Table 2.

Derivation of irRC overall responses

Measurable responseNonmeasurable responseOverall response
Index and new, measurable lesions (tumor burden),* %Non-index lesionsNew, nonmeasurable lesionsUsing irRC
↓100Unequivocal progressionAnyirPR
↓≥50Unequivocal progressionAnyirPR
↓<50 to <25↑Absent/StableAnyirSD
↓<50 to <25↑Unequivocal progressionAnyirSD
  • *Decreases assessed relative to baseline, including measurable lesions only (>5 × 5 mm).

  • Assuming response (irCR) and progression (irPD) are confirmed by a second, consecutive assessment at least 4 wk apart.