2015 Guidance on cancer immunotherapy development in early-phase clinical studies

Cancer Science
Guidance Development Review CommitteeBiostatistics Subcommittee

Abstract

The development of cancer immunotherapies is progressing rapidly with a variety of technological approaches. They consist of "cancer vaccines", which are based on the idea of vaccination, "effector cell therapy", classified as passive immunotherapy, and "inhibition of immunosuppression", which intends to break immunological tolerance to autoantigens or immunosuppressive environments characterizing antitumor immune responses. Recent reports showing clinical evidence of efficacy of immune checkpoint inhibitors and adoptive immunotherapies with tumor-infiltrating lymphocytes and tumor-specific receptor gene-modified T cells indicate the beginning of a new era for cancer immunotherapy. This guidance summarizes ideas that will be helpful to those who plan to develop cancer immunotherapy. The aims of this guidance are to discuss and offer important points in early phase clinical studies of innovative cancer immunotherapy, with future progress in this field, and to contribute to the effective development of cancer immunotherapy aligned with the scope of regulatory science. This guidance covers cancer vaccines, effector cell therapy, and inhibition of immunosuppression, including immune checkpoint inhibitors.

References

Mar 17, 2001·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·R M SimonJ A Berzofsky
Jun 14, 2003·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Antoni RibasJames S Economou
Sep 2, 2004·Nature Medicine·Steven A RosenbergNicholas P Restifo
May 24, 2005·Statistics in Medicine·Sally HunsbergerEdward L Korn
Oct 11, 2005·Cancer Treatment and Research·Richard Simon
Mar 25, 2006·Nature Reviews. Immunology·Weiping Zou
Jul 1, 2006·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Eric J SmallRobert M Hershberg
Sep 27, 2008·Proceedings of the National Academy of Sciences of the United States of America·Chrysoula I LiakouPadmanee Sharma
Mar 12, 2009·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Larry RubinsteinDan Sargent
Oct 17, 2009·Immunity·Sylvia JanetzkiMark M Davis
Nov 26, 2009·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Jedd D WolchokF Stephen Hodi
Mar 10, 2010·Statistics in Medicine·Karen MesserThomas A Lane
Jun 3, 2010·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Julie R BrahmerSuzanne L Topalian
Jun 8, 2010·The New England Journal of Medicine·F Stephen HodiWalter J Urba
Oct 16, 2010·Nature Reviews. Immunology·Martin F Bachmann, Gary T Jennings
Dec 8, 2010·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Antje HoeringJohn Crowley
May 3, 2011·Blood·Sally M AmosMichael H Kershaw
Jun 7, 2011·The New England Journal of Medicine·Caroline RobertJedd D Wolchok
Jan 13, 2012·Cancer Research·John C CastleUgur Sahin
Feb 10, 2012·Nature·Hirokazu MatsushitaRobert D Schreiber
Mar 23, 2012·Nature Reviews. Cancer·Drew M Pardoll
May 23, 2012·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Jeffrey S WeberAxel Hauschild
Jun 5, 2012·The New England Journal of Medicine·Suzanne L TopalianMario Sznol
Jun 5, 2012·The New England Journal of Medicine·Julie R BrahmerJon M Wigginton
Aug 3, 2012·Statistics in Medicine·Guosheng YinJiajing Xu
Oct 31, 2012·Cancer Science·Akira YamadaKyogo Itoh
Apr 10, 2013·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Yuan Ji, Sue-Jane Wang
Apr 23, 2013·Cellular & Molecular Immunology·Min ChengZhigang Tian
Jun 4, 2013·The New England Journal of Medicine·Omid HamidAntoni Ribas
Jun 4, 2013·The New England Journal of Medicine·Jedd D WolchokMario Sznol
Jul 31, 2013·Immunity·Greg T Motz, George Coukos
Oct 10, 2013·Nature Biotechnology·Cedrik M BrittenUlrich Kalinke
Dec 7, 2013·Nature Medicine·Steven G ReedChristopher B Fox
Dec 18, 2013·Immunological Reviews·Christian S Hinrichs, Steven A Rosenberg
Dec 19, 2013·Frontiers in Immunology·Shin-Ichiro FujiiMasaru Taniguchi
Jan 16, 2014·Annual Review of Immunology·Marcela V MausCarl H June
Jan 25, 2014·Nature Reviews. Cancer·Pierre G CoulieThierry Boon
Feb 21, 2014·Science Translational Medicine·Marco L DavilaRenier Brentjens

❮ Previous
Next ❯

Citations

Jan 26, 2017·Clinical and Experimental Medicine·Hailing LiuFuling Zhou
Oct 26, 2018·Laboratory Investigation; a Journal of Technical Methods and Pathology·Jonathan A HenselSelvarangan Ponnazhagan
May 26, 2017·Biomedicines·Silvia Martin LluesmaLana E Kandalaft

❮ Previous
Next ❯

Methods Mentioned

BETA
biopsy
PCR

Related Concepts

Related Feeds

Cell Checkpoints & Regulators

Cell cycle checkpoints are a series of complex checkpoint mechanisms that detect DNA abnormalities and ensure that DNA replication and repair are complete before cell division. They are primarily regulated by cyclins, cyclin-dependent kinases, and the anaphase-promoting complex/cyclosome. Here is the latest research.

Allogenic & Autologous Therapies

Allogenic therapies are generated in large batches from unrelated donor tissues such as bone marrow. In contrast, autologous therapies are manufactures as a single lot from the patient being treated. Here is the latest research on allogenic and autologous therapies.

Cancer Vaccines

Cancer vaccines are vaccines that either treat existing cancer or prevent development of a cancer.

Autoimmune Diseases

Autoimmune diseases occur as a result of an attack by the immune system on the body’s own tissues resulting in damage and dysfunction. There are different types of autoimmune diseases, in which there is a complex and unknown interaction between genetics and the environment. Discover the latest research on autoimmune diseases here.

CREs: Gene & Cell Therapy

Gene and cell therapy advances have shown promising outcomes for several diseases. The role of cis-regulatory elements (CREs) is crucial in the design of gene therapy vectors. Here is the latest research on CREs in gene and cell therapy.

Related Papers

Advances in Experimental Medicine and Biology
Hiroaki Ikeda, Hiroshi Shiku
Annals of the New York Academy of Sciences
Patrick Hwu, S A Rosenberg
Current Opinion in Immunology
David H Munn, Vincenzo Bronte
© 2022 Meta ULC. All rights reserved