Table 3.
Timepoint response 1 | Timepoint response 2 | Timepoint response 3 | Timepoint response 4 | Timepoint response 5 | iBOR | |
---|---|---|---|---|---|---|
Example 1 | iCR | iCR, iPR, iUPD, or NE | iCR, iPR, iUPD, or NE | iUPD | iCPD | iCR |
Example 2 | iUPD | iPR, iSD, or NE | iCR | iCR, iUPD, or NE | iCR, iPR, iSD, iUPD, iCPD, or NE | iCR |
Example 3 | iUPD | iPR | iPR, iSD, iUPD, or NE | iPR, iSD, iUPD, NE, or iCPD | iPR, iSD, iUPD, NE, or iCPD | iPR |
Example 4 | iUPD | iSD or NE | iPR | iPR, iSD, iUPD, or NE | iPR, iSD, iUPD, iCPD, or NE | iPR |
Example 5 | iUPD | iSD | iSD, iUPD, or NE | iSD, iUPD, iCPD, or NE | iSD, iUPD, iCPD, or NE | iSD |
Example 6 | iUPD | iCPD | Any | Any | Any | iCPD |
Example 7 | iUPD | iUPD (no iCPD) | iCPD | Any | Any | iCPD |
Example 8 | iUPD | NE | NE | NE | NE | iUPD |
Eight examples are presented for patients with target disease at baseline, but many more scenarios exist following the same principles. Table assumes a randomised study in which confirmation of complete response or partial response is not required. For patients with non-target disease only at baseline, only iCR or non-complete response or non-progression of disease can be assigned at each timepoint (not shown in the table for ease of presentation). “i” indicates immune responses assigned using iRECIST. iBOR=best overall response. iCR=complete response. iPR=partial response. NE=not evaluable. iUPD=unconfirmed progression. iCPD=confirmed progression. iSD=stable disease. RECIST=Response Evaluation Criteria in Solid Tumours.