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Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors: Proceedings of a Workshop [Paperback / softback]

  • Format: Paperback / softback, 88 pages, height x width: 229x152 mm
  • Pub. Date: 05-Oct-2019
  • Publisher: National Academies Press
  • ISBN-10: 0309490863
  • ISBN-13: 9780309490863
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  • Format: Paperback / softback, 88 pages, height x width: 229x152 mm
  • Pub. Date: 05-Oct-2019
  • Publisher: National Academies Press
  • ISBN-10: 0309490863
  • ISBN-13: 9780309490863
Other books in subject:
In recent years, significant progress has been made in the clinical development and use of various types of cancer immunotherapy, all of which rely on the immune system to fight cancer. The majority of new cancer drug applications submitted to the Food and Drug Administration (FDA) are for immunotherapies or combinations involving immunotherapies. One type of immunotherapy is an immune checkpoint inhibitor. Cells in the human body have proteins that regulate the immune system response to foreign invaders (e.g., cancer cells, microorganisms). However, cancer cells can coopt these "checkpoint" proteins and thwart the immune system's ability to recognize and attack cancer cells. To help promote an immune response to cancer, researchers have developed immune checkpoint inhibitors that enable T-cells to recognize cancer cells as foreign and to prevent deactivation of an immune system response.





To examine the challenges and opportunities to develop combination cancer therapies that include immune checkpoint inhibitors, the National Cancer Policy Forum held a workshop on July 16-17, 2018, in Washington, DC. This workshop convened stakeholders with a broad range of expertise, including cancer researchers, clinicians, patient advocates, and representatives from industry, academia, and government. This publication summarizes the presentations and discussions from the workshop.

Table of Contents



Front Matter Proceedings of a Workshop Appendix A: Statement of Task Appendix B: Workshop Agenda
Acronyms And Abbreviations xix
Proceedings Of A Workshop
1(1)
Workshop Overview
1(2)
The Landscape For Immune Checkpoint Inhibitor Therapy
3(9)
The Impact of Immune Checkpoint Inhibitors on Cancer Treatment
7(3)
Understanding Resistance to Immune Checkpoint Inhibitor Therapy
10(2)
Strategies For Combinations With PD-1/PD-L1 Inhibitors
12(11)
Demonstration of Independent Action Versus Mechanism-Based Preclinical Data
12(4)
Sequencing Administration of Combination Strategies
16(1)
Prioritization and Redundancy
16(3)
Regulatory Considerations
19(4)
Biomarkers In Development Or In Use For Immune Checkpoint Inhibitor Therapies
23(13)
Types of Biomarker Tests
24(7)
Immunohistochemistry Testing
24(2)
Genomic Testing
26(1)
Expression Signatures
27(2)
Multiplex Fluorescence
29(1)
Circulating Tumor Markers
30(1)
The Microbiome
31(1)
Challenges with Biomarker Development
31(5)
Biomarker Development for Single-Agent Versus Combination Therapy
31(1)
Defining Thresholds for Biomarker Results
32(1)
Biomarkers for Site-Agnostic Indications
33(1)
Availability of Biospecimens for Biomarker Discovery and Development
34(2)
Clinical Trial Design Strategies For Combination Immunotherapy
36(8)
Patient-Centered Trial Outcomes
36(2)
Endpoints for Clinical Trials
38(1)
Dosing, Sequencing Administration, and Treatment Duration for Combinations
38(1)
Trial Designs to Promote Efficiency
39(5)
Master Protocols for Combination Trials
39(3)
Shared or External Control Arms
42(2)
Real-World Data
44(3)
Collaboration and Real-World Data Sharing
46(1)
Wrap-Up
47(2)
References
49(12)
Appendix A Statement of Task 61(2)
Appendix B Workshop Agenda 63