Table 2.
Tumor response by IRC and investigator review per RECIST v1.1, mRECIST and iRECIST (EAS, N = 62)
| IRC review | Investigator review | |||||
|---|---|---|---|---|---|---|
| RECIST v1.1 | mRECIST | iRECIST | RECIST v1.1 | mRECIST | iRECIST | |
| Confirmed objective response, n (%) [95% CIa] |
24 (38.7) [26.6, 51.9] |
29 (46.8) [34.0, 59.9] |
24 (38.7) [26.6, 51.9] |
26 (41.9) [29.5, 55.2] |
29 (46.8) [34.0, 59.9] |
27 (43.5) [31.0, 56.7] |
| BOR/iBOR, n (%) | ||||||
| CR/iCR | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.6) | 1 (1.6) | 1 (1.6) |
| PR/iPR | 24 (38.7) | 29 (46.8) | 24 (38.7) | 25 (40.3) | 28 (45.2) | 26 (41.9) |
| SD/iSD | 32 (51.6) | 27 (43.5) | 32 (51.6) | 27 (43.5) | 24 (38.7) | 28 (45.2) |
| PD | 5 (8.1) | 5 (8.1) | n/a | 8 (12.9) | 8 (12.9) | n/a |
| iUPD | n/a | n/a | 2 (3.2) | n/a | n/a | 2 (3.2) |
| iCPD | n/a | n/a | 3 (4.8) | n/a | n/a | 4 (6.5) |
| Not assessableb | 1 (1.6) | 1 (1.6) | 1 (1.6) | 1 (1.6) | 1 (1.6) | 1 (1.6) |
| DCR, n (%) [95% CIa] |
56 (90.3) [80.1, 96.4] |
56 (90.3) [80.1, 96.4] |
56 (90.3) [80.1, 96.4] |
53 (85.5) [74.2, 93.1] |
53 (85.5) [74.2, 93.1] |
55 (88.7) [78.1, 95.3] |
a95% CI was estimated using the Clopper-Pearson method. b One patient received 1 dose of tislelizumab and 8 days lenvatinib and died with confirmed clinical disease progression before the first radiological assessment. IRC Independent Review Committee, RECIST Response Evaluation Criteria in Solid Tumors, mRECIST Modified RECIST, BOR Best overall response, CR Complete response, PR Partial response, PD Progressive disease, SD Stable disease, iRECIST Immune RECIST “i” indicates immune responses assessed using iRECIST, iBOR = BOR, iCR = CR iPR = PR iSD = SD, iUPD Unconfirmed disease progression, iCPD Confirmed disease progression, DCR Disease control rate, EAS Efficacy evaluable analysis set, CI Confidence interval, n/a Not applicable, NE Not evaluable