Table 6.

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.