Found statistical difference of overall Survival… South Korea’s first real-world data
In the case of first-line treatment of hepatocellular carcinoma (HCC) with Lenvima (Ingredient: Lenvatinib, Eisai), research has shown that Nexavar (Ingredient: Sorafenib, Bayer) may be a better option than Opdivo (Ingredient: Nivolumab, BMSㆍOno) as a second-line treatment.
Lenvima and Nexavar are reimbursable in the first-line treatment for advanced unresectable HCC.
However, unlike Nexavar, which has been the standard first-line treatment for HCC for more than a decade, Lenvima was relatively recently licensed and had limited evidence for follow-up treatments.
The joint research team of Yonsei University Severance Hospital and Sungkyunkwan University Samsung Hospital unveiled the real-world data comparing Nexavar and Opdivo as a follow-up treatment option after Lenvima at The Liver Week 2021, a virtual conference of the Korean Association for the Study of the Liver.
The study analyzed a total of 60 patients diagnosed with advanced HCC from November 2018 to October 2020 and underwent follow-up treatment with Nexavar or Opdivo after the first-line treatment with Lenvima.
52 out of 60 received follow-up treatment with Nexavar, eight were treated with Opdivo, and if the disease progressed after second-line treatment, additional treatment continued with Nexavar, Opdivo, transarterial chemoembolization (TACE), or hepatic artery injection chemotherapy (HAIC).
According to the study, the median progressive-free survival (PFS) was 3.3 months for the Nexavar group and 3.0 months for Opdivo, but there was no statistical difference between the two groups.
In contrast, the median overall survival (OS) showed a statistical difference, 8.7 months for Nexavar and 3.0 months for Opdivo (p=0.046).
ECOG Performance Status, lymph node metastasis, total bilirubin, and treatment option (Nexavar vs. Opdivo) were identified as predictors related to death in second-line treatment.
Among them, the risk of death was more than three times higher for lymph node metastasis (HR=3.363), and ECOG PS of 2 was almost twice as high as in the case of 0 or 1 (HR=1.721).
On the other hand, when Nexavar was administered as a second-line treatment, the risk of death was reduced by less than half compared to that of Opdivo (HR=0.406).
The researchers gave meaning to the study as the first in South Korea to compare the effects of Nexavar and Opdivo in a second-line treatment environment after Lenvima’s initial treatment in patients with advanced HCC.
They then said that the Lenvima-Nexavar sequential therapy significantly improved the survival period than Lenvima-Opdivo sequential therapy and evaluated that Nexavar is an independent variable that reduces the risk of death compared to Opdivo in second-line treatment.
However, the researchers added that the study population is small and that larger-scale research is needed to gain public confidence.
