Table 3

Concordance in best overall response achieved prior to use of non-protocol-specified anticancer therapy per iRECIST and RECIST V.1.1 in the anti-PD-1/PD-L1 antibody-treated population

CRPRSDPDNE/baselineTotal
iCR258130 5 0276 (5.8%)
iPR01178 11 32 01221 (25.7%)
iSD0011105901169 (24.6%)
iCPD0004050405 (8.5%)
iUPD000119201192 (25.1%)
NE/baseline0000488*488 (10.3%)
Total2581191112116934884751
  • The bold values identify the 48 patients with response per iRECIST but only progression or stable disease per RECIST v.1.1

  • *Includes 355 patients with no postbaseline tumor assessment; 78 patients receiving non-protocol-specified anticancer therapy prior to first postbaseline tumor assessment, 29 patients in whom not all target tumors were assessed in postbaseline evaluations and 26 patients whose assessment of iSD was conducted too early to be considered durable and who had no further assessment or received non-protocol therapy.

  • iCPD, confirmed progression of disease; iCR/CR, complete response; iPR/PR, partial response; iSD/SD, stable disease; iUPD, unconfirmed progression of disease; NE, not evaluable; PD, progression of disease; RECIST, Response Evaluation Criteria in Solid Tumours.