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Pipeline Insight: Cancer Overview - Lung, Brain, Head and Neck, Thyroid

Published by: Datamonitor

Published: Jul. 22, 2008 - 328 Pages


Table of Contents


ABOUT DATAMONITOR HEALTHCARE
About the Oncology pharmaceutical analysis team
CHAPTER 1 EXECUTIVE SUMMARY
Scope of the analysis
Datamonitor insight into the cancer market
Contributing experts
Related reports
Upcoming reports
CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS
Pipeline overview
Late-phase pipeline
Pipeline by indication
The higher-incidence tumor types remain the most popular indications for drug development
CHAPTER 3 R&D APPROACH
Classification of pipeline products
Cytotoxics
Antihormonal therapies
Molecular targeted therapies
Single-target signal transduction inhibitors
Angiogenesis inhibitors
Apoptosis inducers
Cell cycle inhibitors
Multi-targeted inhibitors
Epigenetic modulators
Immunotherapeutic agents
CHAPTER 4 NON-SMALL CELL LUNG CANCER
Overview of NSCLC
Definition
NSCLC accounts for about 80% of all lung cancers
Epidemiology
There will be more than 380,000 new cases of NSCLC in the seven major markets in 2017
Mortality from NSCLC is high
Treatment of NSCLC
Unmet needs in NSCLC
Summary of unmet needs
Effective treatments are required for both advanced and early-stage disease
NSCLC needs to be recognized as a heterogeneous disease
Less toxic treatments for poor performance status patients are required
The treatment of NSCLC is in need of overall refinement
Pipeline overview
Pipeline summary
Late-phase pipeline
Phase II pipeline
Comparative forecasts
Definition of current comparator therapy
Pipeline candidates
Erbitux (cetuximab; ImClone/Merck Serono/Bristol-Myers Squibb)
Drug overview
Key historical events
Clinical development in NSCLC
Datamonitor comments
Nexavar (sorafenib; Bayer Schering)
Drug overview
Key historical events
Clinical development in NSCLC
Datamonitor comments
Sutent (sunitinib; Pfizer)
Drug overview
Key historical events
Clinical development in NSCLC
Datamonitor comments
Tovok (BIBW 2992; Boehringer Ingelheim)
Drug overview
Key historical events
Clinical development in NSCLC
Datamonitor comments
Vargatef (BIBF 1120; Boehringer-Ingelheim)
Drug overview
Key historical events
Clinical development in NSCLC
Datamonitor comments
Zactima (vandetanib; AstraZeneca)
Drug overview
Key historical events
Clinical development in NSCLC
Datamonitor comments
Zolinza (vorinostat; Merck & Co)
Drug overview
Key historical events
Clinical development in NSCLC
Datamonitor comments
Aflibercept (VEGF-Trap; Sanofi-Aventis/Regeneron)
Drug overview
Key historical events
Clinical development in NSCLC
Datamonitor comments
ASA-404 (Antisoma/Novartis)
Drug overview
Key historical events
Clinical development in NSCLC
Datamonitor comments
CBT-1 (CBA Pharma)
Drug overview
Key historical events
Clinical development in NSCLC
Datamonitor comments
CP-751871 (Pfizer)
Drug overview
Key historical events
Clinical development in NSCLC
Datamonitor comments
Motesanib (AMG706; Amgen/Takeda Pharmaceutical)
Drug overview
Key historical events
Clinical development in NSCLC
Datamonitor comments
Abraxane (albumin-bound paclitaxel; Abraxis)
Drug overview
Key historical events
Clinical development in NSCLC
Datamonitor comments
Glutoxim (NOV-002; Novelos)
Drug overview
Key historical events
Clinical development in NSCLC
Datamonitor comments
Javlor (vinflunine; Pierre Fabre)
Drug overview
Key historical events
Clinical development in NSCLC
Datamonitor comments
Lipoplatin (liposomal cisplatin; Regulon)
Drug overview
Key historical events
Clinical development in NSCLC
Datamonitor comments
Taxoprexin (DHA paclitaxel; Luitpold)
Drug overview
Key historical events
Clinical development in NSCLC
Datamonitor comments
Opaxio (paclitaxel polyglumex; Cell Therapeutics/Novartis)
Drug overview
Key historical events
Clinical development in NSCLC
Datamonitor comments
Lucanix (NovaRx)
Drug overview
Key historical events
Clinical development in NSCLC
Datamonitor comments
Stimuvax (BLP-25; Merck Serono)
Drug overview
Key historical events
Clinical development in NSCLC
Datamonitor comments
MAGE-A3 ASCI (GSK1572932A; GlaxoSmithKline)
Drug overview
Key historical events
Clinical development in NSCLC
Datamonitor comments
Satisfaction of unmet needs
Approval of pipeline drugs will offer alternative treatment options, however, are unlikely to significantly fulfil unmet needs
CHAPTER 5 SMALL CELL LUNG CANCER
Overview of SCLC
Definition
Epidemiology
The incidence of SCLC is decreasing with declining smoking prevalence
Poor survival rates result in a high mortality from SCLC
Treatment of SCLC
Unmet needs in SCLC
Summary of unmet needs
There is a need for more effective systemic therapies to improve patient survival
R&D activity in the field must be intensified
A better understanding of the molecular basis of the disease may help in the development of novel targeted agents
Pipeline overview
Pipeline summary
Late-phase pipeline
Phase II pipeline
Comparative forecasts
Definition of current comparator therapy
Pipeline candidates
Picoplatin (AMD-473; Poniard Pharmaceuticals)
Drug overview
Key historical events
Clinical development in SCLC
Datamonitor comments
Satisfaction of unmet needs
Picoplatin is unlikely to offer any significant improvements in terms of patient survival
CHAPTER 6 MESOTHELIOMA
Overview of mesothelioma
Definition
Mesothelioma is almost always caused by sustained exposure to asbestos
Epidemiology
Forecast incidence is difficult to predict for mesothelioma, although the cancer is relatively rare
Survival rates for mesothelioma have improved minimally over the years
Treatment of mesothelioma
Unmet need in mesothelioma
Summary of unmet needs
Increasing incidence and need for earlier diagnosis
Low rate of curative surgery
Lack of approved therapies and low R&D interest
Pipeline overview
Pipeline summary
Late-phase pipeline
Phase II pipeline
Comparative forecasts
Definition of current comparator therapy
Pipeline candidates
Onconase (Alfacell Corp; ranpirnase)
Drug overview
Key historical events
Clinical development in mesothelioma
Datamonitor comments
Zolinza (vorinostat; Merck & Co)
Drug overview
Key historical events
Clinical development in mesothelioma
Datamonitor comments
Satisfaction of unmet needs
Onconase and Zolinza meet some unmet needs in terms of providing much needed alternative treatment options
CHAPTER 7 PRIMARY BRAIN CANCER
Overview of primary brain cancer
Definition
Glioma is the most common type of primary brain cancer
Epidemiology
Incidence of brain cancer is rising in line with the ageing population
Mortality from brain cancer is very high in comparison to its incidence
Treatment of primary brain cancer
Unmet need in primary brain cancer
Summary of unmet needs
More effective chemotherapy options needed
Blood-brain barrier may prove an obstacle to overcome
Need for neuroprotective therapy
Pipeline overview
Pipeline summary
Late-phase pipeline
Phase II pipeline
Comparative forecasts
Definition of current comparator therapy
Pipeline candidates
Theraloc (nimotuzumab; YM Biosciences/Biocon Biopharmaceuticals)
Drug overview
Key historical events
Clinical development in brain cancer
Datamonitor comments
Cerepro (sitimagene ceradenovec; Ark Therapeutics)
Drug overview
Key historical events
Clinical development in brain cancer
Datamonitor comments
Satisfaction of unmet needs
Temodar will retain its leading status for some time to come in the primary brain cancer market
CHAPTER 8 HEAD AND NECK CANCER
Overview of head and neck cancer
Definition
Head and neck cancers comprise around 6% of all tumors worldwide
Epidemiology
Incidence will continue to rise in line with the ageing population
Mortality is high due to frequent late-stage diagnosis and lack of effective treatments
Treatment of head and neck cancer
Unmet need in head and neck cancer
Summary of unmet needs
Currently available therapies induce modest response rates
High level of treatment-related morbidity and poor quality of life
Early-stage diagnosis is limited, thereby compromising survival
High economic burden
Pipeline overview
Pipeline summary
Late-phase pipeline
Phase II pipeline
Comparative forecasts
Definition of current comparator therapy
Pipeline candidates
Avastin (bevacizumab; Genentech/Roche/Chugai)
Drug overview
Key historical events
Clinical development in head and neck cancer
Datamonitor comments
Tarceva (erlotinib; OSI Pharmaceuticals/Genentech/Roche)
Drug overview
Key historical events
Clinical development in head and neck cancer
Datamonitor comments
Tykerb (lapatinib; GlaxoSmithKline)
Drug overview
Key historical events
Clinical development in head and neck cancer
Datamonitor comments
Vectibix (panitumumab; Amgen)
Drug overview
Key historical events
Clinical development in head and neck cancer
Datamonitor comments
Zalutumumab (HuMax-EGFR; Genmab/Medarex)
Drug overview
Key historical events
Clinical development in head and neck cancer
Datamonitor comments
Alimta (pemetrexed; Eli Lilly)
Drug overview
Key historical events
Clinical development in head and neck cancer
Datamonitor comments
Lipoplatin (liposomal cisplatin; Regulon)
Drug overview
Key historical events
Clinical development in head and neck cancer
Datamonitor comments
Multikine (mixture of naturally occurring cytokines; CEL-SCI)
Drug overview
Key historical events
Clinical development in head and neck cancer
Datamonitor comments
Proxinium (VB4-845; Viventia Biotech)
Drug overview
Key historical events
Clinical development in head and neck cancer
Datamonitor comments
Advexin (contusugene; Introgen Therapeutics)
Drug overview
Key historical events
Clinical development in head and neck cancer
Datamonitor comments
INGN-241 (Introgen Therapeutics)
Drug overview
Key historical events
Clinical development in head and neck cancer
Datamonitor comments
Satisfaction of unmet needs
Superiority over current standard therapies is unlikely to be shown by the current pipeline
CHAPTER 9 THYROID CANCER
Overview of thyroid cancer
Definition
Thyroid cancer occurs more frequently in women and at a younger age
Epidemiology
Incidence of thyroid cancer is rising due to increasing use of ultrasound to detect small tumors
Thyroid cancer is one of the least deadly tumor types
Treatment of thyroid cancer
Unmet need in thyroid cancer
Summary of unmet need
R&D interest is exceedingly low
Few alternative treatment options exist upon disease recurrence
Pipeline overview
Pipeline summary
Late-phase pipeline
Phase II pipeline
Comparative forecasts
Definition of current comparator therapy
Pipeline candidates
Zybrestat (combretastatin; OXiGENE)
Drug overview
Key historical events
Clinical development in thyroid cancer
Datamonitor comments
Axitinib (AG-13736; Pfizer)
Drug overview
Key historical events
Clinical development in thyroid cancer
Datamonitor comments
Satisfaction of unmet needs
Axitinib and Zybrestat could form viable therapies where few alternative treatment options exist
APPENDIX A
Bibliography
List of tables
List of figures
List of abbreviations
Methodology
Datamonitor forecast methodology
Epidemiology forecasts
Product forecasts
Datamonitor drug assessment summary
APPENDIX B
About Datamonitor
About Datamonitor Healthcare
Datamonitor Healthcare's therapy area capabilities
About the Disease analysis team
Disclaimer
List of Tables
Table 1: Late-phase cytotoxics pipeline for NSCLC, SCLC, mesothelioma, primary brain cancer, head and neck cancer, and thyroid cancer, 2008
Table 2: Late-phase targeted therapies pipeline for NSCLC, SCLC, mesothelioma, primary brain cancer, head and neck cancer, and thyroid cancer, 2008
Table 3: Late-phase immunotherapies pipeline for NSCLC, SCLC, mesothelioma, primary brain cancer, head and neck cancer, and thyroid cancer, 2008
Table 4: Late-phase gene therapies pipeline for NSCLC, SCLC, mesothelioma, primary brain cancer, head and neck cancer, and thyroid cancer, 2008
Table 5: Pipeline split by developmental phase and indication, 2008
Table 6: Forecast incidence of NSCLC in the seven major pharmaceutical markets, 2002-2017
Table 7: Phase III NSCLC pipeline, 2008 (targeted therapies)
Table 8: Phase III NSCLC pipeline, 2008 (cytotoxic and immunotherapies)
Table 9: Phase II NSCLC pipeline, 2008 (targeted therapies)
Table 10: Phase II NSCLC pipeline, 2008 (cytotoxics)
Table 11: Phase II NSCLC pipeline, 2008 (immunotherapies and others)
Table 12: Forecasting assumptions for NSCLC pipeline products across the seven major markets, 2008 (molecular targeted therapies, 1 of 4)
Table 13: Forecasting assumptions for NSCLC pipeline products across the seven major markets, 2008 (molecular targeted therapies, 2 of 4)
Table 14: Forecasting assumptions for NSCLC pipeline products across the seven major markets, 2008 (molecular targeted therapies, 3 of 4)
Table 15: Forecasting assumptions for NSCLC pipeline products across the seven major markets, 2008 (molecular targeted therapies, 4 of 4)
Table 16: Forecasting assumptions for NSCLC pipeline products across the seven major markets, 2008 (cytotoxic therapies, 1 of 2)
Table 17: Forecasting assumptions for NSCLC pipeline products across the seven major markets, 2008 (cytotoxic therapies, 2 of 2)
Table 18: Forecasting assumptions for NSCLC pipeline products across the seven major markets, 2008 (immunotherapies)
Table 19: Pipeline NSCLC product sales forecasts across the seven major markets, 2008-2017 ($m)
Table 20: Avastin: key historical facts
Table 21: Taxotere: key historical facts
Table 22: Erbitux: key historical events
Table 23: Clinical development of Erbitux in NSCLC, 2008
Table 24: Preliminary results of Erbitux with carboplatin and a taxane in first-line NSCLC (BMS-099)
Table 25: Nexavar: key historical events
Table 26: Clinical development of Nexavar in NSCLC, 2008
Table 27: Sutent: key historical events
Table 28: Clinical development of Sutent in NSCLC, 2008
Table 29: Tovok: key historical events
Table 30: Clinical development of Tovok in NSCLC, 2008
Table 31: Vargatef: key historical events
Table 32: Zactima's multiple anticancer targets
Table 33: Zactima: key historical events
Table 34: Clinical development of Zactima in NSCLC, 2008
Table 35: Zolinza: key historical events
Table 36: Clinical development of Zolinza in NSCLC, 2008
Table 37: Aflibercept: key historical events
Table 38: Clinical development of aflibercept in NSCLC, 2008
Table 39: ASA-404: key historical events
Table 40: Clinical development of ASA-404 in NSCLC, 2008
Table 41: CBT-1: key historical events
Table 42: Clinical development of CBT-1 in NSCLC, 2008
Table 43: CP-751871: key historical events
Table 44: Clinical development of CP-751871 in NSCLC, 2008
Table 45: Motesanib: key historical events
Table 46: Clinical development of motesanib in NSCLC, 2008
Table 47: Abraxane: key historical events
Table 48: Clinical development of Abraxane in NSCLC, 2008
Table 49: Glutoxim: key historical events
Table 50: Clinical development of Glutoxim in NSCLC, 2008
Table 51: Javlor: key historical events
Table 52: Clinical development of Javlor in NSCLC, 2008
Table 53: Lipoplatin: key historical events
Table 54: Clinical development of Lipoplatin in NSCLC, 2008
Table 55: Taxoprexin: key historical events
Table 56: Clinical development of Taxoprexin in NSCLC, 2008
Table 57: Opaxio: key historical events
Table 58: Clinical development of Opaxio in NSCLC, 2008
Table 59: STELLAR 2: Phase III results for Opaxio versus Taxotere in second-line NSCLC in patients with PS0-2
Table 60: STELLAR 3: Phase III results for Opaxio plus carboplatin in first-line NSCLC in patients with PS2
Table 61: STELLAR 4: Phase III results for Opaxio versus Gemzar or vinorelbine in first-line NSCLC in patients with PS2
Table 62: Clinical development of Opaxio in women with advanced NSCLC and normal estrogen levels: the PTG306 and PTG307 trials
Table 63: Lucanix: key historical events
Table 64: Clinical development of Lucanix in NSCLC, 2008
Table 65: Stimuvax: key historical events
Table 66: Clinical development of Stimuvax in NSCLC,e II trial and follow-up results for neoadjuvant Multikine in head and neck cancer
Figure 69: Interim Phase III results for second-line Proxinium in advanced head and neck cancer
Figure 70: Phase I dose-escalation trial for Proxinium in advanced head and neck cancer
Figure 71: Preliminary results from the Phase III T301 study comparing second-line Advexin with methotrexate in recurrent head and neck cancer
Figure 72: Incidence and mortality from thyroid cancer in 2008 and 2017 across the seven major markets
Figure 73: Summary of unmet needs in the thyroid cancer market
Figure 74: Datamonitor drug assessment summary for the pipeline thyroid cancer products, 2008
Figure 75: Pipeline thyroid cancer product sales forecasts across the seven major markets, 2008-2017 ($m)
Figure 76: Phase II results for first-line Zybrestat in advanced anaplastic thyroid cancer patients
Figure 77: Phase II results for axitinib in thyroid cancer patients refractory or unsuitable for radioiodine therapy
Figure 78: Datamonitor drug assessment summary of pipeline molecular targeted therapies in development for hematological malignancies, 2007




Abstract

Introduction

In 2008, the six tumor types covered in this report are forecast to account for over 666,000 new cases of cancer, obviously representing an enormous market potential. However, it is the higher-incidence tumor types that continue to attract drug developers, with lower-incidence cancers potentially suffering due to unfulfilled unmet needs via a lack of R&D activity.

Scope
  • Examination of the solid cancer pipeline with in-depth clinical and commercial profiles of Phase III candidates for six tumor types
  • Seven major pharmaceutical market sales forecasts for Phase III pipeline products through to 2017 with product-specific assumptions
  • Segmentation and analysis of the current solid tumor pipeline by developmental phase, drug class and indication for six tumor types
  • Insight and analysis of market potential including commercial opportunity, epidemiology, commonalities across cancers and discussion of unmet needs
Highlights
    A low level of interest from drug developers means unmet needs in the SCLC, mesothelioma, primary brain and thyroid cancer markets are likely to remain unfulfilled. Drug developers should realize that despite being low-incidence tumor types, high unmet needs could result in significant financial rewards and a foothold in the market to build upon.

    Erbitux (cetuximab; ImClone/Bristol-Myers Squibb/Merck Serono) shows the most promise in the current NSCLC pipeline. Recent clinical trial results mean Erbitux may become a viable option in the first-line treatment of NSCLC, particularly for those patients ineligible for Avastin (bevacizumab; Genentech/Roche) therapy.

    Vectibix (panitumumab; Amgen) and zalutumumab (HuMax-EGFR; Genmab/Medarex) show great promise to compete with Erbitux in the head and neck cancer market, particularly due to potential toxicity advantages that fully human monoclonal antibodies may have.

Reasons to Purchase
  • Identify key drugs and companies within the oncology pipeline based on sales forecasts to 2017 and Datamonitor drug assessment
  • Characterize unmet need and poorly served markets within oncology and assess the potential for pipeline products to provide satisfaction
  • Assess the shifting oncology market dynamic and how future treatment of solid tumors will incorporate pipeline products
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