonitor comments
CHAPTER 10 MONOCLONAL ANTIBODIES TARGETING UNPRECEDENTED RECEPTORS
- Overview of monoclonal antibodies
- Pipeline summary
- MLN2704
- Profile
- Drug overview
- Clinical data
- Datamonitor comments
- Marketing factors
- TRIAL-R1 and -R2 MoAb
- Profile
- Clinical data
- Datamonitor comments
- Marketing factors
CHAPTER 11 INNOVATIVE EARLY-STAGE PROJECTS
- Pipeline summary
- Efaproxiral (efaproxyn, revaproxyn)
- Patrin (lomeguatrib)
- AQ4N
CHAPTER 12 SUMMARY ASSESSMENT OF MOLECULAR-TARGETED TREATMENTS IN ONCOLOGY
APPENDIX A
- Methodology
- Datamonitor forecast methodology
- Datamonitor drug assessment summary
- List of tables
- List of figures
- Contributing experts
- Bibliography
- Apoptosis Stimulators
- Angiogenesis Inhibitors
- Histone deacetylase inhibitors
- Signal-transduction inhibitors
- Cyclin dependent kinases
- Report methodology
APPENDIX B
- 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, Senior Oncology Analyst
- Disclaimer
List of Tables
- Table 1: Incidence of cancer in the seven major pharmaceutical markets,
2004-12
- Table 2: Sales forecasts for key molecular-targeted therapies in clinical
development ($m), 2004-12
- Table 3: Drug assessment summary of molecular -targeted treatments in
clinical devlopmentdevelopment
- Table 4: Common mutations involved in tumor development
- Table 5: Summary of key indications for innovative therapies in the
oncology market
- Table 6: Screening definitions
- Table 7: Surgical viability definitions
- Table 8: Usefulness of pharmacotherapy definitions
- Table 9: Examples of naturally occurring angiogenesis stimulators
- Table 10: Molecular targeted drugs in development, 2004
- Table 11: Apoptosis stimulators in clinical development, 2004
- Table 12: Assumptions and factors influencing Genasense's sales forecast
- Table 13: Research/clinical and commercial attractiveness of Genasense
- Table 14: Research/clinical and commercial attractiveness of Affinitak
- Table 15: Assumptions and factors influencing Aptosyn sales forecast
- Table 16: Research/clinical and commercial attractiveness of Aptosyn
- Table 17: Summary of research/clinical and commercial attractiveness of
apoptosis stimulators
- Table 19: Assumptions and factors influencing Neovastat sales forecast
- Table 20: Research/clinical and commercial attractiveness of Neovastat
- Table 21: Assumptions and factors influencing Avastin sales forecast
- Table 22: Research/clinical and commercial attractiveness of Avastin
- Table 23: Research/clinical and commercial attractiveness of CAI
- Table 24: Assumptions and factors influencing vatalanib sales forecast
- Table 25: Research/clinical and commercial attractiveness of vatalanib
- Table 26: Research/clinical and commercial attractiveness of BMS-275291
- Table 27: Summary of research/clinical and commercial attractiveness of
apoptosis stimulators
- Table 28: Histone deacetylase inhibitors in R&D pipeline, 2004
- Table 29: Assumptions and factors influencing FK-228 sales forecast
- Table 30: Research/ clinical and commercial attractiveness of FK-228
- Table 31: Assumptions and factors influencing SAHA sales forecast
- Table 32: Research/ clinical and commercial attractiveness of SAHA
- Table 33: Research/ clinical and commercial attractiveness of Pivanex
- Table 34: Summary of research/clinical and commercial attractiveness of
HDAC inhibitors
- Table 35: Signal transduction inhibitors in R&D, 2004
- Table 36: Early-phase trial results of Erbitux
- Table 37: BOND trial summary results
- Table 38: Preliminary safety analysis of Erbitux with or without FOLFOX in
second line
- Table 39: Current Phase III trials of Erbitux
- Table 40: Clinical trial results of Erbitux for NSCLC
- Table 41: Assumptions and factors influencing Erbitux's sales forecast
- Table 42: Research/clinical and commercial attractiveness of Erbitux
- Table 43: Summary of key results in the INTACT 1 trial
- Table 44: Summary of key results in the INTACT 2 trial
- Table 45: Subset analysis of patients with adenocarcinoma who received 90
days or more chemotherapy
- Table 46: Phase II clinical trial results for single-agent Iressa in
breast cancer
- Table 47: Current Iressa Phase II clinical trials
- Table 48: Phase II trials of Iressa in SCCHN
- Table 49: Results of Phase II trial of Iressa in colorectal cancer
- Table 50: Assumptions and factors influencing the sales forecast for
Iressa
- Table 51: Research/clinical and commercial attractiveness of Iressa
- Table 52: Phase III trials of Tarceva in NSCLC
- Table 53: Phase II trials of Tarceva in malignant gliomas (MG)
- Table 54: Current Tarceva Phase II breast cancer trials
- Table 55: Assumptions and factors influencing Tarceva sales forecast
- Table 56: Research/ clinical and commercial attractiveness of Tarceva
- Table 57: Assumptions and factors influencing ABX-EGF sales forecast
- Table 58: Research/ clinical and commercial attractiveness of ABX-EGF
- Table 59: Ongoing Phase II and Phase III trials for lapatinib
- Table 60: Assumptions and factors influencing lapatinib sales forecast
- Table 61: Research/clinical and commercial attractiveness of lapatinib
- Table 62: Assumptions and factors influencing SU11248 sales forecast
- Table 63: Research/ clinical and commercial attractiveness of SU11248
- Table 64: Assumptions and factors influencing BAY 43-9006 sales forecast
- Table 65: Research/ clinical and commercial attractiveness of BAY 43-9006
- Table 66: Assumptions and factors influencing Zarnestra sales forecast
- Table 67: Research/ clinical and commercial attractiveness of Zarnestra
- Table 68: Research/clinical and commercial attractiveness of Sarasar
- Table 69: Summary of research/clinical and commercial attractiveness of
signal transduction inhibitors
- Table 70: Cell cycle regulators in the R&D pipeline, 2004
- Table 71: Conjugated MoAbs in clinical development
- Table 72: Naked MoAbs in clinical development
- Table 73: Innovative drugs in early-stage clinical development
- Table 74: Datamonitor drug assessment parameters
List of Figures
- Figure 1: Sales forecasts for key molecular-targeted therapies in clinical
development, 2004-12
- Figure 2: Datamonitor drug assessment summary
- Figure 3: Datamonitor drug assessment summary by drug class
- Figure 4: Increasing combined incidence for breast, lung, prostate and
colorectal cancer with increasing age
- Figure 5: Incidence increases, while the rate of cure and death reduces
disease prevalence
- Figure 6: Point prevalence for colorectal and lung cancer differs markedly
despite similar rates of incidence
- Figure 7: Unmet needs in cancer, 2004
- Figure 8: The process of tumor angiogenesis
- Figure 9: Summary of research/clinical and commercial attractiveness of
apoptosis stimulators
- Figure 10: Sales forecast for Genasense to 2012
- Figure 11: Research/clinical and commercial attractiveness of Genasense
- Figure 12: Research/clinical and commercial attractiveness of Affinitak
- Figure 13: Sales forecast for Aptosyn to 2012
- Figure 14: Research/clinical and commercial attractiveness of Aptosyn
- Figure 15: Summary of research/clinical and commercial attractiveness of
apoptosis stimulators
- Figure 16: Summary of research/clinical and commercial attractiveness of
apoptosis stimulators
- Figure 17: Sales forecast for Neovastat to 2012
- Figure 18: Research/clinical and commercial attractiveness of Neovastat
- Figure 19: Sales forecast for Avastin 2004-to 2012
- Figure 20: Research/clinical and commercial attractiveness of Avastin
- Figure 21: Research/clinical and commercial attractiveness of CAI
- Figure 22: Sales forecasts for vatalanib to 2012
- Figure 23: Research/clinical and commercial attractiveness of vatalanib
- Figure 24: Research/clinical and commercial attractiveness of BMS-275291
- Figure 25: Summary of research/clinical and commercial attractiveness of
apoptosis stimulators
- Figure 26: Summary of research/clinical and commercial attractiveness of
HDAC inhibitors
- Figure 27: Sales forecast for FK-228 to 2012
- Figure 28: Research/ clinical and commercial attractiveness of FK-228
- Figure 29: Sales forecast for SAHA to 2012
- Figure 30: Research/ clinical and commercial attractiveness of SAHA
- Figure 31: Research/ clinical and commercial attractiveness of Pivanex
- Figure 32: Summary of research/clinical and commercial attractiveness of
HDAC inhibitors
- Figure 33: Summary of research/clinical and commercial attractiveness of
signal transduction inhibitors
- Figure 34: BOND trial design
- Figure 40: Erbitux sales forecast to 2012
- Figure 35: Research/clinical and commercial attractiveness of Erbitux
- Figure 36: Iressa revenue forecasts to 2012
- Figure 37: Research/clinical and commercial attractiveness of Iressa
- Figure 38: Sales forecast for Tarceva to 2012
- Figure 39: Research/ clinical and commercial attractiveness of Tarceva
- Figure 40: Sales forecast for ABX-EGF to 2012
- Figure 41: Research/ clinical and commercial attractiveness of ABX-EGF
- Figure 42: Sales forecast for lapatinib to 2012
- Figure 43: Research/ clinical and commercial attractiveness of lapatinib
- Figure 44: Sales forecast for SU11248 to 2012
- Figure 45: Research/ clinical and commercial attractiveness of SU11248
- Figure 46: Sales forecast for BAY 43-9006 to 2012
- Figure 47: Research/ clinical and commercial attractiveness of BAY 43-9006
- Figure 48: Sales forecast for Zarnestra to 2012
- Figure 49: Research/ clinical and commercial attractiveness of Zarnestra
- Figure 50: Research/clinical and commercial attractiveness of Sarasar
- Figure 51: Summary of research/clinical and commercial attractiveness of
signal transduction inhibitors
- Figure 52: Summary of Datamonitor assessment by drug
- Figure 53: Summary of Datamonitor assessment by drug class
- Figure 54: Example of Datamonitor drug assessment scorecard
- Figure 55: Example of Datamonitor drug assessment graph
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