Key clinical point: Patients with advanced hepatocellular carcinoma (aHCC) and alpha-fetoprotein (AFP) levels ≥400 ng/mL experience a consistent survival benefit with ramucirumab therapy irrespective of baseline prognostic covariates.
Major finding: Ramucirumab vs. placebo improved overall survival in patients with viral (hazard ratio [HR] 0.76; 95% CI 0.60-0.97) and nonviral (HR 0.56; 95% CI 0.49-0.79) etiologies and in those with above-median AFP levels (≥4,081.5 ng/mL; HR 0.71; 95% CI 0.54-0.95).
Study details: Findings are from a post hoc meta-analysis of the phase 3 REACH and REACH-2 trials involving 542 patients with aHCC and AFP levels ≥400 ng/mL who were randomly assigned to receive ramucirumab (n = 316) or placebo (n = 226).
Disclosures: The study was sponsored by Eli Lilly and Company. JM Llovet, A Singal, A Villanueva, R Finn, M Kudo, P Galle, M Ikeda, and A Zhu reported receiving grants, personal/advisory board/consulting fees, or honoraria from various sources, including Eli Lilly. The other authors are employees or shareholders of Eli Lilly.
Source: Llovet JM et al. Prognostic and predictive factors in patients with advanced HCC and elevated alpha-fetoprotein treated with ramucirumab in two randomized phase III trial. Clin Cancer Res. 2022 (Mar 4). Doi: 10.1158/1078-0432.CCR-21-4000