Pipeline Insight: Therapeutic Cancer Vaccines - Prospect of first approval set to reinvigorate interest from major companies

Introduction

No therapeutic cancer vaccine has received approval in any of the seven major pharmaceutical markets, despite extensive research efforts. However, with one product in pre-registration in the US, the prospect of the first marketed therapeutic cancer vaccine in the seven major markets is now closer to reality.

Scope

*Forecast sales of the therapeutic cancer vaccines in late-phase development in the seven major markets over the period 2009 to 2018

*In-depth profiles and analysis for all vaccines in late-phase development, including trial data, SWOT analysis and clinical and commercial potential

*Segmentation and analysis of the therapeutic cancer vaccine pipeline by developmental phase, class, indication and technology platform

*Insight and analysis of market potential for therapeutic cancer vaccines including commercial opportunity, unmet needs and patient potential

Highlights

The theoretical market potential for therapeutic cancer vaccines in the seven major markets totals over $4.7 billion. Due to the limitations associated with the first generation of cancer vaccines, Datamonitor forecasts the current late-phase therapeutic cancer vaccines to achieve lower sales of $1.3 billion by 2018.

High risk and uncertain rewards have limited larger companies' involvement in the therapeutic cancer vaccines. Of the larger companies, GlaxoSmithKline and Merck KGaA have made the greatest commitment. The prospect of the first therapeutic vaccine approval in the US could stimulate renewed interest in this therapy class from further key players.

Of the 13 vaccines in late-phase development, Provenge (Dendreon), Stimuvax (Merck KGaA/Oncothyreon) and MAGE-A3 ASCI (GlaxoSmithKline) have the highest clinical and commercial potential. Provenge is likely to be the first therapeutic cancer vaccine to market, having shown a statistically significant overall survival advantage in prostate cancer.

Reasons to Purchase

*Justify go/no-go decisions on the basis of potential return on investment

*Identifying licensing opportunities based on company portfolio and market needs

*Use product profiles to aid pricing and reimbursement decisions


Report Highlights
The theoretical market potential for therapeutic cancer vaccines in the seven major markets totals over $4.7 billion. Due to the limitations associated with the first generation of cancer vaccines, Datamonitor forecasts the current late-phase therapeutic cancer vaccines to achieve lower sales of $1.3 billion by 2018.

High risk and uncertain rewards have limited larger companies' involvement in the therapeutic cancer vaccines. Of the larger companies, GlaxoSmithKline and Merck KGaA have made the greatest commitment. The prospect of the first therapeutic vaccine approval in the US could stimulate renewed interest in this therapy class from further key players.

Of the 13 vaccines in late-phase development, Provenge (Dendreon), Stimuvax (Merck KGaA/Oncothyreon) and MAGE-A3 ASCI (GlaxoSmithKline) have the highest clinical and commercial potential. Provenge is likely to be the first therapeutic cancer vaccine to market, having shown a statistically significant overall survival advantage in prostate cancer.
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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 disease market 4
Contributing experts 5
Related reports 5
Upcoming related reports 6
Table of Contents 7
1. Pipeline Overview and Dynamics 8
Key findings 8
Pipeline overview 9
Pipeline summary 9
There are 13 therapeutic cancer vaccines in late-phase clinical development in the seven major markets 9
High barriers to commercialization have restricted the number of personalized therapeutic cancer vaccines in clinical development 11
Peptide-based vaccines are the most common technology class in the therapeutic cancer vaccines pipeline 12
A disproportionately high number of therapeutic cancer vaccines are in development for melanoma 14
Comparative forecasts 16
Datamonitor forecasts the late-phase therapeutic cancer vaccines to realize sales of $1.3 billion by 2018 16
Datamonitor pipeline assessment summary 16
Key companies involved in the therapeutic cancer vaccines pipeline 18
Analysis of the therapeutic cancer vaccines pipeline by company 18
High risk and uncertain rewards have limited Big Pharma involvement in the therapeutic cancer vaccines pipeline 18
GlaxoSmithKline has made the greatest commitment to therapeutic cancer vaccines of all the Big Pharma 20
Therapeutic cancer vaccine deals and alliances 21
There have been relatively few deals and alliances involving therapeutic cancer vaccines in recent years 21
2. Therapeutic Cancer Vaccines - Market Potential 24
Key findings 24
Introduction to therapeutic cancer vaccines 25
Tumors and the immune system 25
There is substantial evidence supporting a link between tumors and the immune system 25
Researchers have identified a large number of tumor antigens 25
Definition of therapeutic cancer vaccines 26
Therapeutic cancer vaccines are defined as 'active specific immunotherapy' 26
Classification of therapeutic cancer vaccines 27
Evaluation of therapeutic cancer vaccine technology platforms 28
Anti-idiotype vaccines 28
Antigen-presenting cell (APC) vaccines 29
DNA vaccines 30
Heat-shock proteins 30
Peptide-based vaccine 30
Recombinant protein-based vaccines 31
Whole-cell vaccines 31
Clinical barriers facing therapeutic cancer vaccine developers 33
Factors limiting the efficacy of therapeutic cancer vaccines 33
Tumor escape mechanisms allow tumor cells to evade recognition and destruction by the immune system 33
Positive outcomes to therapeutic vaccination are less likely in patients with late-stage disease 34
Strategies for improving cancer vaccine efficacy 34
Combining vaccines with chemotherapy or monoclonal antibodies could help to inhibit tumor escape 34
Vaccine adjuvants are commonly used to boost immune responses 36
Trials in early-stage patients are likely to be more successful but pose significant challenges 36
Unmet needs in cancer 37
Therapeutic cancer vaccines have the potential to address several unmet needs in cancer 37
Patient potential 39
Assessment of therapeutic cancer vaccine patient potential and market potential 39
3. R&D Approach 41
Key findings 41
Clinical trial design for therapeutic cancer vaccines: a different approach to oncology R&D 42
Patient selection 42
Early-stage patients are likely to show better responses to immunotherapy 42
Patient cohort homogeneity is particularly important in therapeutic cancer vaccine clinical trials 42
Biomarkers could play an important role in patient selection for therapeutic cancer vaccine clinical trials 43
Dosing 43
Maximum tolerated dose does not determine the optimum dose for therapeutic cancer vaccines 43
Endpoints 43
Overall survival is the most robust primary endpoint for licensing applications 43
Response rates from single-arm Phase II trials do not effectively support go/no-go decisions 44
Therapeutic cancer vaccine clinical trials should incorporate immunological endpoints 44
Monitoring for autoimmune manifestations is important in therapeutic cancer vaccine clinical trials 45
Monitoring for delayed vaccine effects 45
Clinical trial designs should take into account the possibility of a delayed immune response 45
Co-administered drugs 46
Combinations of vaccines with other drug therapies should be evaluated from early- through to late-stage 46
4. Pipeline Analysis & Forecasts: Personalized Vaccines 47
Key findings 47
Overview for personalized therapeutic vaccines 48
Pipeline summary 48
Comparative forecasts 49
BiovaxID (Accentia Biopharmaceuticals) 52
Drug overview 52
Drug profile 52
Key historical events 53
SWOT analysis 54
Clinical trial data 55
Phase III study shows that maintenance BiovaxID prolongs disease-free survival in follicular lymphoma 55
Phase II data in mantle cell lymphoma show that BiovaxID treatment is feasible in B-cell-depleted patients 56
Clinical attractiveness 57
BiovaxID's positive Phase III data represent an important milestone for therapeutic vaccines... 57
...but clinical relevance of the data is doubtful 57
Commercial attractiveness 58
As a personalized vaccine, BiovaxID will have to overcome major economical and logistical barriers 58
Rituxan will provide fierce competition for BiovaxID in the first-line maintenance setting 58
Forecasts to 2018 58
M-Vax (Avax Technologies) 59
Drug overview 59
Drug profile 59
Key historical events 60
SWOT analysis 61
Clinical trial data 62
Clinical attractiveness 63
As a personalized vaccine, M-Vax will have to offer significant efficacy advantages over the other vaccines in late-phase development for melanoma 63
The toxicity associated with Proleukin could restrict uptake of M-Vax 63
Commercial attractiveness 63
Fierce competition from standardized therapeutic vaccines in development for melanoma is likely 63
Datamonitor drug assessment score card for M-Vax 64
Forecasts to 2018 64
Oncophage (vitespen; Antigenics) 65
Drug overview 65
Drug profile 66
Key historical events 67
SWOT analysis 68
Clinical trial data 69
Retrospective analysis of Phase III RCC data suggest that Oncophage improves recurrence-free survival in a subgroup of patients 69
Clinical attractiveness 70
Oncophage is targeting a high unmet need group of patients 70
Commercial attractiveness 70
Oncophage will struggle to penetrate the more lucrative seven major markets 70
Forecasts to 2018 71
Provenge (sipuleucel-T; Dendreon) 71
Drug overview 71
Drug profile 72
Key historical events 73
SWOT analysis 74
Clinical trial data 75
Phase III D9901 study shows Provenge to confer a statistically significant improvement in overall survival, however, it failed to meet its primary endpoint of improving time to progression 76
Phase III IMPACT study shows Provenge to confer a statistically significant improvement in overall survival, therefore meeting the trial's primary endpoint 77
Combined D9901 and D9902A subgroup analysis shows Taxotere administered upon disease progression to Provenge-treated patients results in a prolonged survival benefit 78
Preliminary results from the PROTECT trial suggest Provenge's efficacy in early-stage prostate cancer 78
Clinical attractiveness 79
Provenge may represent a viable alternative for those patients precluded from Taxotere therapy 79
Potential exists for line extension of Provenge into the adjuvant setting 80
Commercial attractiveness 80
Provenge has already generated considerable controversy 80
Provenge's probable high cost and complex manufacture may be offset by being the first vaccine to demonstrate a survival benefit in prostate cancer 81
The backing of an established oncology player could enhance Provenge's commercial potential 81
Datamonitor drug assessment score card for Provenge 82
Forecasts to 2018 83
5. Pipeline Analysis & Forecasts: Standardized Vaccines 84
Key findings 84
Overview for standardized therapeutic vaccines 85
Pipeline summary 85
Comparative forecasts 87
Abagovomab (ACA-125; Menarini/CellControl Biomedical) 90
Drug overview 90
Drug profile 90
Key historical events 91
SWOT analysis 92
Clinical trial data 93
Phase I/II data show that abagovomab induces immune responses and is well tolerated in ovarian cancer 94
Clinical attractiveness 96
There is considerable doubt surrounding the clinical potential of abagovomab in Stage III/IV ovarian cancer 96
Commercial attractiveness 96
Menarini's lack of oncology presence could make partnership with a larger oncology player necessary 96
First-line maintenance setting could be a relatively lucrative niche population for abagovomab 96
Datamonitor drug assessment score card for abagovomab 97
Forecasts to 2018 98
Allovectin-7 (velimogene aliplasmid; Vical) 98
Drug overview 98
Drug profile 99
Key historical events 100
SWOT analysis 101
Clinical trial data 102
Vical discontinued Phase III development of lower dose Allovectin-7 in metastatic melanoma 102
Phase II data for higher dose Allovectin-7 show activity and tolerability in Stage III/IV melanoma 103
Clinical attractiveness 103
It is uncertain whether high-dose Allovectin-7 will be significantly more effective than low-dose Allovectin-7 103
Gene therapy technology likely to generate particular skepticism and caution from physicians 104
Intratumoral route of administration will limit Allovectin's indication expansion potential 104
Commercial attractiveness 104
Finding a marketing partner in the US and EU markets could prove challenging for Vical 104
Datamonitor drug assessment score card for Allovectin-7 105
Forecasts to 2018 106
Gp100:209-217(210M) (National Cancer Institute) 106
Drug overview 106
Drug profile 107
Key historical events 107
SWOT analysis 108
Clinical trial data 109
Phase III data show that gp100:209-217(210M) is active in melanoma 109
Clinical attractiveness 110
Positive Phase III data mark an important milestone for therapeutic cancer vaccines in melanoma... 110
...although it is doubtful whether the data are sufficient to support approval at this stage 110
The toxicity associated with Proleukin could restrict uptake of gp100:209-217(210M) 110
Commercial attractiveness 111
Despite positive Phase III data, gp100:209-217(210M) has not yet attracted a partner from industry 111
Forecasts to 2018 111
GV-1001 (tertomotide; Kael-GemVax) 111
Drug overview 111
Drug profile 112
Key historical events 113
SWOT analysis 114
Clinical trial data 115
One Phase III study of GV-1001 in pancreatic cancer has been terminated 115
Phase I/II data show that GV-1001 plus GM-CSF induces an immune response in unresectable pancreatic cancer 116
Phase I/II data in NSCLC point to GV-1001's potential in other indications 117
Clinical attractiveness 117
PrimoVax Phase III failure highlights the difficulties of sequencing chemotherapy with vaccines 117
Commercial attractiveness 117
Negative Phase III data could make it difficult to attract a larger partner 117
Merck & Co could provide a major competitive threat if its telomerase-based vaccines reach the market 117
Datamonitor drug assessment score card for GV-1001 118
Forecasts to 2018 119
Lucanix (belagenpumatucel-L; NovaRx) 119
Drug overview 119
Drug profile 120
Key historical events 120
SWOT analysis 121
Clinical trial data 122
Clinical attractiveness 123
It will be very challenging for Lucanix to show a survival advantage in late-stage NSCLC 123
Commercial attractiveness 124
Lucanix could face strong competition in the maintenance setting from Alimta 124
Datamonitor drug assessment score card for Lucanix 125
Forecasts to 2018 126
MAGE-A3 ASCI (astuprotimut-r; GlaxoSmithKline) 126
Drug overview 126
Drug profile 127
Key historical events 128
SWOT analysis 129
Clinical trial data 129
Phase II data show non-statistically significant disease-free survival improvement in early-stage non-small cell lung cancer 131
Phase II data show that AS15 adjuvant is superior to AS02 adjuvant in melanoma 132
Clinical attractiveness 132
Early-stage NSCLC could be a favorable setting for MAGE-A3 ASCI 132
MAGE-A3 ASCI's tolerability will be an advantage in the maintenance setting for platinum-treated patients 133
Potential to select patients most likely to respond to therapy could be a significant advantage 134
MAGE-A3 ASCI's potential in melanoma is less certain than in NSCLC 134
Commercial attractiveness 134
The need for patients to express MAGE-A3 restricts the commercial potential of MAGE-A3 ASCI 134
GlaxoSmithKline's experience of both the oncology and vaccines market will give a competitive advantage 134
Datamonitor drug assessment score card for MAGE-A3 ASCI 135
Forecasts to 2018 136
MDX-1379 (Bristol-Myers Squibb) 137
Drug overview 137
Drug profile 138
Key historical events 139
SWOT analysis 140
Clinical trial data 141
MDX-1379 plus ipilimumab induced a modest percentage of durable response in Stage IV melanoma 141
Clinical attractiveness 142
Autoimmune events could make the risk: benefit ratio for MDX-1379 plus ipilimumab unfavorable 142
Phase II data show limited evidence of MDX-1379's clinical activity... 142
...although there is strong proof-of-concept for therapeutic vaccines based on gp100 in melanoma 143
Commercial attractiveness 143
The combination of two expensive biologics will be unattractive to payers 143
Datamonitor drug assessment score card for MDX-1379 144
Forecasts to 2018 145
PR1 peptide antigen (The Vaccine Company) 145
Drug overview 145
Drug profile 146
Key historical events 147
SWOT analysis 148
Clinical trial data 149
PR1 peptide antigen induced immune and clinical responses in patients with myeloid hematological malignancies in Phase I/II trial 150
Clinical attractiveness 151
PR1 peptide antigen could fulfill the unmet need for more tolerable treatment options in elderly AML patients 151
Commercial attractiveness 151
PR-1 peptide antigen would benefit from the backing of a more experienced company 151
Datamonitor drug assessment score card for PR1 peptide antigen 152
Forecasts to 2018 153
Stimuvax (BLP-25; Merck KGaA/Oncothyreon) 153
Drug overview 153
Drug profile 154
Key historical events 155
SWOT analysis 156
Clinical trial data 157
Phase II data show that locoregional Stage III non-small cell lung cancer patients may be optimal target patient population for Stimuvax 158
There is a lack of clinical trial data for Stimuvax in breast cancer 159
Clinical attractiveness 159
Stimuvax could fill a niche in the NSCLC market 159
Stimuvax's clinical potential in breast cancer is difficult to predict 159
Commercial attractiveness 160
Merck KGaA's experience in the oncology market will prove valuable for the successful commercialization of Stimuvax 160
Datamonitor drug assessment score card for Stimuvax 161
Forecasts to 2018 162
Bibliography 164
APPENDIX 172
Methodology 172
Product forecasts 172
Datamonitor drug assessment scorecard 172
About Datamonitor 173
About Datamonitor Healthcare 173
About the Oncology analysis team 174
Datamonitor consulting 174
Disclaimer 174
List of Tables
Table 1: Therapeutic vaccines in late-phase clinical development (Phase III or pre-registration) for cancer in the seven major markets, 2009 10
Table 2: Sales forecasts for late-phase pipeline therapeutic cancer vaccines in the seven major markets, 2009-2018 ($m) 16
Table 3: Therapeutic cancer vaccines in clinical development by Big Pharma, 2009 20
Table 4: Deals and alliances involving therapeutic cancer vaccines in clinical development, 2001-09 22
Table 5: Summary advantages and disadvantages associated with the most commonly used technology platforms for the pipeline therapeutic cancer vaccines, 2008 28
Table 6: Unmet needs in selected cancer indications, 2009 37
Table 7: Datamonitor assessment of patient potential and market potential ($m) for therapeutic cancer vaccines in selected indications, 2018 39
Table 8: Personalized therapeutic vaccines in late-phase clinical development (Phase III or pre-registration) for cancer in the seven major markets, 2009 48
Table 9: Forecast assumptions for personalized therapeutic cancer vaccines in late-phase development in the seven major markets, 2009 50
Table 10: Sales forecasts for late-phase personalized therapeutic cancer vaccines in the seven major markets, 2009-2018 ($m) 51
Table 11: BiovaxID - drug profile, 2009 52
Table 12: BiovaxID: key historical events 53
Table 13: Clinical development of BiovaxID, 2009 55
Table 14: M-Vax - drug profile, 2009 59
Table 15: M-Vax: key historical events 60
Table 16: M-Vax: clinical development, 2009 62
Table 17: Sales forecast for M-Vax in melanoma across the seven major markets, 2009-2018 ($m) 64
Table 18: Oncophage - drug profile, 2009 66
Table 19: Oncophage: key historical events 67
Table 20: Clinical development of Oncophage, 2009 69
Table 21: Provenge - drug profile, 2009 72
Table 22: Provenge: key historical events 73
Table 23: Clinical development of Provenge in prostate cancer, 2009 75
Table 24: Sales forecast for Provenge in metastatic castrate-resistant prostate cancer across the seven major markets, 2009-2018 ($m) 83
Table 25: Therapeutic vaccines in late-phase clinical development (Phase III or pre-registration) for cancer in the seven major markets, 2009 85
Table 26: Forecast assumptions for standardized therapeutic cancer vaccines in late-phase development in the seven major markets, 2009 (1of 2) 87
Table 27: Forecast assumptions for standardized therapeutic cancer vaccines in late-phase development in the seven major markets, 2009 (2 of 2) 88
Table 28: Sales forecasts for late-phase standardized therapeutic cancer vaccines in the seven major markets, 2009-2018 ($m) 89
Table 29: Abagovomab - drug profile, 2009 90
Table 30: Abagovomab: key historical events 91
Table 31: Clinical development of abagovomab, 2009 93
Table 32: Sales forecast for abagovomab in ovarian cancer across the seven major markets, 2009-2018 ($m) 98
Table 33: Allovectin-7 - drug profile, 2009 99
Table 34: Allovectin-7: key historical events 100
Table 35: Clinical development of Allovectin-7, 2009 102
Table 36: Sales forecast for Allovectin-7 in melanoma across the seven major markets, 2009-2018 ($m) 106
Table 37: Gp100:209-217(210M) - drug profile, 2009 107
Table 38: Gp100:209-217(210M): key historical events 107
Table 39: GV-1001 - drug profile, 2009 112
Table 40: GV-1001: key historical events 113
Table 41: Clinical development of GV-1001, 2009 115
Table 42: Sales forecast for GV-1001 in pancreatic cancer across the seven major markets, 2009-2018 ($m) 119
Table 43: Lucanix - drug profile, 2009 120
Table 44: Lucanix: key historical events 120
Table 45: Clinical development of Lucanix, 2009 122
Table 46: Sales forecast for Lucanix in NSCLC across the seven major markets, 2009-2018 ($m) 126
Table 47: MAGE-A3 ASCI - drug profile, 2009 127
Table 48: MAGE-A3 ASCI: key historical events 128
Table 49: Clinical development of MAGE-A3 ASCI, 2009 130
Table 50: Sales forecast for MAGE-A3 ASCI in non-small cell lung cancer (NSCLC) across the seven major markets, 2009-2018 ($m) 136
Table 51: Sales forecast for MAGE-A3 ASCI in melanoma across the seven major markets, 2009-2018 ($m) 136
Table 52: Combined sales forecast for MAGE-A3 ASCI (in NSCLC and melanoma) across the seven major markets, 2009-2018 ($m) 137
Table 53: MDX-1379 - drug profile, 2009 138
Table 54: MDX-1379: key historical events 139
Table 55: Clinical development of MDX-1379, 2009 141
Table 56: Sales forecast for MDX-1379 in melanoma across the seven major markets, 2009-2018 ($m) 145
Table 57: PR1 peptide antigen - drug profile, 2009 146
Table 58: PR1 peptide antigen: key historical events 147
Table 59: Clinical development of PR1 peptide antigen, 2009 149
Table 60: Sales forecast for PR1 peptide antigen in acute myeloid leukemia (AML) across the seven major markets, 2009-2018 ($m) 153
Table 61: Stimuvax - drug profile, 2009 154
Table 62: Stimuvax: key historical events 155
Table 63: Clinical development of Stimuvax, 2009 157
Table 64: Sales forecast for Stimuvax in non-small cell lung cancer (NSCLC) across the seven major markets, 2009-2018 ($m) 162
Table 65: Sales forecast for Stimuvax in breast cancer across the seven major markets, 2009-2018 ($m) 162
Table 66: Combined sales forecast for Stimuvax (in NSCLC and breast cancer) across the seven major markets, 2009-2018 ($m) 163
Table 67: Datamonitor drug assessment parameters 172
List of Figures
Figure 1: Number of personalized therapeutic cancer vaccines in clinical development versus number of standardized therapeutic cancer vaccines in clinical development, 2009 11
Figure 2: Analysis of the therapeutic cancer vaccines clinical pipeline by class of technology platform, 2009 12
Figure 3: Number of therapeutic cancer vaccines in development by indication, 2009 14
Figure 4: Datamonitor drug assessment summary for the therapeutic cancer vaccines in late-phase clinical development in the seven major markets, 2009 17
Figure 5: Analysis of the therapeutic cancer vaccines pipeline by type of company, 2009 18
Figure 6: Classification of tumor antigens most commonly targeted by the therapeutic cancer vaccines, 2009 26
Figure 7: Classification of therapeutic cancer vaccines, 2009 27
Figure 8: Clinical barriers to successful therapeutic cancer vaccine development and potential solutions 33
Figure 9: Datamonitor drug assessment summary for the personalized therapeutic cancer vaccines in late-phase clinical development in the seven major markets, 2009 49
Figure 10: BiovaxID SWOT analysis, 2009 54
Figure 11: BiovaxID: Phase III results as first-line consolidation therapy in follicular lymphoma 56
Figure 12: M-Vax SWOT analysis, 2009 61
Figure 13: M-Vax: Phase I/II results in Stage IIIb-IV melanoma 62
Figure 14: M-Vax - Datamonitor drug assessment summary, 2009 64
Figure 15: Oncophage SWOT analysis, 2009 68
Figure 16: Provenge SWOT analysis, 2009 74
Figure 17: Provenge: Phase III D9901 results of investigation in asymptomatic metastatic castration-resistant prostate cancer 76
Figure 18: Provenge: Phase III IMPACT results of investigation in asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer 77
Figure 19: Provenge: analysis of patient subgroup from Phase III D9901 and D9902A studies who received Taxotere following Provenge or placebo 78
Figure 20: Provenge: preliminary Phase III PROTECT results of investigation in hormone-sensitive non-metastatic prostate cancer 79
Figure 21: Provenge - Datamonitor drug assessment summary, 2009 82
Figure 22: Datamonitor drug assessment summary for the standardized cancer vaccines in late-phase clinical development in the seven major markets, 2009 86
Figure 23: Abagovomab SWOT analysis, 2009 92
Figure 24: Phase I/II study results of abagovomab in ovarian cancer 94
Figure 25: Phase I/II study results of abagovomab in ovarian cancer 95
Figure 26: Abagovomab - Datamonitor drug assessment summary, 2009 97
Figure 27: Allovectin-7 SWOT analysis, 2009 101
Figure 28: Phase II results investigating high-dose Allovectin-7 in recurrent or unresponsive Stage III/IV melanoma 103
Figure 29: Allovectin-7 - Datamonitor drug assessment summary, 2009 105
Figure 30: Gp100:2019-217(210M) SWOT analysis, 2009 108
Figure 31: Phase III trial results for gp100:209-217(210M) plus high-dose (HD) interleukin-2 (IL-2) in melanoma 109
Figure 32: GV-1001 SWOT analysis, 2009 114
Figure 33: Phase I/II trial results investigating GV-1001 in unresectable pancreatic cancer 116
Figure 34: GV-1001 - Datamonitor drug assessment summary, 2009 118
Figure 35: Lucanix SWOT analysis, 2009 121
Figure 36: Phase II results for Lucanix in advanced non-small cell lung cancer (NSCLC) 123
Figure 37: Lucanix - Datamonitor drug assessment summary, 2009 125
Figure 38: MAGE-A3 ASCI SWOT analysis, 2009 129
Figure 39: Phase II results for MAGE-A3 ASCI as adjuvant therapy in completely resected Stage IB/II non-small cell lung cancer (NSCLC) 131
Figure 40: Phase II results for MAGE-A3 ASCI unresectable and metastatic melanoma 132
Figure 41: MAGE-A3 ASCI - Datamonitor drug assessment summary, 2009 135
Figure 42: MDX-1379 SWOT analysis, 2009 140
Figure 43: Phase II trial results investigating a second-line combination of ipilimumab and MDX-1379 in Stage IV melanoma patients 142
Figure 44: MDX-1379 - Datamonitor drug assessment summary, 2009 144
Figure 45: PR1 peptide antigen SWOT analysis, 2009 148
Figure 46: Phase I/II trial results investigating PR1 peptide antigen in mixed myeloid hematological malignancies 150
Figure 47: PR1 peptide antigen - Datamonitor drug assessment summary, 2009 152
Figure 48: Stimuvax SWOT analysis, 2009 156
Figure 49: Phase IIb results for Stimuvax maintenance therapy in advanced non-small cell lung cancer (NSCLC) 158
Figure 50: Stimuvax - Datamonitor drug assessment summary, 2009 161

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