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 events 100
Clinical development in NSCLC 101
Datamonitor comments 103
Glutoxim (NOV-002; Novelos) 105
Drug overview 105
Key historical events 105
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 fulfil unmet needs 136
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
Epidemiology 155
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 ageing 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 events 186
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 ageing 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 196
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
