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
- 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
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