Stakeholder Opinions: Primary Brain Cancer

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Publication Date: 2005-07-06

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The incidence of glioblastoma is increasing. Schering-Plough's temozolomide has gained approval as first line therapy for glioblastoma and has provided some survival benefit. However, median survival is still a modest fifteen months. Thus, the glioblastoma market is characterized by a high level of unmet need and consequently lucrative commercial value.

Scope

Overview of disease including epidemiology, biology of glioma and prognostic variables

Current treatment options and clinical controversies including comments from opinion leaders

Key recommendations in the areas of greatest unmet need in glioblastoma patients

Profiles of agents in late stage development including opinions from glioma specialists

Report Highlights
Temozolomide's approval as first line therapy for glioblastoma is a significant advance for these patients. The surge in US sales since its March 2005 approval reflects the current dearth in effective therapy for these patients. Temozolomide has raised the bar for other agents and, as such, physician expectation is now higher

Peregrine's Cotara is in late stage development for glioblastoma. However, Datamonitor believes that Cotara's cumbersome administration and low physician awareness may hinder uptake

Opinion leaders feel the future for glioblastoma treatment will focus on novel targeted treatments. Eli Lilly's enzastaurin has demonstrated a 20% response rate in heavily pre-treated patients in Phase II trials, and may be the most promising early developmental agent at present. Phase III trials are planned combining enzastaurin with temozolomide

Reasons to Purchase

Understand the limitations of current therapy available to glioma patients and the potential of future therapy

Identify future market opportunities based on opinion leader comments regarding unmet needs, marketed products and those in the pipeline

Plan new product development based on an understanding of physician expectation for improvements in survival, quality of life and economic constraints

CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope - page 3
- Datamonitor insight into the brain cancer market - page 4
CHAPTER 2 INTRODUCTION: A DIVERSE RANGE OF HETEROGENOUS NEOPLASMS - page 13
- Epidemiology - page 15
- Staging and classification systems for primary brain tumors - page 21
  - TNM staging system is of limited utility - page 21
  - WHO classifies brain tumors by histological origin of tumor cell - page 21
  - WHO grading of brain tumors provides prognostic utility - page 24
  - Gliomas account for 77% of the malignant brain tumors - page 24
    - Astrocytomas - page 25
    - Oligodendrogliomas - page 27
    - Mixed gliomas - page 27
- Prior cranial irradiation and genetic predisposition are the only established risk-factors for brain tumor development - page 28
- Prognosis for glioma patients is primarily related to histological grade, age and performance status - page 31
  - For treatment purposes patients may be stratified according to the recursive partitioning analysis (RPA) classification. - page 32
  - Some molecular markers have demonstrated prognostic utility regarding response to chemotherapy - page 34
    - Loss of heterozygosity indicates response to lumustine, procarbazine and vincristine therapy in oligodendroglioma - page 34
    - Hypermethylation of O6-methylguanine-DNA methyltransferase promotor indictates increased sensitivity to temozololimide in glioblastoma patients - page 35
CHAPTER 3 CURRENT TREATMENT OPTIONS - page 38
- Supportive care - page 39
- Surgical options for glioma patients - page 40
- Radiotherapy options for glioma patients - page 40
- Treatment of low-grade glioma - page 43
  - The 'gold-standard' treatment for low-grade glioma may be changing - page 44
  - No clinical benefit of immediate radiation therapy following surgery for low-grade glioma - page 45
  - No radiotherapy dose-response in patients with low-grade glioma - page 45
- Treatment of glioblastoma - page 46
  - Schering-Plough's temozolomide (Temodal/Temodar) has rapidly become the new gold standard of care for glioblastoma - page 48
- Temozolomide (Temodar, Temodal), Schering-Plough - page 49
  - Temozolomide with radiotherapy confers increased survival in glioblastoma patients - page 49
  - Temozolomide has a manageable toxicity profile - page 50
  - Temozolomide benefits from its oral availability - page 50
  - Temozolomide, European Medicines Agency application approved June 2005 - page 51
CHAPTER 4 UNMET NEEDS - page 52
- Disruption of the bloob-brain barrier can cloud accuracy of Imaging techniques - page 52
  - Imaging - page 52
  - Drug penetration through the blood brain barrier continues to hamper drug development - page 53
  - Adverse interaction of supportive therapy with definitive therapy drugs - page 54
- Measuring tumor response requires evolution in the era of targeted treatment - page 55
  - Improvements in clinical trial design necessary - page 57
  - Alternative Phase II trial design - page 58
  - Temozolomide 'raises the bar' as suitable clinical endpoints - page 58
  - Effective agents needed to counter inevitable tumor recurrence - page 59
- Costs associated with treating glioma patients - page 59
  - Despite low incidence brain cancer exerts significant costs on healthcare systems - page 59
  - Inpatient stays are the main driver of costs associated with brain cancer patients - page 63
  - Agents in development for glioma benefit from fast track and orphan drug status - page 65
CHAPTER 5 PIPELINE DRUGS - page 67
- Cotara (131I-ch, TNT-1B, 131I-TNT), Peregrine Pharmaceuticals - page 67
- Cintredekin besudotox (IL13-PE38; NK-408), Neopharm - page 70
- Nimotuzumab (TheraCIM h-R3: as Theraloc in Europe), YM Biosciences/Center of Molecular Immunology/Oncoscience - page 72
- TransMID (XR-311), Xenova - page 74
- Phase II trial drugs - page 76
  - Enzastaurin (LY-317615; 317615.2HCI), Eli Lilly - page 77
    - Enzastaurin demonstrates clinical benefit in recurrent or progressive glioma - page 77
    - Overall enzastaurin had a favorable safety profile - page 78
    - Potential association of anti-cogulation therapy, enzastaurin and intratumoral bleeds - page 78
    - Phase III trials for enzastaurin planned - page 79
    - Significant uptake expected if Phase III trial results are positive - page 79
  - Erlotinib (Tarceva, Genentech/Roche/OSI) - page 80
    - Modest single agent activity in glioblastoma - page 80
    - Combining erlotinib with radiation appears to demonstrate acceptable toxicity - page 81
    - Race is on to identify biomarkers predictive of response - page 82
    - High EGFR expression and low levels of phosphorylated Akt may be suggestive of responder groups to erlotinib. - page 83
    - Further investigations need to be carried out to confirm these associations - page 83
    - Erlotinib will achieve significant uptake if efficacy shown - page 83
CHAPTER 6 OPINION LEADER TRANSCRIPTS - page 85
- Contributing experts - page 85
  - European opinion leader 1 - page 86
  - European opinion leader 2 - page 94
  - US opinion leader 1 - page 102
  - US opinion leader 2 - page 115
  - US opinion leader 3 - page 126
CHAPTER 7 APPENDIX - page 132
- References - page 132
- Methodology - epidemiology - page 136
- Integrity of incidence data - page 136
  - Static incidence data - page 136
- List of tables - page 138
- List of figures - page 140
- About Datamonitor - page 141
  - About Datamonitor Healthcare - page 141
  - Datamonitor Healthcare's research and analysis methodologies - page 142
- Datamonitor Healthcare's therapy area capabilities - page 142
  - About the Oncology analysis team - page 143
- Disclaimer - page 144

List of Tables
Table 1: Datamonitor estimates of glioblastoma incidence across the seven major markets, 2003-15 - page 8
Table 2: Crude incidence rates of primary brain cancer in the seven major markets - page 16
Table 3: Datamonitor estimates of the incidence of malignant brain cancer in the seven major markets, 2003-15 - page 17
Table 4: Datamonitor estimates of the incidence of glioma in the seven major markets, 2003-15 - page 18
Table 5: Datamonitor estimates of glioblastoma across the seven major markets, 2003-15 - page 20
Table 6: Summary of nine types of brain cancer - page 23
Table 7: WHO grading of CNS tumors - page 24
Table 8: Summary of gliomas arising from transformation of astrocytomas - page 26
Table 9: Summary of characteristics of oligodendrogliomas and mixed gliomas - page 27
Table 10: Genetic predisposition to intracranial tumors - page 30
Table 11: Relative survival rates of gliomas versus other tumor types - page 32
Table 12: Survival estimates by RPA class - page 34
Table 13: Methylated MGMT confers better prognosis for glioblastoma patients - page 36
Table 14: Surgical and radiotherapy techniques used for glioma patients - page 42
Table 15: Five- year survival rates of partial resection versus total resection in patients with low-grade glioma - page 44
Table 16: Clinical trial results demonstrating no benefit of immediate radiotherapy and clinical benefit of low dose radiotherapy over high dose radiotherapy in low-grade glioma - page 46
Table 17: EORTC Phase III trial results supporting FDA approval of temozolomide for newly diagnosed glioblastoma - page 50
Table 18: Grade 3 or 4 hematological toxicity associated with temozolomide. - page 50
Table 19: Summary of patient and control cohort demographics - page 60
Table 20: Temozolomide sales for first quarter 2005 are 52% increased compared to first quarter 2004 - page 65
Table 21: Phase III drugs - page 67
Table 22: Comparison of peritumoral delivery and intratumoral delivery - page 71
Table 23: Phase II drugs - page 76
Table 24: Phase II trial results for enzastaurin in patients with recurrent high-grade gliomas. - page 78
Table 25: Intratumoral bleeds in patients on enzasturin may be associated with anti-coagulation therapy - page 79
Table 26: Phase II trials of erlotinib in glioma - page 81
Table 27: Combining erlotinib with radiation therapy demonstrates acceptable toxicity - page 82

List of Figures
Figure 1: Schematic diagram of the brain - page 15
Figure 2: Datamonitor estimates of the incidence of malignant brain cancer in the seven major markets, 2003-15 - page 17
Figure 3: Datamonitor estimates of the incidence of gliomas in the seven major markets, 2003-15 - page 18
Figure 4: Distribution of primary brain and CNS gliomas - page 19
Figure 5: Datamonitor estimates of glioblastoma across the seven major markets, 2003-15 - page 20
Figure 6: Diagram illustrating the location of brain tumors - page 22
Figure 7: Diagram illustrating the six RPA classes for glioma patients - page 33
Figure 8: Current treatment options for primary brain cancer patients - page 39
Figure 9: Mean monthly rate of emergency room visits, hospitalizations and length of stay for brain cancer patients versus controls - page 61
Figure 10: Mean monthly rate of outpatient radiology and laboratory procedures office visits and pharmacy drugs dispensed in brain cancer patients and cancer-free controls - page 62
Figure 11: Inpatient stays drive the costs associated with brain cancer patients - page 63
Figure 12: Comparison of the mean monthly and overall healthcare costs between brain cancer patients and controls - page 64

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Stakeholder Opinions: Primary Brain Cancer

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