Table of Contents

Pipeline Insight: Cancer Overview - Gastrointestinal, Skin, Sarcomas - Overview of the current solid cancer pipeline, including in-depth analysis of late-phase products for a variety of tumor types, clinical trial data, sales forecasts through to 2017 and key opinion leader insight.

Product Code: dmhc2473

Publication Date: 19-Dec-2008

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Overview

Introduction

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.

Scope

· 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

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.

Reasons to Purchase

· 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 fulfil them

· Assess the shifting oncology market dynamic and how future treatment of solid tumors will incorporate pipeline products

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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 tables	253
List of figures	254
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	266
List of Tables
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
List of Figures
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

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