National Academies Press: OpenBook
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×

Policy Issues in the
Clinical Development
and Use of Immunotherapy
for Cancer Treatment

Proceedings of a Workshop

Erin Balogh, Kimberly Maxfield, Margie Patlak, and Sharyl J. Nass,
Rapporteurs

National Cancer Policy Forum

Board on Health Care Services

Health and Medicine Division

images

THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×

THE NATIONAL ACADEMIES PRESS500 Fifth Street, NWWashington, DC 20001

This activity was supported by Contract No. 200-2011-38807 (Task Order No. 0051) and Contract No. HHSN263201200074I (Task Order No. HHSN26300052) with the Centers for Disease Control and Prevention and the National Cancer Institute/National Institutes of Health, respectively, and by the American Association for Cancer Research, American Cancer Society, American College of Radiology, American Society for Radiation Oncology, American Society of Clinical Oncology, American Society of Hematology, Association of American Cancer Institutes, AstraZeneca, Bristol-Myers Squibb, Cancer Support Community, CEO Roundtable on Cancer, Helsinn Healthcare SA, LIVESTRONG Foundation, National Comprehensive Cancer Network, Novartis Oncology, Oncology Nursing Society, and Pfizer Inc. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.

International Standard Book Number-13: 978-0-309-44232-9
International Standard Book Number-10: 0-309-44232-X
Digital Object Identifier: 10.17226/23497

Additional copies of this publication are available for sale from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu.

Copyright 2016 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America

Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2016. Policy issues in the clinical development and use of immunotherapy for cancer treatment: Proceedings of a workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×

Image

The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Marcia McNutt is president.

The National Academy of Engineering was established in 1964 under the charter of the National Academy of Sciences to bring the practices of engineering to advising the nation. Members are elected by their peers for extraordinary contributions to engineering. Dr. C. D. Mote, Jr., is president.

The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president.

The three Academies work together as the National Academies of Sciences, Engineering, and Medicine to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine.

Learn more about the National Academies of Sciences, Engineering, and Medicine at www.national-academies.org.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×

Image

Reports document the evidence-based consensus of an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and committee deliberations. Reports are peer reviewed and are approved by the National Academies of Sciences, Engineering, and Medicine.

Proceedings chronicle the presentations and discussions at a workshop, symposium, or other convening event. The statements and opinions contained in proceedings are those of the participants and have not been endorsed by other participants, the planning committee, or the National Academies of Sciences, Engineering, and Medicine.

For information about other products and activities of the Academies, please visit nationalacademies.org/whatwedo.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×

WORKSHOP PLANNING COMMITTEE1

SAMIR N. KHLEIF (Chair), Director, Georgia Cancer Center at Augusta University

AMY P. ABERNETHY, Chief Medical Officer and Senior Vice President for Oncology, Flatiron Health

MALCOLM K. BRENNER, Professor, Center for Gene Therapy, Baylor College of Medicine

MICHAEL CALIGIURI, Chief Executive Officer, James Cancer Hospital and Solove Research Institute; Director, The Ohio State University Comprehensive Cancer Center

GWEN DARIEN, Executive Vice President, Patient Advocacy, National Patient Advocate Foundation

LEE M. KRUG, Disease Area Head, Lung and Head & Neck Cancer, Immuno-Oncology, Bristol-Myers Squibb

RICHARD A. LARSON, Professor of Medicine and Director, Hematologic Malignancies Clinical Research Program, The University of Chicago, Comprehensive Cancer Center

STEVEN A. ROSENBERG, Chief, Surgery Branch, National Cancer Institute

DEBORAH SCHRAG, Chief, Division of Population Sciences, Professor of Medicine, Department of Medical Oncology, Harvard Medical School, Dana-Farber Cancer Institute

MARC THEORET, Lead Medical Officer, Division of Oncology Products, Office of Hematology and Oncology Products, Food and Drug Administration

Project Staff

SHARYL J. NASS, Director, National Cancer Policy Forum

ERIN BALOGH, Senior Program Officer

KIMBERLY MAXFIELD, Mirzayan Science and Technology Policy Fellow (January-May 2016)

PATRICK ROSS, Research Assistant (until July 2016)

CYNDI TRANG, Research Assistant

___________________

1 The National Academies of Sciences, Engineering, and Medicine’s planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×

This page intentionally left blank.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×

NATIONAL CANCER POLICY FORUM1

MICHAEL CALIGIURI (Chair), Chief Executive Officer, James Cancer Hospital and Solove Research Institute; Director, The Ohio State University Comprehensive Cancer Center

PATRICIA A. GANZ (Vice Chair), Distinguished Professor, University of California, Los Angeles, Fielding School of Public Health, Director, Cancer Prevention and Control Research, Jonsson Comprehensive Cancer Center

AMY P. ABERNETHY, Chief Medical Officer and Senior Vice President for Oncology, Flatiron Health

LUCILE ADAMS-CAMPBELL, Professor of Oncology, Associate Director for Minority Health and Health Disparities Research, Georgetown University Lombardi Cancer Center

KENNETH ANDERSON, Kraft Family Professor of Medicine, American Cancer Society Clinical Research Director, Jerome Lipper Multiple Myeloma Center, Harvard Medical School, Dana-Farber Cancer Institute

MONICA M. BERTAGNOLLI, Richard E. Wilson Professor of Surgery, Harvard Medical School; Chief, Division of Surgical Oncology, Dana-Farber/Brigham and Women’s Cancer Center; Group Chair, Alliance for Clinical Trials in Oncology

OTIS W. BRAWLEY, Chief Medical Officer, American Cancer Society

CARLTON BROWN, Director of Professional Services, Oregon Nurses Association

ROBERT W. CARLSON, Chief Executive Officer, National Comprehensive Cancer Network

GREGORY CURT, Executive Director, External Scientific and Clinical Relations, U.S. Medical Affairs, AstraZeneca

WENDY DEMARK-WAHNEFRIED, Professor and Webb Endowed Chair of Nutrition Sciences, Associate Director for Cancer Prevention and Control, University of Alabama at Birmingham Comprehensive Cancer Center

___________________

1 The National Academies of Sciences, Engineering, and Medicine’s forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.

Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×

GEORGE D. DEMETRI, Professor of Medicine, Harvard Medical School; Director, Ludwig Center, Senior Vice President for Experimental Therapeutics, Dana-Farber Cancer Institute, Associate Director for Clinical Sciences, Dana-Farber/Harvard Cancer Center

JAMES H. DOROSHOW, Deputy Director for Clinical and Translational Research, National Cancer Institute

JOHN FRIEND II, Senior Vice President, Helsinn Therapeutics

LORI HOFFMAN HŌGG, Veterans Health Administration National Oncology Clinical Advisor and Program Manager, Prevention Policy, Department of Veterans Affairs

LINDA HOUSE, President, Cancer Support Community

HEDVIG HRICAK, Chair, Department of Radiology, Memorial Sloan Kettering Cancer Center

SAMIR N. KHLEIF, Director, Georgia Cancer Center at Augusta University

RONALD M. KLINE, Medical Officer, Patient Care Models Group, Center for Medicare & Medicaid Innovation, Centers for Medicare & Medicaid Services

LEE M. KRUG, Disease Area Head, Lung and Head & Neck Cancer, Immuno-Oncology, Bristol-Myers Squibb

RICHARD A. LARSON, Professor of Medicine and Director, Hematologic Malignancies Clinical Research Program, The University of Chicago Comprehensive Cancer Center

MICHELLE M. LE BEAU, Arthur and Marian Edelstein Professor of Medicine and Director, The University of Chicago Comprehensive Cancer Center

GRETA MASSETTI, Associate Director for Science, Division of Cancer Prevention and Control, Centers for Disease Control and Prevention

DANIEL R. MASYS, Affiliate Professor, Biomedical and Health Informatics, University of Washington School of Medicine

MARTIN J. MURPHY, Chief Executive Officer, CEO Roundtable on Cancer

LOYCE PACE, Executive Advisor for Programs and Policy, LIVESTRONG

RICHARD PAZDUR, Acting Director, Oncology Center of Excellence; Director, Office of Hematology and Oncology Products, Food and Drug Administration

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×

STEVEN PIANTADOSI, Phase One Foundation Endowed Chair and Director, Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center

JENNIFER A. PIETENPOL, Director, Vanderbilt-Ingraham Cancer Center, Executive Vice President for Research, Vanderbilt University Medical Center, and Benjamin F. Byrd, Jr. Professor of Oncology, Vanderbilt University

MACE L. ROTHENBERG, Chief Development Officer, Oncology Pfizer Global Product Development, Pfizer Inc.

RICHARD L. SCHILSKY, Senior Vice President and Chief Development Officer, American Society of Clinical Oncology

DEBORAH SCHRAG, Chief, Division of Population Sciences, Professor of Medicine, Department of Medical Oncology, Harvard Medical School, Dana-Farber Cancer Institute

YA-CHEN TINA SHIH, Professor of Health Economics, Chief, Section of Cancer Economics and Policy, Department of Health Services Research, University of Texas MD Anderson Cancer Center

ELLEN V. SIGAL, Chair and Founder, Friends of Cancer Research

RALPH WEICHSELBAUM, Daniel K. Ludwig Professor and Chair, Department of Radiation; Oncology and Cellular Director, Ludwig Center for Metastasis Research; The University of Chicago Medical Center

GEORGE J. WEINER, President, Association of American Cancer Institutes; C.E. Block Chair of Cancer Research, Professor of Internal Medicine, and Director, Holden Comprehensive Cancer Center, University of Iowa

RICHARD WOODMAN, Senior Vice President and Head, North America Oncology Clinical Development & Medical Affairs, Novartis Pharmaceuticals Corporation

WENDY WOODWARD, Associate Professor and the Section Chief of Clinical Breast Radiation, Department of Radiation Oncology, University of Texas MD Anderson Cancer Center

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×

National Cancer Policy Forum Staff

SHARYL J. NASS, Forum Director and Director, Board on Health Care Services

ERIN BALOGH, Senior Program Officer

MATINA KAKALIS, Summer Intern (May-July 2016)

KIMBERLY MAXFIELD, Mirzayan Science and Technology Policy Fellow (January-May 2016)

PATRICK ROSS, Research Assistant (until July 2016)

CYNDI TRANG, Research Assistant

PATRICK BURKE, Financial Associate

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×

Reviewers

This Proceedings of a Workshop has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published Proceedings of a Workshop as sound as possible and to ensure that the Proceedings of a Workshop meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the process. We wish to thank the following individuals for their review of this Proceedings of a Workshop:

JAY A. BERZOFSKY, National Cancer Institute

LISA H. BUTTERFIELD, University of Pittsburgh

BAHIJA JALLAL, AstraZeneca and MedImmune

CRYSTAL L. MACKALL, Stanford University and Stanford Cancer Institute

RAJESHWARI SRIDHARA, Food and Drug Administration

Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of the Proceedings of a Workshop before its release. The review of this Proceedings of a Workshop was overseen by LESLIE Z. BENET, University of California,

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×

San Francisco. He was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the rapporteurs and the institution.

Page xiii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×

Acknowledgments

Support from the many annual sponsors of the National Academies of Sciences, Engineering, and Medicine’s National Cancer Policy Forum is crucial to the work of the Forum. Federal sponsors include the Centers for Disease Control and Prevention and the National Cancer Institute/National Institutes of Health. Non-federal sponsors include the American Association for Cancer Research, American Cancer Society, American College of Radiology, American Society for Radiation Oncology, American Society of Clinical Oncology, American Society of Hematology, Association of American Cancer Institutes, AstraZeneca, Bristol-Myers Squibb, Cancer Support Community, CEO Roundtable on Cancer, Helsinn Healthcare SA, LIVESTRONG Foundation, National Comprehensive Cancer Network, Novartis Oncology, Oncology Nursing Society, and Pfizer Inc.

The Forum wishes to express its gratitude to the expert speakers whose presentations helped examine the policy issues in the clinical development and use of immunotherapy for cancer treatment. The Forum also wishes to thank the members of the planning committee for their work in developing an excellent workshop agenda.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×

This page intentionally left blank.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×

Acronyms and Abbreviations

ACCC Association of Community Cancer Centers
AGNIS A Growable Network Information Service
ALL acute lymphoblastic leukemia
AML acute myeloid leukemia
AMP Association for Molecular Pathology
ASCO American Society of Clinical Oncologists
BOR best overall response
CAR chimeric antigen receptor
CAR T-cell therapy chimeric antigen receptor T-cell therapy
CBER Center for Biologics Evaluation and Research
CD4+ cluster of differentiation 4
CD8+ cluster of differentiation 8
CEA carcinoembryonic antigen
CED Coverage with Evidence Development
CIBMTR Center for International Blood and Marrow Transplant Research
CMS Centers for Medicare & Medicaid Services
CR complete response
CTLA-4 cytotoxic T-lymphocyte-associated molecule-4
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
DRiP defective ribosomal product from misfolded proteins
EHR electronic health record
EMA European Medicines Agency
EU European Union
FDA Food and Drug Administration
GM-CSF granulocyte-macrophage colony-stimulating factor
gp100 glycoprotein 100
HER2 human epidermal growth factor receptor 2
HLA human leukocyte antigen
ICER incremental cost-effectiveness ratio
ICLIO Institute for Clinical Immuno-Oncology
IL interleukin
irRC Immune-Related Response Criteria
LD longest diameter
MABEL minimally anticipated biologic effect level
MART-1 melanoma antigen recognized by T-cells 1
MHC major histocompatibility complex
NCI National Cancer Institute
NCTN National Clinical Trials Network
NHL non-Hodgkin’s lymphoma
NHS National Health Service
NICE National Institute of Health and Clinical Excellence
NKT natural killer T
PD progressive disease
PD-1 programmed cell death protein 1
PD-L1 programmed cell death ligand 1
PET positron emission tomography
PFS progression-free survival
PIM Promising Innovative Medicine
PR partial response
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
PRO patient-reported outcome
PSA prostate-specific antigen
QALY quality-adjusted life year
RECIST Response Evaluation Criteria In Solid Tumors
SD stable disease
SITC Society for Immunotherapy of Cancer
SLiP short-lived protein
TCR T-cell receptor
TGF transforming growth factor
TGFβ transforming growth factor beta
TIL tumor-infiltrating lymphocyte
Page xxii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×

This page intentionally left blank.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
Page R1
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
Page R2
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
Page R3
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
Page R4
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
Page R5
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
Page R6
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
Page R7
Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
Page R8
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
Page R9
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
Page R10
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
Page R11
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
Page R12
Page xiii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
Page R13
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
Page R14
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
Page R15
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
Page R16
Page xvii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
Page R17
Page xviii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
Page R18
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
Page R19
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
Page R20
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
Page R21
Page xxii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
Page R22
Next: Proceedings of a Workshop »
Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop Get This Book
×
Buy Paperback | $50.00 Buy Ebook | $39.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

Immunotherapy is a form of cancer therapy that harnesses the body’s immune system to destroy cancer cells. In recent years, immunotherapies have been developed for several cancers, including advanced melanoma, lung cancer, and kidney cancer. In some patients with metastatic cancers who have not responded well to other treatments, immunotherapy treatment has resulted in complete and durable responses. Given these promising findings, it is hoped that continued immunotherapy research and development will produce better cancer treatments that improve patient outcomes.

With this promise, however, there is also recognition that the clinical and biological landscape for immunotherapies is novel and not yet well understood. For example, adverse events with immunotherapy treatment are quite different from those experienced with other types of cancer therapy. Similarly, immunotherapy dosing, therapeutic responses, and response time lines are also markedly different from other cancer therapies. To examine these challenges and explore strategies to overcome them, the National Academies of Sciences, Engineering, and Medicine held a workshop in February and March of 2016. This report summarizes the presentations and discussions from the workshop.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!