972P - Efficacy and safety of lenvatinib vs sorafenib in hepatocellular carcinoma: A multi-center real-world study from the LINK Research Network

Background

Recent studies have shown the non-inferiority of Lenvatinib (LEN) compared to Sorafenib (SOR) in survival outcomes in hepatocellular carcinoma (HCC), significantly influencing treatment strategies. This study aimed to corroborate these findings by assessing the comparative efficacy and safety of LEN and SOR as first-line (1L) therapies by leveraging real-world data from South Korea.

Methods

Utilizing the LINK database, we identified HCC patients diagnosed from January 2015 to June 2022, treated with either 1L LEN or SOR. Additional exclusions, beyond standard LINK criteria, included patients who had undergone liver transplant at any point or those who had received hepatectomy, loco-regional therapy, or radiation within 28 days prior to 1L. We analyzed real-world overall survival (rwOS), time to first dose reduction, and adverse events (AEs) of interest such as such as hypertension, increases in alanine aminotransferase (ALT) and aspartate aminotransferase (AST), hand-foot syndrome (HFS), and proteinuria. Incidence rates (IRs) per 1,000 person-years (PYs) were compared between the groups using propensity score matching to adjust for confounders, maintaining an alpha level of 0.05 for statistical significance.

Results

Of 1,361 patients (1L LEN: 359, 1L SOR: 1,002), 1:1 PS-matching yielded 343 pairs with balanced covariates. 1L LEN showed a significantly longer median rwOS of 9.6 months (95% CI: 8.3-10.8) compared to 7.4 months (95% CI: 6.4-9.3) for 1L SOR (p=0.013). Time to first dose reduction was longer for 1L LEN (96.7 vs. 37.4 days, p<0.001) without significant difference in IRs (908.3 vs. 1072.6, p=0.252). Regarding AEs, 1L LEN had higher IRs of hypertension (204.5 vs. 129.7, p=0.046) and proteinuria (576.1 vs. 240.5, p<0.001), while 1L SOR had higher IRs of HFS (220.4 vs. 404.4, p=0.003), ALT increase (2,058.1 vs. 3,386.2, p<0.001), and AST increase (4,814.0 vs. 10,349.1, p<0.001).

Conclusions

The study confirms that 1L LEN offers survival benefits and a distinct safety profile compared to 1L SOR, as observed in clinical trials. Leveraging real-world data underscores its importance in validating long-term outcomes in clinical practice and supports therapeutic decisions for HCC.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

IQVIA Solutions Korea Ltd.

Funding

Eisai Korea Inc.

Disclosure

All authors have declared no conflicts of interest.