There Is an Urgent Need for More Efficacious High-Grade Glioma Treatments, but Will the Current Therapeutic Pipeline Suffice?

Decision Resources, Inc, December 2011, Pages: 33

There is a dearth of drug treatment options for high-grade glioma, especially for glioblastoma multiforme (GBM), which has a particularly poor prognosis. Meager advancements in prolonging the survival of patients have been made over the last decade, and there is a pressing need for efficacious therapies that are both safe and tolerable. The role of Roche's Avastin (bevacizumab) in GBM is still debated, and the results of ongoing pivotal studies are eagerly anticipated with the hope that they will enlighten us regarding this biological therapy. With mediocre enthusiasm surrounding the late-stage pipeline for high-grade glioma, considerable opportunity remains for drug developers.

Executive Summary
Strategic Considerations
Stakeholder Implications
Introduction
Disease Overview
WHO Grading System
Prognosis
Tumor Type, Tumor Location, and Resectability
Biomarkers
Pathways and Drug Targets
Angiogenesis
Epidermal Growth Factor Pathway
Current Therapies
Overview
Gliadel Wafers for High-Grade Glioma: A Controversial Treatment?
The Role of Temodar in the Treatment of High-Grade Glioma
The Significance of MGMT Promoter Methylation
Drug Treatment Strategies for Recurrent High-Grade Glioma
Treatment with Roche/Genentech/Chugai's Avastin
Clinical Development of Roche/Genentech/Chugai's Avastin
Emerging Therapies
Overview
Cilengitide (EMD-121974)
TheraCIM/Theraloc (Nimotuzumab)
Rindopepimut (CDX-110)
Trabedersen (AP-12009)
Challenges and Market Opportunities for Glioma
Overview
Agents that Improve Survival in Glioblastoma Multiforme Patients
Effective Therapies for Patients Who Harbor Unmethylated MGMT Promoters
Effective Therapies for Recurrent Patients Who Fail Avastin Treatment
Improvement in Quality of Life
Bibliography

Tables

1 WHO Grading System for Glioma

2 Survey question: For each of the following glioma classifications, what percentages of patients receive a complete resection? Partial resection? Or are unresectable?

3 Phase II BRAIN study: Safety Data for Avastin and Avastin plus Camptosar in Recurrent Glioblastoma Multiforme (Stage IV) Patients

4 Select Drug Therapies in Clinical Development for High-Grade Glioma

Figures

1 Survey question: For newly diagnosed high-grade (grade III anaplastic glioma and grade IV GBM) patients you treat, what percentage receives the following type of treatments?

2 Survey question: For your newly diagnosed high-grade (grade III anaplastic glioma and grade IV GBM) patients receiving adjuvant chemotherapy or chemoradiotherapy, what percentage receives the following drug treatments?

3 Survey question: For all high-grade (grade III anaplastic glioma and GBM) patients with recurrent disease (second- and third-line) you treat, what percentage receives the following type of treatment?

4 Survey question: In relation to the use of an implanted Gliadel (carmustine; BCNU) wafer and postoperative radiotherapy with concomitant and adjuvant Temodar (temozolomide) in high-grade glioma patients, please select one response for each of the following statements that most closely reflects your opinion

5 Survey question: For all high-grade (grade III anaplastic glioma and GBM) patients with recurrent disease (second- and third-line) you treat with chemotherapy or targeted therapy, what percentage receives the following treatments?

6 Survey question: Please indicate your level of satisfaction with Avastin (bevacizumab) as a treatment for high-grade glioma patients with recurrent disease on the following attributes

7 Survey question: Please indicate your level of concern for the following grade 3/4 adverse side effects/toxicities induced by Avastin (bevacizumab) treatment

8 Survey question: In newly diagnosed (first-line) GBM patients, do you believe that the addition of Avastin to the current standard of care will significantly improve overall survival and progression-free survival (the primary end points of the pivotal Phase III study)?

9 Survey question: Please rank the following therapies in terms of the likelihood that they will demonstrate efficacy and clinical benefit in Phase III studies for the treatment of high-grade glioma

10 Survey question: What are the greatest unmet needs for the treatment of high-grade glioma?

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