非小細胞肺癌のパイプライン治療薬

Abstract

Overview

Introduction

Non-small cell lung cancer accounts for about 80% of all lung cancers. In 2008, the incidence of NSCLC is forecast to exceed 367,000 new cases in the seven major pharmaceutical markets. The high incidence of the disease and the large unmet need make NSCLC an attractive market for new drug development.

Scope

• Research and analysis of the NSCLC pipeline with in-depth clinical and commercial assessment of Phase III candidates
• Seven major pharmaceutical market sales forecasts to 2017 for key pipeline candidates incorporating product specific assumptions and events
• Segmentation and analysis of the current NSCLC pipeline by developmental phase, drug class and developer
• Analysis of the NSCLC market potential, including identification of unmet needs, commercial opportunities, and key trends in development

Report Highlights

Datamonitor has identified 104 drugs in the NSCLC pipeline, 15% of which are in late-phase development. Collectively, these late-phase products have a forecast sales potential of up to $4,056m by 2017 in the seven major pharmaceutical markets.

Molecular targeted therapies are the focus of R&D in NSCLC, accounting for 60% of the entire pipeline. Of the molecular targeted therapies in late-phase development, Erbitux (cetuximab; ImClone/Merck Serono/Bristol-Myers Squibb) is forecast to achieve the highest level of sales, with $473m by 2017.

The current late-phase pipeline is unlikely to satisfy the high level of unmet need in the treatment of NSCLC. However, pipeline drugs are still likely to realize notable uptake, despite offering only incremental improvements in efficacy or toxicity.

Reasons to Purchase

• Acquire a detailed appreciation and impartial perspective of the NSCLC pipeline
• Identify the key products in late-phase development based on sales forecasts to 2017 and Datamonitor' s drug assessment methodology
• Identify opportunities and risks influencing R&D in NSCLC, unmet needs in the treatment of the disease, and trends in current development

Table of Contents

• ABOUT DATAMONITOR HEALTHCARE
  • About the Oncology pharmaceutical analysis team
• CHAPTER 1 EXECUTIVE SUMMARY
  • Scope of the analysis
  • Datamonitor insight into the NSCLC market
  • Related reports
  • Upcoming reports
• CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS
  • Pipeline overview
    • Drugs in late-phase development for NSCLC
    • Drugs in Phase II development for NSCLC
    • Drugs in Phase I development for NSCLC
  • Pipeline by development phase and therapy class
    • There are over 100 drugs in the NSCLC pipeline, more thanhalf of which are molecular targeted therapies
  • Pipeline by mode of action
    • Pipeline drugs have diverse modes of action
  • Pipeline by indication
    • The majority of drugs are being investigated in thefirst-line treatment of advanced disease
  • Pipeline by company
    • Nearly 100 different companies or institutions areinvolved in the NSCLC pipeline
    • Merck Serono is the only company with two drugs in PhaseIII development for NSCLC
    • Top three companies in terms of the number of NSCLCpipeline candidates are Pfizer, Novartis and Bristol-Myers Squibb
  • Pfizer
  • Novartis
  • Bristol Myers Squibb
  • Key metrics
  • Datamonitor pipeline assessment summary
• CHAPTER 3 NON-SMALL CELL LUNG CANCER - MARKET POTENTIAL
  • Definition of NSCLC
    • Non-small cell lung cancer accounts for about 80% of alllung cancers
    • Three major types of NSCLC exist
    • Staging of NSCLC is usually based on the AJCC Tumor NodeMetastases (TNM) staging system
      • A revised staging system may have treatment implicationsin the future
    • The NSCLC market is segmented according to disease stage
    • Risk factors in the development of NSCLC
  • Overview of NSCLC treatment
    • The treatment of early-stage disease (Stages I-IIIA)
      • The management of early-stage disease is largely based onsurgery
      • Adjuvant chemotherapy may benefit a subset of patientswith early-stage disease
      • Radiotherapy has a central role in the treatment ofunresectable early-stage disease
    • The treatment of advanced disease (Stages IIIB-IV)
      • Chemoradiotherapy is the standard of care in patients withunresectable Stage IIIB disease
      • A recent trial has generated controversy regarding the useof consolidation chemotherapy in unresectable Stage III disease
      • Systemic platinum-based chemotherapy has a central role inthe management of advanced disease
      • The addition of Avastin may offer an added advantage for asubset of patients
      • A number of options are available for previously-treatedpatients
    • The role of targeted therapies in the treatment of NSCLC
      • Avastin is extensively used in the first-line setting, butonly a subset of patients is eligible for treatment
      • Off-label use of Tarceva is taking place in the first-linesetting
      • AstraZeneca will be seeking EU approval for Iressa in thesecond-line setting
      • Targeted therapies may find an application in a number ofsettings in NSCLC
    • The treatment of NSCLC is moving into an era ofindividualized medicine
  • The epidemiology of NSCLC
    • There will be more than 380,000 new cases of NSCLC in theseven major markets in 2017
    • Mortality from NSCLC is high
    • NSCLC is predominantly a disease of the elderly
    • Adenocarcinoma has become the most common histologicalsubtype of NSCLC
    • Asia will face a major epidemic of lung cancer in thefuture
    • NSCLC incidence and mortality rates are still increasingin women
    • NSCLC in never-smokers may become more prevalent in thefuture
    • Increased detection by screening is unlikely to affectNSCLC incidence
  • NSCLC is an attractive market for new product development
  • Unmet need in NSCLC
    • Effective treatments are required for both advanced andearly-stage disease
    • NSCLC needs to be recognized as a heterogeneous disease
    • Less toxic treatments for poor performance status patientsare required
    • The treatment of NSCLC is in need of an overall refinement
• CHAPTER 4 R&D APPROACH
  • Classification of pipeline products
    • Cytotoxic therapies
    • Molecular targeted therapies
      • Single-target signal transduction inhibitors
      • Angiogenesis inhibitors
      • Apoptosis inducers
      • Cell cycle inhibitors
      • Multi-targeted inhibitors
      • Epigenetic modulators
    • Immunotherapeutic agents
  • Evolution in NSCLC clinical trial design
    • The heterogeneity of NSCLC makes patient selection acritical issue
    • Targeted trial designs utilizing biomarkers areincreasingly used
    • Early-phase clinical trials and endpoints may needredefining
    • Barriers may still exist to the accrual of patients toNSCLC trials
    • NSCLC trials may not be very representative of theclinical setting
• CHAPTER 5 MOLECULAR TARGETED THERAPIES ANALYSIS ANDFORECASTS
  • Overview of molecular targeted therapies
    • Pipeline summary
      • Late-phase pipeline of molecular targeted therapies
      • Phase II pipeline of molecular targeted therapies
      • Phase I pipeline of molecular targeted therapies
    • Comparative forecasts
    • Definition of current comparator therapy
      • Avastin (bevacizumab Genentech/Roche/Chugai)
  • Erbitux (cetuximab; ImClone/Merck Serono/Bristol-MyersSquibb)
    • Drug overview
    • Key historical events
    • Clinical development in NSCLC
      • Phase III study of Erbitux with cisplatin and vinorelbinemeets its primary endpoint of improved survival
      • Phase III study of Erbitux with carboplatin and a taxanefails to meet its primary endpoint
      • A number of other trials have evaluated Erbitux in NSCLC
      • A combination of chemotherapy, Erbitux, and Avastin isbeing evaluated
      • Erbitux may enhance the efficacy of chemoradiotherapy inthe treatment of unresectable, locally advanced disease
    • Datamonitor comments
      • Erbitux may become the first EGFR inhibitor to show asurvival improvement in combination with chemotherapy in the first-linesetting
      • The extent to which US physicians will adopt the cisplatin/vinorelbineregimen may affect Erbitux' s uptake
      • Erbitux may achieve a higher uptake in patients who arenot eligible for Avastin treatment
      • Erbitux could find additional application in the treatmentof locally advanced, unresectable
• NSCLC
  • Forecasts to 2017
  • Nexavar (sorafenib; Bayer Schering)
    • Drug overview
    • Key historical events
    • Clinical development in NSCLC
      • The combination of Nexavar with platinum-basedchemotherapy fails to improve overall survival in a Phase III study
      • Nexavar monotherapy results in disease stabilization inthe second and third-line settings
      • An additional study has evaluated
• Nexavar monotherapy inthe second-line setting
  • Datamonitor comments
    • Nexavar' s potential in NSCLC now significantly limited
    • Nexavar joins the growing number of TKIs that have failedin the first-line setting
    • Bayer Schering has adopted a ' conservative' strategy forNexavar' s Phase III trial with Gemzar and cisplatin
  • Forecasts to 2017
  • Recentin (cediranib; AstraZeneca)
    • Drug overview
    • Key historical events
    • Clinical development in NSCLC
      • Two Phase I trials have evaluated Recentin in thefirst-line treatment of advanced NSCLC
    • Datamonitor comments
      • Recentin fails to progress into Phase III in advancedNSCLC
  • Sutent (sunitinib; Pfizer)
    • Drug overview
    • Key historical events
    • Clinical development in NSCLC
      • Sutent monotherapy shows moderate clinical activity in thesecond- and third-line setting of advanced NSCLC
      • The combination of Sutent with Gemzar and cisplatin issafe and tolerable
    • Datamonitor comments
      • The toxicity and cost of adding Sutent to Tarceva willneed to be justified
      • Targeting the second-line setting may be a successfulstrategy for Sutent
    • Forecasts to 2017
  • Zactima (vandetanib; AstraZeneca)
    • Drug overview
    • Key historical events
    • Clinical development in NSCLC
    • The addition of Zactima to platinum-based chemotherapyimproves progression-free survival in the first-line setting
      • The combination of Zactima with Taxotere and with Iressaimproves progression-free survival in the second-line setting
    • Datamonitor comments
      • Zactima' s multi-targeted nature could offer a competitiveadvantage
      • Zactima is targeting a broad population ofpreviously-treated, advanced NSCLC patients
      • The head-to-head trial against Tarceva is a high-riskstrategy
      • AstraZeneca' s strength in the oncology market will be keyto Zactima' s success
    • Forecasts to 2017
  • Zolinza (vorinostat; Merck & Co)
    • Drug overview
    • Key historical events
    • Clinical development in NSCLC
      • Zolinza shows moderate clinical activity as a second-linemonotherapy in NSCLC
      • A Phase II trial of Zolinza with Tarceva inrelapsed/refractory NSCLC was terminated
      • Zolinza shows preliminary evidence of clinical activity incombination with chemotherapy
    • Datamonitor comments
      • A different strategy may have improved Zolinza' s chancesof success in the NSCLC market
    • Forecasts to 2017
  • Aflibercept (VEGF-Trap; Sanofi Aventis/Regeneron)
    • Drug overview
    • Key historical events
    • Clinical development in NSCLC
      • Aflibercept shows manageable toxicity and some evidence ofclinical activity in heavily pre-treated, advanced NSCLC patients
    • Datamonitor comments
      • The combination of aflibercept with Taxotere will have todemonstrate a favorable toxicity profile
      • Aflibercept' s Phase III trial may not be accounting forthe current standards of care
      • Aflibercept' s Phase II trial results are interpreted usingthe modified RECIST criteria
      • Presence in oncology field will aid commercialization ofaflibercept
    • Forecasts to 2017
  • BIBW 2992 (Boehringer Ingelheim)
    • Drug overview
    • Key historical events
    • Clinical development in NSCLC
      • Phase III study will evaluate BIBW 2992 in patients whohave failed prior therapy with reversible EGFR inhibitors
      • BIBW 2992 shows preliminary evidence of activity in aPhase I study in solid malignancies
    • Datamonitor comments
      • Targeting patients who are Tarceva-refractory may be asuccessful entry strategy into the NSCLC market
  • Motesanib (AMG706; Amgen/Takeda Pharmaceutical)
    • Drug overview
    • Key historical events
    • Clinical development in NSCLC
      • The combination of motesanib with chemotherapy is safe andshows preliminary evidence of clinical activity
    • Datamonitor comments
      • Can motesanib succeed where other tyrosine kinaseinhibitors have failed?
      • Amgen runs a high risk with the inclusion of squamous cellpatients in motesanib' s Phase III trial
    • Forecasts to 2017
• CHAPTER 6 CYTOTOXIC THERAPIES ANALYSIS AND FORECASTS
  • Overview of cytotoxic therapies
    • Pipeline summary
      • Late-phase pipeline of cytotoxic therapies
      • Phase II pipeline of cytotoxic therapies
      • Phase I pipeline of cytotoxic therapies
    • Comparative forecasts
    • Definition of current comparator therapy
      • Taxotere (docetaxel; Sanofi-Aventis)
  • Abraxane (albumin-bound paclitaxel; Abraxis)
    • Drug overview
    • Key historical events
    • Clinical development in NSCLC
      • The combination of Abraxane with carboplatin and Avastinis well-tolerated
      • Abraxane shows clinical activity and a favorable toxicityprofile as a first-line monotherapy in metastatic NSCLC
    • Datamonitor comments
      • A novel taxane with an improved toxicity profile couldgain a share of the NSCLC market
      • There is a high chance of approval for Abraxane in NSCLC
      • Abraxane' s sales growth in the breast cancer market may beindicative of an uptake in NSCLC
    • Forecasts to 2017
  • Glutoxim (NOV-002; Novelos)
    • Drug overview
    • Key historical events
    • Clinical development in NSCLC
      • Glutoxim has been evaluated in the first-line treatment ofadvanced NSCLC
    • Datamonitor comments
      • Glutoxim' s clinical and commercial potential cannot beevaluated
    • Forecasts to 2017
  • Javlor (vinflunine; Pierre Fabre)
    • Drug overview
    • Key historical events
    • Clinical development in NSCLC
      • Javlor shows efficacy equivalent to that of Taxotere in aPhase III trial in advanced NSCLC
    • Datamonitor comments
      • Pierre Fabre' s intentions for Javlor in NSCLC are unclear
      • Javlor will face intense competition in the second-linesetting
      • Javlor could increase its uptake with use in combinationwith radiotherapy
    • Forecasts to 2017
  • Lipoplatin (liposomal cisplatin; Regulon)
    • Drug overview
    • Key historical events
    • Clinical development in NSCLC
      • The combination of Lipoplatin with Gemzar is safe andshows evidence of clinical activity
      • Lipoplatin shows a better toxicity profile than cisplatinas part of a combination regimen with paclitaxel
    • Datamonitor comments
      • Favorable market conditions exist for novel cytotoxicagents such as Lipoplatin
      • A more experienced oncology player could improveLipoplatin' s chances of success in the market
    • Forecasts to 2017
  • Taxoprexin (DHA paclitaxel; Luitpold)
    • Drug overview
    • Key historical events
    • Clinical development in NSCLC
      • Taxoprexin shows moderate clinical efficacy and anunfavorable toxicity profile in a Phase II trial
    • Datamonitor comments
      • Taxoprexin' s clinical results to date raise concernsregarding its future in the NSCLC market
    • Forecasts to 2017
  • Xyotax (paclitaxel polyglumex; Cell Therapeutics/Novartis)
    • Drug overview
    • Key historical events
    • Clinical development in NSCLC
      • Three Phase III trials failed to meet their primaryendpoints of improved overall survival
      • Combined analysis of STELLAR 3 and STELLAR 4 showed asurvival benefit in women
    • Datamonitor comments
      • Non-inferiority may grant Xyotax' approval in anunderserved patient population with poor prognosis
      • It is unclear whether Cell Therapeutics will achieve areturn on Xyotax' s development costs
      • The use of a prognostic biomarker for the selection ofpatients could enhance Xyotax' s clinical results
    • Forecasts to 2017
• CHAPTER 7 IMMUNOTHERAPIES ANALYSIS AND FORECASTS
  • Overview of immunotherapies
    • Pipeline summary
      • Late-phase pipeline of immunotherapies
      • Phase II pipeline of immunotherapies
      • Phase I pipeline of immunotherapies
    • Comparative forecasts
    • Definition of current comparator therapy
  • Stimuvax (BLP-25; Merck Serono)
    • Drug overview
    • Key historical events
    • Clinical development in NSCLC
      • Stimuvax shows evidence of a survival benefit in patientswith Stage IIIB locoregional disease
    • Datamonitor comments
      • The need for a minimally toxic maintenance therapy maydrive Stimuvax' s uptake
      • Stimuvax may have to overcome regulatory hurdles...
    • Forecasts to 2017
  • MAGE-A3 ASCI (GSK1572932A; GlaxoSmithKline)
    • Drug overview
    • Key historical events
    • Clinical development in NSCLC
      • MAGE-A3 ASCI decreases the risk of cancer recurrence aftersurgery in a Phase II trial
    • Datamonitor comments
      • An adjuvant therapy with a favorable toxicity profilewould be welcome in the NSCLC market
      • Recruitment to the large Phase III trial may presentchallenges
      • MAGE-A3 needs to overcome regulatory and pharmacoeconomicobstacles
    • Forecasts to 2017
• APPENDIX
  • Bibliography
• List of figures
  • List of abbreviations
  • Contributing experts
  • Methodology
    • Datamonitor forecast methodology
      • Epidemiology forecasts
      • Product forecasts
    • Datamonitor drug assessment summary
  • About Datamonitor
    • About Datamonitor Healthcare
  • Datamonitor Healthcare' s therapy area capabilities
    • About the Disease Analysis Team
    • Disclaimer
• List of Tables
  • Table 1: Drugs in Phase III development for NSCLC, 2008
  • Table 2: Drugs in Phase II development for NSCLC, 2008
  • Table 3: Drugs in Phase I development for NSCLC, 2008
  • Table 4: NSCLC pipeline drugs by development phase andtherapy class, 2008
  • Table 5: Merck Serono' s NSCLC pipeline portfolio, 2008
  • Table 6: Merck Serono' s marketed oncology portfolio,2008
  • Table 7: Pfizer' s NSCLC pipeline portfolio, 2008
  • Table 8: Pfizer' s marketed oncology portfolio, 2008
  • Table 9: Novartis' s NSCLC pipeline portfolio, 2008
  • Table 0: Novartis' s marketed cancer portfolio, 2008
  • Table 11: Bristol-Myers Squibb' s NSCLC pipelineportfolio, 2008
  • Table 12: Bristol-Myers Squibb' s marketed cancerportfolio, 2008
  • Table 13: Late-phase NSCLC drug sales forecasts in theseven major markets ($m), 2008-2017
  • Table 14: The use of surgery in NSCLC: results of anational US survey
  • Table 15: Cisplatin-based adjuvant therapy: LACEmeta-analysis results
  • Table 16: Use of chemotherapy in NSCLC: results of anational US survey
  • Table 17: Comparison of four chemotherapy regimens inadvanced NSCLC: results of the Eastern Cooperative Group (ECOtudy 1594
  • Table 18: Drugs used in the second- and third-linetreatment of advanced NSCLC
  • Table 19: FDA approval of Avastin in the first-linetreatment of advanced non-squamous NSCLC
  • Table 20: Selected ongoing clinical development ofAvastin in NSCLC, 2008
  • Table 21: FDA approval of Tarceva in the second- andthird-line treatment of advanced NSCLC
  • Table 22: Selected ongoing clinical development ofTarceva in NSCLC, 2008
  • Table 23: Results of the Phase III study of Iressaversus Taxotere in the second/third-line treatment of advanced NSCLC(INTEREST)
  • Table 24: Datamonitor' s forecast incidence of NSCLC inthe seven major pharmaceutical markets, 2008-2017
  • Table 25: Datamonitor' s forecast mortality of NSCLC inthe seven major pharmaceutical markets, 2008-2017
  • Table 26: Molecular targeted therapies in Phase IIIdevelopment for NSCLC, 2008
  • Table 27: Molecular targeted therapies in Phase IIdevelopment for NSCLC, 2008
  • Table 28: Molecular targeted thPhase Idevelopment for NSCLC, 2008
  • Table 29: Avastin: Key historical facts
  • Table 30: Erbitux: Key historical events
  • Table 31: Ongoing clinical trials involving Erbitux inNSCLC, 2008
  • Table 32: Phase II results of Gemzar and platinumchemotherapy alone or in combination with Erbitux in first-line NSCLC
  • Table 33: Phase II results of Erbitux with carboplatinand Taxotere in first-line NSCLC
  • Table 34: Phase II results of Erbitux monotherapy inpreviously treated NSCLC
  • Table 35: Forecasting assumptions for Erbitux in theseven major pharmaceutical markets, 2008 (1 of 2)
  • Table 36: Forecasting assumptions for Erbitux in theseven major pharmaceutical markets, 2008 (2 of 2)
  • Table 37: Erbitux sales forecast in first-line, advancedNSCLC in the seven major pharmaceutical markets ($m), 2008-2017
  • Table 38: Nexavar: Key historical events
  • Table 39: Ongoing clinical trials involving Nexavar inNSCLC, 2008
  • Table 40: Forecasting assumptions for Nexavar in theseven major pharmaceutical markets, 2008 (1 of 2)
  • Table 41: Forecasting assumptions for Nexavar in theseven major pharmaceutical markets, 2008 (2 of 2)
  • Table 42: Nexavar sales forecast in first-line, advancedNSCLC in the seven major pharmaceuticalmarkets ($m), 2008-2017
  • Table 43: Recentin: Key historical events
  • Table 44: Ongoing clinical trials involving Recentin inNSCLC, 2007
  • Table 45: Sutent: Key historical events
  • Table 46: Ongoing clinical trials involving Sutent inNSCLC, 2008
  • Table 47: Forecasting assumptions for Sutent in theseven major pharmaceutical markets, 2008 (1 of 2)
  • Table 48: Forecasting assumptions for Sutent in theseven major pharmaceutical markets, 2008 (2 of 2)
  • Table 49: Sutent sales forecast in second-line, advancedNSCLC in the seven major pharmaceutical markets ($m), 2008-2017
  • Table 50: Zactima' s multiple anticancer targets
  • Table 51: Zactima: Key historical events
  • Table 52: Ongoing clinical trials involving Zactima inNSCLC, 2008
  • Table 53: Forecasting assumptions for Zactima in theseven major pharmaceutical markets, 2008 (1 of 2)
  • Table 54: Forecasting assumptions for Zactima in theseven major pharmaceutical markets, 2008 (2 of 2)
  • Table 55: Zactima sales forecast in second-line,advanced NSCLC in the seven major pharmaceuticalmarkets($m),2008-2017
  • Table 56: Zolinza: Key historical events
  • Table 57: Ongoing clinical trials involving Zolinza inNSCLC, 2008
  • Table 58: Forecasting assumptions for Zolinza in theseven major pharmaceutical markets, 2008 (1 of 2)
  • Table 59: Forecasting assumptions for Zolinza in theseven major pharmaceutical markets, 2008 (2 of 2)
  • Table 60: Zolinza sales forecast in first-line, advancedNSCLC in the seven major pharmaceutical markets ($m),2008-2017
  • Table 61: Aflibercept: Key historical events
  • Table 62: Ongoing clinical trials involving afliberceptin NSCLC, 2008
  • Table 63: Forecasting assumptions for aflibercept in theseven major pharmaceutical markets, 2008 (1 of 2)
  • Table 64: Forecasting assumptions foaflibercept in theseven major pharmaceutical markets, 2008 (2 of 2)
  • Table 65: Aflibercept sales forecast in second-line,advanced NSCLC in the seven major pharmaceutical markets ($m), 2008-2017
  • Table 66: BIBW 2992: Key historical events
  • Table 67: Ongoing clinical trials involving BIBW 2992 inNSCLC, 2008
  • Table 68: Motesanib: Key historical events
  • Table 69: Ongoing clinical trials involving motesanib inNSCLC, 2008
  • Table 70: Forecasting assumptions for motesanib in theseven major pharmaceutical markets, 2008 (1 of 2)
  • Table 71: Forecasting assumptions for motesanib in theseven major pharmaceutical markets, 2008 (1 of 2)
  • Table 72: Motesanib sales forecast in first-line,advanced NSCLC in the seven major pharmaceutical markets ($m), 2008-2017
  • Table 73: Cytotoxic therapies in Phase III developmentfor NSCLC, 2008
  • Table 74: Cytotoxic therapies in Phase II developmentfor NSCLC, 2008
  • Table 75: Cytotoxic therapies in Phase I development forNSCLC, 2008
  • Table 76: Taxotere: Key historical facts
  • Table 77: Abraxane: Key historical events
  • Table 78: Ongoing clinical trials involving Abraxane,2008
  • Table 79: Forecasting assumptions for Abraxane in theseven major pharmaceutical markets, 2008 (1 of 2)
  • Table 80: Forecasting assumptions for Abraxane in theseven major pharmaceutical markets, 2008 (2 of 2)
  • Table 81: Abraxane sales forecast in first-line,advanced NSCLC in the seven major pharmaceutical markets ($m),2008-2017
  • Table 82: Glutoxim: Key historical events
  • Table 83: Ongoing clinical trials involving Glutoxim inNSCLC, 2008
  • Table 84: Forecasting assumptions for Glutoxim in theseven major pharmaceutical markets, 2008 (1 of 2)
  • Table 85: Forecasting assumptions for Glutoxim in theseven major pharmaceutical markets, 2008 (2 of 2)
  • Table 86: Glutoxim sales forecast in first-line,advanced NSCLC in the seven major pharmaceutical markets ($m), 2008-2017
  • Table 87: Javlor: Key historical events
  • Table 88: Ongoing clinical trials involving Javlor inNSCLC, 2008
  • Table 89: Forecasting assumptions for Javlor in theseven major pharmaceutical markets, 2008 (1 of 2)
  • Table 90: Forecasting assumptions for Javlor in theseven major pharmaceutical markets, 2008 (2 of 2)
  • Table 91: Javlor sales forecast in second-line, advancedNSCLC in the seven major pharmaceutical markets ($m), 2008-2017
  • Table 92: Lipoplatin: Key historical events
  • Table 93: Ongoing clinical trials involving Lipoplatinin NSCLC, 2008
  • Table 94: Forecasting assumptions for Lipoplatin in theseven major pharmaceutical markets, 2008 (1 of 2)
  • Table 95: Forecasting assumptions for Lipoplatin in theseven major pharmaceutical markets, 2008 (2 of 2)
  • Table 96: Lipoplatin sales forecast in first-line,advanced NSCLC in the seven major pharmaceutical markets ($m), 2008-2017
  • Table 97: Taxoprexin: Key historical events
  • Table 98: Ongoing clinical trials involving Taxoprexinin NSCLC, 2008
  • Table 99: Forecasting assumptions for Taxoprexin in theseven major pharmaceutical markets, 2008 (1 of 2)
  • Table 100: Forecasting assumptions for Taxoprexin in theseven major pharmaceutical markets, 2008 (2 of 2)
  • Table 101: Taxoprexin sales forecast in first-line,advanced NSCLC in the seven major pharmaceutical markets ($m), 2008-2017
  • Table 102: Xyotax: Key historical events
  • Table 103: Ongoing clinical trials involving Xyotax inNSCLC, 2008
  • Table 104: STELLAR 2: Phase III results for Xyotaxversus Taxotere in second-line NSCLC in patients with PS0-2
  • Table 105: STELLAR 3: Phase III results for Xyotax pluscarboplatin in first-line NSCLC in patients with PS2
  • Table 106: STELLAR 4: Phase III results for Xyotaxversus Gemzar or vinorelbine in first-line NSCLC in patients with PS2
  • Table 107: Clinical development of Xyotax in women withadvanced NSCLC and normal estrogen levels: the PTG306 and PTG307 trials
  • Table 108: Forecasting assumptions for Xyotax in theseven major pharmaceutical marke
  • Table 109: Forecasting assumptions for Xyotax in theseven major pharmaceutical markets, 2008 (2 of 2)
  • Table 110: Xyotax sales forecast in the first-linetreatment of advanced NSCLC in PS2 patients (EU) and in women (US/Japan)($m), 2008-2017
  • Table 111: Immunotherapies in Phase III development forNSCLC, 2008
  • Table 112: Immunotherapies in Phase II development forNSCLC, 2008
  • Table 113: Immunotherapies in Phase I development forNSCLC, 2008
  • Table 114: Stimuvax: Key historical events
  • Table 115: Ongoing clinical trials involving Stimuvax inNSCLC, 2008
  • Table 116: Forecasting assumptions for Stimuvax in theseven major pharmaceutical markets, 2008 (1 of 2)
  • Table 117: Forecasting assumptions for Stimuvax in theseven major pharmaceutical markets, 2008 (2 of 2)
  • Table 118: Stimuvax sales forecast in unresectable StageIII NSCLC in the seven major pharmaceutical markets ($m), 2008-2017
  • Table 119: MAGE-A3 ASCI: Key historical events
  • Table 120: Ongoing clinical trials involving MAGE-A3ASCI in NSCLC, 2007
  • Table 121: Forecasting assumptions for MAGE-A3 ASCI inthe seven major pharmaceutical markets, 2008 (1 of 2)
  • Table 122: Forecasting assumptions for MAGE-A3 ASCI inthe seven major pharmaceutical markets, 2008 (2 of 2)
  • Table 123: MAGE-A3 ASCI sales forecast in the adjuvanttreatment of resectable, MAGE-A3 positive, Stage
• IB, II, and IIIA NSCLC inthe seven major pharmaceutical markets ($m), 2008-2017
  • Table 124: Abbreviations used in Pipeline Insight:Non-small cell lung cancer
  • Table 125: Datamonitor drug assessment parameters
• List of Figures
  • Figure 1: NSCLC pipeline drugs by development phase andtherapy class, 2008
  • Figure 2: NSCLC pipeline drugs by mode of action, 2008
  • Figure 3: NSCLC Phase III pipeline drugs by mode ofaction, 2008
  • Figure 4: Number of drugs in Phase III development byclinical setting (line of therapy) for NSCLC, 2008
  • Figure 5: Number of companies/institutions involved inthe NSCLC pipeline
  • Figure 6: Late-phase molecular targeted therapies salesforecasts in the seven major pharmaceutical markets, 2008-2017
  • Figure 7: Late-phase cytotoxic therapies sales forecastsin the seven major pharmaceutical markets, 2008-2017
  • Figure 8: Late-phase immunotherapies sales forecasts inthe seven major pharmaceutical markets, 2008-2017
  • Figure 9: Clinical and commercial attractiveness ofmolecular targeted therapies in late-phase development for NSCLC, 2008
  • Figure 10: Clinical and commercial attractiveness ofcytotoxic therapies in late-phase development for NSCLC, 2008
  • Figure 11: Clinical and commercial attractiveness ofimmunotherapies in late-phase development for NSCLC, 2008
  • Figure 12: WHO classification of epithelial lung tumors
  • Figure 13: Characteristics of squamous cell carcinoma,adenocarcinoma, and large cell carcinoma
  • Figure 14: AJJC TNM staging system of NSCLC: grouping ofTNM subsets
  • Figure 15: AJJC TNM staging system of NSCLC: definitionof TNM
  • Figure 16: Risk factors in the development of NSCLC
  • Figure 17: The role of surgery, chemotherapy andradiotherapy in the management of NSCLC
  • Figure 18: Drug therapies routinely used in thetreatment of advanced NSCLC
  • Figure 19: Opportunities for the use of targetedtherapies in NSCLC
  • Figure 20: Opportunities and risks in the development ofnovel agents for NSCLC
  • Figure 21: Novel clinical trial design: randomizeddiscontinuation
  • Figure 22: Design of the BATTLE program: a step towardpersonalized medicine
  • Figure 23: Clinical and commercial attractiveness ofmolecular targeted therapies in late-phase development for NSCLC, 2008
  • Figure 24: Phase III molecular targeted therapies salesforecasts in the seven major pharmaceutical markets, 2008-2017
  • Figure 25: Design of a Phase III study of Erbitux withcisplatin and vinorelbine in first-line, EGFR-positive NSCLC (FLEX trial)
  • Figure 26: Phase II results for Erbitux with vinorelbineand cisplatin in first-line, EGFR-positive NSCLC
  • Figure 27: Phase II results for concurrent andsequential carboplatin, paclitaxel and Erbitux in first-line NSCLC
  • Figure 28: Phase II results for Erbitux withchemoradiotherapy in first-line NSCLC
  • Figure 29: Erbitux sales forecast in first-line,advanced NSCLC in the seven major pharmaceutical markets ($m), 2008-2017
  • Figure 30: Phase II results for Nexavar monotherapy insecond- or third-line NSCLC
  • Figure 31: Phase II results for Nexavar monotherapy insecond-line NSCLC
  • Figure 32: Nexavar sales forecast in first-line,advanced NSCLC in the seven major pharmaceutical markets ($m), 2008-2017
  • Figure 33: Recentin mode of action
  • Figure 34: Phase II results for Sutent monotherapy insecond- or third-line NSCLC
  • Figure 35: Sutent sales forecast in second-line,advanced NSCLC in the seven major pharmaceutical markets ($m), 2008-2017
  • Figure 36: Phase II results for Zactima with carboplatinand paclitaxel in first-line NSCLC
  • Figure 37: Phase II results for Zactima with Taxotere insecond-line NSCLC
  • Figure 38: Phase II results for Zactima versus Iressa insecond-or third-line NSCLC
  • Figure 39: Phase III studies of Zactima in NSCLC
  • Figure 40: Zactima sales forecast in second-line,advanced NSCLC in the seven major pharmaceutical markets ($m), 2008-2017
  • Figure 41: Phase II results for Zolinza monotherapy insecond-line NSCLC
  • Figure 42: Zolinza sales forecast in first-line,advanced NSCLC in the seven major pharmaceutical markets ($m), 2008-2017
  • Figure 43: Interim Phase II results for afliberceptmonotherapy in third-line NSCLC
  • Figure 44: Aflibercept sales forecast in second-line,advanced NSCLC in the seven major pharmaceutical markets ($m), 2008-2017
  • Figure 45: Phase I results for BIBW 2992 in patientswith advanced solid malignancies
  • Figure 46: Phase Ib results for motesanib withcarboplatin and paclitaxel or Vectibix in first- or second-line NSCLC
  • Figure 47: Motesanib sales forecast in first-line,advanced NSCLC in the seven major pharmaceutical markets ($m), 2008-2017
  • Figure 48: Clinical and commercial attractiveness ofcytotoxic therapies in Phase III development for NSCLC, 2008
  • Figure 49: Phase III cytotoxic therapies sales forecastsin the seven major pharmaceutical markets, 2008-2017
  • Figure 50: Interim Phase II results for Abraxane withcarboplatin and Avastin in first-line NSCLC
  • Figure 51: Phase II results for Abraxane monotherapy infirst-line NSCLC
  • Figure 52: Abraxane sales forecast in first-line,advanced NSCLC in the seven major pharmaceutical markets ($m), 2008-2017
  • Figure 53: Phase I/II results for Glutoxim withchemotherapy in first-line NSCLC
  • Figure 54: Glutoxim sales forecast in first-line,advanced NSCLC in the seven major pharmaceutical markets ($m), 2008-2017
  • Figure 55: Phase III results for Javlor versus Taxoterein second-line NSCLC
  • Figure 56: Javlor sales forecast in second-line,advanced NSCLC in the seven major pharmaceutical markets ($m), 2008-2017
  • Figure 57: Interim Phase III results for Lipoplatin withGemzar in first-line NSCLC
  • Figure 58: Interim Phase III results for Lipoplatin withpaclitaxel in first-line NSCLC
  • Figure 59: Lipoplatin sales forecast in first-line,advanced NSCLC in the seven major pharmaceutical markets ($m), 2008-2017
  • Figure 60: Phase II results for Taxoprexin monotherapyin first-line NSCLC
  • Figure 61: Taxoprexin sales forecast in first-line,advanced NSCLC in the seven major pharmaceutical markets ($m), 2008-2017
  • Figure 62: Xyotax sales forecast in the first-linetreatment of advanced NSCLC in PS2 patients (EU) and in women (US/Japan)($m), 2008-2017
  • Figure 63: Clinical and commercial attractiveness ofimmunotherapies in Phase III development for NSCLC, 2008
  • Figure 64: Phase III immunotherapies sales forecasts inthe seven major pharmaceutical markets, 2008-2017
  • Figure 65: Phase IIb results for Stimuvax maintenancetherapy in advanced NSCLC
  • Figure 66: Stimuvax sales forecast in unresectable StageIII NSCLC in the seven major pharmaceutical markets ($m), 2008-2017
  • Figure 67: Phase II results for MAGE-A3 ASCI as adjuvanttherapy in completely resected Stage IB/II NSCLC
  • Figure 68: MAGE-A3 ASCI sales forecast in the adjuvanttreatment of resectable, MAGE-A3 positive, Stage IB, II, and IIIA NSCLC inthe seven major pharmaceutical markets ($m), 2008-2017
  • Figure 69: Datamonitor drug assessment summary ofpipeline molecular targeted therapies in development for hematologicalmalignancies, 2007