Pipeline Insight: Gastrointestinal Cancer Overview - Metastatic Gastrointestinal Cancers Represent A

Introduction

The five tumor types covered in this report are set to account for nearly 898,000 new patients in 2010. Collectively, the 18 drugs in Phase III development for the gastrointestinal cancers are forecast to achieve $5,404m in sales by 2019. Not all unmet needs will be fulfilled, therefore significant commercial opportunities exist for drug developers seeking to enter the market.

Scope

*Examination of the gastrointestinal cancers pipeline with in-depth clinical and commercial profiles of Phase III candidates

*Seven major pharmaceutical market sales forecasts for Phase III pipeline products through to 2019 with product-specific assumptions

*Segmentation and analysis of the current gastrointestinal cancers pipeline by developmental phase, drug class and company

*Insight and analysis of market potential including commercial opportunity, epidemiology and discussion of unmet needs

Highlights

There are 166 drugs in clinical development for the gastrointestinal cancers. Molecular targeted therapies are the predominant therapy class in the pipeline, accounting for 67%. Cytotoxic therapies account for 2% of the pipeline, while immunotherapies account for 15% and gene therapies for 16%.

Colorectal cancer is one of the 'big four' tumor types and has traditionally been a popular R&D target due to its high patient and commercial potential. Following the success of Avastin, drug developers are trying to emulate this, with all three late-phase pipeline products for colorectal cancer targeting angiogenesis.

Pancreatic cancer suffers from high levels of unmet need due to poor prognosis and a resistant nature, resulting in a high rate of Phase III failure. High unmet needs are likely to equate to high commercial reward, which has been noticed by drug developers, making pancreatic cancer the second most popular R&D target after colorectal cancer.

Reasons to Purchase

*Identify key drugs and companies within the gastrointestinal cancers pipeline based on sales forecasts to 2019 and Datamonitor drug assessment

*Characterize unmet need and poorly served patient groups within gastrointestinal cancer and assess the potential for pipeline products to fulfill them

*Assess the shifting gastrointestinal cancer market dynamic and how future treatment will incorporate pipeline products

Table of Contents :

"Overview 1

Catalyst 1

Summary 1

ABOUT HEALTHCARE 2

About the Oncology pharmaceutical analysis team 2

Executive Summary 3

Strategic scoping and focus 3

insight into the gastrointestinal cancers market 3

Contributing experts 5

Related reports 5

Upcoming related reports 5

Table of Contents 6

1. Pipeline Overview and Dynamics 7

Key findings 7

Pipeline overview 7

Pipeline summary 7

Molecular targeted therapies-either novel agents or marketed products undergoing indication expansion-form the bulk of the current late-phase gastrointestinal cancers pipeline 7

Pancreatic cancer has emerged as a popular R&D target due to a significant level of unmet need which could result in high commercial reward 9

Comparative forecasts 10

Key companies involved in the gastrointestinal cancers pipeline 11

Amgen 11

Eli Lilly 12

Roche 13

Key R&D company strategies 15

The metastatic gastrointestinal cancer population holds the most commercial potential, with the highest levels of unmet need in the second-line setting for some tumor types 15

The inclusion of molecular targeted therapies into treatment of gastrointestinal cancers appears to be the way forward 15

2. R&D Approach 16

Key findings 16

Clinical trial design in gastrointestinal cancers 16

Patient selection 16

Increasingly significant in the era of targeted treatment 16

Clinical trial duration 17

Sufficient follow-up is necessary to establish true clinical benefit 17

The advent of novel therapies 17

Diversity of targeted therapies will require an evolution in clinical trial design 17

Clinical trial endpoints in gastrointestinal cancers 18

Most oncology clinical trials designate multiple endpoints 18

Survival 18

Quality of life 18

Tumor response rates 18

Toxicity 19

Time to tumor progression 19

3. Colorectal Cancer 20

Key findings 20

Disease overview 20

Definition 20

Colorectal cancer is the third most common tumor type and cause of cancer-related death in both men and women 20

Patient segmentation 21

The American Joint Committee on Cancer TNM classification system has replaced the older Dukes staging system 21

Epidemiology 21

Seven major markets 21

Rest of the world 23

Current treatment options 24

Current comparator therapy 27

Eloxatin (oxaliplatin; Sanofi-Aventis) 27

Unmet need in colorectal cancer 27

Better screening approaches needed to decrease mortality rates 28

More effective therapies are needed in both early-stage and advanced disease 28

Biomarkers and the selection of patients may help improve outcomes 29

Target product profile versus current level of attainment 30

Pipeline analysis and forecasts 31

Pipeline summary 31

Comparative forecasts 33

Aflibercept (VEGF-Trap; Regeneron/Sanofi-Aventis) 35

Drug overview 35

Drug profile 35

Key historical events 36

Clinical trial data 37

Phase II results show aflibercept to confer better antitumor activity in patients previously treated with Avastin 38

SWOT analysis 38

drug assessment scorecard for aflibercept 39

Clinical and commercial attractiveness 40

Aflibercept's primary development in second-line colorectal cancer means direct competition with Avastin in the first-line setting can be avoided... 40

...although several factors may hamper aflibercept's uptake in the second-line setting 41

Aflibercept still needs to differentiate itself from other angiogenesis inhibitors in development for colorectal cancer 41

Presence in colorectal cancer will aid commercialization of aflibercept 41

Satisfaction of unmet needs 41

Forecasts to 2019 42

Brivanib (BMS-582664; Bristol-Myers Squibb) 43

Drug overview 43

Drug profile 43

Key historical events 44

Clinical trial data 45

Phase I/II results show brivanib to confer better clinical benefit in patients with wild-type KRAS tumors 45

SWOT analysis 46

drug assessment scorecard for brivanib 47

Clinical and commercial attractiveness 47

Better clinical benefit in wild-type KRAS tumors could boost brivanib's apparent efficacy in second-line colorectal cancer 47

Economic evaluation is an encouraging inclusion as part of the Phase III trial endpoints 48

Clinical efficacy of brivanib could be enhanced if Phase III development was alongside chemotherapy... 48

...as could eventual uptake in the second-line colorectal cancer setting 49

Bristol-Myers Squibb offers ideal credentials to ensure brivanib's potential in colorectal cancer is maximized 49

Satisfaction of unmet needs 49

Forecasts to 2019 50

Recentin (cediranib; AstraZeneca) 51

Drug overview 51

Drug profile 51

Key historical events 52

Clinical trial data 53

Top-line results from the Phase III HORIZON III study failed to show any benefit of Recentin over Avastin in combination with first-line chemotherapy 54

Phase II results show Avastin to confer greater progression-free survival alongside standard second-line chemotherapy than Recentin 54

SWOT analysis 55

drug assessment scorecard for Recentin 55

Clinical and commercial attractiveness 56

Phase III HORIZON III results mean Recentin will find it difficult to compete in the first-line setting... 56

...while the ongoing Phase III HORIZON II study is high-risk 57

Avastin's mode of action and formulation may be more effective than Recentin's 57

Targeting the Japanese market? 57

AstraZeneca's strength in the oncology market will be key in Recentin's success 58

Satisfaction of unmet needs 58

Forecasts to 2019 59

4. Esophageal Cancer 60

Key findings 60

Disease overview 60

Definition 60

Esophageal cancer is a major source of cancer-related death 60

Patient segmentation 61

Esophageal cancer has been pathologically staged since 2002 61

Epidemiology 62

Seven major markets 62

Rest of the world 64

Current treatment options 64

Current comparator therapy 66

Xeloda (capecitabine; Roche) 66

Unmet need in esophageal cancer 66

Earlier diagnosis could improve prognosis of esophageal cancer 67

New and more effective systemic therapies for advanced disease are required 68

More effective neoadjuvant and/or adjuvant therapy to reduce relapse rates 68

More large-scale, randomized clinical trials are necessary to define optimal treatment strategies 68

Target product profile versus current level of attainment 69

Pipeline analysis and forecasts 70

Pipeline summary 70

Comparative forecasts 72

Tykerb (lapatinib; GlaxoSmithKline) 73

Drug overview 73

Drug profile 73

Key historical events 74

Clinical trial data 75

One Phase II trial has shown minimal activity in second-line metastatic esophageal cancer, and two Phase II studies have been terminated to date 76

SWOT analysis 76

drug assessment scorecard for Tykerb 77

Clinical and commercial attractiveness 78

Minimal clinical data have been reported for Tykerb in esophageal cancer, making it difficult to judge its clinical attractiveness 78

EGFR inhibition is a popular strategy for gastrointestinal tumors, but experience in esophageal cancer has been dubious so far 79

HER-2 inhibition is a rarer strategy, although has proven successful in gastric cancer 79

Concerns exist over Tykerb's association with hepatotoxicity 79

Tykerb's oral formulation may prove problematic... 80

...however, it could become the first approved therapy for esophageal cancer 80

Satisfaction of unmet needs 80

Forecasts to 2019 81

5. Gastric Cancer 82

Key findings 82

Disease overview 82

Definition 82

Gastric cancer is the second most common tumor type on a global scale 82

Patient segmentation 83

A more detailed Japanese staging system exists for gastric cancer, but is not used in the US or Europe 83

Epidemiology 84

Seven major markets 84

Rest of the world 87

For more information, please visit :

http://www.aarkstore.com/reports/Pipeline-Insight-Gastrointestinal-Cancer-Overview-Metastatic-gastrointestinal-cancers-represent-a-significant-commercial-opportunity-due-to-a-lack-of-approved-drugs-45103.html

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