Frontier Pharma: Glioblastoma Multiforme - Cancer Immunotherapies Dominate First-in-Class Product Innovation
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.
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.
Glioblastoma market set for strong innovation, with 120 first-in-class programs, says GBI Research
Glioblastoma, a particularly aggressive form of brain tumor, has a promising treatment pipeline, with 120 first-in-class programs acting on 86 first-in-class molecular targets, according to business intelligence provider GBI Research.
The company’s latest report states that the glioblastoma therapy pipeline, which includes 512 products active across all stages of development, is moderately sized but highly innovative. Potential factors driving the pipeline include vast unmet need, a growing patient pool if disease prognosis can be improved, a lack of approved options in the market landscape, and a recently improved understanding of the disease pathophysiology, facilitating the development of novel compounds.
Adam Bradbury, MSc, Associate Analyst for GBI Research, explains: “Pipeline innovation has far-reaching strategic implications for all market participants as, despite the high attrition rate in glioblastoma, it is highly likely that many of the numerous first-in-class products, a number of which are supported by promising preclinical data, will reach the market over the coming decade, potentially transforming the clinical and commercial landscape.”
For players in the market, the case for investment in innovative products has not weakened as a result of the challenging commercial environments in developed markets and, increasingly, developed nations. On the contrary, despite higher stakes and greater risks, the return on investment for innovative products reaching the market remains attractive and could increase in significance in years to come.
Bradbury continues: “There are many signaling pathways and cellular processes in glioblastoma that remain untargeted by the limited number of associated marketed products. While growth factor signaling, such as by vascular endothelial growth factor, is inhibited in current glioblastoma treatments, evidence is mounting for the importance of other parallel mechanisms, such as cancer stem cell growth, and extracellular matrix remodeling.”
In terms of the glioblastoma deals landscape, activity is moderate and the mean value for co-development deals is below the industry average at $196.2 million, although the mean value of licensing deals is above the industry average at $168 million, according to GBI Research.
Bradbury concludes: “One of the most lucrative recent deals, a licensing agreement between AstraZenenca and Targacept, involved a current first-in-class product, and was valued at $1.2 billion. Despite the risk that can be associated with first-in-class products, they have still been shown to be a highly desirable investment option.”
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