Advancing Novel Endpoints in Oncology Trials: A Systematic Review

This review is designed to equip researchers and medical-affairs teams with actionable insights into next-generation oncologyendpoints. Below are three illustrative findings drawn from a 27-page analysis; many additional insights are available in the fullreview. High pretreatment CD8 expression and major pathological response in resectable stage IIIA/B NSCLC correlate with prolongeddisease-free survival after neoadjuvant chemoimmunotherapy, validating immune biomarkers as stratification endpoints. Major pathological response in NSCLC following ≥4 cycles of neoadjuvant immunochemotherapy links to lower recurrence andimproved overall survival, endorsing MPR as a surrogate endpoint for trial design. Royston-Parmar spline modelling outperforms Cox methods under non-proportional hazards in immunotherapy trials, illustrating flexible statistical endpoints that capture time-varying efficacy. 3978Records screened 25Studies included Jan 2018–Mar 2025Coverage window