Phase III REFLECT study of Lenvima in hepatocellular carcinoma published in The Lancet.- Eisai.
Eisai Inc. announced that the positive results of a Phase III study (REFLECT study, Study 304) of Lenvima (lenvatinib mesylate) in patients with unresectable hepatocellular carcinoma (HCC) have been published in the online version of The Lancet. The REFLECT study reported on in the paper was a multicenter, open-label, randomized, global Phase III study comparing the efficacy and safety of lenvatinib versus sorafenib, a standard treatment for advanced hepatocellular carcinoma, as a first-line treatment in patients with unresectable HCC.
In this study, lenvatinib demonstrated a treatment effect on the primary endpoint of Overall Survival (OS) by statistical confirmation of non-inferiority to sorafenib. Additionally, lenvatinib showed statistically significant and clinically meaningful improvements in the secondary endpoints of progression-free survival (PFS), time to progression (TTP) and objective response rate (ORR). The paper also reported on the results of an exploratory analysis of the secondary endpoints based on blinded independent imaging review (IIR). The IIR was conducted using both RECIST 1.1, which uses the traditional assessment of the effect on change in tumor diameter, and mRECIST, which takes into account areas of tumor necrosis in addition to the RECIST 1.1 criteria. Results of the IIR analyses were consistent with and corroborated those for the investigator assessments demonstrating an improvement in PFS and TTP, as well as an increase in ORR as compared with sorafenib. In this study, the five most common adverse events observed in the lenvatinib arm were hypertension, diarrhea, decreased appetite, weight loss and fatigue, which is consistent with the known safety profile of lenvatinib.
See: "Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase III non-inferiority trial." Masatoshi Kudo et al. The Lancet 09 February 2018 DOI: https://doi.org/10.1016/S0140-6736(18)30207-1
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