Small Cell Lung Cancer and Malignant Mesothelioma

Abstract

Overview

Introduction

SCLC accounts for one-fifth of all lung tumor types. More than 80,000 new cases are expected to be diagnosed in 2007 in the seven major markets, although it is set to decrease due to changing smoking habits. Mesothelioma is rarer, although incidence is expected to increase in the coming years in Europe and Japan given the heavy use of asbestos in the 1970s and long latency period of the disease.

Scope of this report

  • Overview of small cell lung cancer (SCLC) and mesothelioma, including epidemiology, staging, prognosis and unmet needs
  • Review of current treatment modalities and physician opinion of existing and future treatment strategies
  • Evaluation of key drugs currently used in the treatment of SCLC and mesothelioma
  • Assessment of late-phase drugs in development for SCLC and mesothelioma including key opinion leaders' view on their potential

Research and analysis highlights

Despite decreasing incidence, unmet needs in SCLC remain high due to poor prognosis and lack of effective treatment. R&D interest in the disease is low; however, this represents an opportunity for developing companies in the SCLC market.

Alimta is approved for other lung cancer indications including NSCLC and mesothelioma. It is in a Phase III trial in SCLC and Datamonitor believes that, although unlikely to show significant efficacy advantage over current standard, Alimta may potentially demonstrate toxicity advantages, in which case, it may usurp etoposide as standard therapy.

Incidence of malignant mesothelioma may have peaked in the US but is set to increase over the next two decades in Europe and Japan due to the later uptake of asbestos in these markets. Nevertheless, overall incidence of mesothelioma remains low; as is the R&D interest in the disease.

Key reasons to read this report

  • Evaluate opportunities and risks in the SCLC and mesothelioma markets by analyzing the clinical and commercial attractiveness of key drugs
  • Assess key success factors that drive the SCLC and mesothelioma markets to estimate the potential of existing and pipeline drugs for the diseases
  • Understand current and future competitive dynamics of SCLC and mesothelioma to determine the future size and scope of the markets

Table of Contents

  • ABOUT HEALTHCARE
    • About the Oncology pharmaceutical analysis team
      • Nish Saini - Lead Analyst, Oncology
  • CHAPTER 1 EXECUTIVE SUMMARY
    • Scope of analysis
  • CHAPTER 2 SCLC OVERVIEW
    • Introduction
    • Subtypes
    • SCLC strongly associated with smoking
    • Diagnosis
    • Staging - VALG or IASLC system?
      • Nearly two-thirds are diagnosed in extensive stage
    • Prognosis
      • Poor prognosis in extensive stage
      • Slow improvement in prognosis
    • Epidemiology
      • One-fifth of lung cancer cases are SCLC
      • Decreasing incidence of SCLC
      • Incidence calculation
      • Incidence forecast calculation
  • CHAPTER 3 CURRENT SCLC TREATMENT OPTIONS
    • Introduction
    • Treatment modalities
      • Limited stage
        • Surgical care remains confined to few patients
        • Quality of surgery depends on surgeon specialty
        • Surgery plus chemotherapy
        • Chemoradiotherapy improves survival in limited stage SCLC
        • Prophylactic cranial irradiation (PCI) for distant recurrence
      • Extensive stage
        • Chemotherapy alone is the primary treatment modality
    • Chemotherapy regimens
      • CAV superseded by PE regimen
      • Addition of a third agent to PE brings mixed results
        • Ifosfamide improves survival at the expense of increased toxicity
        • Paclitaxel not recommended for SCLC
        • Taxotere confers modest efficacy
      • Alternating regimens?
      • Carboplatin as alternative to cisplatin
        • Carboplatin plus etoposide more popular than cisplatin plus etoposide in the EU
      • Irinotecan in Japan
        • Success not replicated in the West
      • Amrubicin in Japan
      • High-dose and dose-intense chemotherapy in SCLC
      • Second-line therapy
        • Hycamtin remains the only approved drug for relapsed SCLC
        • No standard therapy for refractory SCLC
        • Amrubicin is used commonly in Japan
        • Summary of Phase II trial results for second-line SCLC
  • CHAPTER 4 UNMET NEEDS IN SCLC
    • Introduction
    • Unmet needs
      • Improving prognosis of SCLC
        • Need for earlier diagnosis
        • Strong association with smoking
        • Low curative surgery rate
        • Lack of efficacious drugs
      • Less toxic drug regimens required
      • Low R&D interest
  • CHAPTER 5 SCLC PIPELINE ANALYSIS
    • Pipeline drugs for SCLC
      • Pipeline drugs by phase
        • Low number of Phase III drugs
      • Pipeline drugs by drug class
        • Two-thirds are molecular-targeted therapy
      • Pipeline drugs by phase and drug class
    • Late-phase pipeline drug profile
      • Alimta (pemetrexed) - Eli Lillly
        • Profile
        • Trial results
        • Toxicity may be the key for Alimta in SCLC
        • Potential US patent extension for Alimta
      • Thalomid (thalidomide) - Celgene/Pharmion
        • Trial results
        • Limited potential in SCLC
      • Other key pipeline drugs in Phase II development
      • Picoplatin - Poniard Pharmaceuticals
      • Avastin (bevacizumab) - Genentech/Roche
      • Nexavar (sorafenib) - Bayer Schering/Onyx
      • Iressa (gefitinib) - AstraZeneca
      • Recentin (AZD2171) - AstraZeneca
  • CHAPTER 6 MALIGNANT MESOTHELIOMA
    • Disease overview
      • Types of mesothelioma
      • Causes
      • Staging
        • Stage distribution
      • Prognosis
      • Epidemiology
    • Current treatment options
      • Surgery
      • Radiotherapy
      • Chemotherapy
        • Alimta
        • Gemzar
    • Unmet needs in malignant mesothelioma
    • Pipeline analysis
      • Pipeline drug by phase
      • Pipeline drug by drug class
      • Late-phase pipeline drug profile
        • Zolinza (vorinostat) - Merck & Co
        • Onconase (ranpirnase) - Alfacell
  • APPENDIX
    • Contributing experts
    • UN Population Data
    • Bibliography
    • List of tables
    • List of figures
      • About the Oncology analysis team
    • Disclaimer
    • List of Tables
      • Table 1: Incidence of SCLC in the seven major markets, 2002
      • Table 2: Estimated incidence rates for SCLC, 2002-2016
      • Table 3: Forecast SCLC incidence, 2007-2016
      • Table 4: Five-year survival rates following resection by stage
      • Table 5: Results of major 1980s and 1990s trials of neoadjuvant chemotherapy in SCLC, 1984-1994
      • Table 6: Results of Phase II trial by Tsuchiya et al. (2005)
      • Table 7: Results of major trials of adjuvant chemotherapy in SCLC, 1978-2000
      • Table 8: Indirect comparison of amrubicin versus topotecan in second-line SCLC, 1997-2006
      • Table 9: Summary of recent Phase II trial results for second-line treatment of SCLC, 2003-06
      • Table 10: Pipeline drugs for SCLC, 2007
      • Table 11: Ongoing late-phase clinical trials for SCLC, 2007
      • Table 12: Summary results of Phase II trial by Socinski et al. (2006)
      • Table 13: Summary results of Phase III trial by Breton et al. (2006)
      • Table 14: Summary results of Phase II trial by Cooney et al. (2005)
      • Table 15: Ongoing Phase II trials of Avastin in SCLC, 2007
      • Table 16: Various staging systems used for mesothelioma
      • Table 17: Epidemiologic features of malignant mesothelioma, 2005
      • Table 18: Summary results of Phase III trial by Vogelzang et al. (2003)
      • Table 19: Pipeline drugs for malignant mesothelioma, 2007
      • Table 20: Ongoing late-phase clinical trials for mesothelioma, 2007
      • Table 21: Summary results of Phase II trial by Mikulski et al. (2002)
      • Table 22: Interim analysis of Phase IIIb trial for Onconase in mesothelioma, 2006
      • Table 23: UN Population Data, 2002-2016
    • List of Figures
      • Figure 1: Anatomy of the respiratory system
      • Figure 2: Stage distribution at diagnosis
      • Figure 3: Two-year survival rate and median survival by stage
      • Figure 4: Five-year survival rates of NSCLC and SCLC in the US, 1975-2002
      • Figure 5: Two- and five-year survival rates for SCLC in the US, 1973-2002
      • Figure 6: Proportion of SCLC versus NSCLC in the US and EU, 2006
      • Figure 7: Incidence rate of SCLC in the US,1975-2003
      • Figure 8: Incidence of SCLC in the seven major markets, 2002
      • Figure 9: Forecast SCLC incidence, 2007, 2010, 2013, 2016
      • Figure 10: Use of various chemotherapy regimens in the EU for SCLC in first line, 2006
      • Figure 11: Use of various chemotherapy regimens in Japan for SCLC in first line, 2005
      • Figure 12: Sales volume of cigarettes in China, 1981-1995
      • Figure 13: Pipeline drugs for SCLC by phase, 2007
      • Figure 14: Pipeline drugs for SCLC by drug class, 2007
      • Figure 15: Pipeline drugs by phase and drug class, 2007
      • Figure 16: Percentage use of Alimta by indication in the five major EU markets, 2006
      • Figure 17: Summary results of Phase II trial by Socinski et al. (2006)
      • Figure 18: Correlation between mesothelioma incidence and asbestos use, 1995-2000
      • Figure 19: Stage distribution at diagnosis in the US, 1996-2002
      • Figure 20: Five-year survival rates for mesothelioma in the US, 1975-1998
      • Figure 21: Incidence rate of malignant mesothelioma in the US, Europe and Japan, 2005
      • Figure 22: Unmet needs in malignant mesothelioma, 2007
      • Figure 23: Pipeline drugs for mesothelioma by phase, 2006
      • Figure 24: Pipeline drugs for mesothelioma by drug class, 2006

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