Table 2

Frequency (n) and proportion of the total population (%) of concordance/discordance between BOR assessed by RECIST 1.1 and irBOR assessed by irRECIST

irBOR by irRECIST, n (%)BOR by RECIST 1.1, n (%)
CRPRSDPDNEOverall
irCR42 (2.4)3 (0.2)†2 (0.1)†1 (<0.1)*048 (2.7)
irPR1 (<0.1)†172 (9.7)8 (0.5)11 (0.6)0192 (10.9)
irSD00592 (33.5)135 (7.6)0727 (41.2)
irPD000530 (30.0)4 (0.2)534 (30.3)
irNE00062 (3.5)202 (11.4)264 (15.0)
Overall43 (2.4)175 (9.9)602 (34.1)739 (41.9)206 (11.7)1765 (100)
  • The discordant subgroup (a BOR assessment of PD or NE and an irBOR assessment of disease control, ie, irSD or better) is shown: of patients with PD, 135 had irSD, 11 had irPR, and 1 had irCR (n=147).

  • *This patient had pseudoprogression; the patient initially had disease progression (PD by RECIST) and later had a CR (irCR).

  • †Due to data errors by the investigator in the assessment of BOR by RECIST 1.1.

  • BOR, best overall response; CR, complete response; irBOR, immune-related BOR; irCR, immune-related CR; irNE, immune-related NE; irPD, immune-related PD; irPR, immune-related PR; irRECIST, immune-related RECIST; irSD, immune-related SD; NE, not evaluable; PD, progressive disease; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; SD, stable disease.