Pipeline Insight: Cancer Overview - Breast, Gynecological, Genitourinary - Diverse drugs approaching the market for many tumor types

In 2008, the six tumor types covered in this report are forecast to account for over 1.2m new cases of cancer. Collectively, the 36 different drugs in Phase III development for the six tumor types are forecast to achieve $7,049m in sales by 2017. This constitutes a significant proportion of the oncology market, thus representing ample commercial opportunities for drug developers.

Report Highlights
Avastin (bevacizumab; Genentech/Roche) has shown the greatest potential in the ovarian cancer pipeline to date, with encouraging response rates in heavily pretreated patients, alongside the commercially favorable backing of Genentech and Roche, who have considerable experience in the oncology market.

Abiraterone (CB-7630; Cougar Biotechnology/BTG) shows the greatest potential in the prostate cancer pipeline. Abiraterone shows real promise in providing an effective therapy in the second-line or higher setting among patients where all lines of antihormonal therapy and Taxotere (docetaxel; Sanofi-Aventis) have failed.

In the RCC pipeline, Afinitor (everolimus; Novartis) shows the most promise, by providing a treatment option for tyrosine kinase inhibitor-refractory patients, who currently face a lack of viable therapies. Afinitor is the first drug to show a Phase III clinical benefit in this patient population, which could have a great impact on treatment.
[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 11
Breast cancer and prostate cancer will always remain popular R&D targets, however, the niche indications are increasing in popularity 11
CHAPTER 3 R&D APPROACH 12
Classification of pipeline products 12
Cytotoxics 12
Antihormonal therapies 13
Molecular targeted therapies 14
Immunotherapeutic agents 15
Oncology clinical trial design 16
CHAPTER 4 BLADDER CANCER 18
Overview of bladder cancer 18
Definition 18
Bladder cancer is a common tumor type in males 18
Epidemiology 19
Incidence of bladder cancer will rise due to an increase in industrialization, lifestyle factors and an ageing population 19
Mortality from bladder cancer is very low in the early stages, however, rises dramatically once the tumor spreads 19
Treatment of bladder cancer 21
Unmet need in bladder cancer 21
Summary of unmet needs 21
Increase early diagnosis to enhance survival 22
Agents with better routes of administration in comparison with intravesical therapy 23
A better 'standard' for advanced disease with less toxicity is needed 23
Salvation of the bladder is the ideal 23
Pipeline overview 24
Pipeline summary 24
Late-phase pipeline 25
Phase II pipeline 25
Comparative forecasts 26
Definition of current comparator therapy 28
Pipeline candidates 29
Urocidin (MCC; Bioniche) 29
Drug overview 29
Key historical events 29
Clinical development in bladder cancer 30
Datamonitor comments 32
EOquin (apaziquone; Spectrum Pharmaceuticals) 32
Drug overview 32
Key historical events 33
Clinical development in bladder cancer 33
Datamonitor comments 36
Valstar (valrubicin; Indevus) 36
Drug overview 36
Key historical events 37
Clinical development in bladder cancer 37
Datamonitor comments 38
Larotaxel (XRP-9881; Sanofi-Aventis) 39
Drug overview 39
Key historical events 39
Clinical development in bladder cancer 39
Datamonitor comments 40
Satisfaction of unmet needs 41
Some satisfaction of unmet needs will occur, however, further research is needed in advanced disease 41
CHAPTER 5 BREAST CANCER 42
Overview of breast cancer 42
Definition 42
Breast cancer remains the most common cancer and second most common cause of cancer-related death in women worldwide 42
Epidemiology 42
Incidence of breast cancer will continue to rise as lifestyles associated with risk factors are increasingly adopted and in line with the ageing population 42
While mortality rates are low in comparison to incidence, absolute mortality shows breast cancer remains a leading cause of death in women 43
Treatment of breast cancer 45
Unmet need in breast cancer 45
Summary of unmet needs 45
Effective treatment for metastatic disease still remains elusive 46
A wider range of treatment options is necessary for hormone receptor-negative and HER-2 negative patients 46
Elderly patients remain underserved in terms of treatment options 47
More convenient and better tolerated therapies are needed 47
Pipeline overview 48
Pipeline summary 48
Late-phase pipeline 50
Phase II pipeline 50
Comparative forecasts 54
Definition of current comparator therapy 57
Pipeline candidates 57
Afinitor (everolimus; Novartis) 57
Drug overview 57
Key historical events 58
Clinical development in breast cancer 58
Datamonitor comments 61
Armala (pazopanib; GlaxoSmithKline) 63
Drug overview 63
Key historical events 63
Clinical development in breast cancer 63
Datamonitor comments 65
Omnitarg (pertuzumab; Genentech/Roche/Chugai) 67
Drug overview 67
Key historical events 67
Clinical development in breast cancer 67
Datamonitor comments 70
Sutent (sunitinib; Pfizer) 72
Drug overview 72
Key historical events 72
Clinical development in breast cancer 72
Datamonitor comments 75
Ramucirumab (IMC-1121B; ImClone) 76
Drug overview 76
Key historical events 77
Clinical development in breast cancer 77
Datamonitor comments 78
Eribulin (E7389; Eisai) 79
Drug overview 79
Key historical events 79
Clinical development in breast cancer 79
Datamonitor comments 82
Satisfaction of unmet needs 84
The four targeted therapies in late-phase development for breast cancer show promise in fulfilling some unmet need 84
CHAPTER 6 CERVICAL CANCER 85
Overview of cervical cancer 85
Definition 85
Cervical cancer constitutes 17% of all gynecological tumors 85
Epidemiology 86
Incidence rates of cervical cancer have decreased due to screening programs, however overall incidence will rise in line with the ageing population 86
Mortality is relatively high in comparison to incidence of cervical cancer given its propensity for early diagnosis 87
Treatment of cervical cancer 88
Unmet need in cervical cancer 88
Summary of unmet needs 88
Better systemic therapy is required for metastatic and recurrent disease 89
More large-scale, randomized clinical trials are necessary to define optimal treatment strategies across cervical cancer 90
The cervical cancer pipeline is relatively sparse 90
Pipeline overview 90
Pipeline summary 90
Late-phase pipeline 91
Phase II pipeline 92
Comparative forecasts 93
Definition of current comparator therapy 95
Pipeline candidates 96
Gemzar (gemcitabine; Eli Lilly) 96
Drug overview 96
Key historical events 96
Clinical development in cervical cancer 96
Datamonitor comments 99
Tirazone (tirapazamine; National Cancer Institute/Stanford University/SRI International) 100
Drug overview 100
Key historical events 101
Clinical development in cervical cancer 101
Datamonitor comments 103
Satisfaction of unmet needs 104
Unmet needs are unlikely to be fulfilled by the current pipeline 104
CHAPTER 7 OVARIAN CANCER 106
Overview of ovarian cancer 106
Definition 106
Ovarian cancer is the most frequent cause of cancer-related death from gynecological malignancies 106
Epidemiology 106
Incidence of ovarian cancer will rise in line with the ageing population since it affects primarily postmenopausal women 106
Mortality from ovarian cancer is relatively high in comparison with its incidence due to a high rate of diagnosis at Stage III disease 107
Treatment of ovarian cancer 108
Unmet need in ovarian cancer 109
Summary of unmet needs 109
Earlier rates of diagnosis are needed 110
Less invasive surgical techniques are required 111
More effective systemic therapies are needed across multiple lines of treatment 111
Increase level of R&D interest 112
Pipeline overview 112
Pipeline summary 112
Late-phase pipeline 114
Phase II pipeline 114
Comparative forecasts 117
Definition of current comparator therapy 120
Pipeline candidates 121
Avastin (bevacizumab; Genentech/Roche) 121
Drug overview 121
Key historical events 121
Clinical development in ovarian cancer 122
Datamonitor comments 127
Telcyta (canfosfamide; Telik) 128
Drug overview 128
Key historical events 128
Clinical development in ovarian cancer 129
Datamonitor comments 132
Phenoxodiol (Marshall Edwards) 133
Drug overview 133
Key historical events 133
Clinical development in ovarian cancer 133
Datamonitor comments 135
Karenitecin (cositecan; BioNumerik) 136
Drug overview 136
Key historical events 136
Clinical development in ovarian cancer 137
Datamonitor comments 138
Opaxio (paclitaxel poliglumex; Cell Therapeutics/Novartis) 139
Drug overview 139
Key historical events 139
Clinical development in ovarian cancer 140
Datamonitor comments 142
Yondelis (trabectedin; PharmaMar/Johnson & Johnson) 143
Drug overview 143
Key historical events 144
Clinical development in ovarian cancer 145
Datamonitor comments 146
Patupilone (EPO-906; Novartis) 147
Drug overview 147
Key historical events 147
Clinical development in ovarian cancer 148
Datamonitor comments 149
Abagovomab (ACA-125; Menarini/CellControl BioMedical) 150
Drug overview 150
Key historical events 150
Clinical development in ovarian cancer 151
Datamonitor comments 152
Satisfaction of unmet needs 154
Unmet needs in ovarian cancer will be fulfilled to some extent by means of providing numerous alternative treatment options 154
CHAPTER 8 PROSTATE CANCER 155
Overview of prostate cancer 155
Definition 155
The most common cancer type and second-leading cause of cancer-related death in males 155
Epidemiology 155
Incidence of prostate cancer continues to rise with advances in screening procedures 155
Mortality from prostate cancer is relatively low given the high propensity for early diagnosis 156
Treatment of prostate cancer 157
Unmet need in prostate cancer 158
Summary of unmet needs 158
Side effects from antihormonal therapies may affect compliance 159
Alternative treatment options are needed for hormone-refractory patients 159
Greater R&D interest is needed in terms of innovative therapies 160
Pipeline overview 160
Pipeline summary 160
Late-phase pipeline 162
Phase II pipeline 163
Comparative forecasts 167
Definition of current comparator therapy 170
Pipeline candidates 171
Avastin (bevacizumab; Genentech/Roche) 171
Drug overview 171
Key historical events 171
Clinical development in prostate cancer 172
Datamonitor comments 176
Xinlay (atrasentan; Abbott) 177
Drug overview 177
Key historical events 177
Clinical development in prostate cancer 178
Datamonitor comments 181
Abiraterone (CB-7630; Cougar Biotechnology/BTG) 183
Drug overview 183
Key historical events 183
Clinical development in prostate cancer 184
Datamonitor comments 186
Aflibercept (VEGF-Trap; Regeneron/Sanofi-Aventis) 188
Drug overview 188
Key historical events 188
Clinical development in prostate cancer 189
Datamonitor comments 190
Zibotentan (ZD-4054; AstraZeneca) 191
Drug overview 191
Key historical events 191
Clinical development in prostate cancer 191
Datamonitor comments 193
Cabazitaxel (XRP-6258; Sanofi-Aventis) 195
Drug overview 195
Key historical developments 195
Clinical development in prostate cancer 195
Datamonitor comments 196
Firmagon (degarelix; Ferring/Astellas) 197
Drug overview 197
Key historical developments 197
Clinical development in prostate cancer 198
Datamonitor comments 200
GVAX (CG-8123; Cell Genesys/Takeda) 201
Drug overview 201
Key historical events 202
Clinical development in prostate cancer 202
Datamonitor comments 203
Provenge (sipuleucel-T; Dendreon) 205
Drug overview 205
Key historical events 205
Clinical development in prostate cancer 206
Datamonitor comments 210
Tookad (padoporfin; Weizmann Institute/Steba Biotech) 212
Drug overview 212
Key historical events 212
Clinical development in prostate cancer 213
Datamonitor comments 214
Satisfaction of unmet needs 215
Superiority over current standard therapies is unlikely to be shown by the current pipeline 215
CHAPTER 9 RENAL CELL CARCINOMA 216
Overview of renal cell carcinoma 216
Definition 216
Renal cell carcinoma has become a popular R&D indication for drug developers 216
Epidemiology 216
Incidence of renal cell carcinoma will continue to rise in line with the ageing population, increasing rates of obesity and more frequent diagnosis following imaging procedures 216
Mortality is high in late-stage RCC patients 217
Treatment of RCC 218
Unmet need in RCC 219
Summary of unmet need 219
Adjuvant therapy to prevent relapse following surgery in Stage I-III patients 219
More systemic therapies required to provide options in later lines of treatment 220
Non-clear cell RCC subtypes must be the focus of future therapies 221
Pipeline overview 221
Pipeline summary 221
Late-phase pipeline 223
Phase II pipeline 223
Comparative forecasts 226
Definition of current comparator therapy 228
Pipeline candidates 229
Afinitor (everolimus; Novartis) 229
Drug overview 229
Key historical events 229
Clinical development in RCC 230
Datamonitor comments 232
Armala (pazopanib; GlaxoSmithKline) 233
Drug overview 233
Key historical events 234
Clinical development in RCC 234
Datamonitor comments 236
Rencarex (WX-G250; Wilex) 237
Drug overview 237
Key historical events 237
Clinical development in RCC 238
Datamonitor comments 240
Axitinib (AG-13736; Pfizer) 241
Drug overview 241
Key historical events 242
Clinical development in RCC 242
Datamonitor comments 243
Oncophage (vitespen; Antigenics) 244
Drug overview 244
Key historical events 245
Clinical development in RCC 246
Datamonitor comments 247
Reniale (LipoNova) 248
Drug overview 248
Key historical events 248
Clinical development in RCC 249
Datamonitor comments 251
TroVax (MVA-h5T4; Oxford Biomedica/Sanofi-Aventis) 251
Drug overview 251
Key historical events 252
Clinical development in RCC 252
Datamonitor comments 254
Satisfaction of unmet needs 255
Afinitor shows great promise for fulfilling unmet needs in later lines of therapy, while Rencarex and Reniale show potential in the adjuvant setting 255
APPENDIX A 256
Bibliography 256
List of tables 275
List of figures 276
List of abbreviations 277
Contributing experts 280
Methodology 281
Datamonitor forecast methodology 281
Epidemiology forecasts 281
Product forecasts 281
Datamonitor drug assessment summary 282
APPENDIX B 284
About Datamonitor 284
About Datamonitor Healthcare 284
Datamonitor Healthcare's therapy area capabilities 285
About the Disease analysis team 286
Disclaimer 287
[Inhaltsverzeichnis ausblenden]

Table 1: Late-phase cytotoxics pipeline for bladder cancer, breast cancer, cervical cancer, ovarian cancer, prostate cancer and RCC, 2008 8
Table 2: Late-phase immunotherapies pipeline for bladder cancer, breast cancer, cervical cancer, ovarian cancer, prostate cancer and RCC, 2008 9
Table 3: Late-phase endocrine and photodynamic therapies pipeline for bladder cancer, breast cancer, cervical cancer, ovarian cancer, prostate cancer and RCC, 2008 9
Table 4: Late-phase targeted therapies pipeline for bladder cancer, breast cancer, cervical cancer, ovarian cancer, prostate cancer and RCC, 2008 10
Table 5: Pipeline split by developmental phase and indication, 2008 11
Table 6: Cytotoxic subgroup mechanisms of action 13
Table 7: Antihormonal subgroup mechanisms of action 14
Table 8: Targeted therapy subgroup mechanisms of action 15
Table 9: Immunotherapy subgroup mechanisms of action 16
Table 10: Oncology clinical trial design factors 17
Table 11: Crude incidence rate of bladder cancer per 100,000 population in the seven major pharmaceutical markets, 2002 18
Table 12: Forecast incidence of bladder cancer in the seven major pharmaceutical markets, 2002-2017 19
Table 13: Five-year survival rates by stage of bladder cancer, 1975-2000 20
Table 14: Late-phase bladder cancer pipeline, 2008 25
Table 15: Phase II bladder cancer pipeline, 2008 26
Table 16: Forecasting assumptions for bladder cancer pipeline products across the seven major markets, 2008 (1 of 2) 27
Table 17: Forecasting assumptions for bladder cancer pipeline products across the seven major markets, 2008 (2 of 2) 27
Table 18: Pipeline bladder cancer product sales forecasts across the seven major markets, 2008-2017 ($m) 28
Table 19: TheraCys: key historical facts 29
Table 20: Urocidin: key historical events 30
Table 21: Clinical development of Urocidin in bladder cancer, 2008 30
Table 22: EOquin: key historical events 33
Table 23: Clinical development of EOquin in bladder cancer, 2008 34
Table 24: Valstar: key historical events 37
Table 25: Larotaxel: key historical events 39
Table 26: Clinical development of larotaxel in bladder cancer, 2008 40
Table 27: Fulfillment of unmet needs by pipeline bladder cancer drugs, 2008 41
Table 28: Forecast incidence of breast cancer in the seven major pharmaceutical markets, 2002-2017 43
Table 29: Eight-year survival rates by stage of breast cancer 44
Table 30: Phase III breast cancer pipeline, 2008 50
Table 31: Phase II breast cancer pipeline, 2008 (targeted therapies) 50
Table 32: Phase II breast cancer pipeline, 2008 (cytotoxics) 52
Table 33: Phase II breast cancer pipeline, 2008 (immunotherapies) 53
Table 34: Phase II breast cancer pipeline, 2008 (miscellaneous) 54
Table 35: Forecasting assumptions for breast cancer pipeline products across the seven major markets, 2008 (1 of 2) 55
Table 36: Forecasting assumptions for breast cancer pipeline products across the seven major markets, 2008 (2 of 2) 55
Table 37: Pipeline breast cancer product sales forecasts across the seven major markets, 2008-2017 ($m) 56
Table 38: Taxotere: key historical facts 57
Table 39: Afinitor: key historical events 58
Table 40: Clinical development of Afinitor in breast cancer, 2008 59
Table 41: Armala: key historical events 63
Table 42: Clinical development of Armala in breast cancer, 2008 64
Table 43: Omnitarg: key historical events 67
Table 44: Clinical development of Omnitarg in breast cancer, 2008 68
Table 45: Sutent: key historical events 72
Table 46: Clinical development of Sutent in breast cancer, 2008 73
Table 47: Ramucirumab: key historical events 77
Table 48: Clinical development of ramucirumab in breast cancer, 2008 77
Table 49: Eribulin: key historical events 79
Table 50: Clinical development of eribulin in breast cancer, 2008 80
Table 51: Fulfillment of unmet needs by pipeline breast cancer drugs, 2008 84
Table 52: Datamonitor's forecast incidence of cervical cancer in the seven major pharmaceutical markets, 2002-2017 86
Table 53: Phase III cervical cancer pipeline, 2008 92
Table 54: Phase II cervical cancer pipeline, 2008 (targeted therapies) 92
Table 55: Phase II cervical cancer pipeline, 2008 (cytotoxics and immunotherapies) 93
Table 56: Forecasting assumptions for pipeline cervical cancer products across the seven major markets, 2008 94
Table 57: Pipeline cervical cancer product sales forecasts across the seven major markets, 2008-2017 ($m) 94
Table 58: Hycamtin: key historical facts 95
Table 59: Gemzar: key historical events 96
Table 60: Clinical development of Gemzar in cervical cancer, 2008 97
Table 61: Phase II study results investigating single-agent Gemzar in previously treated advanced cervical cancer 98
Table 62: Phase II study results investigating second-line Gemzar-based combination regimens in advanced cervical cancer 99
Table 63: Tirazone: key historical events 101
Table 64: Clinical development of Tirazone in cervical cancer, 2008 101
Table 65: Fulfillment of unmet needs by pipeline cervical cancer drugs, 2008 105
Table 66: Datamonitor's forecast incidence of ovarian cancer in the seven major pharmaceutical markets, 2002-2017 107
Table 67: Stage distribution at diagnosis 108
Table 68: Five-year survival rate by stage of ovarian cancer 108
Table 69: Phase III ovarian cancer pipeline, 2008 114
Table 70: Phase II ovarian cancer pipeline, 2008 (targeted therapies) 115
Table 71: Phase II ovarian cancer pipeline, 2008 (cytotoxics) 116
Table 72: Phase II ovarian cancer pipeline, 2008 (miscellaneous) 117
Table 73: Forecasting assumptions for pipeline ovarian cancer products across the seven major markets, 2008 (1 of 3) 118
Table 74: Forecasting assumptions for pipeline ovarian cancer products across the seven major markets, 2008 (2 of 3) 118
Table 75: Forecasting assumptions for pipeline ovarian cancer products across the seven major markets, 2008 (3 of 3) 119
Table 76: Pipeline ovarian cancer product sales forecasts across the seven major markets, 2008-2017 ($m) 119
Table 77: Hycamtin: key historical facts 120
Table 78: Avastin: key historical events 121
Table 79: Clinical development of Avastin in ovarian cancer, 2008 122
Table 80: Telcyta: key historical events 129
Table 81: Clinical development of Telcyta in ovarian cancer, 2008 129
Table 82: Phenoxodiol: key historical events 133
Table 83: Clinical development of phenoxodiol in ovarian cancer, 2008 134
Table 84: Karenitecin: key historical events 137
Table 85: Clinical development of Karenitecin in ovarian cancer, 2008 137
Table 86: Opaxio: key historical events 140
Table 87: Clinical development of Opaxio in ovarian cancer, 2008 141
Table 88: Yondelis: key historical events 144
Table 89: Clinical development of Yondelis in ovarian cancer, 2008 145
Table 90: Patupilone: key historical events 147
Table 91: Clinical development of patupilone in ovarian cancer, 2008 148
Table 92: Abagovomab: key historical events 150
Table 93: Clinical development of abagovomab in ovarian cancer, 2008 151
Table 94: Fulfillment of unmet needs by pipeline ovarian cancer drugs, 2008 154
Table 95: Datamonitor's forecast incidence of prostate cancer in the seven major pharmaceutical markets, 2002-2017 156
Table 96: Late-phase prostate cancer pipeline, 2008 162
Table 97: Phase II prostate cancer pipeline, 2008 (targeted therapies) 163
Table 98: Phase II prostate cancer pipeline, 2008 (cytotoxics) 165
Table 99: Phase II prostate cancer pipeline, 2008 (immunotherapies) 166
Table 100: Phase II prostate cancer pipeline, 2008 (miscellaneous) 167
Table 101: Forecasting assumptions for pipeline prostate cancer products across the seven major markets, 2008 (1 of 3) 168
Table 102: Forecasting assumptions for pipeline prostate cancer products across the seven major markets, 2008 (2 of 3) 168
Table 103: Forecasting assumptions for pipeline prostate cancer products across the seven major markets, 2008 (3 of 3) 169
Table 104: Pipeline prostate cancer product sales forecasts across the seven major markets, 2008-2017 ($m) 169
Table 105: Taxotere: key historical facts 171
Table 106: Avastin: key historical events 172
Table 107: Clinical development of Avastin in prostate cancer, 2008 173
Table 108: Xinlay: key historical events 178
Table 109: Clinical development of Xinlay in prostate cancer, 2008 178
Table 110: Abiraterone: key historical events 183
Table 111: Clinical development of abiraterone in prostate cancer, 2008 184
Table 112: Aflibercept: key historical events 189
Table 113: Clinical development of aflibercept in prostate cancer, 2008 189
Table 114: Zibotentan: key historical events 191
Table 115: Clinical development of zibotentan in prostate cancer, 2008 192
Table 116: Cabazitaxel: key historical events 195
Table 117: Clinical development of cabazitaxel in prostate cancer, 2008 196
Table 118: Firmagon: key historical events 198
Table 119: Clinical development of Firmagon in prostate cancer, 2008 198
Table 120: GVAX: key historical events 202
Table 121: Clinical development of GVAX in prostate cancer, 2008 202
Table 122: Phase II results for GVAX monotherapy in HRPC 203
Table 123: Provenge: key historical events 206
Table 124: Clinical development of Provenge in prostate cancer, 2008 207
Table 125: Tookad: key historical events 213
Table 126: Clinical development of Provenge in prostate cancer, 2008 213
Table 127: Fulfillment of unmet needs by pipeline prostate cancer drugs, 2008 215
Table 128: Datamonitor's forecast incidence of RCC in the seven major pharmaceutical markets, 2002-2017 217
Table 129: Five-year survival rate by stage of RCC, 2004 218
Table 130: Stage of RCC at diagnosis 220
Table 131: Phase III RCC pipeline, 2008 223
Table 132: Phase II RCC pipeline, 2008 (targeted therapies) 224
Table 133: Phase II RCC pipeline, 2008 (immunotherapies) 225
Table 134: Phase II RCC pipeline, 2008 (cytotoxics) 226
Table 135: Forecasting assumptions for pipeline RCC products across the seven major markets, 2008 (1 of 2) 226
Table 136: Forecasting assumptions for pipeline RCC products across the seven major markets, 2008 (2 of 2) 227
Table 137: Pipeline RCC product sales forecasts across the seven major markets, 2008-2017 ($m) 227
Table 138: Sutent: key facts 229
Table 139: Afinitor: key historical events 230
Table 140: Clinical development of Afinitor in RCC, 2008 231
Table 141: Armala: key historical events 234
Table 142: Clinical development of Armala in RCC, 2008 235
Table 143: Rencarex: key historical events 238
Table 144: Clinical development of Rencarex in RCC, 2008 238
Table 145: Axitinib: key historical events 242
Table 146: Clinical development of axitinib in RCC, 2008 242
Table 147: Oncophage: key historical events 245
Table 148: Reniale: key historical events 249
Table 149: TroVax: key historical events 252
Table 150: Clinical development of TroVax in RCC, 2008 253
Table 151: Fulfillment of unmet needs by pipeline RCC drugs, 2008 255
Table 152: List of abbreviations 277
Table 153: Datamonitor drug assessment parameters 282
Figure 1: Forecast incidence and mortality from bladder cancer in 2008 and 2017 across the seven major markets 20
Figure 2: Summary of unmet needs in the bladder cancer market, 2008 22
Figure 3: Datamonitor drug assessment summary for the pipeline bladder cancer products, 2008 24
Figure 4: Pipeline bladder cancer product sales forecasts across the seven major markets, 2008-2017 ($m) 28
Figure 5: Phase II study investigating Urocidin in high-risk superficial bladder cancer 31
Figure 6: Phase II study investigating EOquin in recurrent non-invasive bladder cancer 35
Figure 7: Forecast incidence and mortality from breast cancer in 2008 and 2017 across the seven major markets 44
Figure 8: Summary of unmet needs in the breast cancer market, 2008 46
Figure 9: Datamonitor drug assessment summary for the pipeline breast cancer products, 2008 49
Figure 10: Pipeline breast cancer product sales forecasts across the seven major markets, 2008-2017 ($m) 56
Figure 11: Phase II trial results investigating neoadjuvant Afinitor plus Femara in hormone receptor-positive breast cancer 60
Figure 12: Phase II results investigating first/second-line Afinitor monotherapy in metastatic breast cancer 61
Figure 13: Phase II results investigating first-line Tykerb with or without Armala in HER-2-positive advanced or metastatic breast cancer 65
Figure 14: Phase II results investigating Omnitarg plus Herceptin in HER-2-positive metastatic breast cancer following failure of prior Herceptin 69
Figure 15: Phase II results investigating single-agent Omnitarg metastatic breast cancer with low HER-2 expression 70
Figure 16: Phase II results investigating single-agent Sutent in previously treated metastatic breast cancer 74
Figure 17: Phase II study investigating second-line or higher eribulin in chemotherapy-refractory advanced breast cancer patients 81
Figure 18: Phase II study investigating third-line or higher eribulin in chemotherapy-refractory advanced breast cancer patients 82
Figure 19: Incidence and mortality from cervical cancer in 2008 and 2017 across the seven major markets 87
Figure 20: Summary of unmet needs in the cervical cancer market, 2008 89
Figure 21: Datamonitor drug assessment summary for the pipeline cervical cancer products, 2008 91
Figure 22: Pipeline cervical cancer product sales forecasts across the seven major markets, 2008-2017 ($m) 95
Figure 23: Phase II trial investigating first/second-line Tirazone and cisplatin in metastatic cervical cancer patients (Maluf study) 102
Figure 24: Phase II trial investigating first-line Tirazone and cisplatin in metastatic cervical cancer patients 103
Figure 25: Incidence and mortality from ovarian cancer in 2008 and 2017 across the seven major markets 107
Figure 26: Summary of unmet needs in the ovarian cancer market, 2008 110
Figure 27: Datamonitor drug assessment summary for the pipeline ovarian cancer products, 2008 113
Figure 28: Pipeline ovarian cancer product sales forecasts across the seven major markets, 2008-2017 ($m) 120
Figure 29: Phase II trial investigating Avastin monotherapy or combination chemotherapy regimens in heavily pretreated ovarian cancer 124
Figure 30: Phase II trial investigating third-line Avastin and Hycamtin in platinum-refractory recurrent ovarian cancer 125
Figure 31: Phase II trial investigating first-line Avastin, cisplatin and paclitaxel in optimally debulked Stage II/III ovarian cancer 126
Figure 32: Phase III ASSIST-1 study comparing third-line Telcyta with Doxil or Hycamtin 130
Figure 33: Phase III ASSIST-3 study comparing second-line Telcyta + carboplatin with Doxil 131
Figure 34: Preliminary Phase IIa results investigating a second-line combination of phenoxodiol with either paclitaxel or cisplatin 135
Figure 35: Phase II results investigating third-line Karenitecin in recurrent or persistent ovarian cancer 138
Figure 36: Phase II trial results investigating Opaxio in newly diagnosed Stage III/IV ovarian cancer patients 142
Figure 37: Pooled results from three Phase II trials investigating Yondelis in advanced relapsed ovarian cancer 146
Figure 38: Phase I/II trial investigating second-line patupilone in refractory or relapsed advanced ovarian cancer 149
Figure 39: Phase I/II trial investigating maintenance abagovomab following chemotherapy for recurrent ovarian cancer 152
Figure 40: Incidence and mortality from prostate cancer in 2008 and 2017 across the seven major markets 157
Figure 41: Summary of unmet needs in the prostate cancer market, 2008 159
Figure 42: Datamonitor drug assessment summary for the pipeline prostate cancer products, 2008 161
Figure 43: Pipeline prostate cancer product sales forecasts across the seven major markets, 2008-2017 ($m) 170
Figure 44: Initial Phase II results investigating first-line Avastin, Taxotere and estramustine in metastatic HRPC 174
Figure 45: Phase II results investigating first-line Avastin, Taxotere and Thalomid in metastatic HRPC 175
Figure 46: Meta-analysis of pooled data from the M96-594 and M00-211 clinical trials in metastatic HRPC 179
Figure 47: Phase III M00-244 study results in non-metastatic HRPC 181
Figure 48: Preliminary Phase II COU-AA-004 results for second/third-line abiraterone and prednisone in advanced HRPC 185
Figure 49: Combined COU-AA-001 Phase I/II and COU-AA-003 Phase II results in chemotherapy-naïve patients and taxane-pretreated patients 186
Figure 50: Phase II study investigating first-line zibotentan in HRPC metastatic to the bone 193
Figure 51: Phase III CS21 study results comparing Firmagon to Lupron in hormone-sensitive prostate cancer 199
Figure 52: Phase III D9901 results investigating Provenge in asymptomatic metastatic HRPC 208
Figure 53: Analysis of patient subgroup from Phase III D9901 and D9902A studies who received Taxotere following Provenge or placebo 209
Figure 54: Phase III PROTECT results investigating Provenge in hormone-sensitive non-metastatic prostate cancer 210
Figure 55: Incidence and mortality from RCC in 2008 and 2017 across the seven major markets 218
Figure 56: Summary of unmet needs in the RCC market, 2008 219
Figure 57: Datamonitor drug assessment summary for the pipeline RCC cancer products, 2008 222
Figure 58: Pipeline RCC product sales forecasts across the seven major markets, 2008-2017 ($m) 228
Figure 59: Phase III RECORD-1 trial results investigating Afinitor in tyrosine kinase inhibitor-refractory metastatic RCC 232
Figure 60: Final analysis of a Phase II trial investigating single-agent Armala in cytokine-naïve and refractory patients 236
Figure 61: Phase II results for Rencarex monotherapy in metastatic RCC 239
Figure 62: Phase II results for Rencarex and interferon-alfa in metastatic RCC 240
Figure 63: Phase II results for axitinib in RCC patients refractory to Sutent, Nexavar and/or cytokine therapy 243
Figure 64: Phase III trial data investigating adjuvant Reniale 250
Figure 65: Datamonitor drug assessment summary of pipeline molecular targeted therapies in development for hematological malignancies, 2007 283
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