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Pipeline Insight: Therapeutic Cancer Vaccines - Prospect of First Approval set to Reinvigorate Interest from Major Companies Product Image

Pipeline Insight: Therapeutic Cancer Vaccines - Prospect of First Approval set to Reinvigorate Interest from Major Companies

  • Published: December 2009
  • 174 pages
  • Datamonitor

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 of this title

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 READ MORE >

Overview
Catalyst
Summary
ABOUT DATAMONITOR HEALTHCARE
About the Oncology pharmaceutical analysis team
Executive Summary
Strategic scoping and focus
Datamonitor insight into the disease market
Contributing experts
Related reports
Upcoming related reports

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

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