Stakeholder Opinions: Pancreatic Cancer - Gemzar dominance will continue among high levels of persistent unmet needs

Published by: Datamonitor

Published: Mar. 12, 2009 - 89 Pages

Table of Contents

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

Abstract

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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