Stakeholder Opinions: Pancreatic Cancer - Gemzar dominance will continue among high levels of persistent unmet needs
Datamonitor
March 12, 2009 89 Pages - SKU: DFMN2171304
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Introduction
Only 15-20% of pancreatic cancer patients have resectable disease, therefore most receive systemic therapy. Gemzar (gemcitabine; Eli Lilly) forms the current standard of care for advanced disease. Despite this, no treatment is truly effective, with five-year survival at 5% for all stages of disease. Significant unmet needs therefore remain, with ample commercial opportunities for drug developers.
Scope
- Pancreatic cancer overview, including definition, risk factors, epidemiology forecasts and discussion of unmet needs
- Current diagnosis and treatment of pancreatic cancer, including drug regimens used by stage and ongoing controversies
- Examination of the late-phase pancreatic cancer pipeline and market opportunities for drug developers
- Stakeholder opinions based on qualitative interviews with key opinion leaders in the field of pancreatic cancer
Highlights
Gemzar is the current standard of care for unresectable locally advanced and metastatic pancreatic cancer. Despite this, Gemzar is only associated with median overall survival of 5.7 months and a one-year survival rate of 18%. It is therefore clear that treatment of pancreatic cancer continues to be plagued by high levels of unmet need.
Other lines of therapy in pancreatic cancer remain ill defined due to a lack of definitive randomized clinical trial data. Controversy persists regarding the use of neoadjuvant versus adjuvant therapy, while the role of radiotherapy alongside chemotherapy in these settings continues to provoke debate.
The pancreatic cancer pipeline is relatively active, with six Phase III agents. Despite this, Gemzar is set to retain its leading status for the foreseeable future. While promising Phase II results have been shown, this has yet to be translated into Phase III efficacy. As a result, no pipeline agent has yet shown the potential to replace Gemzar.
Reasons to Purchase
- Identify the limitations of current therapy available to pancreatic cancer patients and the potential of future therapy
- Understand current epidemiological trends in pancreatic cancer and ongoing treatment controversies
- Assess the opportunities for innovative targeted therapies in the pancreatic cancer market, particularly in metastatic disease
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- ABOUT DATAMONITOR HEALTHCARE
- About the Oncology pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Datamonitor insight into the pancreatic cancer market
- Contributing experts
- Related reports
- Upcoming reports
- CHAPTER 2 DISEASE OVERVIEW
- Introduction
- Disease overview
- Pancreatic cancer represents a major health issue in the developed world
- Anatomy of the pancreas
- Pancreatic cancer
- Definition
- The majority of patients present with metastatic spread
- Pathology
- 90% of pancreatic cancers arise in the ductal epithelium
- Epidemiology
- Incidence of pancreatic cancer will continue to rise as a reflection of the aging population
- Mortality from pancreatic cancer is nearly equal to its incidence
- Risk factors
- Older age
- Male gender
- Black ethnicity
- Cigarette smoking
- Obesity
- Diet high in fat and red/processed meat
- Genetic syndromes
- Chronic pancreatitis
- Diabetes mellitus
- Symptoms
- Non-specific symptoms result in a frequent late diagnosis
- Screening
- Screening in the general population is not cost effective, although may be warranted in high-risk populations
- Diagnosis
- Imaging techniques and biopsy are used to diagnose pancreatic cancer
- Staging
- The TNM staging system does not take resectability of a tumor into account, therefore an alternative clinical staging system is often used
- Survival
- Survival is exceedingly poor for pancreatic cancer patients, even those diagnosed at an early stage of disease
- Prognosis
- Tumor size and extent of lymph node involvement are the main prognostic factors in pancreatic cancer
- Prevention
- Prevention of pancreatic cancer may be possible by avoiding known risk factors such as cigarette smoking
- CHAPTER 3 CURRENT TREATMENT OPTIONS AND CONTROVERSIES
- Introduction
- Treatment overview
- Treatment guidelines for pancreatic cancer are similar across the seven major pharmaceutical markets
- Treatment of resectable pancreatic cancer
- Surgery
- Despite offering the only chance of a cure, survival following resection of pancreatic cancer remains poor
- Adjuvant therapy
- US guidelines recommend adjuvant therapy for resectable pancreatic cancer, however, its use remains controversial in the EU and Japan
- Controversy exists over the role of radiotherapy in the adjuvant setting
- When adjuvant chemotherapy is used, Gemzar is the preferred agent of choice
- Neoadjuvant therapy
- Neoadjuvant therapy is recommended for patients with borderline resectable tumors despite a lack of data from large-scale randomized trials
- Treatment of locally advanced unresectable and metastatic pancreatic cancer
- Surgery
- Surgery can serve palliative purposes in advanced pancreatic cancer
- Chemoradiotherapy
- Chemoradiotherapy can be administered to unresectable locally advanced patients, however, its use remains controversial due to high toxicity
- First-line chemotherapy
- Gemzar-based chemotherapy forms the current standard of care for locally advanced unresectable and metastatic pancreatic cancer
- 5-fluorouracil is still used to some extent in pancreatic cancer due to its genericized status
- Combination chemotherapy regimens may be of use in patients with good performance status
- Targeted therapy
- Despite being approved for pancreatic cancer, use of Tarceva remains controversial due to the small survival benefit shown
- Second-line therapy
- Second-line chemotherapy may offer palliative effects in patients with a good performance status
- CHAPTER 4 UNMET NEEDS
- Introduction
- Unmet needs
- Improving prognosis of pancreatic cancer
- Associated with exceptionally poor survival rates across all stages of disease
- Earlier rates of diagnosis are desperately needed in order to boost survival
- More effective treatment options are required across all stages of disease
- An effective neoadjuvant or adjuvant regimen is required to prevent high rates of recurrence after surgery for early-stage disease
- A lack of effective systemic therapies exists, therefore a higher level of R&D interest is needed
- More options for the few patients who receive second-line treatment are needed
- Summary of unmet needs
- CHAPTER 5 PIPELINE ANALYSIS
- The pancreatic cancer pipeline
- Phase III pipeline
- Phase II pipeline
- Phase I pipeline
- Phase III pipeline candidates
- Theraloc (nimotuzumab; YM Biosciences/Biocon)
- Drug overview
- Key historical events
- Clinical development in pancreatic cancer
- Datamonitor comments
- Aflibercept (VEGF-Trap; Regeneron/Sanofi-Aventis)
- Drug overview
- Key historical events
- Clinical development in pancreatic cancer
- Datamonitor comments
- Masitinib (AB-1010; AB Science)
- Drug overview
- Key historical events
- Clinical development in pancreatic cancer
- Datamonitor comments
- Larotaxel (XRP-9881; Sanofi-Aventis)
- Drug overview
- Key historical events
- Clinical development in pancreatic cancer
- Datamonitor comments
- GV-1001 (tertomotide; Pharmexa)
- Drug overview
- Key historical events
- Clinical development in pancreatic cancer
- Datamonitor comments
- TNFerade (TNF-alpha gene therapy; GenVec)
- Drug overview
- Key historical events
- Clinical development in pancreatic cancer
- Datamonitor comments
- BIBLIOGRAPHY
- Bibliography
- APPENDIX
- List of tables
- List of figures
- About Datamonitor
- About Datamonitor Healthcare
- Datamonitor Healthcare's therapy area capabilities
- About the Oncology analysis team
- Disclaimer
- List of Tables
- Table 1: Crude incidence rates for pancreatic cancer by gender per 100,000 in the seven major pharmaceutical markets
- Table 2: Forecast incidence of pancreatic cancer in the seven major pharmaceutical markets, 2002-2018
- Table 3: Crude mortality rates for pancreatic cancer by gender per 100,000 in the seven major pharmaceutical markets
- Table 4: Risk factors for the development of pancreatic cancer
- Table 5: TNM classification and staging system for pancreatic cancer
- Table 6: Stage distribution for pancreatic cancer in the US, 1992-98
- Table 7: Five-year survival rates and median survival for pancreatic cancer, 1992-98
- Table 8: Five-year survival rates and median survival for resected and non-resected pancreatic cancer, 1992-98
- Table 9: Phase III results for Gemzar-based combination chemotherapy regimens in advanced pancreatic cancer
- Table 10: Clinical trial results for second-line chemotherapy in advanced pancreatic cancer
- Table 11: Five-year survival rates and median survival for pancreatic cancer, 1992-98
- Table 12: Five-year survival rates and median survival for resected and non-resected pancreatic cancer, 1992-98
- Table 13: Phase III pancreatic cancer pipeline, 2009
- Table 14: Phase II pancreatic cancer pipeline, 2009 (targeted therapies)
- Table 15: Phase II pancreatic cancer pipeline, 2009 (cytotoxics)
- Table 16: Phase II pancreatic cancer pipeline, 2009 (immunotherapies and gene therapies)
- Table 17: Phase I pancreatic cancer pipeline, 2009 (targeted therapies)
- Table 18: Phase I pancreatic cancer pipeline, 2009 (cytotoxics, gene therapies and immunotherapies)
- Table 19: Theraloc: key historical events, 2004-09
- Table 20: Clinical development of Theraloc in pancreatic cancer, 2009
- Table 21: Aflibercept: key historical events, 2003-08
- Table 22: Clinical development of aflibercept in pancreatic cancer, 2009
- Table 23: Masitinib: key historical events, 2004-08
- Table 24: Clinical development of masitinib in pancreatic cancer, 2009
- Table 25: Larotaxel: key historical events, 2004-08
- Table 26: Clinical development of larotaxel in pancreatic cancer, 2009
- Table 27: GV-1001: key historical events, 2006-08
- Table 28: Clinical development of GV-1001 in pancreatic cancer, 2009
- Table 29: TNFerade: key historical events, 2002-08
- Table 30: Clinical development of TNFerade in pancreatic cancer, 2008
- List of Figures
- Figure 1: Anatomy of the pancreas
- Figure 2: Forecast incidence and mortality from pancreatic cancer in 2009 and 2018 across the seven major pharmaceutical markets
- Figure 3: Pancreatic cancer treatment overview, 2009
- Figure 4: Phase III results investigating first-line Gemzar versus 5-fluorouracil in advanced symptomatic pancreatic cancer
- Figure 5: Phase III results investigating first-line Gemzar with or without Tarceva in unresectable locally advanced or metastatic pancreatic cancer
- Figure 6: Summary of unmet needs in the pancreatic cancer market, 2009
- Figure 7: Preliminary Phase II results for second-line Theraloc in locally advanced or metastatic pancreatic cancer
- Figure 8: Phase II trial investigating first-line Gemzar with masitinib in locally advanced and metastatic pancreatic cancer
- Figure 9: Phase I/II trial results investigating GV-1001 in unresectable pancreatic cancer
- Figure 10: Interim results from the Phase III PACT trial
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