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Immuno-oncology Development Trends and Opportunities

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Immuno-oncology Development Trends and Opportunities


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Immuno-oncology Development Trends and Opportunities

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Immuno-oncology Development Trends and Opportunities



Executive Summary

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

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

4.2.1 IO Agents in Development by MOA and by Indication 35

4.2.2 Ongoing Clinical Trials by Sponsor Type 38

4.2.3 Key and Emerging Indications for Checkpoint Modulators 42

4.2.4 Key and Emerging Indications for Bispecific Antibodies 47

4.2.5 Key and Emerging Indications for Cancer Vaccines 49

4.2.6 Key and Emerging Indications for Cell Therapies 53

4.2.7 Key and Emerging Indications for Oncolytic Viruses 56

4.3 Combinations of Approved IO Agents 59

4.4 Clinical Targets and Predictive Biomarkers for IO Agents 66

4.4.1 Clinical Targets for Checkpoint Modulators 68

4.4.2 Clinical Targets for Bispecific Antibodies 71

4.4.3 Clinical Targets for Cell Therapies 73

4.4.4 Predictive Biomarkers for IO Agents 77

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

To know more information on Purchase by Section, please send a mail to sales@kenresearch.com

Single User License:
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Report can be shared globally by unlimited users within the purchasing corporation e.g. all employees of a single company

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