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Pipeline Insight: Gastrointestinal Cancer Overview - Metastatic Gastrointestinal Cancers Represent a Significant Commercial Opportunity Due to a Lack of Approved Drugs

NEW YORK, Nov. 4, 2010 /PRNewswire/ -- announces that a new market research report is available in its catalogue:

Pipeline Insight: Gastrointestinal Cancer Overview - Metastatic gastrointestinal cancers represent a significant commercial opportunity due to a lack of approved drugs


IntroductionThe 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.


*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

HighlightsThere are 166 drugs in clinical development for the gastrointestinal cancers. Molecular targeted therapies ar>Clinical trial data 143

Only Phase I results in solid tumors have been made available to date 143

SWOT analysis 144

Datamonitor drug assessment scorecard for ramucirumab 144

Clinical and commercial attractiveness 145

A lack of clinical trial data makes it difficult to judge ramucirumab's potential in gastric cancer 145

Ramucirumab will lose out to Afinitor in terms of first-to-market advantage for second-line gastric cancer 145

The failure of Avastin in the first-line setting may work in ramucirumab's favor 146

Eli Lilly's experience in the oncology market will prove crucial in ensuring ramucirumab's success in gastric cancer 146

Satisfaction of unmet needs 146

Forecasts to 2019 147

6. Hepatocellular Carcinoma 149

Key findings 149

Disease overview 149

Definition 149

Hepatitis is a known risk factor for hepatocellular carcinoma 149

Patient segmentation 150

Several staging systems exist for hepatocellular carcinoma 150

Epidemiology 151

Seven major markets 151

Rest of the world 152

Current treatment options 153

Current comparator therapy 155

Nexavar (sorafenib; Onyx Pharmaceuticals/Bayer Schering) 155

Unmet need in hepatocellular carcinoma 155

Better systemic therapy is required in all lines of treatment 156

Clinical trials are currently poorly designed 157

Target product profile versus current level of attainment 157

Pipeline analysis and forecasts 158

Pipeline summary 158

Comparative forecasts 160

Brivanib (BMS-582664; Bristol-Myers Squibb) 163

Drug overview 163

Drug profile 163

Key historical events 164

Clinical trial data 165

Phase II results show brivanib to confer activity in both the first- and second-line treatment settings for advanced hepatocellular carcinoma 165

SWOT analysis 166

Datamonitor drug assessment scorecard for brivanib 167

Clinical and commercial attractiveness 168

Competing with Nexavar in the first-line setting may be difficult unless brivanib demonstrates significant superiority... 168

...therefore it is commercially astute of Bristol-Myers Squibb to also target alternative treatment settings 169

Development as an adjuvant to first-line trans-arterial chemo-embolization could also enhance uptake of brivanib 169

Bristol-Myers Squibb is well placed to ensure brivanib's potential in hepatocellular carcinoma is maximized 169

Satisfaction of unmet needs 169

Forecasts to 2019 170

Tarceva (erlotinib; OSI Pharmaceuticals/Genentech/Roche) 171

Drug overview 171

Drug profile 171

Key historical events 172

Clinical trial data 173

Phase II results show Tarceva to confer antitumor activity in advanced hepatocellular carcinoma both as a monotherapy, in combination with chemotherapy and in combination with other molecular targeted therapies 174

SWOT analysis 174

Datamonitor drug assessment scorecard for Tarceva 175

Clinical and commercial attractiveness 176

Tarceva in combination with angiogenesis inhibition has resulted in very encouraging survival results... 176

...therefore Phase III development in combination with Nexavar should in theory result in enhanced efficacy 176

The overall cost of a combination of Nexavar and Tarceva could be prohibitively expensive in some markets 177

Roche's leading position in the oncology market will almost certainly result in success 177

Satisfaction of unmet needs 177

Forecasts to 2019 178

Afinitor (everolimus; Novartis) 179

Drug overview 179

Drug profile 179

Key historical events 180

Clinical trial data 181

Phase I data suggest that Afinitor is capable of stabilizing progression of hepatocellular carcinoma 182

SWOT analysis 182

Datamonitor drug assessment scorecard for Afinitor 183

Clinical and commercial attractiveness 183

Afinitor's potential is difficult to judge in hepatocellular carcinoma owing to lack of reported data 183

Afinitor is likely to lose out on first-to-market advantage in second-line gastric cancer... 184

...although its mechanism of action could differentiate it from the competition 184

Novartis's experience in the oncology market will prove crucial to ensuring Afinitor's success in hepatocellular carcinoma 184

Satisfaction of unmet needs 184

Forecasts to 2019 185

Linifanib (ABT-869; Abbott) 186

Drug overview 186

Drug profile 186

Key historical events 187

Clinical trial data 188

Phase II results show linifanib to confer clinical benefit in both the first- and second-line treatment settings for advanced hepatocellular carcinoma 188

SWOT analysis 189

Datamonitor drug assessment scorecard for linifanib 190

Clinical and commercial attractiveness 191

By excluding second-line patients from the ongoing Phase III trial, linifanib could show equivalent or superior survival results to Nexavar 191

Other pipeline agents pose a significant threat to linifanib... 192

...therefore Abbott could also target alternative treatment settings or patient subgroups within hepatocellular carcinoma to differentiate linifanib 192

To maximize linifanib's commercial potential, Abbott would be astute in taking on board a marketing partner 192

Satisfaction of unmet needs 192

Forecasts to 2019 193

ThermoDox (liposomal doxorubicin; Celsion/Yakult Honsha) 194

Drug overview 194

Drug profile 194

Key historical events 195

Clinical trial data 196

Phase I results show a favorable overall response rate and low local recurrence rate for ThermoDox and radiofrequency ablation in hepatocellular carcinoma and cancer metastatic to the liver 196

SWOT analysis 197

Datamonitor drug assessment scorecard for ThermoDox 197

Clinical and commercial attractiveness 198

Phase I results are insufficient to judge ThermoDox's commercial potential 198

Most hepatocellular carcinoma patients present with disease that is too advanced for radiofrequency ablation 199

In order to optimize ThermoDox's commercial potential, Celsion should seek a partner experienced in the oncology market 199

Satisfaction of unmet needs 199

Forecasts to 2019 200

Sutent (sunitinib; Pfizer) 200

Drug overview 200

Drug profile 201

Key historical events 201

Clinical trial data 202

Phase II studies show evidence of some antitumor activity, although toxicity and fatalities associated with Sutent are a concern 203

SWOT analysis 204

Datamonitor drug assessment scorecard for Sutent 205

Clinical and commercial attractiveness 205

Sutent will have to show significantly superior survival benefits in order to effectively compete with

Nexavar in the advanced hepatocellular carcinoma population and overcome negative Phase II results 205

Other late-phase pipeline agents also pose a competitive threat to Sutent 206

Altering Sutent's target patient population in hepatocellular carcinoma could be the key to commercial success 206

Pfizer's growing position in the oncology market will assist in Sutent's potential success 206

Satisfaction of unmet needs 206

Forecasts to 2019 207

7. Pancreatic Cancer 209

Key findings 209

Disease overview 209

Definition 209

Pancreatic cancer represents a major health issue in the developed world 209

Patient segmentation 210

The TNM staging system does not take resectability of a tumor into account, therefore an alternative clinical staging system is often used 210

Epidemiology 210

Seven major markets 210

Rest of the world 212

Current treatment options 213

Current comparator therapy 215

Gemzar (gemcitabine; Eli Lilly) 215

Unmet need in pancreatic cancer 217

Pancreatic cancer is associated with exceptionally poor survival rates across all stages of disease 217

Earlier rates of diagnosis are desperately needed in order to boost survival 218

A lack of effective systemic therapies exists, therefore a higher level of R&D interest is needed 219

An effective neoadjuvant or adjuvant regimen is required to prevent high rates of recurrence after surgery for early-stage disease 219

More options for the few patients who receive second-line treatment are needed 219

Target product profile versus current level of attainment 220

Pipeline analysis and forecasts 220

Pipeline summary 220

Comparative forecasts 222

Abraxane (albumin-bound paclitaxel; Abraxis Bioscience/Taiho) 224

Drug overview 225

Drug profile 225

Key historical events 226

Clinical trial data 227

Phase II results show Abraxane monotherapy to confer an encouraging median overall survival in the second-line metastatic pancreatic cancer setting 228

Phase I/II results show the addition of Abraxane to first-line Gemzar to boost median overall survival by several months over Gemzar monotherapy 229

SWOT analysis 230

Datamonitor drug assessment scorecard for Abraxane 230

Clinical and commercial attractiveness 231

A combination of encouraging clinical data and key opinion leader enthusiasm mean Abraxane is currently the most promising late-phase pipeline candidate for pancreatic cancer 231

Identification of a potential biomarker could further increase apparent efficacy of Abraxane in pancreatic cancer 232

The widespread availability of generic standard paclitaxel may hamper uptake of Abraxane... 232

...however, Abraxane's efficacy in pancreatic cancer arises in part due to its albumin-bound formulation 232

The taxanes are not typically used to treat pancreatic cancer... 232

Abraxis Bioscience's experience in breast cancer will prove useful if Abraxane is approved for pancreatic cancer 233

Satisfaction of unmet needs 233

Forecasts to 2019 233

TNFerade (golnerminogene; GenVec) 234

Drug overview 234

Drug profile 234

Key historical events 235

Clinical trial data 236

Interim data from the PACT study show a 25% reduction in the risk of death when TNFerade is added to standard first-line therapy 237

SWOT analysis 237

Datamonitor drug assessment scorecard for TNFerade 238

Clinical and commercial attractiveness 239

Unmet needs in pancreatic cancer are so high, that if final PACT results are positive, TNFerade will be enthusiastically received 239

No gene therapies are approved for cancer in the seven major markets 240

Intratumoral administration into a pancreatic tumor may prove problematic 240

GenVec may struggle to achieve commercial success for TNFerade without a more experienced oncology player 240

Satisfaction of unmet needs 240

Forecasts to 2019 241

Masitinib (AB-1010; AB Science) 242

Drug overview 242

Drug profile 242

Key historical events 243

Clinical trial data 244

Phase II trial shows a first-line combination of Gemzar and masitinib to confer similar efficacy to Gemzar monotherapy and other Gemzar-based combinations 244

SWOT analysis 245

Datamonitor drug assessment scorecard for masitinib 246

Clinical and commercial attractiveness 247

If Phase II results can be replicated in the ongoing Phase III study, then approval will be likely 247

Masitinib should in theory confer greater efficacy alongside Gemzar than Tarceva due to inhibition of multiple pathways 248

AB Science will need to price masitinib competitively in order to enhance its uptake 248

In order to optimize masitinib's commercial potential, AB Science should seek a partner experienced in the human oncology market 248

Satisfaction of unmet needs 248

Forecasts to 2019 249

Tertomotide (GV-1001; Pharmexa/Kael-GemVax) 250

Drug overview 250

Drug profile 250

Key historical events 251

Clinical trial data 252

A Phase III trial investigating GV-1001 followed by sequential Gemzar in advanced pancreatic cancer patients has already failed 252

Phase I/II trial data indicate an immune response is correlated with prolonged survival 253

SWOT analysis 254

Datamonitor drug assessment scorecard for GV-1001 255

Clinical and commercial attractiveness 255

Replication of Phase I/II median survival in the ongoing Phase III studies will almost surely guarantee approval 255

PrimoVax Phase III failure highlights the difficulties of sequencing chemotherapy with therapeutic cancer vaccines 256

GV-1001 may struggle to achieve optimal market penetration without a more experienced oncology player 256

A lack of precedent regarding approval of therapeutic cancer vaccines exists 257

Satisfaction of unmet needs 257

Forecasts to 2019 257

Bibliography 259

Journals 259

Websites 269

Datamonitor reports 274

Other 274


Methodology 275

Epidemiology forecasts 275

Product forecasts 275

Datamonitor drug assessment scorecard 276

About Datamonitor 278

About Datamonitor Healthcare 278

About the Disease analysis team 278

Datamonitor consulting 279


To order this report:Pharmaceutical Industry: Pipeline Insight: Gastrointestinal Cancer Overview - Metastatic gastrointestinal cancers represent a significant commercial opportunity due to a lack of approved drugs

More  Market Research Report

Check our  Company Profile, SWOT and Revenue Analysis!Contact:Nicolas BombourgReportlinkerEmail: nbo@reportlinker.comUS: (805)652-2626Intl: +1 805-652-2626 e 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

Overview 1

Catalyst 1

Summary 1


About the Oncology pharmaceutical analysis team 2

Executive Summary 3

Strategic scoping and focus 3

Datamonitor insight into the gastrointestinal cancers market 3

Contributing experts 5

Related reports 5

Upcoming related reports 5


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

Datamonitor 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

Datamonitor 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 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

Datamonitor 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

Datamonitor 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

Current treatment options 88

Current comparator therapy 90

Taxotere (docetaxel; Sanofi-Aventis) 90

Unmet need in gastric cancer 91

Lack of effective systemic therapy 92

Poorly defined standard treatment regimens 92

Poor control of distant metastases 93

Complete lack of second-line options 93

Target product profile versus current level of attainment 93

Pipeline analysis and forecasts 94

Pipeline summary 94

Comparative forecasts 96

Herceptin (trastuzumab; Genentech/Roche/Chugai) 99

Drug overview 99

Drug profile 99

Key historical events 100

Clinical trial data 101

Phase III ToGA study shows the addition of Herceptin to first-line chemotherapy to result in a 2.7 month survival benefit in HER-2-positive metastatic gastric cancer 102

SWOT analysis 103

Datamonitor drug assessment scorecard for Herceptin 103

Clinical and commercial attractiveness 104

Herceptin is the first molecular targeted therapy to gain approval for gastric cancer 104

Targeting HER-2-positive patients specifically is in line with the trend for more personalized therapy... 104

...however, restricts Herceptin's commercial potential in gastric cancer 105

Tykerb could pose a competitive threat to Herceptin 105

Concerns exist over Herceptin's association with cardiotoxicity 105

Roche's leading position in the oncology market will almost certainly lead to success 106

Satisfaction of unmet needs 106

Forecasts to 2019 106

Avastin (bevacizumab; Genentech/Roche/Chugai) 107

Drug overview 107

Drug profile 107

Key historical events 108

Clinical trial data 110

The Phase III AVAGAST study failed to meet its primary endpoint of improving overall survival in the first-line metastatic gastric cancer setting 110

Several Phase II studies have shown encouraging survival results associated with Avastin, however, the risk of gastrointestinal perforations and bleeding remains a major concern 110

SWOT analysis 111

Datamonitor drug assessment scorecard for Avastin 112

Clinical and commercial attractiveness 113

Failure of the Phase III AVAGAST study to meet its primary endpoints in first-line metastatic gastric cancer is a setback... 113

...although Avastin could still have a role in resectable gastric cancer 114

Roche's leading position in the oncology market will almost certainly result in success 114

Increasingly cost-conservative healthcare systems could restrict potential uptake of Avastin 114

Satisfaction of unmet needs 115

Forecasts to 2019 115

Erbitux (cetuximab; Eli Lilly/Bristol-Myers Squibb/Merck KGaA) 116

Drug overview 116

Drug profile 116

Key historical events 117

Clinical trial data 118

Several Phase II studies have shown encouraging survival results associated with Erbitux, with a potential tumor response correlation linked to incidence of acneiform rash 119

SWOT analysis 120

Datamonitor drug assessment scorecard for Erbitux 121

Clinical and commercial attractiveness 122

Phase II data show a comparable response rate to the current first-line standard, but the Phase III EXPAND trial will need to demonstrate superior overall survival 122

Erbitux's cost may hinder its uptake in certain markets... 122

...although if use is targeted to specific patient subtypes, then the issue of cost may be overcome 123

Satisfaction of unmet needs 123

Forecasts to 2019 124

Afinitor (everolimus; Novartis) 125

Drug overview 125

Drug profile 125

Key historical events 126

Clinical trial data 127

Phase II results showed 0% overall response rate, but a very encouraging median overall survival of 10.1 months in heavily pretreated metastatic gastric cancer patients 128

SWOT analysis 128

Datamonitor drug assessment scorecard for Afinitor 129

Clinical and commercial attractiveness 130

If Phase III trial replicates Phase II survival, then Afinitor could become the standard of care in second-line metastatic gastric cancer 130

A relatively high rate of treatment discontinuation due to adverse events was seen in the Phase II study 130

Afinitor is set to be the first agent to reach the market for second-line metastatic gastric cancer 131

Afinitor shows applicability for use across the wider gastric cancer population 131

Design of the Phase III GRANITE-1 study may unnecessarily come under fire 131

Novartis's experience in the oncology market will prove crucial in ensuring Afinitor's success in gastric cancer 131

Satisfaction of unmet needs 131

Forecasts to 2019 132

Tykerb (lapatinib; GlaxoSmithKline) 133

Drug overview 133

Drug profile 133

Key historical events 134

Clinical trial data 135

Phase II results have shown minimal activity in first-line metastatic gastric cancer and failure to meet its primary endpoint of overall response rate 136

SWOT analysis 136

Datamonitor drug assessment scorecard for Tykerb 137

Clinical and commercial attractiveness 138

Minimal clinical data have been reported for Tykerb in gastric cancer, making it difficult to judge its clinical attractiveness 138

Dual inhibition of EGFR and HER-2 is a relatively new strategy in treatment of gastric cancer 139

Concerns exist over Tykerb's association with hepatotoxicity 139

Tykerb could provide strong competition to Herceptin in HER-2-positive gastric cancer 139

Satisfaction of unmet needs 139

Forecasts to 2019 140

Ramucirumab (IMC-1121B; Eli Lilly) 141

Drug overview 141

Drug profile 141

Key historical events 142


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