Immune checkpoint inhibitors (ICI) targeting cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) and programmed death 1 (PD-1) have transformed the management of advanced cancers. In addition to the many tumor-intrinsic factors, there is ample evidence that the gut microbiome modulates immunological and clinical responses to anti-cancer immunotherapy. The gut microbiome, comprising the bacteria, archaea, fungi and viruses that live in the human digestive tracts of humans, has long been implicated in determining host immunity, but its impact upon response to ICI therapy in mice and humans with cancer has only recently been appreciated. Therapeutic interventions to optimize microbiota composition to improve immunotherapy outcomes have shown promise in mice and humans with cancer. We will discuss the rationale for gut microbiome-based therapies of cancer, new data on the complex interactions between the gut microbiome and response to cancer immunotherapy, the results from early phase clinical trials, and future developments.
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