PharmaFocus: Supportive Care in Oncology

PharmaFocus: Supportive Care in Oncology

Summary

Supportive care in oncology is a broad term that is composed of indications that are either a symptom of a patients cancer or a side effect of cancer treatment. This report focuses on six prominent cancer supportive care indications: chemotherapy-induced nausea and vomiting (CINV), cancer cachexia, oral mucositis, bone metastases, chemotherapy-induced neutropenia (CIN), and chemotherapy-induced anemia (CIA).

There is a consensus among KOLs across the 7MM that supportive oncology had not been given much priority by physicians and institutions in the past. However, there is also a consensus that this situation has been improving in recent years, with increasing recognition of the importance of supportive care.

A growing library of evidence indicates that supportive care: increases likelihood of completing treatment, without the need for dose reductions or treatment pauses; can reduce costs for healthcare institutions; and can improve quality of life for patients-all of which will become increasingly important as patients continue to live longer and cancer progresses to become more like a chronic disease. Despite the trends in oncology towards targeted therapies, KOLs agree that chemotherapy will remain the backbone of cancer treatment for the next five to 10 years. Thus, as the incidence of cancer rises over the next 10 years, so will the cases of chemotherapy-related conditions, in addition to a rise in general oncology-related conditions.

Scope

- Highlight KOL views on the past, present, and future trends in supportive care in oncology in their countries
- Provide cancer and cancer supportive care epidemiological insight
- Provide an overview of the market landscape and available therapies
- Provide an overview of all late-stage (Phase II and III) candidates and evaluate the prominent pipeline agents that are closest to market entry
- Identify the unmet needs and opportunities in each indication
- Highlight R&D strategies used by developers in this field, alongside clinical trial design considerations and challenges
- Provide detailed key opinion leader insight throughout each indication and aspect of this report.

Reasons to buy

The report will enable you to -
- Develop business strategies by understanding the trends shaping and driving the global supportive care in oncology market
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global supportive care market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments, and strategic partnerships.

1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 7
1.2 List of Figures 8
2 Executive Summary 9
2.1 Traditionally Overlooked Field, but Recognition of Supportive Oncology is Growing Across the 7MM, and will Continue to do so in the Next Five to Ten Years. 9
2.2 Marketed Landscape Varies Significantly - Blockbuster Drugs in CIN, CIA, and Bone Metastases, but Nothing Available for Cancer Cachexia 9
2.3 CIN and Oral Mucositis Possess the Largest Late Stage (Phase II and III) Pipelines 10
2.4 Unmet Needs Remain in Each Indication, Primarily in Cancer Cachexia and Oral Mucositis, Given the Lack of Effective Therapies 10
2.5 R&D and Clinical Trial Design in Supportive Oncology Presents Unique Challenges 11
2.6 What Do Physicians Think? 11
3 Introduction 13
3.1 Objectives 13
3.2 Related Reports 13
4 Supportive Care in Oncology Global Landscape: KOL Views 15
4.1 Overview 15
4.2 US Supportive Care Landscape 16
4.2.1 Current Status of Supportive Care in Oncology 16
4.2.2 Physician and Patient Attitudes Towards Supportive Care in Oncology 17
4.2.3 Future Trends 19
4.3 UK Supportive Care Landscape 19
4.3.1 Current Status of Supportive Oncology and Physician/Patient Attitudes towards Supportive Oncology 20
4.3.2 Future Trends 22
4.4 Germany Supportive Care Landscape 22
4.4.1 Current Status of Supportive Oncology and Physician/Patient Attitudes towards Supportive Oncology 23
4.4.2 Future Trends 24
4.5 Spain Supportive Care Landscape 25
4.6 Japan Supportive Care Landscape 26
4.6.1 Who Provides Supportive Care in Japan 26
4.6.2 Current State of Supportive Oncology in Japan 27
4.6.3 Future Trends 28
4.7 Guidelines Followed by KOLs 29
4.7.1 Chemotherapy Induced Nausea and Vomiting 29
4.7.2 Chemotherapy-Induced Neutropenia 30
5 Epidemiology 32
5.1 Cancer Background, Global and Historic Trends 32
5.2 Methodology and Sources 34
5.2.1 Assumptions and Methods 41
5.3 Epidemiology for Supportive Care in Oncology (2016-2026) 48
5.3.1 Diagnosed Incident Cases of All Cancer 48
5.3.2 Diagnosed Incident Cases of All Cancer Receiving Chemotherapy Treatment 48
5.3.3 Diagnosed Incident Cases of Chemotherapy-Induced Conditions 49
5.3.4 Diagnosed Incident Cases of Prostate Cancer 50
5.3.5 Diagnosed Incident Cases of Prostate Cancer That Develop Bone Metastasis 51
5.3.6 Diagnosed Incident Cases of Breast Cancer 52
5.3.7 Diagnosed Incident Cases of Breast Cancer That Develop Bone Metastasis 53
5.3.8 Diagnosed Incident Cases of Lung Cancer 54
5.3.9 Diagnosed Incident Cases of Lung Cancer that Develop Bone Metastasis 55
5.3.10 Five-Year Diagnosed Prevalent Cases of All Cancer 56
5.4 Discussion, Limitations and Strengths of Analysis 57
6 Marketed Products 59
6.1 Chemotherapy-Induced Nausea and Vomiting 59
6.1.1 Emend and Emend for Injection 61
6.1.2 Varubi and Varubi IV 63
6.1.3 Aloxi 65
6.1.4 Sustol 66
6.1.5 Akynzeo 67
6.1.6 Syndros and Marinol 68
6.1.7 Olanzapine - Off-Label Use 69
6.2 Cancer Cachexia 70
6.3 Oral Mucositis 71
6.3.1 Kepivance 72
6.3.2 Mucosta (Off-Label) and Gels for Oral Mucositis 73
6.4 Bone Metastases 74
6.4.1 Xgeva 75
6.4.2 Xofigo 77
6.4.3 Zometa and Aredia 78
6.5 Chemotherapy-Induced Neutropenia 81
6.5.1 Neupogen 82
6.5.2 Filgrastim Biosimilars 83
6.5.3 Granix and Granocyte 84
6.5.4 Neulasta 85
6.5.5 Lonquex and Leukine 86
6.6 Chemotherapy Induced Anemia 88
6.6.1 Procrit/Eprex/Epogen 89
6.6.2 Epoetin Alfa Biosimilars, NeoRecormon, and Eporatio / Biopoin 90
6.6.3 Aranesp 91
7 Pipeline Assessment 93
7.1 Chemotherapy-Induced Nausea and Vomiting 93
7.1.1 CINV Phase II and III Pipeline 93
7.1.2 APD403 (Amisulpride) - Acacia Pharma 94
7.1.3 Cinvanti (Aprepitant/HTX-019) - Heron Therapeutics 96
7.2 Cancer Cachexia 99
7.2.1 Cancer Cachexia Phase II and III Pipeline Overview 99
7.2.2 Adlumiz (Anamorelin) - Helsinn 101
7.2.3 Xilonix (MABp1) - XBiotech 106
7.3 Oral Mucositis 109
7.3.1 Oral Mucositis Phase II and III Pipeline Overview 109
7.3.2 SGX942 (Dusquetide) - Soligenix Inc. 110
7.3.3 Validive (Clonidine Lauriad) - Onxeo/Monopar Therapeutics 113
7.4 Bone Metastases 116
7.4.1 Bone Metastases Phase II and III Pipeline Overview 116
7.4.2 Tanezumab - Pfizer and Eli Lilly 117
7.5 Chemotherapy-Induced Neutropenia 120
7.5.1 CIN Phase II and III Pipeline Overview 120
7.5.2 Rolontis (eflapegrastim/SPI-2012) - Spectrum Pharmaceuticals and Hanmi Pharmaceuticals 123
7.5.3 Plinabulin (NPI-2358) - BeyondSpring Pharmaceuticals 125
7.6 Chemotherapy-Induced Anemia 128
7.6.1 CIA Phase II and III Pipeline Overview 128
7.6.2 SPP-003 (5-Aminolevulinic Acid Hydrochloride and Sodium Ferrous Citrate) - SBI Pharmaceuticals 129
8 Unmet Needs and Opportunities 131
8.1 Chemotherapy-Induced Nausea and Vomiting 131
8.1.1 Therapies with More Effective Control of Nausea 132
8.1.2 Novel Mechanisms of Action and Differentiation from Currently Available Therapies 134
8.1.3 CINV Treatment/Regimens for Oral Anti-Cancer Drugs 135
8.1.4 Education of Stakeholders on Available Treatment Options and Proper Utilization 136
8.1.5 Other Unmet Needs 137
8.2 Cancer Cachexia 138
8.2.1 Huge Unmet Need for Treatments 139
8.2.2 Need for Improved Diagnosis and Identification of Cachexia in Obese Patients 142
8.2.3 Lack of Research, and Cachexia Not Given Priority in Cancer Care 143
8.3 Oral Mucositis 144
8.3.1 Need for Effective Treatments 145
8.3.2 Improved Forms of Administration 146
8.4 Bone Metastases 147
8.4.1 New Targets and Novel Mechanisms of Action 147
8.4.2 Improvements in Quality of Life and in Pain 148
8.4.3 Therapies with Oral Administration 150
8.4.4 Further Investigation of Corticosteroids for Painful Bone Metastases 150
8.5 Chemotherapy-Induced Neutropenia 151
8.5.1 New Treatments to Update Regimens from the Decades-Old Therapies Currently Available 151
8.5.2 New Forms of Administration, Fewer Side Effects, and Biomarkers 152
8.6 Chemotherapy-Induced Anemia 154
8.6.1 Therapies with a Better Side Effect Profile and Faster Demonstration of Effectiveness than ESAs 154
8.6.2 Further Investigation of IV Iron in CIA, and Subsequent Update to Treatment Guidelines 155
9 R&D Strategies and Clinical Trial Design 158
9.1 Overview of Clinical Development in Supportive Oncology 158
9.2 Chemotherapy-Induced Nausea and Vomiting 159
9.2.1 R&D Strategies 159
9.2.2 Clinical Trial Design Considerations 161
9.3 Cancer Cachexia 163
9.3.1 R&D Strategies 163
9.3.2 Clinical Trial Design Considerations 164
9.4 Oral Mucositis 168
9.4.1 R&D Strategies 168
9.4.2 Clinical Trial Considerations 169
9.5 Bone Metastasis 171
9.5.1 R&D Strategies and Clinical Trial Considerations 171
9.6 Chemotherapy-Induced Neutropenia 173
9.6.1 R&D Strategies 173
9.6.2 Clinical Trial Design Considerations 174
9.7 Chemotherapy-Induced Anemia 176
9.7.1 R&D Strategies and Clinical Trial Design Considerations 176
10 Appendix 178
10.1 Bibliography 178
10.2 Abbreviations 188
10.3 Primary Research - KOLs Interviewed for This Report 191
10.4 About the Authors 194
10.4.1 Analyst 194
10.4.2 Therapy Area Director 194
10.4.3 Epidemiologists 195
10.4.4 Reviewers 195
10.4.5 Global Director of Therapy Analysis and Epidemiology 196
10.4.6 Global Head and EVP of Healthcare Operations and Strategy 197
10.5 About GlobalData 198
10.6 Contact Us 198
10.7 Disclaimer 198

List Of Tables

Table 1: 7MM, Diagnosed Incident Cases of All Cancer, Men and Women, Ages 20 Years 48
Table 2: CINV Marketed Products Overview 59
Table 3: Types of CINV 59
Table 4: Product Profile - Emend 61
Table 5: Product Profile - Emend for Injection / IVemend 61
Table 6: Product Profile - Varubi and Varubi IV 63
Table 7: Product Profile - Aloxi 65
Table 8: Product Profile - Sustol 66
Table 9: Product Profile - Akynzeo 67
Table 10: Product Profile - Kepivance 72
Table 11: Bone Metastases Marketed Products Overview 74
Table 12: Product Profile - Xgeva 75
Table 13: Product Profile - Xofigo 77
Table 14: Product Profile - Zometa 78
Table 15: Product Profile - Aredia 80
Table 16: CIN Marketed Products Overview 81
Table 17: Product Profile - Neupogen 82
Table 18: Filgrastim Biosimilars 83
Table 19: Product Profile - Granix 84
Table 20: Product Profile - Granocyte 84
Table 21: Product Profile - Neulasta 85
Table 22: Product Profile - Lonquex 86
Table 23: Product Profile - Leukine 87
Table 24: CIA Marketed Products Overview 88
Table 25: National Cancer Institute Anemia Scale 88
Table 26: Product Profile - Procrit/Eprex/Epogen 89
Table 27: Epoetin Alfa Biosimilars 91
Table 28: Product Profile - NeoRecormon 91
Table 29: Product Profile - Eporatio/Biopoin 91
Table 30: Product Profile - Aranesp 91
Table 31: CINV Phase II and III Pipeline 93
Table 32: APD403 (Amisulpride) - Acacia Pharma, SWOT Analysis, 2017 96
Table 33: Cinvanti (Aprepitant/HTX-019) - Heron Therapeutics, SWOT Analysis, 2017 98
Table 34: Cancer Cachexia Phase II and III Pipeline 99
Table 35: Adlumiz (Anamorelin) - Helsinn, SWOT Analysis, 2017 104
Table 36: Xilonix (MABp1) - XBiotech, SWOT Analysis, 2017 108
Table 37: Oral Mucositis Phase II and III Pipeline 109
Table 38: Phase III Clinical Development Programs for SGX942 (Dusquetide) in Oral Mucositis 111
Table 39: SGX942 (Dusquetide) - Soligenix, SWOT Analysis, 2017 113
Table 40: Validive (Clonidine Lauriad) - Onxeo / Monopar Therapeutics, SWOT Analysis, 2017 115
Table 41: Bone Metastases Phase II and III Pipeline 116
Table 42: Phase III Clinical Development Programs for Tanezumab - Pfizer and Eli Lilly in Bone Metastases 117
Table 43: Tanezumab - Pfizer and Eli Lilly, SWOT Analysis, 2017 119
Table 44: CIN Phase II and III Pipeline 120
Table 45: Phase III Clinical Development Program for Rolontis (Eflapegrastim/SPI-2012 - Spectrum Pharmaceuticals and Hanmi Pharmaceuticals) in CIN 124
Table 46: Rolontis (Eflapegrastim/SPI-2012) - Spectrum Pharmaceuticals and Hanmi Pharmaceuticals, SWOT Analysis, 2017 125
Table 47: Phase II/III Clinical Development Programs for Plinabulin (NPI-2358) - BeyondSpring Pharmaceuticals in CIN 126
Table 48: Plinabulin (NPI-2358) - BeyondSpring Pharmaceuticals, SWOT Analysis, 2017 128
Table 49: CIA Phase II and III Pipeline 128
Table 50: SPP-003 (5-Aminolevulinic Acid Hydrochloride and Sodium Ferrous Citrate) - SBI Pharmaceuticals, SWOT Analysis, 2017 130
Table 51: Oral Mucositis Pipeline Agents: Methods of Administration 146
Table 52: Definitions of the Most Common CINV Trial Endpoints 161
Table 53: Oral Mucositis Late-Stage Pipeline Agents: FDA Fast Track Designations 168
Table 54: Primary Endpoints Used in Trials for Oral Mucositis Pipeline Agents 169
Table 55: Examples of Primary and Secondary Endpoints that Can Be Studied in CIN Trials 176
Table 56: Common Outcomes of Interest in Anemia Clinical Trials 177

List Of Figures

Figure 1: 7MM, Age-Standardized Diagnosed Incidence of All Cancer, Men, Ages 18 Years, 2016-2026 33
Figure 2: 7MM, Age-Standardized Diagnosed Incidence of All Cancer, Women, Ages 18 Years, 2016-2026 34
Figure 3: 7MM, Sources Used to Forecast Diagnosed Incident Cases of All Cancer 35
Figure 4: 7MM, Sources Used to Forecast Five-Year Diagnosed Prevalent Cases of All Cancer 36
Figure 5: 7MM, Sources Used to Forecast Diagnosed Incident Cases of Prostate Cancer 37
Figure 6: 7MM, Sources Used to Forecast Diagnosed Incident Cases of Breast Cancer 38
Figure 7: 7MM, Sources Used to Forecast Diagnosed Incident Cases of Lung Cancer 39
Figure 8: 7MM, Sources Used to Forecast Chemotherapy-Induced Conditions 40
Figure 9: 7MM, Sources Used to Forecast Bone Metastasis in Prostate, Breast, and Lung Cancer 41
Figure 10: 7MM, Diagnosed Incident Cases of All Cancer Receiving Chemotherapy Treatment, Men and Women, Ages 18 Years 49
Figure 11: 7MM, Diagnosed Incident Cases of All Cancer With Chemotherapy-Induced Conditions, Men and Women, Ages 18 Years 50
Figure 12: 7MM, Diagnosed Incident Cases of Prostate Cancer, Men, Ages 35 Years 51
Figure 13: 7MM, Diagnosed Incident Cases of Prostate Cancer That Have Developed or Will Develop Bone Metastasis, Men, Ages 35 Years 52
Figure 14: 7MM, Diagnosed Incident Cases of Breast Cancer, Women, Ages 20 Years 53
Figure 15: 7MM, Diagnosed Incident Cases of Breast Cancer That Have Developed or Will Develop Bone Metastasis, Women, Ages 20 Years 54
Figure 16: 7MM, Diagnosed Incident Cases of Lung Cancer, Men and Women, Ages 20 Years 55
Figure 17: 7MM, Diagnosed Incident Cases of Lung Cancer That Have Developed or Will Develop Bone Metastasis, Men and Women, Ages 20 Years 56
Figure 18: 7MM, Five-Year Diagnosed Prevalent Cases of All Cancer, Men and Women, All Ages 57
Figure 19: Unmet Needs and Opportunities in CINV, 2017 131
Figure 20: Unmet Needs and Opportunities in Cancer Cachexia, 2017 139
Figure 21: Unmet Needs and Opportunities in Oral Mucositis 2017 144
Figure 22: Unmet Needs and Opportunities in Bone Metastases, 2017 147
Figure 23: Unmet Needs and Opportunities in CIN, 2017 151
Figure 24: Unmet Needs and Opportunities in CIA 2017 154

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