Stakeholder Opinions: Ovarian Cancer - Approaching the era of molecular targeted therapy

Introduction

Despite advances in the management of the disease, outcomes remain poor for patients with advanced epithelial ovarian cancer. The high level of unmet need, coupled with the large size of the patient population, is driving extensive R&D interest in this indication. The anticipated incorporation of molecular targeted therapies into treatment is expected to improve patient outcomes in the future.

Scope

*Ovarian cancer overview, including disease definition, epidemiology, discussion of unmet needs, and market potential

*Current treatment options for ovarian cancer and ongoing controversies

*Examination of the late-phase ovarian cancer pipeline, including drug profiles of late-stage agents

*Stakeholder opinions based on qualitative interviews with key opinion leaders from the US and EU

Highlights

Ovarian cancer is the leading cause of death from gynecological malignancies in the Western world. This is because the majority of epithelial ovarian cancer patients present with advanced disease at diagnosis, where treatment has a palliative rather than curative intent.

While first-line platinum-based chemotherapy can result in high response rates of over 70-80%, the majority of patients will advanced epithelial ovarian cancer will eventually relapse with incurable disease. As such, there is a need for novel first-line therapies to improve survival rates.

R&D interest in ovarian cancer is high. There are currently 85 drugs in the pipeline, which is dominated by molecular targeted therapies (42%) and cytotoxic therapies (33%). Competition for the approval of the first molecular targeted therapy in ovarian cancer is fierce.

Reasons to Purchase

*Estimate the number of treatable patients and identify unmet needs for future drug development opportunities

*Understand the current treatment of the disease, as well as opportunities and threats in the ovarian cancer market

*Analyze the current ovarian cancer pipeline and the potential of late-stage drugs

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Overview 1
Catalyst 1
Summary 1
About Datamonitor healthcare 2
About the Oncology pharmaceutical analysis team 2
Executive Summary 3
Scope of the analysis 3
Datamonitor insight into the ovarian cancer market 3
Related reports 4
Upcoming reports 4
Table of Contents 5
Patient Potential 6
Key findings 6
Definition 6
Epithelial tumors 7
The vast majority of ovarian cancers are epithelial in origin 7
The majority of epithelial ovarian cancers are sporadic in nature 8
Germ cell tumors 8
Sex cord-stromal tumors 8
A successful screening test for ovarian cancer has not been developed 8
Ovarian cancer is a surgically staged malignancy 9
Epidemiology 12
The incidence of ovarian cancer in the seven major markets is forecast to reach nearly 63,000 cases by 2019 12
The highest ovarian cancer rates prevail in Northern European countries 14
Current treatment options 15
Most early-stage patients are treated with surgery and chemotherapy 15
Surgery has a central role in the management of advanced disease 16
First-line platinum-based chemotherapy is the standard of care for advanced disease 17
The use of intraperitoneal chemotherapy remains controversial 20
Maintenance therapy has not been shown to improve overall survival 21
The treatment of recurrent disease is rarely curative and depends on patients' platinum sensitivity 22
Platinum-based combination chemotherapy is recommended for platinum-sensitive recurrent disease 23
A number of single agents can be used in the treatment of platinum-resistant recurrent disease 25
Unmet need 25
More effective agents are required for the treatment of advanced disease 25
An effective screening test could significantly improve patient survival 26
R&D efforts should be directed towards molecular targeted therapies 26
Less invasive surgical approaches should be explored for early-stage patients 27
Market potential 28
Key findings 28
Current market overview 28
Opportunities and threats 29
Opportunities 29
Significant unmet need remains in the treatment of advanced disease 29
There is increased interest in the development of molecular targeted therapies 30
There is a large patient base in ovarian cancer, and a high commercial attractiveness 30
Threats 30
The development of an effective screening modality could decrease the patient base 30
Pipeline Analysis 31
Key findings 31
Ovarian cancer pipeline overview 31
Ovarian cancer late-phase pipeline 37
Avastin (bevacizumab; Genentech/Roche/Chugai) 37
Drug profile 37
Development overview 38
Product positioning 41
SWOT analysis 42
Karenitecin (cositecan; BNP-1350; BioNumerik) 43
Drug profile 43
Development overview 44
Product positioning 46
SWOT analysis 47
Opaxio (paclitaxel poliglumex; Cell Therapeutics/Novartis) 47
Drug profile 48
Development overview 48
Product positioning 49
SWOT analysis 50
Paclical (micellar paclitaxel formulation; Oasmia) 52
Drug profile 52
Development overview 52
Product positioning 53
SWOT analysis 54
Tarceva (erlotinib; Genentech/Roche/Chugai/OSI) 55
Drug profile 55
Development overview 55
Product positioning 58
SWOT analysis 59
Vargatef (intedanib; BIBF-1120; Boehringer Ingelheim) 60
Drug profile 60
Development overview 61
Product positioning 62
SWOT analysis 63
Votrient (pazopanib; GlaxoSmithKline) 63
Drug profile 63
Development overview 64
Product positioning 67
SWOT analysis 68
Farletuzumab (MORAb-003; Morphotek/Eisai) 69
Drug profile 69
Development overview 70
Product positioning 73
SWOT analysis 74
Abagovomab (Menarini/Cell Control Biomedical) 74
Drug profile 74
Development overview 75
Product positioning 77
SWOT analysis 77
Bibliography 79
Journals 79
Websites 84
Datamonitor reports 86
Appendix 87
Contributing experts 87
Report methodology 87
About Datamonitor 87
About Datamonitor Healthcare 87
About the Oncology analysis team 88
Disclaimer 90
List of Tables
Table 1: Staging of ovarian cancer using the International Federation of Gynecology and Obstetrics (FIGO) and American Joint Committee on Cancer (AJCC) classification 10
Table 2: Crude incidence rates of ovarian cancer per 100,000 population in the seven major pharmaceutical markets, 2002 12
Table 3: Forecast incidence of ovarian cancer in the seven major pharmaceutical markets, 2002-2019 12
Table 4: Top 5 countries with the highest crude incidence rates of ovarian cancer, 2002 14
Table 5: Survival results for randomized Phase III trials comparing cisplatin-paclitaxel with carboplatin-paclitaxel in advanced ovarian cancer 17
Table 6: Survival and selected toxicity results for randomized Phase III trial comparing docetaxel-carboplatin versus paclitaxel-carboplatin in ovarian cancer 18
Table 7: Randomized trials in platinum-sensitive ovarian cancer 23
Table 8: Selected clinical trial results for Yondelis presented at the American Society of Clinical Oncology (ASCO) meeting, June 2010 24
Table 9: Drugs approved by the US Food & Drug Administration (FDA) for the treatment of ovarian cancer 29
Table 10: Pipeline agents in Phase III development for ovarian cancer, 2010 31
Table 11: Pipeline agents in Phase II development for ovarian cancer, 2010 32
Table 12: Pipeline agents in Phase I development for ovarian cancer, 2010 34
Table 13: Avastin - drug profile, 2010 38
Table 14: Ongoing Phase III clinical trials for Avastin in ovarian cancer, 2010 39
Table 15: Selected Phase II trials of Avastin in ovarian cancer 40
Table 16: Karenitecin - drug profile, 2010 44
Table 17: Ongoing clinical trials for Karenitecin in ovarian cancer, 2010 45
Table 18: Phase II results for Karenitecin in the third-line treatment of recurrent or persistent platinum-resistant epithelial ovarian or primary peritoneal cancer 45
Table 19: Opaxio - drug profile, 2010 48
Table 20: Ongoing clinical trials for Opaxio in ovarian cancer, 2010 49
Table 21: Paclical - drug profile, 2010 52
Table 22: Ongoing clinical trials for Paclical in ovarian cancer, 2010 53
Table 23: Tarceva - drug profile, 2010 55
Table 24: Ongoing clinical trials for Tarceva in ovarian cancer, 2010 56
Table 25: Clinical trial results for Tarceva maintenance therapy in ovarian cancer 57
Table 26: Vargatef - drug profile, 2010 61
Table 27: Ongoing clinical trials for Vargatef in ovarian cancer, 2010 61
Table 28: Phase II results for Vargatef as maintenance therapy in advanced ovarian cancer 62
Table 29: Votrient - drug profile, 2010 63
Table 30: Ongoing clinical trials for Votrient in ovarian cancer, 2010 65
Table 31: Phase II results for Votrient maintenance therapy in epithelial ovarian, fallopian tube or primary peritoneal cancer patients with a rising CA 125 level following first- or second-line therapy 66
Table 32: Farletuzumab - drug profile, 2010 69
Table 33: Ongoing clinical trials for farletuzumab in ovarian cancer, 2010 71
Table 34: Results of a Phase II study evaluating farletuzumab in platinum-sensitive ovarian cancer at first relapse, 2010 72
Table 35: Abagovomab - drug profile, 2010 75
Table 36: Ongoing clinical trials for abagovomab in ovarian cancer, 2010 75
Table 37: Phase I/II results for abagovomab as maintenance therapy in recurrent ovarian cancer 76
List of Figures
Figure 1: Cellular origin of the three main types of ovarian cancer 7
Figure 2: Stage distribution and corresponding 5-year survival rate for ovarian cancer in the US, 1999-2005 11
Figure 3: Forecast incidence and mortality of ovarian cancer in 2010 and 2019 across the seven major pharmaceutical markets 13
Figure 4: Forecast incidence of ovarian cancer in Brazil, Russia, India, and China, 2010 and 2019 15
Figure 5: Key unmet needs in ovarian cancer, 2010 25
Figure 6: Number of drugs in development for ovarian cancer by phase of development, 2010 35
Figure 7: Ovarian cancer pipeline by type of therapy, 2010 36
Figure 8: Ovarian cancer late-phase pipeline by type of therapy, 2010 37
Figure 9: Avastin - SWOT analysis in ovarian cancer, 2010 43
Figure 10: Karenitecin - SWOT analysis in ovarian cancer, 2010 47
Figure 11: Opaxio - SWOT analysis in ovarian cancer, 2010 51
Figure 12: Paclical - SWOT analysis in ovarian cancer, 2010 54
Figure 13: Tarceva - SWOT analysis in ovarian cancer, 2010 60
Figure 14: Vargatef - SWOT analysis in ovarian cancer, 2010 63
Figure 15: Phase II trial design for Votrient maintenance therapy in epithelial ovarian, fallopian tube or primary peritoneal cancer patients with a rising CA 125 level following first- or second-line therapy 66
Figure 16: Votrient - SWOT analysis in ovarian cancer, 2010 69
Figure 17: Design of a Phase II study evaluating farletuzumab in platinum-sensitive ovarian cancer at first relapse 72
Figure 18: Farletuzumab - SWOT analysis in ovarian cancer, 2010 74
Figure 19: Abagovomab - SWOT analysis in ovarian cancer, 2010 78

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