“…Intermediate endpoints, including ORR, DCR, PFS, modified PFS, and milestone survival, have been proposed as surrogate endpoints for immunotherapy in clinical trials. 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 However, these studies were specific to one tumour type, one country/region, or with limited high-qualities trials, and the results were often ambiguous or conflicted due to the biological complexity of cancer. Here, though a comprehensive analysis with phase 3 randomised control trials (RCTs), our primary objective was to assess the study-level of ORR, DCR, PFS, and 1-year OS as surrogate endpoint for outcomes in cancer immunotherapy.…”