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Stakeholder Opinions: Pancreatic Cancer - Gemzar dominance will continue among high levels of persistent unmet needs
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 pancreatic cancer market 3
Contributing experts 4
Related reports 5
Upcoming reports 5
CHAPTER 2 DISEASE OVERVIEW 7
Introduction 7
Disease overview 7
Pancreatic cancer represents a major health issue in the
developed world 7
Anatomy of the pancreas 7
Pancreatic cancer 8
Definition 8
The majority of patients present with metastatic spread 8
Pathology 9
90% of pancreatic cancers arise in the ductal epithelium 9
Epidemiology 9
Incidence of pancreatic cancer will continue to rise as a
reflection of the aging population 9
Mortality from pancreatic cancer is nearly equal to its
incidence 11
Risk factors 12
Older age 13
Male gender 13
Black ethnicity 13
Cigarette smoking 13
Obesity 14
Diet high in fat and red/processed meat 14
Genetic syndromes 14
Chronic pancreatitis 15
Diabetes mellitus 15
Symptoms 16
Non-specific symptoms result in a frequent late diagnosis 16
Screening 16
Screening in the general population is not cost effective,
although may be warranted in high-risk populations 16
Diagnosis 18
Imaging techniques and biopsy are used to diagnose pancreatic
cancer 18
Staging 19
The TNM staging system does not take resectability of a tumor
into account, therefore an alternative clinical staging system
is often used 19
Survival 21
Survival is exceedingly poor for pancreatic cancer patients,
even those diagnosed at an early stage of disease 21
Prognosis 22
Tumor size and extent of lymph node involvement are the main
prognostic factors in pancreatic cancer 22
Prevention 23
Prevention of pancreatic cancer may be possible by avoiding
known risk factors such as cigarette smoking 23
CHAPTER 3 CURRENT TREATMENT OPTIONS AND CONTROVERSIES 24
Introduction 24
Treatment overview 24
Treatment guidelines for pancreatic cancer are similar across
the seven major pharmaceutical markets 24
Treatment of resectable pancreatic cancer 25
Surgery 25
Despite offering the only chance of a cure, survival following
resection of pancreatic cancer remains poor 25
Adjuvant therapy 27
US guidelines recommend adjuvant therapy for resectable
pancreatic cancer, however, its use remains controversial in the
EU and Japan 27
Controversy exists over the role of radiotherapy in the adjuvant
setting 27
When adjuvant chemotherapy is used, Gemzar is the preferred
agent of choice 29
Neoadjuvant therapy 30
Neoadjuvant therapy is
recommended for patients with borderline resectable tumors
despite a lack of data from large-scale randomized trials 30
Treatment of locally advanced unresectable and metastatic
pancreatic cancer 31
Surgery 31
Surgery can serve palliative purposes in advanced pancreatic
cancer 31
Chemoradiotherapy 32
Chemoradiotherapy can be
administered to unresectable locally advanced patients, however,
its use remains controversial due to high toxicity 32
First-line chemotherapy 33
Gemzar-based
chemotherapy forms the current standard of care for locally
advanced unresectable and metastatic pancreatic cancer 33
5-fluorouracil is still used to some extent in pancreatic cancer
due to its genericized status 34
Combination chemotherapy regimens may be of use in patients with
good performance status 35
Targeted therapy 36
Despite being approved for pancreatic cancer, use of Tarceva
remains controversial due to the small survival benefit shown 36
Second-line therapy 38
Second-line chemotherapy may offer palliative effects in
patients with a good performance status 38
CHAPTER 4 UNMET NEEDS 40
Introduction 40
Unmet needs 40
Improving prognosis of pancreatic cancer 40
Associated with exceptionally poor survival rates across all
stages of disease 40
Earlier rates of diagnosis are desperately needed in order to
boost survival 41
More effective treatment options are required across all stages
of disease 43
An effective neoadjuvant or adjuvant regimen is required to
prevent high rates of recurrence after surgery for early-stage
disease 43
A lack of effective systemic therapies exists, therefore a
higher level of R&D interest is needed 43
More options for the few patients who receive second-line
treatment are needed 45
Summary of unmet needs 45
CHAPTER 5 PIPELINE ANALYSIS 46
The pancreatic cancer pipeline 46
Phase III pipeline 46
Phase II pipeline 46
Phase I pipeline 50
Phase III pipeline candidates 52
Theraloc (nimotuzumab;
YM Biosciences/Biocon) 52
Drug overview 52
Key historical events 53
Clinical development in pancreatic cancer 54
Datamonitor comments 55
Aflibercept (VEGF-Trap;
Regeneron/Sanofi-Aventis) 57
Drug overview 57
Key historical events 57
Clinical development in pancreatic cancer 58
Datamonitor comments 59
Masitinib (AB-1010; AB
Science) 60
Drug overview 60
Key historical events 60
Clinical development in pancreatic cancer 60
Datamonitor comments 62
Larotaxel (XRP-9881;
Sanofi-Aventis) 63
Drug overview 63
Key historical events 64
Clinical development in pancreatic cancer 64
Datamonitor comments 65
GV-1001 (tertomotide; Pharmexa) 66
Drug overview 66
Key historical events 66
Clinical development in pancreatic cancer 67
Datamonitor comments 68
TNFerade (TNF-alpha gene
therapy; GenVec) 69
Drug overview 69
Key historical events 70
Clinical development in pancreatic cancer 70
Datamonitor comments 72
BIBLIOGRAPHY 74
Bibliography 74
APPENDIX 84
List of tables 84
List of figures 85
About Datamonitor 86
About Datamonitor Healthcare 86
Datamonitor Healthcare's
therapy area capabilities 87
About the Oncology analysis team 87
Disclaimer 89
List of Tables
Table 1: Crude incidence rates for pancreatic cancer by gender
per 100,000 in the seven major pharmaceutical markets 9
Table 2: Forecast incidence of pancreatic cancer in the seven
major pharmaceutical markets, 2002-2018 10
Table 3: Crude mortality rates for pancreatic cancer by gender
per 100,000 in the seven major pharmaceutical markets 11
Table 4: Risk factors for the development of pancreatic cancer
13
Table 5: TNM classification and staging system for pancreatic
cancer 19
Table 6: Stage distribution for pancreatic cancer in the US,
1992-98 21
Table 7: Five-year survival rates and median survival for
pancreatic cancer, 1992-98 22
Table 8: Five-year survival rates and median survival for
resected and non-resected pancreatic cancer, 1992-98 26
Table 9: Phase III results for Gemzar-based combination
chemotherapy regimens in advanced pancreatic cancer 35
Table 10: Clinical trial results for second-line chemotherapy in
advanced pancreatic cancer 39
Table 11: Five-year survival rates and median survival for
pancreatic cancer, 1992-98 40
Table 12: Five-year survival rates and median survival for
resected and non-resected pancreatic cancer, 1992-98 42
Table 13: Phase III pancreatic cancer pipeline, 2009 46
Table 14: Phase II pancreatic cancer pipeline, 2009 (targeted
therapies) 47
Table 15: Phase II pancreatic cancer pipeline, 2009 (cytotoxics)
49
Table 16: Phase II pancreatic cancer pipeline, 2009 (immunotherapies
and gene therapies) 50
Table 17: Phase I pancreatic cancer pipeline, 2009 (targeted
therapies) 51
Table 18: Phase I pancreatic cancer pipeline, 2009 (cytotoxics,
gene therapies and immunotherapies) 52
Table 19: Theraloc: key historical events, 2004-09 53
Table 20: Clinical development of Theraloc in pancreatic cancer,
2009 54
Table 21: Aflibercept: key historical events, 2003-08 57
Table 22: Clinical development of aflibercept in pancreatic
cancer, 2009 58
Table 23: Masitinib: key historical events, 2004-08 60
Table 24: Clinical development of masitinib in pancreatic
cancer, 2009 61
Table 25: Larotaxel: key historical events, 2004-08 64
Table 26: Clinical development of larotaxel in pancreatic
cancer, 2009 64
Table 27: GV-1001: key historical events, 2006-08 66
Table 28: Clinical development of GV-1001 in pancreatic cancer,
2009 67
Table 29: TNFerade: key historical events, 2002-08 70
Table 30: Clinical development of TNFerade in pancreatic cancer,
2008 71
List of Figures
Figure 1: Anatomy of the pancreas 8
Figure 2: Forecast incidence and mortality from pancreatic
cancer in 2009 and 2018 across the seven major pharmaceutical
markets 11
Figure 3: Pancreatic cancer treatment overview, 2009 25
Figure 4: Phase III results investigating first-line Gemzar
versus 5-fluorouracil in advanced symptomatic pancreatic cancer
34
Figure 5: Phase III results investigating first-line Gemzar with
or without Tarceva in unresectable locally advanced or
metastatic pancreatic cancer 37
Figure 6: Summary of unmet needs in the pancreatic cancer
market, 2009 45
Figure 7: Preliminary Phase II results for second-line Theraloc
in locally advanced or metastatic pancreatic cancer 55
Figure 8: Phase II trial investigating first-line Gemzar with
masitinib in locally advanced and metastatic pancreatic cancer
62
Figure 9: Phase I/II trial results investigating GV-1001 in
unresectable pancreatic cancer 68
Figure 10: Interim results from the Phase III PACT trial 72 |
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