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Pipeline Insight: Gastrointestinal Cancer Overview - Metastatic gastrointestinal cancers represent a significant commercial opportunity due to a lack of approved drugs
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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 cance.....
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 [Studien Infos ausblenden] |
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Overview 1 Catalyst 1 Summary 1 ABOUT DATAMONITOR HEALTHCARE 2 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 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 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 ...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 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 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 APPENDIX 275 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 Disclaimer [Inhaltsverzeichnis ausblenden] |
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