ESMO Congress 2023 | OncologyPRO

Abstract 949P

Background

Based on the favorable efficacy and acceptable safety demonstrated by the RESORCE and REFINE studies, multikinase inhibitors, represented by regorafenib (rego), remain the standard and widely-used second-line strategy for advanced hepatocellular carcinoma (HCC). The advent of numerous immune checkpoint inhibitors (ICI) has significantly altered the treatment paradigm for patients (pts) with advanced HCC in recent years. However, there is sitll a lack of large-scale multicenter real-world evidence concerning the concurrent use of rego with ICI. In this study, we aimed to evaluate whether combining rego with ICI provides greater clinical benefit than rego monotherapy.

Methods

This retrospective real-world study was conducted in 5 centers in China between November 2018 to October 2022. A total of 208 pts with advanced HCC receiving either rego plus ICI or rego monotherapy as second-line treatment were included. We compared Overall response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and adverse events (AEs).

Results

Overall, 143 pts received rego plus ICI and 65 pts received rego. The median follow-up period was 13.8 (95% CI: 13.1-14.5) months. The rego plus ICI group demonstrated significantly higher ORR (23.8% vs. 9.2%, P=0.014) and DCR (74.8% vs. 53.8%, P=0.003) compared to the rego monotherapy group based on mRECIST criteria. Median PFS (7.5 vs. 3.4 months, P<0.001) and OS (25.6 vs. 16.4 months, P=0.010) were also significantly longer in the rego plus ICI group. The rate of Grade 3-4 AEs was slightly higher in the rego plus ICI group than the rego group (23.8% vs. 20.0%, P=0.546), and no treatment-related deaths occurred in either group. Table: 949P

Tumour response
	RECIST 1.1	mRECIST
	Regorafenib+ICI (n=143)	Regorafenib (n=65)	P value	Regorafenib+ICI (n=143)	Regorafenib (n=65)	P value
Best overall response
Complete response	2 (1.4)	0 (0)	1	2 (1.4)	0 (0)	1
Partial response	22 (15.4)	6 (9.2)	0.228	32 (22.4)	6 (9.2)	0.023*
Stable disease	83 (58.0)	30 (46.2)	0.111	73 (51.0)	29 (44.6)	0.390
Progressive disease	36 (25.2)	27 (41.5)	0.017*	36 (25.2)	28 (43.1)	0.010*
Not evaluable	0 (0)	2 (3.1)	0.097	0 (0)	2 (3.1)	0.097
Objective response	24 (16.8)	6 (9.2)	0.151	34 (23.8)	6 (9.2)	0.014*
Disease control	107 (74.8)	36 (55.4)	0.005*	107 (74.8)	35 (53.8)	0.003*

Notes: data was presented as number (percentage).

Conclusions

Regorafenib combined with ICI is a promising second-line treatment option for advanced HCC, demonstrating encouraging efficacy with an acceptable safety profile compared to regorafenib monotherapy.