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▎WuXi AppTec content team editor
Hepatocellular carcinoma (accounting for about 75%~85% of primary liver cancer) is the sixth most common malignant tumor in the world and the third leading cause
of cancer-related death.
Hepatocellular carcinoma has the characteristics of high vascular density, and its occurrence and development are closely related
to angiogenesis.
Over the past decade, antiangiogenic therapy has been shown to have significant improvements in clinical outcomes and is approved for the treatment of patients with
advanced hepatocellular carcinoma.
leading to angiogenesis.
In a global REACH-2 study, ramoximab significantly improved overall survival (OS) in patients with advanced hepatocellular carcinoma with elevated alpha-fetoprotein (AFP) compared with placebo.
However, the global study included only 44 Chinese patients, which is not large enough to prove that the treatment effect of the Chinese cohort is consistent
with the global results.
To meet regulatory requirements in China, the investigators conducted an extended REACH-2 study to evaluate the efficacy and safety
of ramoximab in patients with advanced liver cancer in China.
Results suggest that ramoximab may be an effective treatment option
in patients with advanced hepatocellular carcinoma with elevated AFP after prior treatment with sorafenib.
The study was recently published in The Lancet sub-journal eClinicalMedicine
.
Professor Qin Shukui of Nanjing Jinling Hospital is the corresponding author of the study; Professor Shao Guoliang of Zhejiang Cancer Hospital, Professor Bai Yuxian of Harbin Medical University Cancer Hospital, and Professor Yuan Xianglin of Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology are the co-first authors
of the study.
Screenshot source: The Lancet sub-journal eClinicalMedicine
REACH-2 China study is a randomized, double-blind, placebo-controlled phase 3 study.
It will be held
from September 16, 2015 to March 15, 2021 at 31 centers in China.
After one-lead lafenib therapy, patients with AFP≥400 ng/mL were randomized (2:1) to receive ramoximumab 8 mg/kg intravenously or placebo once every two weeks (Q2W) until disease progression or unacceptable adverse effects
.
The primary endpoint is OS
.
Of the 104 enrolled Chinese patients (44 in the global study and 60 in the China Extension Study), 70 received ramoximab and 34 received placebo
.
Results showed a median OS of 9.
1 months in the ramoximab group and 6.
2 months in the placebo group (HR = 0.
854 [95% CI: 0.
536 to 1.
359]).
The median progression-free survival (PFS) was 2.
8 months (95% CI: 2.
0~3.
8) in the ramoximab group and 1.
5 months (95% CI: 1.
4~2.
8) in the placebo group (unstratified HR=0.
488 [95% CI: 0.
304~0.
785).
The most common treatment-induced adverse events of grade 3 or more were hypertension (5 [7.
1%] of 70 patients in the ramoximab group versus only 1 [2.
9%] of 34 patients in the placebo group), pneumonia (5 [7.
1%] vs.
1 [2.
9%]), and hyponatremia (4 [5.
7%] vs.
0 [0%]).
In summary, compared with placebo, ramoximab has a clinically meaningful improvement
in OS in Chinese patients with advanced hepatocellular carcinoma with elevated AFP.
Ramotimumab is well tolerated and has a manageable
safety profile.
The findings are consistent
with global REACH-2 studies.
Evidence from the REACH-2 China study suggests that ramoximab may be an effective treatment option in patients with advanced hepatocellular carcinoma with elevated AFP after prior treatment with sorafenib
.
