Comparison of immune-related response criteria (Adapted from Kataoka & Hirano, Ann Transl Med, 2018)288)
| RECIST v1.1289* | irRC171 | irRECIST172 | iRECIST174 | imRECIST173 | |
| Based on | RECIST | WHO criteria165 | irRC and RECIST v1.1 | RECIST v1.1 | irRC and RECIST v1.1 |
| Dimension | One | Two | One | One | One |
| Definition of PD | 20% increase from nadir and 5 mm absolute increase in the sum of target lesions | 25% increase from nadir | 20% increase from nadir | 20% increase from nadir (confirmation necessary) | 20% increase from nadir |
| New lesions | Do define PD Included in sum of measurements | Do not define PD Included in sum of measurements | Do not define PD Included in sum of measurements | Do not define PD Not included in sum of measurements | Do not define PD Included in sum of measurements |
| Confirmation | Protocol-specific based on the therapy, the disease, the anticipated time to response and progression as well as cost and patient convenience | 4 weeks | 4 weeks | 4 weeks—not longer than 8 weeks | 4 weeks |
| Outcomes in development cohort | Prospective cohort with data from >6,500 patients, simulation studies, and literature reviews | OS in ipilimumab-treated melanoma | irRC response in advanced ipilimumab-treated melanoma | Consensus-based | OS in atezolizumab-treated advanced NSCLC and mUC |
*RECIST v1.1 was used in KEYNOTE-119, KEYNOTE-355, and IMpassion130.
imRECIST, immune-modified RECIST; iRECIST, immunotherapy RECIST; irRC, immune-related response criteria; irRECIST, immune-related RECIST; mUC, metastatic urothelial cancer; NSCLC, non-small cell lung cancer; OS, overall survival; PD, progressive disease; ; RECIST, Response Evaluation Criteria In Solid Tumors; WHO, World Health Organization.