Immuno-oncology Development Trends and Opportunities

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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

GlobalData’s Immuno-oncology Development Trends and Opportunities 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.

Amgen
AstraZeneca
Bristol-Myers Squibb
Dendreon Pharmaceuticals
F. Hoffmann-La Roche
Gilead Sciences
Medac Pharma
Merck & Co.
Merck KGaA
Northwest Biotherapeutics
Novartis
Pfizer
Regeneron Pharmaceuticals
Sanofi
Shanghai Sunway Biotech
Shire Pharmaceuticals

Table of Contents

1 Table of Contents (PowerPoint Deck)

1. Preface

1.1 Related Reports

1.2 Upcoming Reports

1.3 Abbreviations

2. Executive Summary

3. Introduction

3.1 Immuno-oncology (IO) Overview

3.2 IO Product Definition and Classification

3.3 Report Structure

3.4 Key Indications for IO Agents

4. Development Opportunities for IO Agents

4.1 Timeline of Recent IO Approvals in the 8MM

4.2 Clinical Development of IO Agents Across Indications

4.2.1 IO Agents in Development by MoA and by Indication

4.2.2 Ongoing Clinical Trials by Sponsor Type

4.2.3 Key and Emerging Indications for Checkpoint Modulators

4.2.4 Key and Emerging Indications for Bispecific Antibodies

4.2.5 Key and Emerging Indications for Cancer Vaccines

4.2.6 Key and Emerging Indications for Cell Therapies

4.2.7 Key and Emerging Indications for Oncolytic Viruses

4.3 Combinations of Approved IO Agents

4.4 Clinical Targets and Predictive Biomarkers for IO Agents

4.4.1 Clinical Targets for Checkpoint Modulators

4.4.2 Clinical Targets for Bispecific Antibodies

4.4.3 Clinical Targets for Cell Therapies

4.4.4 Predictive Biomarkers for IO Agents

5. Acute Lymphoblastic Leukemia (ALL)

5.1 Disease Overview and Epidemiology

5.2 Current Treatment Guidelines and IO Approvals for ALL

5.3 Clinical Trial Activity in ALL

5.4 IO Marketed Product Lifecycle Development in ALL

6. Bladder Cancer

6.1 Disease Overview and Epidemiology

6.2 Current Treatment Guidelines and IO Approvals for Bladder Cancer

6.3 Clinical Trial Activity in Bladder Cancer

6.4 IO Marketed Product Lifecycle Development in Bladder Cancer

7. Breast Cancer

7.1 Disease Overview and Epidemiology

7.2 Current Treatment Guidelines and IO Approvals for Breast Cancer

7.3 Clinical Trial Activity in Breast Cancer

8. Chronic Lymphocytic Leukemia (CLL)

8.1 Disease Overview and Epidemiology

8.2 Current Treatment Guidelines and IO Approvals for CLL

8.3 Clinical Trial Activity in CLL

9. Colorectal Cancer

9.1 Disease Overview and Epidemiology

9.2 Current Treatment Guidelines and IO Approvals for Colorectal Cancer

9.3 Clinical Trial Activity in Colorectal Cancer

9.4 IO Marketed Product Lifecycle Development in Colorectal Cancer

10. Gastric and Gastroesophageal Cancer (GA/GEJAC)

10.1 Disease Overview and Epidemiology

10.2 Current Treatment Guidelines and IO Approvals for GA/GEJAC

10.3 Clinical Trial Activity in GA/GEJAC

10.4 IO Marketed Product Lifecycle Development in GA/GEJAC

11. Glioblastoma

11.1 Disease Overview and Epidemiology

11.2 Current Treatment Guidelines and IO Approvals for Glioblastoma

11.3 Clinical Trial Activity in Glioblastoma

12. Head and Neck Cancer

12.1 Disease Overview and Epidemiology

12.2 Current Treatment Guidelines and IO Approvals for Head and Neck Cancer

12.3 Clinical Trial Activity in Head and Neck Cancer

12.4 IO Marketed Product Lifecycle Development in Head and Neck Cancer

13. Hepatocellular Carcinoma (HCC)

13.1 Disease Overview and Epidemiology

13.2 Current Treatment Guidelines and IO Approvals for HCC

13.3 Clinical Trial Activity in HCC

13.4 IO Marketed Product Lifecycle Development in HCC

14. Melanoma

14.1 Disease Overview and Epidemiology

14.2 Current Treatment Guidelines and IO Approvals for Melanoma

14.3 Clinical Trial Activity in Melanoma

14.4 IO Marketed Product Lifecycle Development in Melanoma

15. Multiple Myeloma

15.1 Disease Overview and Epidemiology

15.2 Current Treatment Guidelines and IO Approvals in Multiple Myeloma

15.3 Clinical Trial Activity in Multiple Myeloma

16. Non-Hodgkin Lymphoma (NHL)

16.1 Disease Overview and Epidemiology

16.2 Current Treatment Guidelines and IO Approvals for NHL

16.3 Clinical Trial Activity in NHL

16.4 IO Marketed Product Lifecycle Development in NHL

17. Non-Small Cell Lung Cancer (NSCLC)

17.1 Disease Overview and Epidemiology

17.2 Current Treatment Guidelines and IO Approvals for NSCLC

17.3 Clinical Trial Activity in NSCLC

17.4 IO Marketed Product Lifecycle Development in NSCLC

18. Ovarian Cancer

18.1 Disease Overview and Epidemiology

18.2 Current Treatment Guidelines and IO Approvals for Ovarian Cancer

18.3 Clinical Trial Activity in Ovarian Cancer

19. Pancreatic Cancer

19.1 Disease Overview and Epidemiology

19.2 Current Treatment Guidelines and IO Approvals for Pancreatic Cancer

19.3 Clinical Trial Activity in Pancreatic Cancer

20. Prostate Cancer

20.1 Disease Overview and Epidemiology

20.2 Current Treatment Guidelines and IO Approvals for Prostate Cancer

20.3 Clinical Trial Activity in Prostate Cancer

20.4 IO Marketed Product Lifecycle Development in Prostate Cancer

21. Renal Cell Carcinoma (RCC)

21.1 Disease Overview and Epidemiology

21.2 Current Treatment Guidelines and IO Approvals for RCC

21.3 Clinical Trial Activity in RCC

21.4 IO Marketed Product Lifecycle Development in Multiple Myeloma

22. Appendix

22.1 Methodology

22.2 Primary Research

22.3 Sources

22.4 About the Authors

22.5 About GlobalData

22.6 Contact Us

22.7 Disclaimer

Frequently asked questions

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