Introduction
Immuno-oncology Development Trends and Opportunities
Summary
Immuno-oncology (IO) is the treatment of cancer with therapies that stimulate or suppress the body’s own immune system. Several distinct modalities of IO therapy exist, including bispecific T-cell engaging monoclonal antibodies, cellular immunotherapy and adoptive cellular therapy, cancer vaccines, checkpoint modulating monoclonal antibodies, and oncolytic viruses.
This report provides an overview of current clinical development trends for IO within the 8MM (France, Germany, Italy, Spain, UK, US, Japan, China), including a history of recent approvals, indications currently being explored for IO agents of all modalities, targets being selected for IO therapies, and combination strategies being investigated for approved IO agents. In addition, the report provides disease overviews, epidemiology, current recommended treatment regimens and IO approvals, and IO clinical trial trends for 17 indications which GlobalData has identified as representing the largest commercial opportunities for IO agents. Clinical trial trends analyze ongoing trials by sponsor type and modality, as well as ongoing combination trials for approved IO therapies.
Scope
This report combines primary research from a cross-specialty panel of oncology experts with in-house analyst expertise to provide an assessment of the development landscape. Components of the slide deck include primary and secondary research -
- Quotes from 13 US-, 5EU-, and Japan-based key opinion leaders
- Summary of IO product definitions and classifications
- Overview of development opportunities for IO agents across indications, including emerging indications and clinical targets, and novel combination strategies
- Outline of 17 key indications for IO agents, including current EU and US guideline recommendations, IO’s current place in the treatment algorithm, and a review of ongoing clinical trials
- Call-outs of key information and details
- Insight from GlobalData’s specialist oncology analysts.
Reasons to buy
- Develop business strategies by understanding the trends shaping and driving IO in the 8MM.
- Drive revenues by understanding the key trends, innovative combination strategies and indications likely to impact the IO market in the future.
- Design your development strategy through a review of potential novel targets or combinations across indications.
- Organize your sales and marketing efforts by understanding IO combination approaches across indications that present maximum opportunities for consolidations, investments, and strategic partnerships.
- Develop strategies by understanding expert perceptions of unmet needs in key indications in oncology, and the potential for IO agents to meet those needs.
Table of Contents
Table of Contents
1. Preface 2
1.1 Related Reports 6
1.2 Upcoming Reports 8
1.3 Abbreviations 9
2. Executive Summary 12
3. Introduction 17
3.1 Immuno-oncology Overview 18
3.2 IO Product Definition and Classification 19
3.3 Report Structure 20
3.4 Key Indications for IO Agents 21
4. Development Opportunities for IO Agents 23
4.1 Timeline of Recent IO Approvals in the 8MM 25
4.2 Clinical Development of IO Agents Across Indications 33
4.3 Combinations of Approved IO Agents 59
4.4 Clinical Targets and Predictive Biomarkers for IO Agents 66
5. Acute Lymphoblastic Leukemia (ALL) 78
5.1 Disease Overview and Epidemiology 80
5.2 Current Treatment Guidelines and IO Approvals for ALL 82
5.3 Clinical Trial Activity in ALL 83
5.4 IO Marketed Product Lifecycle Development in ALL 86
6. Bladder Cancer 89
6.1 Disease Overview and Epidemiology 91
6.2 Current Treatment Guidelines and IO Approvals for Bladder Cancer 93
6.3 Clinical Trial Activity in Bladder Cancer 94
6.4 IO Marketed Product Lifecycle Development in Bladder Cancer 97
7. Breast Cancer 100
7.1 Disease Overview and Epidemiology 102
7.2 Current Treatment Guidelines and IO Approvals for Breast Cancer 104
7.3 Clinical Trial Activity in Breast Cancer 105
8. Chronic Lymphocytic Leukemia (CLL) 108
8.1 Disease Overview and Epidemiology 110
8.2 Current Treatment Guidelines and IO Approvals for CLL 112
8.3 Clinical Trial Activity in CLL 113
9. Colorectal Cancer 116
9.1 Disease Overview and Epidemiology 118
9.2 Current Treatment Guidelines and IO Approvals for Colorectal Cancer 120
9.3 Clinical Trial Activity in Colorectal Cancer 121
9.4 IO Marketed Product Lifecycle Development in Colorectal Cancer 124
10. Gastric and Gastroesophageal Cancer (GA/GEJAC) 126
10.1 Disease Overview and Epidemiology 128
10.2 Current Treatment Guidelines and IO Approvals for GA/GEJAC 130
10.3 Clinical Trial Activity in GA/GEJAC 131
10.4 IO Marketed Product Lifecycle Development in GA/GEJAC 134
11. Glioblastoma 136
11.1 Disease Overview and Epidemiology 138
11.2 Current Treatment Guidelines and IO Approvals for Glioblastoma 140
11.3 Clinical Trial Activity in Glioblastoma 141
12. Head and Neck Cancer 144
12.1 Disease Overview and Epidemiology 146
12.2 Current Treatment Guidelines and IO Approvals for Head and Neck Cancer 148
12.3 Clinical Trial Activity in Head and Neck Cancer 149
12.4 IO Marketed Product Lifecycle Development in Head and Neck Cancer 152
13. Hepatocellular Carcinoma (HCC) 154
13.1 Disease Overview and Epidemiology 156
13.2 Current Treatment Guidelines and IO Approvals for HCC 158
13.3 Clinical Trial Activity in HCC 159
13.4 IO Marketed Product Lifecycle Development in HCC 162
14. Melanoma 164
14.1 Disease Overview and Epidemiology 166
14.2 Current Treatment Guidelines and IO Approvals for Melanoma 168
14.3 Clinical Trial Activity in Melanoma 169
14.4 IO Marketed Product Lifecycle Development in Melanoma 172
15. Multiple Myeloma 175
15.1 Disease Overview and Epidemiology 177
15.2 Current Treatment Guidelines and IO Approvals in Multiple Myeloma 179
15.3 Clinical Trial Activity in Multiple Myeloma 180
16. Non-Hodgkin Lymphoma (NHL) 183
16.1 Disease Overview and Epidemiology 185
16.2 Current Treatment Guidelines and IO Approvals for NHL 187
16.3 Clinical Trial Activity in NHL 188
16.4 IO Marketed Product Lifecycle Development in NHL 191
17. Non-Small Cell Lung Cancer (NSCLC) 193
17.1 Disease Overview and Epidemiology 195
17.2 Current Treatment Guidelines and IO Approvals for NSCLC 198
17.3 Clinical Trial Activity in NSCLC 199
17.4 IO Marketed Product Lifecycle Development in NSCLC 202
18. Ovarian Cancer 204
18.1 Disease Overview and Epidemiology 206
18.2 Current Treatment Guidelines and IO Approvals for Ovarian Cancer 208
18.3 Clinical Trial Activity in Ovarian Cancer 209
19. Pancreatic Cancer 212
19.1 Disease Overview and Epidemiology 214
19.2 Current Treatment Guidelines and IO Approvals for Pancreatic Cancer 216
19.3 Clinical Trial Activity in Pancreatic Cancer 217
20. Prostate Cancer 220
20.1 Disease Overview and Epidemiology 222
20.2 Current Treatment Guidelines and IO Approvals for Prostate Cancer 224
20.3 Clinical Trial Activity in Prostate Cancer 225
20.4 IO Marketed Product Lifecycle Development in Prostate Cancer 228
21. Renal Cell Carcinoma (RCC) 230
21.1 Disease Overview and Epidemiology 232
21.2 Current Treatment Guidelines and IO Approvals for RCC 234
21.3 Clinical Trial Activity in RCC 235
21.4 IO Marketed Product Lifecycle Development in Multiple Myeloma 238
22. Appendix 240
22.1 Methodology 241
22.2 Primary Research 245
22.3 Sources 247
22.4 About the Authors 254
22.5 About GlobalData 256
22.6 Contact Us 257
22.7 Disclaimer 258
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