Advances in our knowledge of the immune pathways of cancer have led to increased interest in immunotherapy, which are now a major focus of cancer drug development. The introduction of immunotherapy agents into early and late phase trials has been rapid.
The landscape of early phase oncology trials is evolving to adapt to these novel therapies and to improve the efficiency of drug development. The introduction of a new class of drugs and changing clinical trial landscape has proposed challenging aspects to the treating physician. These include the adjustment to novel clinical trial designs; differing safety measures; interpretation and recognition of immune related toxicities; immune related biomarkers and evolving efficacy signals (induce long-term survival in a proportion of treated patients).