Endpoints, Resistance, and the Architecture of Evidence in Immuno-Oncology

In this episode of Precision Signals, Dr. Sean Khozin speaks with Dr. James Gulley, Chief of the Medical Oncology Service and Co-Director of the Center for Immuno-Oncology at the National Cancer Institute.Dr. Gulley is one of the world’s leading figures in immuno-oncology. He helped bring immune-based cancer therapies from an era of skepticism into a clinical mainstay, shaping both the science and the clinical frameworks that define the field today.Their conversation explores the critical frontiers of immunotherapy: the limits of predictive biomarkers, the biological opacity of treatment resistance, and the shortcomings of current trial designs. They discuss adaptive clinical trials, new endpoints, and the integration of AI into clinical research. Emerging tools such as digital pathology, wearable monitoring, and continuous physiologic data capture are highlighted, including recent work detecting CAR-T toxicity before it becomes clinically evident.