182P - Lenvatinib (LEN) plus anti-PD-1 antibodies vs LEN alone for advanced hepatocellular carcinoma (HCC): A real-world study

Background

Combining LEN with anti-PD-1 antibodies (LEN+PD1) has shown promising anti-tumour effect against advanced HCC in KEYNOTE 524 and Study 117. We assessed LEN+PD1 vs LEN monotherapy in Chinese patients (Pts) with advanced HCC.

Methods

This real-world study included Pts with untreated advanced HCC who received lenvatinib (8 mg/d regardless of bodyweight) ± anti-PD-1 antibodies (q3wk) between Nov 2018 and Nov 2019, and had ≥1 efficacy and safety assessment. Endpoints included objective response rate (ORR), disease control rate (DCR) and progression free survival (PFS) evaluated using mRECIST and RECIST 1.1 every 2 months from treatment initiation, ALBI score and safety.

Results

The study included 22 patients who received LEN+PD1 and 22 who received LEN. For patients in the LEN+PD1 and LEN groups, median follow-up was 6.6 and 5.3 months, mean age was 54.8 and 53.2 years, 81.8 and 90.9% had BCLC stage C disease, and 72.7 and 68.1% were Child-Pugh A, respectively. ORR and DCR were numerically higher in the LEN+PD1 group vs the LEN group (Table) and median PFS was 12.1 (95% CI: 7.9, 16.2) vs 8.9 months (95% CI: 6.6, 11.2; HR=0.58; 95% CI: 0.17, 1.93), respectively. A similar proportion of patients in both groups decreased one ALBI level from baseline (p=0.9331). The most common AEs in the LEN+PD1 group were hypertension (22.7% [5]), decreased appetite (18.2% [4]) and ALT increase (13.6% [3]) and in the LEN group were ALT increase (31.8% [7]), proteinuria (18.2% [4]) and decreased appetite (18.2% [4]). No unexpected safety signals were observed. Table: 182P

Conclusions

LEN ± anti-PD-1 antibodies was effective and well tolerated in first-line treatment of patients with advanced HCC. LEN+PD1 showed a trend towards higher ORR, DCR, and longer PFS vs LEN, with no increase in hepatotoxicity. However, further evaluation in randomized, prospective trials is required.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.