Efficacy and safety of tislelizumab plus lenvatinib as first-line treatment in patients with unresectable hepatocellular carcinoma: a multicenter, single-arm, phase 2 trial

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% CI^a]	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 assessable^b	1 (1.6)	1 (1.6)	1 (1.6)	1 (1.6)	1 (1.6)	1 (1.6)
DCR, n (%) [95% CI^a]	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

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