Frontier Pharma: Head and Neck Cancer - Immunotherapies and Signal Transduction Inhibitors Dominate First-in-Class Innovation

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Head and neck squamous cell carcinoma is the sixth most common cancer, and its incidence is rising. The term head and neck cancer (HNC) comprises a number of malignancies that usually begin in the squamous cells that line the moist, mucosal surfaces inside the head and neck. These cancers develop inside the mouth, nose and throat. The annual incidence of head and neck cancers worldwide is more than 550,000 cases, with around 300,000 related deaths. Peak incidence occurs between the ages of 55 and 64.

The HNC 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 sized, with 340 products active across all stages of development. First-in-class products only constitute approximately a third of the pipeline, and represent 39% of products with a disclosed target. The most widely studied group of first-in-class targets are cancer immunotherapies. This has been heavily influenced by the success of Opdivo and Keytruda, which are used in the treatment of HNC (after 2016 FDA approvals) and other oncology indications. The first-in-class targets analyzed in this report have shown encouraging efficacy profiles, and some show the ability to chemosensitize cancer cells.

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Potential driving factors for the market include a large treatment population, the typically poor outcome, a high chance of recurrence for treated patients, a growing patient pool if disease prognosis can be improved, a lack of targeted therapy options in the market, and the 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 HNC, 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 likely that the concurrent use of multiple targeted therapies alongside other available modes of therapy will improve treatment outcomes.

Scope

• The report analyzes innovation in HNC in the context of the overall pipeline and current market landscape. It also analyzes the deals landscape surrounding first-in-class products, and pinpoints opportunities for in-licensing.
• A brief introduction to HNC is provided, including symptoms, pathophysiology, and an overview of pharmacotherapy and treatment algorithms.
• The changing molecular target landscape between the market and the pipeline is reviewed, 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 is included.
• First-in-class molecular targets are identified and assessed, 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.
• An assessment is made of the licensing and co-development deal landscape for HNC therapies.

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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 HNC market in terms of dominant molecule types and targets, highlighting what the current unmet needs are and how they can be addressed. This knowledge enables a competitive understanding of the gaps in the market.
• Analyze the HNC 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 HNC deals landscape by analyzing trends in licensing and co-development deals.

Table of Contents

1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 3
1.2 List of Figures 3

2 Executive Summary 4
2.1 High Unmet Need and Limited but Expanding Number of Marketed Options 4
2.2 Large but Highly Innovative Pipeline 4
2.3 Lucrative Deals Landscape, Mostly Involving Currently Established Targets 4

3 The Case for Innovation in the Head and Neck Cancer 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 Sustained Innovation 6
3.5 Report Guidance 7

4 Clinical and Commercial Landscape 8
4.1 Disease Overview 8
4.2 Disease Symptoms 8
4.3 Diagnosis 9
4.4 Etiology 9
4.4.1 Age, Ethnicity and Gender 9
4.4.2 Genetic Factors 10
4.4.3 Smoking, Alcohol and Environmental Factors 10
4.4.4 Viruses 10
4.5 Pathophysiology 11
4.5.1 Tumor Initiation and Aberrant Cell Proliferation and Survival 11
4.5.2 Tumor Metabolic Shift 12
4.5.3 Tumor Progression, Micro-environment Alteration, Angiogenesis and Metastasis 12
4.5.4 Cancer Stem Cells 13
4.6 Epidemiology 14
4.7 Prognosis 15
4.8 Head and Neck Cancer Treatment 15
4.8.1 Surgery and Radiation Therapy 16
4.8.2 Overview of Marketed Products for Head and Neck Cancer 17
4.8.3 Current Unmet Need in the Head and Neck Cancer Market 19

5 Assessment of Pipeline Product Innovation 20
5.1 Head and Neck Cancer Pipeline by Phase, Molecule Type and Molecular Target 20
5.2 First-in-Class Pipeline Programs 24

6 Signaling Network, Disease Causation and Innovation Alignment 32
6.1 The Complexity of Signaling Networks in Oncology 32
6.2 Signaling Pathways, Disease-Causing Mutations and First-in-Class Molecular Target Integration 33
6.3 First-in-Class Target Matrix Assessment 33