Market Report Source

Overview

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 of this report

• 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

Research and analysis 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.

Key reasons to read this report:

• 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

Table of Contents

ABOUT DATAMONITOR HEALTHCARE 2
About the Oncology pharmaceutical analysis team 2

CHAPTER 1 EXECUTIVE SUMMARY 3
Scope of the analysis 3
Datamonitor insight into the cancer market 3
Contributing experts 5
Related reports 5
Upcoming reports 6

CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS 8
Pipeline overview 8
Late-phase pipeline 8
Pipeline by indication 11
The higher-incidence tumor types remain the most popular indications for drug development 11

CHAPTER 3 R&D APPROACH 12
Classification of pipeline products 12
Cytotoxics 12
Antihormonal therapies 13
Molecular targeted therapies 14

• Single-target signal transduction inhibitors 15


• Angiogenesis inhibitors 15


• Apoptosis inducers 16


• Cell cycle inhibitors 16


• Multi-targeted inhibitors 17


• Epigenetic modulators 17

Immunotherapeutic agents 17

CHAPTER 4 NON-SMALL CELL LUNG CANCER 19
Overview of NSCLC 19
Definition 19
NSCLC accounts for about 80% of all lung cancers 19
Epidemiology 19
There will be more than 380,000 new cases of NSCLC in the seven major markets in 2017 19
Mortality from NSCLC is high 20
Treatment of NSCLC 21
Unmet needs in NSCLC 22
Summary of unmet needs 22
Effective treatments are required for both advanced and early-stage disease 23
NSCLC needs to be recognized as a heterogeneous disease 24
Less toxic treatments for poor performance status patients are required 25
The treatment of NSCLC is in need of overall refinement 25
Pipeline overview 25
Pipeline summary 25
Late-phase pipeline 28
Phase II pipeline 30
Comparative forecasts 35
Definition of current comparator therapy 42
Pipeline candidates 44

Erbitux (cetuximab; ImClone/Merck Serono/Bristol-Myers Squibb) 44
Drug overview 44
Key historical events 44
Clinical development in NSCLC 46
Datamonitor comments 50

Nexavar (sorafenib; Bayer Schering) 53
Drug overview 53
Key historical events 53
Clinical development in NSCLC 54
Datamonitor comments 59

Sutent (sunitinib; Pfizer) 61
Drug overview 61
Key historical events 61
Clinical development in NSCLC 62
Datamonitor comments 64

Tovok (BIBW 2992; Boehringer Ingelheim) 66
Drug overview 66
Key historical events 66
Clinical development in NSCLC 66
Datamonitor comments 68

Vargatef (BIBF 1120; Boehringer-Ingelheim) 69
Drug overview 69
Key historical events 70
Clinical development in NSCLC 70
Datamonitor comments 71

Zactima (vandetanib; AstraZeneca) 72
Drug overview 72
Key historical events 72
Clinical development in NSCLC 73
Datamonitor comments 77

Zolinza (vorinostat; Merck & Co) 80
Drug overview 80
Key historical events 80
Clinical development in NSCLC 80
Datamonitor comments 83

Aflibercept (VEGF-Trap; Sanofi-Aventis/Regeneron) 83
Drug overview 83
Key historical events 84
Clinical development in NSCLC 84
Datamonitor comments 86

ASA-404 (Antisoma/Novartis) 88
Drug overview 88
Key historical events 88
Clinical development in NSCLC 88
Datamonitor comments 91

CBT-1 (CBA Pharma) 92
Drug overview 92
Key historical events 92
Clinical development in NSCLC 93
Datamonitor comments 93

CP-751871 (Pfizer) 93
Drug overview 93
Key historical events 94
Clinical development in NSCLC 94
Datamonitor comments 95

Motesanib (AMG706; Amgen/Takeda Pharmaceutical) 96
Drug overview 96
Key historical events 96
Clinical development in NSCLC 96
Datamonitor comments 98

Abraxane (albumin-bound paclitaxel; Abraxis) 99
Drug overview 99
Key historical events100
Clinical development in NSCLC 101
Datamonitor comments 103

Glutoxim (NOV-002; Novelos) 105
Drug overview 105
Key historical events105
Clinical development in NSCLC 106
Datamonitor comments 107

Javlor (vinflunine; Pierre Fabre) 108
Drug overview 108
Key historical events 108
Clinical development in NSCLC 108
Datamonitor comments 111

Lipoplatin (liposomal cisplatin; Regulon) 112
Drug overview 112
Key historical events 112
Clinical development in NSCLC 113
Datamonitor comments 116

Taxoprexin (DHA paclitaxel; Luitpold) 116
Drug overview 116
Key historical events 117
Clinical development in NSCLC 117
Datamonitor comments 118

Opaxio (paclitaxel polyglumex; Cell Therapeutics/Novartis) 119
Drug overview 119
Key historical events 119
Clinical development in NSCLC 120
Datamonitor comments 124

Lucanix (NovaRx) 125
Drug overview 125
Key historical events 125
Clinical development in NSCLC 125
Datamonitor comments 127

Stimuvax (BLP-25; Merck Serono) 128
Drug overview 128
Key historical events 129
Clinical development in NSCLC 129
Datamonitor comments 131

MAGE-A3 ASCI (GSK1572932A; GlaxoSmithKline) 132
Drug overview 132
Key historical events 133
Clinical development in NSCLC 133
Datamonitor comments 134
Satisfaction of unmet needs 136
Approval of pipeline drugs will offer alternative treatment options, however, are unlikely to significantly fulfill unmet needs136

CHAPTER 5 SMALL CELL LUNG CANCER 137
Overview of SCLC 137
Definition 137
Epidemiology 138
The incidence of SCLC is decreasing with declining smoking prevalence 138
Poor survival rates result in a high mortality from SCLC 139
Treatment of SCLC 140
Unmet needs in SCLC 141
Summary of unmet needs 141
There is a need for more effective systemic therapies to improve patient survival 142
R&D activity in the field must be intensified 143
A better understanding of the molecular basis of the disease may help in the development of novel targeted agents 144
Pipeline overview 144
Pipeline summary 144
Late-phase pipeline 145
Phase II pipeline 146
Comparative forecasts 147
Definition of current comparator therapy 149
Pipeline candidates 150

Picoplatin (AMD-473; Poniard Pharmaceuticals) 150
Drug overview 150
Key historical events 150
Clinical development in SCLC 151
Datamonitor comments 153
Satisfaction of unmet needs 154
Picoplatin is unlikely to offer any significant improvements in terms of patient survival 154

CHAPTER 6 MESOTHELIOMA 155
Overview of mesothelioma 155
Definition 155
Mesothelioma is almost always caused by sustained exposure to asbestos 155
Epidemiology155
Forecast incidence is difficult to predict for mesothelioma, although the cancer is relatively rare 155
Survival rates for mesothelioma have improved minimally over the years 157
Treatment of mesothelioma 157
Unmet need in mesothelioma 158
Summary of unmet needs 158
Increasing incidence and need for earlier diagnosis 159
Low rate of curative surgery 159
Lack of approved therapies and low R&D interest 159
Pipeline overview 160
Pipeline summary 160
Late-phase pipeline 160
Phase II pipeline 161
Comparative forecasts 162
Definition of current comparator therapy 163
Pipeline candidates 164

Onconase (Alfacell Corp; ranpirnase) 164
Drug overview 164
Key historical events 164
Clinical development in mesothelioma 164
Datamonitor comments 166

Zolinza (vorinostat; Merck & Co) 167
Drug overview 167
Key historical events 167
Clinical development in mesothelioma 167
Datamonitor comments 169
Satisfaction of unmet needs 169
Onconase and Zolinza meet some unmet needs in terms of providing much needed alternative treatment options 169

CHAPTER 7 PRIMARY BRAIN CANCER 171
Overview of primary brain cancer 171
Definition 171
Glioma is the most common type of primary brain cancer 171
Epidemiology 171
Incidence of brain cancer is rising in line with the aging population 171
Mortality from brain cancer is very high in comparison to its incidence 172
Treatment of primary brain cancer 173
Unmet need in primary brain cancer 174
Summary of unmet needs 174
More effective chemotherapy options needed 175
Blood-brain barrier may prove an obstacle to overcome 175
Need for neuroprotective therapy 176
Pipeline overview 176
Pipeline summary 176
Late-phase pipeline 177
Phase II pipeline 178
Comparative forecasts 180
Definition of current comparator therapy 182
Pipeline candidates 183

Theraloc (nimotuzumab; YM Biosciences/Biocon Biopharmaceuticals) 183
Drug overview 183
Key historical events 183
Clinical development in brain cancer 184
Datamonitor comments 185

Cerepro (sitimagene ceradenovec; Ark Therapeutics) 186
Drug overview 186
Key historical events186
Clinical development in brain cancer 187
Datamonitor comments 189
Satisfaction of unmet needs 190
Temodar will retain its leading status for some time to come in the primary brain cancer market 190

CHAPTER 8 HEAD AND NECK CANCER 191
Overview of head and neck cancer 191
Definition 191
Head and neck cancers comprise around 6% of all tumors worldwide 191
Epidemiology 192
Incidence will continue to rise in line with the aging population 192
Mortality is high due to frequent late-stage diagnosis and lack of effective treatments 192
Treatment of head and neck cancer 193
Unmet need in head and neck cancer 194
Summary of unmet needs 194
Currently available therapies induce modest response rates 195
High level of treatment-related morbidity and poor quality of life 196
Early-stage diagnosis is limited, thereby compromising survival 196
High economic burden 96
Pipeline overview 197
Pipeline summary 197
Late-phase pipeline 198
Phase II pipeline 198
Comparative forecasts 201
Definition of current comparator therapy 204
Pipeline candidates 204

Avastin (bevacizumab; Genentech/Roche/Chugai) 204
Drug overview 204
Key historical events 204
Clinical development in head and neck cancer 205
Datamonitor comments 208

Tarceva (erlotinib; OSI Pharmaceuticals/Genentech/Roche) 209
Drug overview 209
Key historical events 210
Clinical development in head and neck cancer 210
Datamonitor comments 213

Tykerb (lapatinib; GlaxoSmithKline) 215
Drug overview 215
Key historical events 215
Clinical development in head and neck cancer 216
Datamonitor comments 217

Vectibix (panitumumab; Amgen) 218
Drug overview 218
Key historical events 219
Clinical development in head and neck cancer 219
Datamonitor comments 221

Zalutumumab (HuMax-EGFR; Genmab/Medarex) 222
Drug overview 222
Key historical events 222
Clinical development in head and neck cancer 222
Datamonitor comments 224

Alimta (pemetrexed; Eli Lilly) 225
Drug overview 225
Key historical events 226
Clinical development in head and neck cancer 226
Datamonitor comments 229

Lipoplatin (liposomal cisplatin; Regulon) 230
Drug overview 230
Key historical events 231
Clinical development in head and neck cancer 232
Datamonitor comments 233

Multikine (mixture of naturally occurring cytokines; CEL-SCI) 233
Drug overview 233
Key historical events 234
Clinical development in head and neck cancer 234
Datamonitor comments 236

Proxinium (VB4-845; Viventia Biotech) 237
Drug overview 237
Key historical events 237
Clinical development in head and neck cancer 237
Datamonitor comments 239

Advexin (contusugene; Introgen Therapeutics) 240
Drug overview 240
Key historical events 240
Clinical development in head and neck cancer 241
Datamonitor comments 243

INGN-241 (Introgen Therapeutics) 245
Drug overview 245
Key historical events 245
Clinical development in head and neck cancer 245
Datamonitor comments 246
Satisfaction of unmet needs 246
Superiority over current standard therapies is unlikely to be shown by the current pipeline 246

CHAPTER 9 THYROID CANCER 248
Overview of thyroid cancer 248
Definition 248
Thyroid cancer occurs more frequently in women and at a younger age 248
Epidemiology 248
Incidence of thyroid cancer is rising due to increasing use of ultrasound to detect small tumors 248
Thyroid cancer is one of the least deadly tumor types 249
Treatment of thyroid cancer 250
Unmet need in thyroid cancer 251
Summary of unmet need 251
R&D interest is exceedingly low 251
Few alternative treatment options exist upon disease recurrence 251
Pipeline overview 252
Pipeline summary 252
Late-phase pipeline 253
Phase II pipeline 254
Comparative forecasts 254
Definition of current comparator therapy 256
Pipeline candidates 257

Zybrestat (combretastatin; OXiGENE) 257
Drug overview 257
Key historical events 257
Clinical development in thyroid cancer 258
Datamonitor comments 259

Axitinib (AG-13736; Pfizer) 260
Drug overview 260
Key historical events 260
Clinical development in thyroid cancer 261
Datamonitor comments 263
Satisfaction of unmet needs 264
Axitinib and Zybrestat could form viable therapies where few alternative treatment options exist 264

APPENDIX A 265
Bibliography 265
List of tables 290
List of figures 291
List of abbreviations 292
Methodology 295

• Datamonitor forecast methodology 295
• Epidemiology forecasts 295
• Product forecasts 295

Datamonitor drug assessment summary 296

APPENDIX B 298
About Datamonitor 298
About Datamonitor Healthcare 298
Datamonitor Healthcare’s therapy area capabilities 299
About the Disease analysis team 300
Disclaimer 301

List of Tables
Table 1: Late-phase cytotoxics pipeline for NSCLC, SCLC, mesothelioma, primary brain cancer, head and neck cancer, and thyroid cancer, 2008 8

Table 2: Late-phase targeted therapies pipeline for NSCLC, SCLC, mesothelioma, primary brain cancer, head and neck cancer, and thyroid cancer, 2008 9

Table 3: Late-phase immunotherapies pipeline for NSCLC, SCLC, mesothelioma, primary brain cancer, head and neck cancer, and thyroid cancer, 2008 10

Table 4: Late-phase gene therapies pipeline for NSCLC, SCLC, mesothelioma, primary brain cancer, head and neck cancer, and thyroid cancer, 2008 10

Table 5: Pipeline split by developmental phase and indication, 2008 11

Table 6: Forecast incidence of NSCLC in the seven major pharmaceutical markets, 2002-2017 20

Table 7: Phase III NSCLC pipeline, 2008 (targeted therapies) 29

Table 8: Phase III NSCLC pipeline, 2008 (cytotoxic and immunotherapies) 30

Table 9: Phase II NSCLC pipeline, 2008 (targeted therapies) 31

Table 10: Phase II NSCLC pipeline, 2008 (cytotoxics) 33

Table 11: Phase II NSCLC pipeline, 2008 (immunotherapies and others) 34

Table 12: Forecasting assumptions for NSCLC pipeline products across the seven major markets, 2008 (molecular targeted therapies, 1 of 4) 35

Table 13: Forecasting assumptions for NSCLC pipeline products across the seven major markets, 2008 (molecular targeted therapies, 2 of 4) 36

Table 14: Forecasting assumptions for NSCLC pipeline products across the seven major markets, 2008 (molecular targeted therapies, 3 of 4) 36

Table 15: Forecasting assumptions for NSCLC pipeline products across the seven major markets, 2008 (molecular targeted therapies, 4 of 4) 37

Table 16: Forecasting assumptions for NSCLC pipeline products across the seven major markets, 2008 (cytotoxic therapies, 1 of 2) 37

Table 17: Forecasting assumptions for NSCLC pipeline products across the seven major markets, 2008 (cytotoxic therapies, 2 of 2) 38

Table 18: Forecasting assumptions for NSCLC pipeline products across the seven major markets, 2008 (immunotherapies) 38

Table 19: Pipeline NSCLC product sales forecasts across the seven major markets, 2008-2017 ($m) 39

Table 20: Avastin: key historical facts 43

Table 21: Taxotere: key historical facts 43

Table 22: Erbitux: key historical events 45

Table 23: Clinical development of Erbitux in NSCLC, 2008 46

Table 24: Preliminary results of Erbitux with carboplatin and a taxane in first-line NSCLC (BMS-099) 48

Table 25: Nexavar: key historical events 54

Table 26: Clinical development of Nexavar in NSCLC, 2008 55

Table 27: Sutent: key historical events 62

Table 28: Clinical development of Sutent in NSCLC, 2008 63

Table 29: Tovok: key historical events 66

Table 30: Clinical development of Tovok in NSCLC, 2008 67

Table 31: Vargatef: key historical events 70

Table 32: Zactima’s multiple anticancer targets 72

Table 33: Zactima: key historical events 73

Table 34: Clinical development of Zactima in NSCLC, 2008 74

Table 35: Zolinza: key historical events 80

Table 36: Clinical development of Zolinza in NSCLC, 2008 81

Table 37: Aflibercept: key historical events 84

Table 38: Clinical development of aflibercept in NSCLC, 2008 85

Table 39: ASA-404: key historical events 88

Table 40: Clinical development of ASA-404 in NSCLC, 2008 89

Table 41: CBT-1: key historical events 92

Table 42: Clinical development of CBT-1 in NSCLC, 2008 93

Table 43: CP-751871: key historical events 94

Table 44: Clinical development of CP-751871 in NSCLC, 2008 94

Table 45: Motesanib: key historical events 96

Table 46: Clinical development of motesanib in NSCLC, 2008 97

Table 47: Abraxane: key historical events 100

Table 48: Clinical development of Abraxane in NSCLC, 2008 101

Table 49: Glutoxim: key historical events 106

Table 50: Clinical development of Glutoxim in NSCLC, 2008 106

Table 51: Javlor: key historical events 108

Table 52: Clinical development of Javlor in NSCLC, 2008 109

Table 53: Lipoplatin: key historical events 113

Table 54: Clinical development of Lipoplatin in NSCLC, 2008 113

Table 55: Taxoprexin: key historical events 117

Table 56: Clinical development of Taxoprexin in NSCLC, 2008 117

Table 57: Opaxio: key historical events 120

Table 58: Clinical development of Opaxio in NSCLC, 2008 121

Table 59: STELLAR 2: Phase III results for Opaxio versus Taxotere in second-line NSCLC in patients with PS0-2 121

Table 60: STELLAR 3: Phase III results for Opaxio plus carboplatin in first-line NSCLC in patients with PS2 122

Table 61: STELLAR 4: Phase III results for Opaxio versus Gemzar or vinorelbine in first-line NSCLC in patients with PS2 122

Table 62: Clinical development of Opaxio in women with advanced NSCLC and normal estrogen levels: the PTG306 and PTG307 trials 123

Table 63: Lucanix: key historical events 125

Table 64: Clinical development of Lucanix in NSCLC, 2008 126

Table 65: Stimuvax: key historical events 129

Table 66: Clinical development of Stimuvax in NSCLC, 2008 129

Table 67: MAGE-A3 ASCI: key historical events 133

Table 68: Clinical development of MAGE-A3 ASCI in NSCLC, 2007 133

Table 69: Classification of SCLC: the Veteran’s Administration Lung Cancer Study Group (VALCSG) staging system 137

Table 70: Datamonitor’s forecast incidence of SCLC in the seven major pharmaceutical markets, 2002-2017 138

Table 71: Phase III SCLC pipeline, 2008 145

Table 72: Phase II SCLC pipeline, 2008 (targeted therapies) 146

Table 73: Phase II SCLC pipeline, 2008 (cytotoxics and immunotherapies) 147

Table 74: Forecasting assumptions for picoplatin in SCLC across the seven major pharmaceutical markets, 2008 148

Table 75: Picoplatin sales forecasts across the seven major markets, 2008-2017 ($m) 148

Table 76: Hycamtin: key historical facts 149

Table 77: Picoplatin: key historical events 150

Table 78: Clinical development of picoplatin in SCLC, 2008 151

Table 79: Epidemiologic features of malignant mesothelioma, 2005 156

Table 80: Late-phase mesothelioma pipeline, 2008 161

Table 81: Phase II mesothelioma pipeline, 2008 161

Table 82: Forecasting assumptions for pipeline mesothelioma products across the seven major markets, 2008 162

Table 83: Pipeline mesothelioma product sales forecasts across the seven major markets, 2008-2017 ($m) 162

Table 84: Alimta: key facts 163

Table 85: Onconase: key historical events 164

Table 86: Zolinza: key historical events 167

Table 87: Clinical development of Zolinza in mesothelioma, 2008 168

Table 88: Estimated incidence of brain cancer in the seven major pharmaceutical markets, 2002-2017 172

Table 89: Phase III brain cancer pipeline, 2008 177

Table 90: Phase II brain cancer pipeline, 2008 (targeted therapies) 178

Table 91: Phase II brain cancer pipeline, 2008 (cytotoxics) 179

Table 92: Phase II brain cancer pipeline, 2008 (others) 180

Table 93: Forecasting assumptions for pipeline brain cancer products across the seven major markets, 2008 181

Table 94: Pipeline brain cancer product sales forecasts across the seven major markets, 2008-2017 ($m) 181

Table 95: Temodar: key facts 182

Table 96: Theraloc: key historical events 183

Table 97: Clinical development of Theraloc in brain cancer, 2008 184

Table 98: Cerepro: key historical events 187

Table 99: Clinical development of Cerepro in brain cancer, 2008 187

Table 100: Risk factors for subtypes of head and neck cancer 191

Table 101: Estimated incidence of head and neck cancer in the seven major pharmaceutical markets, 2002-2017 192

Table 102: Phase III head and neck cancer pipeline, 2008 198

Table 103: Phase II head and neck cancer pipeline, 2008 (targeted therapies) 199

Table 104: Phase II head and neck cancer pipeline, 2008 (cytotoxics) 200

Table 105: Phase II head and neck cancer pipeline, 2008 (others) 200

Table 106: Forecasting assumptions for pipeline head and neck cancer products across the seven major markets, 2008 (1 of 3) 201

Table 107: Forecasting assumptions for pipeline head and neck cancer products across the seven major markets, 2008 (2 of 3) 202

Table 108: Forecasting assumptions for pipeline head and neck cancer products across the seven major markets, 2008 (3 of 3) 202

Table 109: Pipeline head and neck cancer product sales forecasts across the seven major markets, 2008-2017 ($m) 203

Table 110: Erbitux: key facts 204

Table 111: Avastin: key historical events 205

Table 112: Clinical development of Avastin in head and neck cancer, 2008 206

Table 113: Tarceva: key historical events 210

Table 114: Clinical development of Tarceva in head and neck cancer, 2008 211

Table 115: Tykerb: key historical events 215

Table 116: Clinical development of Tykerb in head and neck cancer, 2008 216

Table 117: Vectibix: key historical events 219

Table 118: Clinical development of Vectibix in head and neck cancer, 2008 219

Table 119: Zalutumumab: key historical events 222

Table 120: Clinical development of zalutumumab in head and neck cancer, 2008 223

Table 121: Alimta: key historical events 226

Table 122: Clinical development of Alimta in head and neck cancer, 2008 227

Table 123: Lipoplatin: key historical events 232

Table 124: Clinical development of Lipoplatin in head and neck cancer, 2008 232

Table 125: Multikine: key historical events 234

Table 126: Clinical development of Multikine in head and neck cancer, 2008 235

Table 127: Proxinium: key historical events 237

Table 128: Clinical development of Proxinium in head and neck cancer, 2008 238

Table 129: Advexin: key historical events 241

Table 130: Clinical development for Advexin in head and neck cancer, 2008 242

Table 131: INGN-241: key historical events 245

Table 132: Estimated incidence of thyroid cancer in the seven major pharmaceutical markets, 2002-2017 249

Table 133: Five-year survival rates by stage of thyroid cancer 249

Table 134: Phase III thyroid cancer pipeline, 2008 253

Table 135: Phase II thyroid cancer pipeline, 2008 254

Table 136: Forecasting assumptions for pipeline thyroid cancer products across the seven major markets, 2008 255

Table 137: Pipeline thyroid cancer product sales forecasts across the seven major markets, 2008-2017 ($m) 255

Table 138: Doxil: key facts 257

Table 139: Zybrestat: key historical events 258

Table 140: Clinical development of Zybrestat in thyroid cancer, 2008 258

Table 141: Axitinib: key historical events 261

Table 142: Phase II development of axitinib in thyroid cancer, 2007 261

Table 143: List of abbreviations 292

Table 144: Datamonitor drug assessment parameters 296

List of Figures
Figure 1: Forecast incidence and mortality from NSCLC in 2008 and 2017 across the seven major markets 20

Figure 2: The role of surgery, chemotherapy and radiotherapy in the management of NSCLC 21

Figure 3: Summary of unmet needs in the NSCLC market 23

Figure 4: Datamonitor drug assessment summary for the molecular targeted therapies in late-phase development for NSCLC, 2008 26

Figure 5: Datamonitor drug assessment summary for the cytotoxic therapies in late-phase development for NSCLC, 2008 27

Figure 6: Datamonitor drug assessment summary for the immunotherapies in late-phase development for NSCLC, 2008 28

Figure 7: Pipeline NSCLC targeted therapies sales forecasts across the seven major markets, 2008-2017 ($m) 40

Figure 8: Pipeline NSCLC cytotoxic therapies sales forecasts across the seven major markets, 2008-2017 ($m) 41

Figure 9: Pipeline NSCLC immunotherapies sales forecasts across the seven major markets, 2008-2017 ($m) 42

Figure 10: Phase III FLEX trial results 47

Figure 11: Phase II results for first-line Erbitux with chemoradiotherapy in locally advanced NSCLC 50

Figure 12: Phase II results for Nexavar monotherapy in second- or third-line NSCLC 57

Figure 13: Phase II results of third-line Nexavar monotherapy: randomized discontinuation design 58

Figure 14: Phase II results for Sutent monotherapy in second- or third-line NSCLC 64

Figure 15: Phase I results for Tovok in patients with advanced solid malignancies 68

Figure 16: Phase II results for Vargatef monotherapy in second- or third-line NSCLC 71

Figure 17: Phase II results for Zactima with carboplatin and paclitaxel in first-line NSCLC 75

Figure 18: Phase II results for Zactima with Taxotere in second-line NSCLC 76

Figure 19: Phase II results for Zactima versus Iressa in advanced NSCLC 77

Figure 20: Phase III studies of Zactima in NSCLC 78

Figure 21: Phase II results for Zolinza monotherapy in second-line NSCLC 82

Figure 22: Interim Phase II results for aflibercept monotherapy in third-line NSCLC 86

Figure 23: Phase II results for ASA-404 with chemotherapy in first-line NSCLC 90

Figure 24: Phase Ib/II results for ASA-404 with chemotherapy in first-line NSCLC 91

Figure 25: Interim Phase II results for CP-751871 with chemotherapy in first-line NSCLC 95

Figure 26: Phase Ib results for motesanib with carboplatin and paclitaxel or Vectibix in first- or second-line NSCLC 98

Figure 27: Interim Phase II results for Abraxane with carboplatin and Avastin in first-line NSCLC 102

Figure 28: Phase II results for Abraxane monotherapy in first-line NSCLC 103

Figure 29: Phase I/II results for Glutoxim with chemotherapy in first-line NSCLC 107

Figure 30: Phase III results for Javlor versus Taxotere in second-line NSCLC 110

Figure 31: Interim Phase III results for Lipoplatin with Gemzar in first-line NSCLC 114

Figure 32: Interim Phase III results for Lipoplatin with paclitaxel in first-line NSCLC 115

Figure 33: Phase II results for Taxoprexin monotherapy in first-line NSCLC 118

Figure 34: Phase II results for Lucanix in advanced NSCLC 127

Figure 35: Phase IIb results for Stimuvax maintenance therapy in advanced NSCLC 130

Figure 36: Phase II results for MAGE-A3 ASCI as adjuvant therapy in completely resected Stage IB/II NSCLC 134

Figure 37: Forecast incidence and mortality from NSCLC in 2008 and 2017 across the seven major markets 139

Figure 38: Overview of SCLC treatment 140

Figure 39: Summary of unmet needs in the SCLC market 142

Figure 40: Datamonitor drug assessment summary for picoplatin in SCLC, 2008 145

Figure 41: Picoplatin sales forecasts across the seven major markets, 2008-2017 ($m) 149

Figure 42: Phase II results for picoplatin in second-line SCLC 152

Figure 43: Five-year survival rates for mesothelioma in the US, 1975-1998 157

Figure 44: Summary of unmet needs in the mesothelioma market 158

Figure 45: Datamonitor drug assessment summary for the pipeline mesothelioma products, 2008 160

Figure 46: Pipeline mesothelioma product sales forecasts across the seven major markets, 2008-2017 ($m) 163

Figure 47: Phase III results for first- or second-line doxorubicin with or without Onconase in mesothelioma patients 165

Figure 48: Phase I results for second-line Zolinza in mesothelioma patients 168

Figure 49: Incidence and mortality from brain cancer in 2008 and 2017 across the seven major markets 173

Figure 50: Summary of unmet needs in the primary brain cancer market 174

Figure 51: Datamonitor drug assessment summary for the pipeline brain cancer products, 2008 177

Figure 52: Pipeline brain cancer product sales forecasts across the seven major markets, 2008-2017 ($m) 182

Figure 53: Phase II results for Theraloc in relapsed or refractory pediatric high-grade gliomas 185

Figure 54: Phase II trial investigating Cerepro in primary and recurrent glioma patients 188

Figure 55: Incidence and mortality from head and neck cancer in 2008 and 2017 across the seven major markets 193

Figure 56: Summary of unmet needs in the head and neck cancer market 195

Figure 57: Datamonitor drug assessment summary for the pipeline head and neck cancer products, 2008 197

Figure 58: Pipeline head and neck cancer product sales forecasts across the seven major markets, 2008-2017 ($m) 203

Figure 59: Phase II results for first-line Alimta and Avastin in advanced head and neck cancer 207

Figure 60: Phase II study investigating Avastin with concurrent radiotherapy and Taxotere in head and neck cancer 208

Figure 61: Interim Phase II results for first-line Tarceva, Taxotere and cisplatin in metastatic or recurrent head and neck cancer 212

Figure 62: Phase II results for first-line Tarceva, cisplatin and radiotherapy for locally advanced head and neck cancer 213

Figure 63: Phase II results for third-line Tykerb in recurrent or metastatic head and neck cancer 217

Figure 64: Preliminary Phase I results for first-line Vectibix and chemoradiotherapy in Stage III/IV head and neck cancer 220

Figure 65: Phase I/II trial results for second-line zalutumumab in patients with recurrent squamous cell head and neck cancer 224

Figure 66: Phase II results for first-line Alimta and Avastin in advanced head and neck cancer 228

Figure 67: Phase II results for first-line Alimta in advanced head and neck cancer 229

Figure 68: Phase II trial and follow-up results for neoadjuvant Multikine in head and neck cancer 236

Figure 69: Interim Phase III results for second-line Proxinium in advanced head and neck cancer 238

Figure 70: Phase I dose-escalation trial for Proxinium in advanced head and neck cancer 239

Figure 71: Preliminary results from the Phase III T301 study comparing second-line Advexin with methotrexate in recurrent head and neck cancer 243

Figure 72: Incidence and mortality from thyroid cancer in 2008 and 2017 across the seven major markets 250

Figure 73: Summary of unmet needs in the thyroid cancer market 251

Figure 74: Datamonitor drug assessment summary for the pipeline thyroid cancer products, 2008 253

Figure 75: Pipeline thyroid cancer product sales forecasts across the seven major markets, 2008-2017 ($m) 256

Figure 76: Phase II results for first-line Zybrestat in advanced anaplastic thyroid cancer patients 259

Figure 77: Phase II results for axitinib in thyroid cancer patients refractory or unsuitable for radioiodine therapy 262

Figure 78: Datamonitor drug assessment summary of pipeline molecular targeted therapies in development for hematological malignancies, 2007 297