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In a global REACH-2 study, ramucirumab significantly improved overall survival (OS) in patients with advanced hepatocellular carcinoma (HCC) with elevated alpha-fetoprotein (AFP)
compared with placebo.
The REACH-2 China study aims to evaluate the efficacy and safety
of ramonizumab in patients with advanced HCC in China.
The REACH-2 China study is a randomized, double-blind, placebo-controlled Phase 3 study that enrolled patients with advanced HCC with AFPs ≥ 400 ng/mL after first-line treatment with sorafenib, randomized (2:1) to ramotulimab (8 mg/kg, intravenously) or placebo (Q2W) until disease progression or intolerable toxicity
.
The primary endpoint was overall survival
.
Overall survival and progression-free survival in both groups
Between September 16, 2015 and March 15, 2021, a total of 104 patients were enrolled (44 in the global study and 60 in the extended study in China).
Seventy patients received rambitumab and 34 received placebo
.
The median overall survival in the rambitrolab and placebo groups was 9.
1 months and 6.
2 months (HR 0.
854),
respectively.
The most common grade 3 and above adverse effects requiring emergency treatment were hypertension (ramurizumab versus placebo: 7.
1 versus 2.
9 percent), pneumonia (7.
1 versus 2.
9 percent), and hyponatremia (5.
7 versus 0 percent).
In summary, compared with placebo, rambitumab prolongs overall survival in Chinese patients with advanced hepatocellular carcinoma with elevated AFP, although statistical differences
are lacking.
Ramotulumab is well tolerated with a manageable safety profile
.
The findings are consistent with global REACH-2 studies and support the beneficial use
of ramonatrumab in this patient population.
Original source:
Guoliang Shao, et al.
Ramucirumab as second-line treatment in Chinese patients with advanced hepatocellular carcinoma and elevated alpha-fetoprotein after sorafenib (REACH-2 China): A randomised, multicentre, double-blind study.
eClinicalMedicine.
October 06, 2022.
https://doi.
org/10.
1016/j.
eclinm.
2022.
101679
