Phase I Clinical Trials in the Era of Immunotherapy

James C. Kuo

Scientia Clinical Research & Prince of Wales Clinical School, University of New South Wales, Sydney, Australia

Dr. James C. Kuo, Scientia Clinical Research & Prince of Wales Clinical School, University of New South Wales, Sydney, Australia.

Keywords: Immunotherapy; Cancer Care; Oncology

Abstract

Immunotherapy has changed the landscape of cancer care and has become the most promising area of cancer research over the recent years. Various stakeholders anticipate a rapid-fire development of immuneoncology (IO) agents and an accelerated regulatory approval timeline has been modernized with, most notably, the breakthrough therapy designation by the US Food and Drug Administration (FDA) in July 2012. Once biomarkers for novel IO agents are identified, the success in obtaining FDA approval for drugs with breakthrough therapy designation, such as ceritinib and durvalumab, after a single-arm phase I/II trial will be multiplied.

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