Lenvatinib mesylate has been approved in Japan for unresectable hepatocellular carcinoma (HCC).

This is the first approval worldwide for lenvatinib mesylate for the indication of unresectable HCC and the first new systemic therapy to be approved in Japan for the front line treatment of HCC in approximately 10 years.

Approval for HCC in Japan follows positive NICE recommendations for advanced renal cell carcinoma and differentiated thryoid cancer.

This approval was based on a phase 3 clinical study (Study 304/REFLECT study) conducted by Eisai investigating lenvatinib mesylate as a first-line treatment in patients with unresectable HCC.

In this study, lenvatinib mesylate demonstrated statistically significant non-inferiority of overall survival (OS) (13.6 months) compared to sorafenib (12.3 months) (hazard ratio [HR] 0.92, 95% confidence interval [CI]=0.79-1.06).

Additionally, lenvatinib mesylate showed highly statistically significant and clinically meaningful improvements as compared to sorafenib in the secondary endpoints of progression-free survival (PFS) (HR 0.66, 95% CI=0.57-0.77, p<0.00001), time to progression (TTP) (HR 0.63, 95% CI=0.53-0.73, p<0.00001), and objective response rate (ORR) (lenvatinib mesylate 24% versus sorafenib 9%, p<0.00001).

Furthermore, lenvatinib mesylate helped to delay deterioration in several quality of life (QOL) and symptom domains (pre-specified secondary endpoint), including in areas such as pain and diarrhoea, compared to sorafenib (nominal p-value<0.05).

In this study, the five most common adverse events observed in the lenvatinib mesylate arm were hypertension (42%), diarrhea (39%), decreased appetite (34%), weight loss (31%) and fatigue (30%), which is consistent with the known safety profile of lenvatinib mesylate.

Liver cancer is the second leading cause of cancer-related deaths, with approximately 750,000 deaths per year estimated globally.

Additionally, approximately 780,000 cases are newly diagnosed each year, about 80 percent of which occur in Asia, including Japan and China.

HCC accounts as the primary reason for 85 percent to 90 percent of liver cancer cases.

It is estimated that there are approximately 42,000 HCC patients in Japan, with approximately 26,000 deaths every year.

To date, treatment options for unresectable HCC have been limited, and the prognosis is very poor, emphasizing that this is an area of high unmet medical need.

Source: BusinessWire