The immuno-oncology framework: Enabling a new era of cancer therapy

Developers of cancer immunotherapy have struggled for decades to achieve clinical success in using the patient's immune system to treat cancer. In the absence of a defined development paradigm for immunotherapies, conventional criteria established for chemotherapy were applied to these agents. This article summarizes the recent lessons for development of agents in the immunotherapy space, describes the systematic creation of a new clinical development paradigm for cancer immunotherapies and integrates this paradigm with the emerging methodological framework for a new clinical sub-specialty of immuno-oncology, which was driven by the collaborative work between the Cancer Immunotherapy Consortium (CIC) of the Cancer Research Institute in the US and the Association for Cancer Immunotherapy (CIMT) in Europe. This new framework provides a better defined development path and a foundation for more reproducible success of future therapies.