Novel cancer immunotherapy agents with survival benefit: recent successes and next steps

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Abstract
The US Food and Drug Administration (FDA) recently approved the immunotherapy agents sipuleucel-T and ipilimumab for the treatment of metastatic prostate cancer and melanoma, respectively. This Opinion article discusses how immunotherapy might be improved by understanding the mechanisms that are responsible for clinical benefit, identifying biomarkers that predict response or toxicity and developing combination therapies. The US Food and Drug Administration (FDA) recently approved two novel immunotherapy agents, sipuleucel-T and ipilimumab, which showed a survival benefit for patients with metastatic prostate cancer and melanoma, respectively. The mechanisms by which these agents provideclinical benefit are not completely understood. However, knowledge of these mechanisms will be crucial for probing human immune responses and tumour biology in order to understand what distinguishes responders from non-responders. The following next steps are necessary: first, the development of immune-monitoring strategies for the identification of relevant biomarkers; second, the establishment of guidelines for the assessment of clinical end points; and third, the evaluation of combination therapy strategies to improve clinical benefit.