Lenvima approved in China for liver cancer.- Eisai/Merck Inc.

Eisai Co and Merck Inc announced today that the China National Medical Products Administration (NMPA) approved the kinase inhibitor Lenvima (lenvatinib) as a single agent for the treatment of patients with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

In China, the application of Lenvima was submitted in October 2017 and was designated for Priority Review by the NMPA due to Lenvima's significant clinical benefit compared to existing treatments, leading to approval in approximately 10 months. This approval marks the first for Lenvima in China, where the incidence of HCC is high, and the first new systemic therapy approved for the first-line treatment of unresectable HCC in China in ten years.

The approval was based on results from the REFLECT study (Study 304), an open-label, Phase III trial where Lenvima demonstrated a treatment effect on overall survival (OS) by statistical confirmation of non-inferiority when compared with the standard of care, sorafenib, in 954 patients with previously untreated unresectable HCC; patients randomized to the Lenvima arm did not have a statistically significant improvement in OS compared to those in the sorafenib arm. Lenvima demonstrated statistically significant superiority and clinically meaningful improvements in progression-free survival (PFS), time to progression (TTP) and objective response rate (ORR). In a subpopulation analysis of 288 patients in the study from the greater Chinese region (mainland China, Hong Kong and Taiwan), Lenvima demonstrated efficacy based on non-inferiority of OS compared to sorafenib, with improvements also observed in PFS, TTP and ORR. Approximately 80% of patients in the subpopulation were living with HCC resulting from chronic hepatitis B virus (HBV), which has high unmet medical need. For these patients, Lenvima demonstrated non-inferiority based on OS compared with sorafenib, thereby demonstrating the effect of Lenvima in patients with HCC resulting from HBV.

In the China package insert, the five most common adverse reactions observed in patients treated with Lenvima were hypertension (45%), fatigue (44%), diarrhea (39%), decreased appetite (34%) and decreased weight (31%), which is consistent with the known side-effect profile of Lenvima.