2015 Guidance on cancer immunotherapy development in early‐phase clinical studies. Issue 12 (December 2015)

• Record Type: Journal Article
• Other Names: Arato Teruyo investigator.; Daimon Takashi investigator.; Heike Yuji investigator.; Ishii Ken investigator.; Itho Kyogo investigator.; Kageyama Shinichi investigator.; Kawakami Yutaka investigator.; Nakayama Eiichi investigator.; Ozawa Keiya investigator.; Sato Noriyuki investigator.; Shiku Hiroshi investigator.; Takeuchi Masahiro investigator.; Tani Kenzaburo investigator.; Tamada Koji investigator.; Ueda Ryuzo investigator.; Yamaguchi Yoshiyuki investigator.; Yamanaka Takeharu investigator.; Yamaue Hiroki investigator.; Yasukawa Masaki investigator.; Iguchi Toyotaka investigator.; Kitano Shigehisa investigator.; Miyahara Yoshihiro investigator.; Nagata Yasuhiro investigator.; Noguchi Masanori investigator.; Terashima Takeshi investigator.; Asano Takeo investigator.; Asonuma Motohiro investigator.; Ikeda Hiroaki investigator.; Kakimi Kazuhiro investigator.; Takesako Kazutoh investigator.; Tanaka Masanori investigator.; Amakasu Kohei investigator.; Yamada Akira investigator.; Harada Naozumi investigator.; Aoshi Taiki investigator.; Kuroda Etsushi investigator.; Kobiyama Kouji investigator.; Muraoka Daisuke investigator.; Yamazaki Naoya investigator.; Kuchiba Aya investigator.; Tanaka Shiro investigator.; Michimae Hirofumi investigator.; Yamada Tomomi investigator.; Hanada Kenichi investigator.; Okada Hideho investigator.; Takebe Naoko investigator.; Hirano Naoto investigator.; Okumura Satoshi investigator.; Sato Daisaku investigator.; Shibatsuji Masayoshi investigator.; Yamaguchi Teruhide investigator.;
• Is Part Of: Cancer science. Volume 106:Issue 12(2015:Dec.)
• Page Start: 1761
• Page End: 1771
• Publication Date: 2015-12
• Subjects: Cancer vaccines -- cell therapy -- clinical trial -- immunotherapy -- monoclonal antibodies; Cancer -- Periodicals; Neoplasms -- Periodicals; Research -- Periodicals; Electronic journals; 616.994005
• DOI: 10.1111/cas.12819
• Languages: English
• ISSNs: 1347-9032

Abstract

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.