Glioblastoma
multiforme (GBM) is a grade IV tumor that arises from astrocytes. It is the
most common and aggressive human brain tumor, accounting for 15.4% of all
primary brain tumors and 60-75% of all astrocytomas. It has a peak incidence
between 55 and 84 years of age, with the median age of diagnosis being 64
years. In the US and EU, the annual incidence was estimated to be three to four
cases per 100,000 people. GBM has a high degree of intratumoral heterogeneity,
which is associated with poor prognosis and the development of drug resistance.
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The GBM market is characterized by a small selection of
marketed product options, consisting of chemotherapies, cancer immunotherapies
and receptor tyrosine kinase inhibitor products. The pipeline is moderately
large, with 512 products active across all stages of development.
First-in-class products only constitute approximately a quarter of the
pipeline, and represent 31% of products with a disclosed target. The most
widely studied group of first-in-class targets are the receptor tyrosine kinase
and ligand inhibitors, a trend that has been heavily influenced by the success
of Avastin, and possibly successful EGFR inhibitors such as Tarceva that are
used in the treatment of other oncology indications.
Potential driving factors for the market include a typically
poor outcome for treated patients, a growing patient pool if disease prognosis
can be improved, a lack of approved options in the market, and a strong
understanding of the disease pathophysiology that has developed over the last
decade, facilitating the development of novel compounds that may fulfill the
unmet needs.
Overall, due to the highly complex and polygenic nature of
GBM, which has numerous subtype classifications, it is unlikely that the
inhibition of a single target will be sufficient to substantially improve
patient prognosis. Instead, it is more likely that the concurrent use of
multiple targeted therapies, along with other available modes of therapy, may
improve treatment outcomes. First-in-class targets analyzed in this report have
shown encouraging efficacy profiles, and some show the ability to
chemosensitize cancer cells.
Scope
- The report analyzes innovation in GBM, in the context of
the overall pipeline and current market landscape. In addition, it analyzes the
deals landscape surrounding first-in-class products, and pinpoints
opportunities for in-licensing.
- A brief introduction to GBM, including symptoms,
pathophysiology, and an overview of pharmacotherapy and treatment algorithms.
- The changing molecular target landscape between the market
and the pipeline, including particular focal points of innovation in the
pipeline.
- A comprehensive review of the pipeline for first-in-class
therapies, analyzed on the basis of stage of development, molecule type and
molecular target.
- Identification and assessment of first-in-class molecular
targets, with a particular focus on early-stage programs for which clinical
utility has yet to be evaluated, as well as literature reviews on novel
molecular targets.
- Assessment of the licensing and co-development deal
landscape for GBM therapies.
Reasons to
buy
- Understand the current clinical and commercial landscape,
including a comprehensive study of disease pathogenesis, diagnosis, prognosis
and the available treatment options.
- Visualize the composition of the GBM market in terms of
dominant molecule types and targets, highlighting what the current unmet needs
are and how they can be addressed. This knowledge allows a competitive
understanding of the gaps in the current market.
- Analyze the GBM pipeline, stratified by stage of
development, molecule type and molecular target.
- Assess the therapeutic potential of first-in-class
targets. Using a proprietary matrix, first-in-class products have been assessed
and ranked according to clinical potential. Promising early-stage targets have
been further reviewed in greater detail.
- Identify commercial opportunities in the GBM deals
landscape by analyzing trends in licensing and co-development deals.
Table of
Content
1 Table of Contents 2
1.1 List of Tables
3
1.2 List of
Figures 3
2 Executive Summary 4
2.1 Low Prevalence
but a High Unmet Need and a Limited Number of Marketed Options 4
2.2 Moderately
Sized but Innovative Pipeline 4
2.3 Moderately
Active Deals Landscape, Mostly Involving Currently Established Targets 4
3 The Case for
Innovation in the Glioblastoma Multiforme Market 5
3.1 Growing
Opportunities for Biologic Products 5
3.2
Diversification of Molecular Targets 6
3.3 Innovative
First-in-Class Product Developments Remain Attractive 6
3.4 Changes in
Clinical and Commercial Environment to be More Favorable to Products Targeting
Niche Patient Populations and Indications 6
3.5 Sustained
Innovation 7
3.6 Report
Guidance 7
4 Clinical and
Commercial Landscape 8
4.1 Disease
Overview 8
4.2 Epidemiology 8
4.3 Disease
Symptoms 8
4.4 Etiology 9
4.5
Pathophysiology 11
4.6 Diagnosis 14
4.7 GBM Prognosis
and Prognostic Factors 15
4.8 Classification
15
5 Assessment of
Pipeline Product Innovation 24
5.1 Glioblastoma
Pipeline by Phase, Molecule Type and Molecular Target 24
5.2 First-in-Class Pipeline Programs 28
6 Signaling Network,
Disease Causation and Innovation Alignment 33
6.1 The Complexity
of Signaling Networks in Oncology 33
6.2 Signaling
Pathways, Disease-Causing Mutations and First-in-Class Molecular Target
Integration 34
6.3 First-in-Class
Target Matrix Assessment 34
7 First-in-Class
Target Evaluation 36
7.1 Pipeline
Programs Targeting AKT 1 and 2 36
7.2 Pipeline
Programs Targeting CDK1/2 37
7.3 Pipeline
Programs Targeting PIK3CB and PIK3CG 38
7.4 Pipeline
Programs which Target NTRK1 39
8 Deals and Strategic
Consolidations 48
8.1 Industry-Wide
First-in-Class Deals 48
8.2 Glioblastoma
Multiforme Deals Landscape 49
8.3 Licensing
Deals 50
9 Appendix 59
9.1 Abbreviations
59
9.2 References 60
9.6 Disclaimer 73
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