Pipeline Insight: Cancer Overview - Gastrointestinal, Skin, Sarcomas

In 2008, the six tumor types covered in this report are forecast to account for over 961,000 new cases of cancer. Collectively, the 32 different drugs in Phase III development for the six tumor types are forecast to achieve $4,789m in sales by 2017. This constitutes a significant proportion of the oncology market, thus representing ample commercial opportunities for drug developers.

Report Highlights
Aflibercept (VEGF-Trap; Regeneron/Sanofi-Aventis) and brivanib (BMS-582664; Bristol-Myers Squibb) show the most potential in the colorectal cancer pipeline. Aflibercept has shown activity following failure of prior standard Avastin (bevacizumab; Genentech/Roche), while brivanib's novel mechanism of action could represent a first-in-class therapy.

Melanoma is the most popular R&D target of the six tumor types covered in this report, due to persistent high unmet needs and a substantial incidence. Elesclomol (STA-4783; Synta Pharmaceuticals/GlaxoSmithKline) currently shows the most potential at present, although only if successful Phase II results can be replicated in Phase III studies.

First-line axitinib (AG-13736; Pfizer) and Gemzar (gemcitabine; Eli Lilly) showed similar response rates and overall survival to first-line Gemzar and Tarceva (erlotinib; Genentech/Roche) in pancreatic cancer. If this can be replicated in Phase III trials, approval is likely, given that Tarceva was approved based on a 2-week survival benefit.
[Studien Infos ausblenden]

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
Related reports 5
Upcoming reports 6
CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS 8
Pipeline overview 8
Late-phase pipeline 8
Pipeline by indication 10
Melanoma emerges as the most popular R&D target, due to a significant level of unmet need which could result in high commercial reward 10
CHAPTER 3 R&D APPROACH 12
Classification of pipeline products 12
Cytotoxics 12
Molecular targeted therapies 13
Immunotherapeutic agents 15
Oncology clinical trial design 15
CHAPTER 4 COLORECTAL CANCER 17
Overview of colorectal cancer 17
Definition 17
Colorectal cancer is the third most common tumor type and cause of cancer-related death in both men and women 17
Epidemiology 18
Incidence continues to rise with an increase in prevalence of risk factors and the aging population 18
Mortality from colorectal cancer is relatively high due to a tendency for later diagnosis 18
Treatment of colorectal cancer 19
Unmet need in colorectal cancer 21
Summary of unmet needs 21
Lack of identifiable risk factors and effective screening tools 22
Prognosis remains poor, despite significant advances in therapy 22
A high rate of disease recurrence illustrates the need for more effective therapies 23
Pipeline overview 23
Definition of current comparator therapy 23
Pipeline summary 24
Late-phase pipeline 26
Phase II pipeline 26
Comparative forecasts 29
Pipeline candidates 32
Afinitor (everolimus; Novartis) 32
Drug overview 32
Key historical events 32
Clinical development in colorectal cancer 33
Datamonitor comments 34
Recentin (cediranib; AstraZeneca) 35
Drug overview 35
Key historical events 36
Clinical development in colorectal cancer 36
Datamonitor comments 38
Sutent (sunitinib; Pfizer) 40
Drug overview 40
Key historical events 40
Clinical development in colorectal cancer 41
Datamonitor comments 43
Aflibercept (VEGF-Trap; Regeneron/Sanofi-Aventis) 44
Drug overview 44
Key historical events 45
Clinical development in colorectal cancer 45
Datamonitor comments 48
Brivanib (BMS-582664; Bristol-Myers Squibb) 49
Drug overview 49
Key historical events 49
Clinical development in colorectal cancer 49
Datamonitor comments 51
Davanat (carbohydrate polymer drug delivery system; Pro-Pharmaceuticals) 52
Drug overview 52
Key historical events 52
Clinical development in colorectal cancer 53
Datamonitor comments 56
Satisfaction of unmet needs 58
Aflibercept and brivanib could eventually provide effective alternative therapies in metastatic colorectal cancer 58
CHAPTER 5 GASTRIC CANCER 59
Overview of gastric cancer 59
Definition 59
Gastric cancer is the second most common tumor type on a global scale 59
Epidemiology 60
Despite a worldwide decline in incidence, gastric cancer remains a major health burden 60
Mortality is a greater concern in the US and Western Europe 61
Treatment of gastric cancer 63
Unmet need in gastric cancer 65
Summary of unmet needs 65
Lack of effective systemic therapy 65
Poorly defined standard treatment regimens 66
Poor control of distant metastases 66
Complete lack of second-line options 67
Pipeline overview 67
Definition of current comparator therapy 67
Pipeline summary 68
Late-phase pipeline 69
Phase II pipeline 69
Comparative forecasts 71
Pipeline candidates 73
Avastin (bevacizumab; Genentech/Roche/Chugai) 73
Drug overview 73
Key historical events 73
Clinical development in gastric cancer 74
Datamonitor comments 77
Erbitux (cetuximab; ImClone/Bristol-Myers Squibb/Merck Serono) 79
Drug overview 79
Key historical events 79
Clinical development in gastric cancer 80
Datamonitor comments 85
Tykerb (lapatinib; GlaxoSmithKline) 85
Drug overview 85
Key historical events 86
Clinical development in gastric cancer 86
Datamonitor comments 88
Satisfaction of unmet needs 89
The three targeted therapies in late-phase development for gastric cancer show promise in fulfilling unmet need if certain hurdles can be overcome 89
CHAPTER 6 HEPATOCELLULAR CARCINOMA 91
Overview of hepatocellular carcinoma 91
Definition 91
Hepatitis is a known risk factor for hepatocellular carcinoma 91
Epidemiology 91
Japan accounts for nearly half of all new hepatocellular carcinoma cases in the seven major markets due to a high prevalence of hepatitis 91
Mortality from hepatocellular carcinoma is high, although prognosis is steadily improving 92
Treatment of hepatocellular carcinoma 93
Unmet need in hepatocellular carcinoma 95
Summary of unmet needs 95
Better systemic therapy is required 95
Clinical trials are currently poorly designed 96
HCC suffers from a relatively modest R&D interest 97
Pipeline overview 97
Definition of current comparator therapy 97
Pipeline summary 98
Late-phase pipeline 99
Phase II pipeline 99
Comparative forecasts 101
Pipeline candidates 104
Sutent (sunitinib; Pfizer) 104
Drug overview 104
Key historical events 104
Clinical development in hepatocellular carcinoma 104
Datamonitor comments 107
ThermoDox (heat-activated doxorubicin; Celsion) 109
Drug overview 109
Key historical events 109
Clinical development in hepatocellular carcinoma 110
Datamonitor comments 110
Miriplatin (SM-11355; Dainippon Sumitomo) 111
Drug overview 111
Key historical events 112
Clinical development in hepatocellular carcinoma 112
Datamonitor comments 113
Litx (talaporfin; Light Sciences Oncology) 114
Drug overview 114
Key historical events 115
Clinical development in hepatocellular carcinoma 115
Datamonitor comments 116
Satisfaction of unmet needs 117
Sutent could provide an effective alternative to Nexavar, however, the remaining pipeline drugs face significant barriers to market entry 117
CHAPTER 7 MELANOMA 118
Overview of melanoma 118
Definition 118
Melanoma is the least common type of skin cancer, although the most potentially fatal 118
Epidemiology 118
Incidence of melanoma will continue to rise due to increasing exposure of the population to UV light 118
Mortality from melanoma is relatively low in comparison to its incidence due to a high rate of early diagnosis 119
Treatment of melanoma 121
Unmet need in melanoma 123
Summary of unmet needs 123
Current therapeutics have a high risk-to-benefit ratio 123
Over the past three decades there have been few significant advances in drug therapy for metastatic disease 124
Early diagnosis is the key to curative treatment 124
Gene profiling will help individualize treatment approaches 124
Pipeline overview 125
Definition of current comparator therapy 125
Pipeline summary 126
Late-phase pipeline 128
Phase II pipeline 128
Comparative forecasts 132
Pipeline candidates 134
Genasense (oblimersen; Genta) 134
Drug overview 134
Key historical events 135
Clinical development in melanoma 136
Datamonitor comments 138
Elesclomol (STA-4783; Synta/GlaxoSmithKline) 139
Drug overview 139
Key historical events 139
Clinical development in melanoma 140
Datamonitor comments 142
Taxoprexin (DHA paclitaxel; Luitpold Pharmaceutical) 143
Drug overview 143
Key historical events 143
Clinical development in melanoma 143
Datamonitor comments 146
PEG-Intron (pegylated interferon-alpha; Schering-Plough) 147
Drug overview 147
Key historical events 147
Clinical development in melanoma 148
Datamonitor comments 149
Ipilimumab (MDX-010; Medarex/Bristol-Myers Squibb) 150
Drug overview 150
Key historical events 150
Clinical development in melanoma 151
Datamonitor comments 156
MDX-1379 (Medarex/Bristol-Myers Squibb) 157
Drug overview 157
Key historical events 157
Clinical development in melanoma 158
Datamonitor comments 159
Allovectin-7 (velimogene aliplasmid; Vical) 160
Drug overview 160
Key historical events 160
Clinical development in melanoma 161
Datamonitor comments 163
Satisfaction of unmet needs 163
The late-phase targeted therapies are most likely to fulfill unmet needs in melanoma, however, only if certain issues can be overcome 163
CHAPTER 8 PANCREATIC CANCER 165
Overview of pancreatic cancer 165
Definition 165
Pancreatic cancer represents a major health issue in the developed world 165
Epidemiology 165
Incidence of pancreatic cancer will continue to rise as a reflection of the aging population 165
Mortality from pancreatic cancer is nearly equal to its incidence 166
Treatment of pancreatic cancer 167
Unmet need in pancreatic cancer 168
Summary of unmet need 168
Associated with exceptionally poor survival rates 169
Earlier rates of diagnosis are desperately needed in order to boost survival 169
A lack of effective systemic therapies exists, therefore an higher level of R&D interest is needed 169
Pipeline overview 170
Definition of current comparator therapy 170
Pipeline summary 170
Late-phase pipeline 172
Phase II pipeline 172
Comparative forecasts 175
Pipeline candidates 178
Aflibercept (VEGF-Trap; Regeneron/Sanofi-Aventis) 178
Drug overview 178
Key historical events 178
Clinical development in pancreatic cancer 179
Datamonitor comments 180
Axitinib (AG-13736; Pfizer) 181
Drug overview 181
Key historical events 181
Clinical development in pancreatic cancer 182
Datamonitor comments 183
Larotaxel (XRP-9881; Sanofi-Aventis) 184
Drug overview 184
Key historical events 184
Clinical development in pancreatic cancer 185
Datamonitor comments 186
GV-1001 (tertomotide; Pharmexa) 187
Drug overview 187
Key historical events 187
Clinical development in pancreatic cancer 187
Datamonitor comments 189
TNFerade (TNF-alpha gene therapy; GenVec) 190
Drug overview 190
Key historical events 191
Clinical development in pancreatic cancer 191
Datamonitor comments 193
Satisfaction of unmet needs 194
Axitinib could fulfill some unmet needs in pancreatic cancer, however, the remaining pipeline drugs are difficult to judge due to a lack of clinical data or the significant hurdles they face 194
CHAPTER 9 SARCOMA 195
Overview of sarcoma 195
Definition 195
Sarcomas represent a diverse group of malignancies 195
Epidemiology 196
The diversity and rarity of sarcomas makes it difficult to determine incidence 196
Evolution of multimodality treatment for sarcomas of the bone has improved survival, while early diagnosis of soft tissue sarcoma allows for relatively high survival 200
Treatment of sarcoma 201
Sarcoma of the bone 201
Soft tissue sarcoma 201
Unmet need in sarcoma 202
Summary of unmet need 202
Better classification methods are needed 203
Greater range of treatment options following surgery and more efficacious agents for advanced disease are necessary 203
Pipeline overview 204
Definition of current comparator therapy 204
Pipeline summary 204
Late-phase pipeline 206
Phase II pipeline 207
Comparative forecasts 209
Pipeline candidates 211
Avastin (bevacizumab; Genentech/Roche) 211
Drug overview 211
Key historical events 212
Clinical development in sarcoma 212
Datamonitor comments 214
Tasigna (nilotinib; Novartis) 215
Drug overview 215
Key historical events 216
Clinical development in sarcoma 216
Datamonitor comments 218
Deforolimus (AP-23573; ARIAD/Merck & Co) 220
Drug overview 220
Key historical events 220
Clinical development in sarcoma 221
Datamonitor comments 223
Retaspimycin (IPI-504; Infinity/MedImmune) 224
Drug overview 224
Key historical events 224
Clinical development in sarcoma 224
Datamonitor comments 226
Ombrabulin (AVE-8062; Sanofi-Aventis/Ajinomoto) 227
Drug overview 227
Key historical events 227
Clinical development in sarcoma 228
Datamonitor comments 229
Mepact (liposomal mifamurtide; IDM Pharma) 229
Drug overview 229
Key historical events 230
Clinical development in sarcoma 230
Datamonitor comments 234
Satisfaction of unmet needs 235
Tasigna shows great potential to fulfill unmet needs in the third-line GIST setting, while deforolimus could provide an effective therapy in the maintenance setting for metastatic soft tissue and bone sarcoma 235
APPENDIX A 236
Bibliography 236
List of abbreviations 255
Contributing experts 258
Methodology 259
Datamonitor forecast methodology 259
Epidemiology forecasts 259
Product forecasts 259
Datamonitor drug assessment summary 260
APPENDIX B 262
About Datamonitor 262
About Datamonitor Healthcare 262
Datamonitor Healthcare's therapy area capabilities 263
About the Disease analysis team 264
Disclaimer 265
[Inhaltsverzeichnis ausblenden]

Table 1: Late-phase cytotoxics pipeline for colorectal cancer, gastric cancer, hepatocellular carcinoma, melanoma, pancreatic cancer and sarcoma, 2008 8
Table 2: Late-phase immunotherapies pipeline for colorectal cancer, gastric cancer, hepatocellular carcinoma, melanoma, pancreatic cancer and sarcoma, 2008 9
Table 3: Late-phase gene and photodynamic therapies pipeline for colorectal cancer, gastric cancer, hepatocellular carcinoma, melanoma, pancreatic cancer and sarcoma, 2008 9
Table 4: Late-phase targeted therapies pipeline for colorectal cancer, gastric cancer, hepatocellular carcinoma, melanoma, pancreatic cancer and sarcoma, 2008 10
Table 5: Pipeline split by developmental phase and indication, 2008 11
Table 6: Cytotoxic subgroup mechanisms of action 13
Table 7: Targeted therapy subgroup mechanisms of action 14
Table 8: Immunotherapy subgroup mechanisms of action 15
Table 9: Oncology clinical trial design factors 16
Table 10: Forecast incidence of colorectal cancer in the seven major pharmaceutical markets, 2002-2017 18
Table 11: Avastin: key facts, 2008 24
Table 12: Phase III colorectal cancer pipeline, 2008 26
Table 13: Phase II colorectal cancer pipeline, 2008 (targeted therapies) 26
Table 14: Phase II colorectal cancer pipeline, 2008 (cytotoxics) 28
Table 15: Phase II colorectal cancer pipeline, 2008 (miscellaneous) 29
Table 16: Forecasting assumptions for colorectal cancer pipeline products across the seven major markets, 2008 (1 of 2) 30
Table 17: Forecasting assumptions for colorectal cancer pipeline products across the seven major markets, 2008 (2 of 2) 30
Table 18: Pipeline colorectal cancer product sales forecasts across the seven major markets, 2008-2017 ($m) 31
Table 19: Afinitor: key historical events 33
Table 20: Clinical development of Afinitor in colorectal cancer, 2008 34
Table 21: Recentin: key historical events 36
Table 22: Clinical development of Recentin in colorectal cancer, 2008 37
Table 23: Sutent: key historical events 41
Table 24: Clinical development of Sutent in colorectal cancer, 2008 42
Table 25: Aflibercept: key historical events 45
Table 26: Clinical development of aflibercept in colorectal cancer, 2008 46
Table 27: Brivanib: key historical events 49
Table 28: Clinical development of brivanib in colorectal cancer, 2008 50
Table 29: Phase I results investigating a second-line or higher combination of Erbitux and brivanib in advanced gastrointestinal malignancies 51
Table 30: Davanat: key historical events 53
Table 31: Clinical development of Davanat in colorectal cancer, 2008 54
Table 32: Fulfillment of unmet needs by pipeline colorectal cancer drugs, 2008 58
Table 33: Crude incidence rates of gastric cancer by gender per 100,000 in the seven major pharmaceutical markets, 2002 59
Table 34: Forecast incidence of gastric cancer in the seven major pharmaceutical markets, 2002-2017 60
Table 35: Five-year survival rates by stage for gastric cancer in the US and Japan 63
Table 36: Taxotere: key facts, 2008 67
Table 37: Phase III gastric cancer pipeline, 2008 69
Table 38: Phase II gastric cancer pipeline, 2008 (targeted therapies) 70
Table 39: Phase II gastric cancer pipeline, 2008 (cytotoxics and immunotherapies) 71
Table 40: Forecasting assumptions for gastric cancer pipeline products across the seven major markets, 2008 71
Table 41: Pipeline gastric cancer product sales forecasts across the seven major markets, 2008-2017 ($m) 72
Table 42: Avastin: key historical events 73
Table 43: Clinical development of Avastin in gastric cancer, 2008 74
Table 44: Erbitux: key historical events 80
Table 45: Clinical development of Erbitux in gastric cancer, 2008 81
Table 46: Tykerb: key historical events 86
Table 47: Clinical development of Tykerb in gastric cancer, 2008 87
Table 48: Fulfillment of unmet needs by pipeline gastric cancer drugs, 2008 90
Table 49: Forecast incidence of hepatocellular carcinoma in the seven major pharmaceutical markets, 2002-2017 92
Table 50: Nexavar: key historical facts 97
Table 51: Phase III hepatocellular carcinoma pipeline, 2008 99
Table 52: Phase II hepatocellular carcinoma pipeline, 2008 (targeted therapies) 100
Table 53: Phase II hepatocellular carcinoma pipeline, 2008 (cytotoxics) 101
Table 54: Phase II hepatocellular carcinoma pipeline, 2008 (immunotherapies) 101
Table 55: Forecasting assumptions for hepatocellular carcinoma pipeline products across the seven major markets, 2008 (1 of 2) 102
Table 56: Forecasting assumptions for hepatocellular carcinoma pipeline products across the seven major markets, 2008 (2 of 2) 102
Table 57: Pipeline hepatocellular carcinoma product sales forecasts across the seven major markets, 2008-2017 ($m) 103
Table 58: Sutent: key historical events 104
Table 59: Clinical development of Sutent in hepatocellular carcinoma, 2008 105
Table 60: ThermoDox: key historical events 109
Table 61: Clinical development of ThermoDox in hepatocellular carcinoma, 2008 110
Table 62: Miriplatin: key historical events 112
Table 63: Litx: key historical events 115
Table 64: Clinical development of Litx in hepatocellular carcinoma, 2008 116
Table 65: Fulfillment of unmet needs by pipeline hepatocellular carcinoma drugs, 2008 117
Table 66: Forecast incidence of melanoma in the seven major pharmaceutical markets, 2002-2017 119
Table 67: Stage distribution of melanoma in the US, 1975-2000 120
Table 68: Five-year survival rates by pathologic stage for melanoma, 2001 121
Table 69: Temodar: key facts 126
Table 70: Phase III melanoma pipeline, 2008 128
Table 71: Phase II melanoma pipeline, 2008 (targeted therapies) 129
Table 72: Phase II melanoma pipeline, 2008 (cytotoxics) 130
Table 73: Phase II melanoma pipeline, 2008 (immunotherapies) 130
Table 74: Phase II melanoma pipeline, 2008 (miscellaneous) 131
Table 75: Forecasting assumptions for melanoma pipeline products across the seven major markets, 2008 (1 of 2) 132
Table 76: Forecasting assumptions for melanoma pipeline products across the seven major markets, 2008 (2 of 2) 133
Table 77: Pipeline melanoma product sales forecasts across the seven major markets, 2008-2017 ($m) 133
Table 78: Genasense: key historical events 135
Table 79: Clinical development of Genasense in melanoma, 2008 136
Table 80: Elesclomol: key historical events 140
Table 81: Clinical development of elesclomol in melanoma, 2008 140
Table 82: Survival analysis of Phase II study of elesclomol + paclitaxel in metastatic melanoma 142
Table 83: Taxoprexin: key historical events 143
Table 84: Clinical development of Taxoprexin in melanoma, 2008 144
Table 85: PEG-Intron: key historical events 148
Table 86: Clinical development of PEG-Intron in melanoma, 2008 148
Table 87: Ipilimumab: key historical events 151
Table 88: Clinical development of ipilimumab in melanoma, 2008 152
Table 89: MDX-1379: key historical events 158
Table 90: Clinical development of MDX-1379 in melanoma, 2008 158
Table 91: Allovectin-7: key historical events 161
Table 92: Clinical development of Allovectin-7 in melanoma, 2008 161
Table 93: Fulfillment of unmet needs by pipeline melanoma drugs, 2008 164
Table 94: Forecast incidence of pancreatic cancer in the seven major pharmaceutical markets, 2002-2017 166
Table 95: Gemzar: key facts 170
Table 96: Phase III pancreatic cancer pipeline, 2008 172
Table 97: Phase II pancreatic cancer pipeline, 2008 (targeted therapies) 173
Table 98: Phase II pancreatic cancer pipeline, 2008 (cytotoxics) 174
Table 99: Phase II pancreatic cancer pipeline, 2008 (miscellaneous) 175
Table 100: Forecasting assumptions for pancreatic cancer pipeline products across the seven major markets, 2008 (1 of 2) 176
Table 101: Forecasting assumptions for pancreatic cancer pipeline products across the seven major markets, 2008 (2 of 2) 176
Table 102: Pipeline pancreatic cancer product sales forecasts across the seven major markets, 2008-2017 ($m) 177
Table 103: Aflibercept: key historical events 179
Table 104: Clinical development of aflibercept in pancreatic cancer, 2008 179
Table 105: Axitinib: key historical events 182
Table 106: Clinical development of axitinib in pancreatic cancer, 2008 182
Table 107: Larotaxel: key historical events 185
Table 108: Clinical development of larotaxel in pancreatic cancer, 2008 185
Table 109: GV-1001: key historical events 187
Table 110: Clinical development of GV-1001 in pancreatic cancer, 2008 188
Table 111: TNFerade: key historical events 191
Table 112: Clinical development of TNFerade in pancreatic cancer, 2008 191
Table 113: Fulfillment of unmet needs by pipeline pancreatic cancer drugs, 2008 194
Table 114: Types of sarcoma of the bone 195
Table 115: Proportion of soft tissue sarcomas based on site of malignancy 196
Table 116: Forecast incidence of sarcoma in the seven major pharmaceutical markets, 2002-2017 197
Table 117: Forecast incidence of soft tissue sarcoma in the seven major pharmaceutical markets, 2002-2017 198
Table 118: Forecast incidence of gastrointestinal stromal tumors in the seven major pharmaceutical markets, 2002-2017 199
Table 119: Forecast incidence of osteosarcoma in the seven major pharmaceutical markets, 2002-2017 200
Table 120: Five-year survival rates by stage of soft tissue sarcoma 201
Table 121: Gleevec: key facts 204
Table 122: Phase III sarcoma pipeline, 2008 206
Table 123: Phase II sarcoma pipeline, 2008 (targeted therapies) 207
Table 124: Phase II sarcoma pipeline, 2008 (cytotoxics) 208
Table 125: Phase II sarcoma pipeline, 2008 (miscellaneous) 209
Table 126: Forecasting assumptions for sarcoma pipeline products across the seven major markets, 2008 (1 of 2) 209
Table 127: Forecasting assumptions for sarcoma pipeline products across the seven major markets, 2008 (2 of 2) 210
Table 128: Pipeline sarcoma product sales forecasts across the seven major markets, 2008-2017 ($m) 210
Table 129: Avastin: key historical events 212
Table 130: Clinical development of Avastin in sarcoma, 2008 213
Table 131: Tasigna: key historical events 216
Table 132: Clinical development of Tasigna in gastrointestinal stromal tumors , 2008 217
Table 133: Deforolimus: key historical events 221
Table 134: Clinical development of deforolimus in sarcoma, 2008 221
Table 135: Retaspimycin: key historical events 224
Table 136: Clinical development of retaspimycin in sarcoma, 2008 225
Table 137: Phase I trial results investigating retaspimycin in GIST and other soft tissue sarcomas 226
Table 138: Ombrabulin: key historical events 228
Table 139: Clinical development of ombrabulin in soft tissue sarcoma, 2008 228
Table 140: Mepact: key historical events 230
Table 141: Clinical development of Mepact in osteosarcoma, 2008 231
Table 142: Updated overall survival results from the Phase III INT-0133 study 234
Table 143: Fulfillment of unmet needs by pipeline sarcoma drugs, 2008 235
Table 144: List of abbreviations 255
Table 145: Datamonitor drug assessment parameters 260
Figure 1: Forecast incidence and mortality from colorectal cancer in 2008 and 2017 across the seven major markets 19
Figure 2: Improving survival in colorectal cancer with newer drug regimens 20
Figure 3: Summary of unmet needs in the colorectal cancer market, 2008 21
Figure 4: Datamonitor drug assessment summary for the pipeline colorectal cancer products, 2008 25
Figure 5: Pipeline colorectal cancer product sales forecasts across the seven major markets, 2008-2017 ($m) 31
Figure 6: Phase II results for second-line FOLFOX + Recentin versus FOLFOX + Avastin in metastatic colorectal cancer 38
Figure 7: Phase II results investigating second-line or higher Sutent in metastatic colorectal cancer after failure of standard therapy 43
Figure 8: Phase II results investigating second-line or higher aflibercept in metastatic colorectal cancer after failure of standard therapy 47
Figure 9: Phase II DAVFU-003 results investigating third/fourth-line Davanat + 5-fluorouracil in recurrent metastatic colorectal cancer 55
Figure 10: Interim Phase II DAVFU-006 results investigating first-line Davanat, 5-fluorouracil, leucovorin + Avastin in advanced colorectal cancer 56
Figure 11: Forecast incidence and mortality from gastric cancer in 2008 and 2017 across the seven major markets 62
Figure 12: Gastric cancer treatment options, 2008 64
Figure 13: Summary of unmet needs in the gastric cancer market, 2008 65
Figure 14: Datamonitor drug assessment summary for the pipeline gastric cancer products, 2008 68
Figure 15: Pipeline gastric cancer product sales forecasts across the seven major markets, 2008-2017 ($m) 72
Figure 16: Phase II results for first-line Avastin, Taxotere and Eloxatin in locally advanced or metastatic gastric cancer 75
Figure 17: Phase II results for first-line Avastin, Camptosar and cisplatin in metastatic gastric cancer 76
Figure 18: Phase II results for first-line Avastin and Taxotere in metastatic gastric cancer 77
Figure 19: Phase II results for first-line Erbitux, Xeloda and cisplatin in advanced gastric cancer 82
Figure 20: Phase II results for first-line Erbitux, Taxotere and cisplatin in locally advanced or metastatic gastric cancer 83
Figure 21: Phase II results for second-line Erbitux and Taxotere in Taxotere-refractory metastatic gastric cancer 84
Figure 22: Phase II results for first-line Tykerb in advanced gastric cancer 88
Figure 23: Five-year survival rates for liver and intrahepatic bile duct cancer, 1975-1998 93
Figure 24: Hepatocellular carcinoma treatment options, 2008 94
Figure 25: Summary of unmet needs in the hepatocellular carcinoma market, 2008 95
Figure 26: Datamonitor drug assessment summary for the pipeline hepatocellular carcinoma products, 2008 98
Figure 27: Pipeline hepatocellular carcinoma product sales forecasts across the seven major markets, 2008-2017 ($m) 103
Figure 28: Phase II results investigating first/second-line single-agent Sutent in unresectable or metastatic hepatocellular carcinoma 106
Figure 29: Preliminary Phase II results investigating first-line single-agent Sutent in unresectable or metastatic hepatocellular carcinoma 107
Figure 30: Phase II results investigating first-line miriplatin in chemotherapy-naïve hepatocellular carcinoma 113
Figure 31: Forecast incidence and mortality from melanoma in 2008 and 2017 across the seven major markets 120
Figure 32: Melanoma treatment options, 2008 122
Figure 33: Summary of unmet needs in the melanoma market, 2008 123
Figure 34: Datamonitor drug assessment summary for the pipeline melanoma products, 2008 127
Figure 35: Pipeline melanoma product sales forecasts across the seven major markets, 2008-2017 ($m) 134
Figure 36: Long-term follow-up results from a Phase III trial investigating first-line dacarbazine with or without Genasense in metastatic melanoma 137
Figure 37: Randomized Phase II trial results investigating a first/second-line combination of paclitaxel and elesclomol in Stage IV melanoma patients 141
Figure 38: Phase II results investigating first-line weekly Taxoprexin in metastatic melanoma 145
Figure 39: Phase II results investigating first-line 3-weekly Taxoprexin in metastatic melanoma 146
Figure 40: Phase III results investigating adjuvant PEG-Intron versus observation in resected Stage III melanoma 149
Figure 41: Phase II results investigating first-line ipilimumab with or without dacarbazine in advanced melanoma 153
Figure 42: Phase II results investigating varying doses of first-line ipilimumab in unresectable Stage III/IV melanoma patients 154
Figure 43: Analysis of data from five Phase I/II clinical trials investigating ipilimumab in Stage III/IV melanoma 155
Figure 44: Phase II trial results investigating a second-line combination of ipilimumab and MDX-1379 in Stage IV melanoma patients 159
Figure 45: Phase II results investigating high-dose Allovectin-7 in recurrent or unresponsive Stage III/IV melanoma 162
Figure 46: Forecast incidence and mortality from pancreatic cancer in 2008 and 2017 across the seven major markets 167
Figure 47: Pancreatic cancer treatment options, 2008 168
Figure 48: Summary of unmet needs in the pancreatic cancer market, 2008 169
Figure 49: Datamonitor drug assessment summary for the pipeline pancreatic cancer products, 2008 171
Figure 50: Pipeline pancreatic cancer product sales forecasts across the seven major markets, 2008-2017 ($m) 177
Figure 51: Randomized Phase II trial investigating first-line Gemzar with or without axitinib in advanced pancreatic cancer 183
Figure 52: Phase I/II trial results investigating GV-1001 in unresectable pancreatic cancer 189
Figure 53: Interim results from the Phase III PACT trial 192
Figure 54: Summary of unmet needs in the sarcoma market 203
Figure 55: Datamonitor drug assessment summary for the pipeline sarcoma products, 2008 205
Figure 56: Pipeline sarcoma product sales forecasts across the seven major markets, 2008-2017 ($m) 211
Figure 57: Phase I/II results investigating first-line Avastin, Taxotere and Gemzar in advanced or recurrent soft tissue sarcoma 214
Figure 58: Phase I trial investigating second-line Tasigna alone or in combination with Gleevec in Gleevec-resistant GIST patients 218
Figure 59: Phase II results investigating first-line deforolimus in unresectable and/or metastatic soft tissue and bone sarcoma patients 222
Figure 60: Phase III INT-0133 study design 232
Figure 61: Phase III INT-0133 results investigating neoadjuvant and adjuvant standard chemotherapy + Mepact in newly diagnosed, resectable osteosarcoma 233
Figure 62: Datamonitor drug assessment summary of pipeline molecular targeted therapies in development for hematological malignancies, 2007 261
[Tabellenverzeichnis ausblenden]