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Stakeholder Opinions: Gastric Cancer - Targeted therapies compete for first-to-market status

Published by: Datamonitor

Published: Apr. 6, 2009 - 76 Pages


Table of Contents


ABOUT DATAMONITOR HEALTHCARE
About the Oncology pharmaceutical analysis team
CHAPTER 1 EXECUTIVE SUMMARY
Scope of analysis
Datamonitor insight into the gastric cancer market
Contributing experts
Related reports
Upcoming reports
CHAPTER 2 DISEASE OVERVIEW
Introduction
Disease overview
Anatomy of the stomach
Gastric cancer
Definition
Pathology/histology
Gastric adenocarcinoma is the most common type of gastric cancer
The heterogeneity of gastric adenocarcinoma requires several classification methods
Epidemiology
Gastric cancer incidence varies geographically
Mortality rates are relatively high across the seven major markets
Risk factors
Infection
Pre-malignant lesions
Genetics
Lifestyle
Symptoms
Non-specific nature of symptoms results in frequent late diagnosis in Western countries
Screening
Japanese laws enforce a population-based screening program
Diagnosis
Endoscopies are the most common procedure for gastric cancer detection
Endoscopic techniques may also serve as a means of treating early gastric cancer
Staging
Different staging systems are used in the US/EU and Japan
The gastric cancer market is segmented according to disease stage
Tumor staging is essential after diagnosis to aid therapy selection
Prognosis and survival
Disease stage determines survival
CHAPTER 3 CURRENT TREATMENT OPTIONS AND CONTROVERSIES
Introduction
Treatment guidelines overview
Gastric cancer treatment by disease stage
Treatment of early-stage disease
The treatment of early-stage disease is based on surgery
Treatment of locoregional disease
Treatment is based on surgery with lymph node dissection
The extent of lymph node dissection remains a matter of debate
Adjuvant chemoradiation is the standard of care in the US
Chemoradiation can be used in medically fit, unresectable patients
Perioperative chemotherapy seems to be the most favored approach in the five major EU markets
Radiotherapy reduces locoregional tumor recurrence but is not widely used
Treatment of advanced disease
The treatment of advanced gastric cancer is mainly palliative
CHAPTER 4 UNMET NEEDS
Key findings
Unmet needs
Effective systemic therapy for advanced disease
Second-line treatment options are required across all stages of gastric cancer
Education of US and EU surgeons on D2 dissection
Early diagnosis and treatment of H. pylori infections and other premalignant lesions may reduce the incidence of gastric cancer
Markers for asymptomatic disease
CHAPTER 5 PIPELINE ANALYSIS
Summary
The gastric cancer pipeline overview
Phase III pipeline
Phase II pipeline
Early-stage pipeline
Phase III drug profiles
Avastin (bevacizumab; Genentech/Roche/Chugai)
Drug overview
Key historical events
Clinical development in gastric cancer
Datamonitor comments
Erbitux (cetuximab; ImClone/Merck KGaA/Bristol-Myers Squibb)
Drug overview
Key Historical Events
Clinical development in gastric cancer
Datamonitor comments
Herceptin (trastuzumab; Genentech/Roche/Chugai)
Drug overview
Key historical events
Clinical development in gastric cancer
Datamonitor comments
Tykerb (lapatinib; GlaxoSmithKline)
Drug overview
Key historical events
Clinical development in gastric cancer
Datamonitor comments
Vectibix (panitumumab; Amgen)
Drug overview
Key historical events
Clinical development in gastric cancer
Datamonitor comments
BIBLIOGRAPHY
Bibliography
APPENDIX
List of tables
List of figures
About Datamonitor
About Datamonitor Healthcare
About the Oncology analysis team
Disclaimer
List of Tables
Table 1: Lauren classification system for gastric adenocarcinoma
Table 2: Crude incidence rates of gastric cancer in the seven major pharmaceutical markets, 2002
Table 3: Forecast incidence of gastric cancer in the seven major pharmaceutical markets, 2009-2019
Table 4: Crude mortality rates of gastric cancer in the seven major pharmaceutical markets, 2002
Table 5: Forecast mortality of gastric cancer in the seven major pharmaceutical markets, 2009-2019
Table 6: Risk factors associated with gastric cancer
Table 7: Screening methods used in gastric cancer
Table 8: TNM classification system for gastric cancer
Table 9: US TNM stage grouping system for gastric cancer
Table 10: R (residual tumor) classification system for gastric cancer
Table 11: Dissection classification for gastric cancer
Table 12: Japanese Surgical Classification System for gastric cancer (1 of 2)
Table 13: Japanese Surgical Classification System for gastric cancer (2 of 2)
Table 14: Japanese Surgical Staging System for gastric cancer
Table 15: Type 0 classification of early gastric tumors
Table 16: 5-year survival rates by stage for gastric cancer in the US and Japan
Table 17: Currently approved drugs in gastric cancer, 2009
Table 18: 5-year survival rates of patients treated with D2 dissection in Japan
Table 19: Chemotherapy study results in the treatment of advanced gastric cancer
Table 20: Phase III gastric cancer pipeline, 2009
Table 21: Phase II gastric cancer pipeline, 2009
Table 22: Early-phase gastric cancer pipeline, 2009
Table 23: Avastin: key historical events, 2004-09
Table 24: Clinical development of Avastin in gastric cancer, 2009
Table 25: Erbitux: key historical events, 2001-09
Table 26: Clinical development of Erbitux in gastric cancer, 2009
Table 27: Herceptin: key historical events, 1998-2009
Table 28: Clinical development of Herceptin in gastric cancer, 2009
Table 29: Tykerb: key historical events, 2003-09
Table 30: Clinical development of Tykerb in gastric cancer, 2009
Table 31: Vectibix: key historical events, 2005-09
Table 32: Clinical development of Vectibix in gastric cancer, 2009
List of Figures
Figure 1: Anatomy of the stomach
Figure 2: Percentage distribution of gastric tumors worldwide, 2008
Figure 3: Forecast total incidence versus total mortality in the seven major pharmaceutical markets, 2009
Figure 4: Progression rates for premalignant lesions to gastric cancer
Figure 5: Gastric cancer stage at presentation in the US, five major EU markets and Japan, 2008
Figure 6: Gastric cancer treatment guidelines by stage of disease in the US, EU, and Japan, 2009
Figure 7: Phase III trial of chemoradiation in non-metastatic gastroesophageal cancer
Figure 8: Phase II trial of adjuvant chemoradiation coupled with D2 node dissection in Asian patients
Figure 9: Phase III study of perioperative chemotherapy in gastric and gastroesophageal cancer
Figure 10: Summary of unmet needs in gastric cancer
Figure 11: Phase II trial of Avastin with modified DCF in metastatic gastric cancer
Figure 12: Phase II study of Avastin, irinotecan and cisplatin in patients with metastatic gastric or gastroesophageal cancers
Figure 13: Phase II study of Erbitux plus modified FOLFOX6 in metastatic gastric cancer
Figure 14: Phase II study of Erbitux and FUFOX in metastatic gastric cancer
Figure 15: Phase II study of Tykerb monotherapy in advanced or metastatic gastric cancer

Abstract

Introduction

Gastric cancer incidence in 2009 is forecast to be 197,000 in the seven major pharmaceutical markets (US, Japan, Germany, France, Italy, Spain, and UK). Although, the global incidence has decreased in recent years, mortality remains high, particularly in the US and Europe. Therefore, predictably a high unmet need remains for effective therapies to improve mortality.

Scope
  • Gastric cancer overview, including definition, risk factors, epidemiology forecasts and discussion of unmet needs
  • Current diagnosis and treatment of gastric cancer, including drug regimens used by stage and ongoing controversies
  • Examination of the late-phase gastric cancer pipeline and market opportunities for drug developers
  • Stakeholder opinions based on qualitative interviews with key opinion leaders in the field of gastric cancer
Highlights

Surgery is the mainstay of gastric cancer treatment. Chemotherapyalone or in combination with radiotherapyhas a role in the treatment of both early-stage and locoregional disease. However, its main application is in the treatment of advanced disease, where it is used with palliative intent and only results in a poor median survival of 79 months.

The Phase III gastric cancer pipeline comprises six drugs, five of which are molecular targeted therapies. All the drugs in the pipeline are intended for use in the first-line treatment of advanced gastric cancer.

The gastric cancer market is currently attracting R&D interest from key pharmaceutical players. Drugs such as Avastin (bevacizumab; Genentech/Roche/Chugai), Herceptin (trastuzumab; Genentech/Roche/Chugai), and Tykerb (lapatinib; GlaxoSmithKline) are seeking line extensions. Approval of any agents will result in a very competitive market.

Reasons to Purchase
  • To estimate the number of treatable patients and understand where high unmet needs exist which may provide opportunity for pipeline agents
  • To gain insight into the current dynamics of gastric cancer management
  • To analyze the current gastric cancer pipeline drugs and understand effects of approval on market dynamics
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