Stakeholder Opinions: Primary Brain Cancer
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Oncology pharmaceutical analysis team - page 2
- Andrew Paramore - Oncology Lead Analyst & Head of Product Development - page 2
- About the Oncology pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the primary brain cancer market - page 4
- Schering-Plough's Temodar (temozolomide) looks set to maintain its commercial success - page 4
- Considerable levels of unmet need and other financial incentives should make the glioma market attractive to drug developers - page 5
- The identification of molecular markers may change glioma treatment patterns in the future, by identifying those patients most likely to benefit from specific therapies - page 5
- There are very few promising late-phase pipeline drugs for glioma; those that show the most promise are the angiogenesis inhibitors - page 6
- Related reports - page 7
- Upcoming reports - page 7
- CHAPTER 2 PRIMARY BRAIN CANCER: BACKGROUND - page 9
- Introduction to primary brain cancer - page 9
- Primary brain cancer: a heterogeneous group of tumors - page 9
- Classification of primary brain tumors - page 10
- WHO primary brain tumor classification system widely used, but could be improved - page 10
- Low-grade astrocytoma (WHO grade II) - page 11
- High-grade astrocytoma (WHO grade III/IV) - page 11
- Oligodendrogliomas - page 12
- Prognosis: high-grade glioma patients face dismal survival prospects - page 12
- Etiology: prior cranial irradiation is the only established risk factor - page 13
- Epidemiology - page 14
- Primary CNS tumors account for 1.35% of all cancers and 2.2% of all cancer-related deaths - page 14
- Astrocytic and oligodendroglial tumors account for 77% of cases of primary brain cancer; glioblastoma is the most prevalent subtype - page 15
- Glioblastoma is most prevalent in patients aged over 60 years - page 16
- Incidence rates of primary brain cancer may be increasing; aging population likely to contribute to increased incidence of glioblastoma - page 17
- Introduction to primary brain cancer - page 9
- CHAPTER 3 CURRENT GLIOMA TREATMENT PRACTICES - page 19
- Overview of glioma treatment practices - page 19
- Surgery and radiotherapy in glioma treatment - page 20
- Surgery has four major purposes in glioma treatment - page 20
- Radiotherapy - page 20
- Chemotherapy in glioma treatment - page 20
- Temodar/Temodal (temozolomide), Schering-Plough - page 21
- Gliadel (carmustine polymer wafer), MGI Pharma - page 22
- Temodar compares favorably to Gliadel for treatment of newly-diagnosed glioblastoma multiforme - page 24
- Nitrosourea and PCV - page 24
- Supportive therapy for glioma patients - page 24
- Corticosteroids - page 24
- Anticonvulsants - page 25
- Treatment of newly diagnosed high-grade glioma - page 26
- Treatment guidelines recommend daily use of Temodar for glioblastoma patients - page 26
- Temodar is firmly established as the standard of care for newly-diagnosed high-grade glioma patients - page 27
- Controversy surrounds use of Gliadel - page 28
- Treatment of newly diagnosed low-grade glioma - page 29
- Guidelines make no firm recommendations on the use of radiotherapy and chemotherapy for low-grade glioma patients - page 29
- Low-grade glioma treatment strategies vary from physician to physician; chemotherapy is reserved for patients with progressive symptoms - page 30
- Treatment of recurrent glioma - page 32
- Guidelines recommend use of chemotherapy for treatment of recurrent high-grade and low-grade glioma - page 32
- Temodar replaced by other chemotherapy for recurrent glioma patients - page 32
- CHAPTER 4 UNMET NEEDS AND OPPORTUNITIES IN THE GLIOMA MARKET - page 34
- Unmet needs in glioma - page 34
- Unmet need 1: more effective first-line chemotherapy needed - page 34
- Temodar only provides a modest survival benefit - page 34
- Well designed Phase II trials needed to ensure potential glioma drugs not overlooked - page 35
- Next step forward in first-line therapy may involve multidrug combinations - page 35
- Unmet need 2: Blood-brain barrier likely to be an obstacle to drug delivery, particularly for monoclonal antibodies - page 36
- Unmet need 3: alternative chemotherapies needed with efficacy equivalent to Temodar for second- and third-line - page 37
- Unmet need 4: alternative to corticosteroids for edema treatment needed - page 37
- Unmet need 5: need for neuroprotective therapy for a subset of high-grade glioma patients showing prolonged survival - page 38
- Unmet need 1: more effective first-line chemotherapy needed - page 34
- Molecular markers for glioma - an emerging trend - page 39
- Patients with active MGMT promoter gene show a limited survival benefit with Temodar; questions remain over feasibility and reliability of testing - page 39
- Ip/19q loss of heterozygosity (LOH) used as diagnostic tool and to help make treatment decisions - page 41
- EGFR and PTEN expression may help decide which glioma patients receive EGFR inhibitors - page 42
- Incentives to enter the glioma market - page 43
- Very few drugs on the market and low bar set by existing therapies - page 43
- Uptake of glioma drugs less likely to be limited by same funding constraints as drugs for other cancer types - page 44
- Glioma drugs benefit from orphan drug designation and Fast Track status - page 44
- Commercial outlook for Temodar - page 45
- Unmet needs in glioma - page 34
- CHAPTER 5 PIPELINE DRUGS - page 47
- Drugs in Phase III trials - page 47
- Overview of glioma drugs in Phase III development - page 47
- Cotara (131I-chTNT-1/B), Peregrine Pharmaceuticals - page 48
- Cotara's novel mechanism of action may prevent development of drug resistance - page 48
- Pivotal product registration trial underway - page 49
- Phase II trial results indicate potential efficacy of Cotara - page 49
- Datamonitor comment: method of drug delivery and low physician awareness could significantly reduce uptake of Cotara - page 50
- CDX-110, Celldex Therapeutics - page 51
- CDX-110 is a cancer vaccine targeting EGFRvIII; Phase II/III trial initiated in April 2007 - page 51
- Datamonitor comment: like other therapeutic cancer vaccines, limited evidence of efficacy shown by CDX-110 to date - page 51
- Cerepro (EG-009), Ark Therapeutics - page 52
- Cerepro is a gene therapy designed to be used in conjunction with ganciclovir - page 52
- Cerepro denied early marketing authorization in Europe on basis of Phase II trial data - page 53
- Datamonitor comment: future success of Cerepro hinges on Phase III trial completion - page 54
- Gleevec/Glivec (imatinib), Novartis - page 54
- Use of Gleevec may be extended to glioma treatment - page 54
- Phase II/III clinical trial of Gleevec currently recruiting glioblastoma multiforme patients - page 55
- Phase II trial data indicate potential clinical efficacy of Gleevec for treatment of glioma - page 55
- Datamonitor comment: despite marketing strength of Novartis, low clinical efficacy may hinder Gleevec's uptake as a glioma treatment - page 57
- TheraCIM (nimotuzumab), YM BioSciences/Center of Molecular Immunology/Biocon Biopharmaceuticals/Oncoscience - page 58
- TheraCIM is a monoclonal antibody targetting the EGFR signal transduction pathway - page 58
- Phase III trial of TheraCIM underway for treatment of pontine glioma in children - page 58
- Phase II trial data indicate that TheraCIM has a favorable side-effect profile and particular efficacy in pediatric pontine glioma patients - page 59
- Datamonitor comment: favorable safety profile could make TheraCIM attractive to physicians, but questions remain over efficacy of EGFR inhibitors in glioma treatment. - page 60
- Drugs in Phase II trials - page 61
- Overview of glioma drugs in Phase II development: pipeline dominated by targeted therapies - page 61
- Genentech/Roche's Avastin (bevacizumab) and AstraZeneca's Recentin (cediranib): anti-angiogenesis drugs show early signs of promise as glioma therapies - page 63
- Phase II trial results indicate that Avastin could potentially find its use extended to treatment of glioma - page 63
- Recentin Phase II trial results for recurrent glioblastoma patients show promise - page 64
- Datamonitor comment: difficult to say yet whether anti-angiogenesis drugs genuinely reduce size of tumor but reduction of edema could be a significant selling point - page 64
- AP-12009, Antisense Pharma - page 66
- AP-12009 is an antisense oligonucleotide inhibiting expression of the tumor growth factor TGF-β2 - page 66
- Phase II studies indicate promising efficacy of AP-12009 in treatment of recurrent or refractory high-grade glioma - page 66
- Panzem NCD (2-methoxyestradiol), EntreMed Inc - page 68
- Panzem NCD is a formulation of 2-methoxyestradiol with several mechanisms of action - page 68
- Phase II data show that Panzem NCD is well-tolerated and potentially shows activity against recurrent glioblastoma multiforme - page 68
- EMD-121974 (cilengitide), Merck - page 68
- EMD-121974 shows only modest activity against recurrent glioma - page 68
- Drugs in Phase III trials - page 47
- APPENDIX A - page 70
- Bibliography - page 70
- List of tables - page 76
- List of figures - page 77
- About Datamonitor - page 78
- About Datamonitor Healthcare - page 78
- About the Oncology analysis team - page 79
- Disclaimer - page 80
- List of Tables
- Table 1: Summary of major types of glioma - page 10
- Table 2: WHO classification of glioma subtypes - page 10
- Table 3: Glioma patient median survival times by tumor subtype/grade - page 13
- Table 4: Estimated incidences of primary brain cancer across the seven major markets, 2002 and 2007 - page 14
- Table 5: Incidence rates and mean age of incidence of astrocytic and oligodendroglial tumors1 - page 15
- Table 6: Estimated incidences of glioma by subtype across the seven major markets, 2007 - page 16
- Table 7: Age distribution of glioblastoma multiforme incidences - page 16
- Table 8: Overview of major approvals for Temodar/Temodal in glioma treatment, 1999-2006 - page 21
- Table 9: Summary of study showing effect of MGMT methylation status on response to Temodar in glioblastoma patients, 2005 - page 40
- Table 10: Summary of study showing effect of 1p/19q LOH on response to Temodar in anaplastic oligodendroglioma and anaplastic oligoastrocytoma, 2006 - page 41
- Table 11: Drugs for glioma in Phase III development, May 2007 - page 48
- Table 12: Drugs for glioma in Phase II development, June 2007 - page 61
- Table 13: Summary of Phase II data for treatment of recurrent/refractory glioblastoma with AP-12009, 2007 - page 67
- Table 14: Summary of Phase II data for treatment of recurrent/refractory anaplastic astrocytoma with AP-12009, 2007 - page 67
- List of Figures
- Figure 1: Estimated proportion of population over 60 years in the seven major markets: 2005, 2010 and 2015 - page 18
- Figure 2: Summary of Phase III trial of Temodar with radiotherapy compared to radiotherapy alone for newly diagnosed glioblastoma multiforme, 2005 - page 22
- Figure 3: Summary of Phase III trial comparing Gliadel to polymer placebo, 2003 - page 23
- Figure 4: Phase II trial results for glioma treatment with Cotara, 2001 - page 50
- Figure 5: Phase II data: recurrent glioblastoma multiforme treatment with Gleevec, 2004 - page 56
- Figure 6: Phase II data: recurrent anaplastic astrocytoma/ anaplastic oligodendroglioma treatment with Gleevec, 2006 - page 57
- Figure 7: Pediatric glioma treatment with TheraCIM (Phase II data), 2006 - page 59
Other users found this report page using the following search terms: brain cancer glioma glioma brain glioblastoma grade multiforme 4 cancer prognosis treatment tumor
If you can't find a report that meets your needs contact LeadDiscovery. We are one of the few report providers with extensive drug development experience and we frequently use this knowledge to help clients source the most appropriate reports or produce reports for them from scratch.