Ramucirumab (Cyramza®), a fully human anti-VEGFR-2 monoclonal antibody, has been approved as monotherapy for the treatment of patients with hepatocellular carcinoma (HCC) and α-fetoprotein levels ≥ 400 ng/mL who have been treated with sorafenib. Ramucirumab significantly prolonged overall survival (OS) and progression-free survival (PFS) relative to placebo in this population in the randomized, double-blind phase 3 REACH 2 trial. These benefits were seen in key prespecified subgroups based on demographic and disease characteristics. Ramucirumab had an acceptable tolerability profile and manageable safety profile in these patients, with the majority of treatment-related adverse events being mild or moderate in severity. The safety profile of ramucirumab was consistent with that expected for agents targeting the VEGF/VEGFR axis. Currently, ramucirumab is the only therapy specifically tested in patients with α-fetoprotein levels ≥ 400 ng/mL, which is associated with an aggressive disease and poor prognosis. Therefore, ramucirumab is an important treatment option for patients with HCC and α-fetoprotein levels ≥ 400 ng/mL who have been treated with sorafenib.

Ramucirumab: A Review in Hepatocellular Carcinoma

Background & Aims Limited data on treatment of elderly patients
with hepatocellular carcinoma (HCC) increase the unmet need.
REACH and REACH-2 were global phase III studies of ramucirumab
in patients with HCC after prior sorafenib, where patients with
alpha-fetoprotein (AFP) >= 400 ng/mL showed an overall
ssurvival (OS) benefit for ramucirumab. These post-hoc analyses
examined efficacy and safety of ramucirumab in patients with
HCC and baseline AFP >= 400 ng/mL by three prespecified age
subgroups ( = 65 to = 75 years). Methods
Individual patient data were pooled from REACH (baseline AFP >=
400 ng/mL) and REACH-2. Kaplan-Meier and Cox proportional
hazards regression methods (stratified by study) assessed OS,
progression-free survival (PFS), time to progression (TTP) and
patient-reported outcomes (Functional Hepatobiliary System
Index-8 [FHSI-8] score). Results A total of 542 patients (<65
years: n = 302; >= 65 to = 75 years: n =
80) showed similar baseline characteristics between ramucirumab
and placebo. Older subgroups had higher hepatitis C and
steatohepatitis incidences, and lower AFP levels, than the <65
years subgroup. Ramucirumab prolonged OS in patients <65 years
(hazard ratio [HR], 0.753; 95% CI 0.581-0.975), >= 65 to <75
years (0.602; 0.419-0.866) and >= 75 years (0.709;
0.420-1.199), PFS and TTP irrespective of age. Ramucirumab
showed similar overall safety profiles across subgroups, with a
consistent median relative dose intensity >= 97.8%. A trend
towards a delay in symptom deterioration in FHSI-8 with
ramucirumab was observed in all subgroups. Conclusions In this
post-hoc analysis, ramucirumab showed a survival benefit across
age subgroups with a tolerable safety profile, supporting its
use in advanced HCC with elevated AFP, irrespective of age,
including >= 75 years.

https://onlinelibrary.wiley.com/doi/epdf/10.1111/liv.14462

Ramucirumab in elderly patients with hepatocellular carcinoma and elevated alpha-fetoprotein after sorafenib in REACH and REACH-2.

Ramucirumab in patients with advanced hepatocellular carcinoma (HCC) and elevated alpha fetoprotein (AFP): An exposure-response analysis

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Ramucirumab in patients with advanced hepatocellular carcinoma (HCC) and elevated alpha fetoprotein (AFP): An exposure-response analysis