Immune response criteria for immunotherapy (iRECIST): Assignment of timepoint response

	Timepoint response with no previous iUPD in any category	Timepoint response with previous iUPD in any category*
Target lesions: iCR; non-target lesions: iCR; new lesions: no	iCR	iCR
Target lesions: iCR; non-target lesions: non-iCR/non-iUPD; new lesions: no	iPR	iPR
Target lesions: iPR; non-target lesions: non-iCR/non-iUPD; new lesions: no	iPR	iPR
Target lesions: iSD; non-target lesions: non-iCR/non-iUPD; new lesions: no	iSD	iSD
Target lesions: iUPD with no change, or with a decrease from last timepoint; non-target lesions: iUPD with no change, or decrease from last timepoint; new lesions: yes	Not applicable	New lesions confirm iCPD if new lesions were previously identified and they have increased in size (≥5 mm in sum of measures for new lesion target or any increase for new lesion non-target) or number; if no change is seen in new lesions (size or number) from last timepoint, assignment remains iUPD
Target lesions: iSD, iPR, iCR; non-target lesions: iUPD; new lesions: no	iUPD	Remains iUPD unless iCPD is confirmed on the basis of a further increase in the size of non-target disease (does not need to meet RECIST 1.1 criteria for unequivocal progression)
Target lesions: iUPD; non-target lesions: non-iCR/non-iUPD, or iCR; new lesions: no	iUPD	Remains iUPD unless iCPD is confirmed on the basis of a further increase in sum of measures ≥5 mm; otherwise, assignment remains iUPD
Target lesions: iUPD; non-target lesions: iUPD; new lesions: no	iUPD	Remains iUPD unless iCPD is confirmed based on a further increase in previously identified target lesion iUPD in sum of measures ≥5 mm or non-target lesion iUPD (previous assessment need not have shown unequivocal progression)
Target lesions: iUPD; non-target lesions: iUPD; new lesions: yes	iUPD	Remains iUPD unless iCPD is confirmed on the basis of a further increase in previously identified target lesion iUPD sum of measures ≥5 mm, previously identified non-target lesion iUPD (does not need to be unequivocal), or an increase in the size or number of new lesions previously identified
Target lesions: non-iUPD or progression; non-target lesions: non-iUPD or progression; new lesions: yes	iUPD	Remains iUPD unless iCPD is confirmed on the basis of an increase in the size or number of new lesions previously identified

Target lesions, non-target lesions, and new lesions defined according to RECIST 1.1 principles; if no pseudoprogression occurs, RECIST 1.1 and iRECIST categories for complete response, partial response, and stable disease would be the same.

iUPD: unconfirmed progression; iCR: complete response; non-iCR/non-iUPD: criteria for neither CR nor PD have been met; iPR: partial response; iSD: stable disease; iCPD: confirmed progression; RECIST: Response Evaluation Criteria in Solid Tumours.
* Previously identified in assessment immediately before this timepoint. "i" indicates immune responses assigned using iRECIST.

Reproduced from: Seymour L, Bogaerts J, Perrone A, et al. iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics. Lancet Oncol 2017; 18:e143. Table used with the permission of Elsevier Inc. All rights reserved.

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Immune response criteria for immunotherapy (iRECIST): Assignment of timepoint response