91P - A real-world study of tislelizumab (Anti-PD-1) plus tyrosine kinase inhibitors for intermediate or advanced hepatocellular carcinoma

Background

Data on elucidating the efficacy and safety of tislelizumab combined with tyrosine kinase inhibitors (TKIs) in hepatocellular carcinoma (HCC) are lacking. Herein, we explored the regimen of tislelizumab plus TKIs for intermediate or advanced HCC patients (pts) in a real-world setting.

Methods

In this study, 73 pts were included between Jul. 2021 and Jul. 2023. Pts were assigned either with tislelizumab plus TKIs (n=33), or tislelizumab plus TKIs plus TACE (n=40), where TKIs included lenvatinib (49.3%), regorafenib (23.3%), donafenib (21.9%), apatinib (2.7%) and anlotinib (2.7%). The primary endpoints were objective response rate (ORR, mRECIST criteria) and progression-free survival (PFS). The secondary endpoints included 6-month and 12-month PFS rates, disease control rate (DCR) and safety.

Results

Among the 73 pts, 80.8% were male, 53.4% had BCLC stage B, 75.3% were Child-Pugh A, 69.9% were first-line recipients and the average age was 62.8 years. The mean follow-up period was 13.3 (95% CI: 11.9-14.8) months and the mean number of TACE sessions were 0.8 (range 0-3) for all patients. The ORR and DCR were 42.5% and 79.5% with a median PFS of 12.6 months (95% CI: 8.71-16.49) and the 6-month, 12-month PFS rates were 69.6% and 50.4%. Compared to the tislelizumab plus TKIs group, the tislelizumab plus TKIs plus TACE group achieved longer median PFS (12.7 months (95% CI 9.17-16.23) vs. 8.4 months (95% CI 4.83-11.97), P=0.132), higher ORR (55.0% vs 27.3%, P = 0.017) and DCR (87.5% vs 69.7%, P = 0.061). Any-grade TRAEs were reported in 59 (80.8%) pts, and grade 3 TRAEs were reported in 16 (21.9%) pts. Most frequent TEAEs (≥10%) included hand-foot syndrome (24.7%), increased transaminase (15.1%), hyperbilirubinemia (13.7%), diarrhea (13.7%) and fever (11.0%). G3 TRAEs occurred in more 5% pts included hand-foot syndrome (8.2%), increased transaminase (6.8%). No grade 4/5 TRAE and new safety signal were identified.

Conclusions

Tislelizumab plus TKIs with TACE appeared to deliver encouraging efficacy and acceptable safety for pts with intermediate or advanced HCC. Further patient recruitment and longer follow up are warranted.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.