{"id":3235,"date":"2018-09-05T00:00:00","date_gmt":"2021-03-18T08:22:03","guid":{"rendered":"https:\/\/www.eisai.com.cn\/?p=3235"},"modified":"2022-03-11T14:30:17","modified_gmt":"2022-03-11T06:30:17","slug":"eisai-and-merck-co-inc-kenilworth-n-j-u-s-a-announce-china-national-medical-products-administration-nmpa-approval-of-lenvima-lenvatinib-for-treatment-of-unresectable-hepatocellular","status":"publish","type":"post","link":"https:\/\/www.eisai.com.cn\/en\/2018\/09\/05\/eisai-and-merck-co-inc-kenilworth-n-j-u-s-a-announce-china-national-medical-products-administration-nmpa-approval-of-lenvima-lenvatinib-for-treatment-of-unresectable-hepatocellular\/","title":{"rendered":"EISAI AND MERCK & CO., INC., KENILWORTH, N.J., U.S.A. ANNOUNCE CHINA NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA) APPROVAL OF LENVIMA\u00ae (LENVATINIB) FOR TREATMENT OF UNRESECTABLE HEPATOCELLULAR CARC"},"content":{"rendered":"

First Approval for LENVIMA in China and First New Therapy for the First-line Treatment of Unresectable HCC Approved in China in a Decade<\/strong><\/p>\n

TOKYO and KENILWORTH, N.J. Sept. 5, 2018 \u2013 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Merck & Co., Inc., Kenilworth N.J., U.S.A., known as MSD outside of the United States and Canada, announced today that the China National Medical Products Administration (NMPA) approved the kinase inhibitor LENVIMA\u00ae<\/sup>\u00a0(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\u2019s 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,1<\/sup>\u00a0and the first new systemic therapy approved for the first-line treatment of unresectable HCC in China in ten years.1<\/sup><\/p>\n

The approval was based on results from the REFLECT study (Study 304)2<\/sup>, an open-label, Phase 3 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. 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, HKSA and Chinese Taiwan), LENVIMA demonstrated efficacy based on non-inferiority of OS compared to sorafenib, with improvements also observed in PFS, TTP and ORR3<\/sup>. 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. (For the detailed data, please refer to “Notes for Editors” below.)<\/span><\/p>\n

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.<\/span><\/p>\n

Liver cancer is the second leading cause of cancer-related deaths and is estimated to be responsible for approximately 750,000 deaths per year globally. Additionally, approximately 780,000 cases are newly diagnosed each year, about 80% of which occur in Asian regions. Specifically, in China, there are approximately 395,000 new cases and 380,000 deaths per year, accounting for approximately 50% of cases worldwide.1<\/sup>\u00a0HCC accounts for 85% to 90% of primary liver cancer cases. Unresectable HCC, for which treatment options are limited, is extremely difficult to treat, and the development of new treatments is necessary.<\/p>\n

Since the initial launch, more than 10,000 patients have been treated with LENVIMA. Today, LENVIMA is approved as a treatment for refractory thyroid cancer in over 50 countries including the United States, Japan, in Europe and Asia, and as combination with everolimus as a second-line treatment for renal cell carcinoma (RCC) in over 45 countries including the United States and in Europe. For HCC, LENVIMA was approved for use in Japan in March 2018, and in the United States and Europe in August 2018. In Japan, approximately 3,000 HCC patients have been treated with LENVIMA since approval of this indication.<\/p>\n

 <\/p>\n

*1<\/sup>\u00a0Overall Survival (OS): The time period from the commencement of cancer treatment up until death by any cause. Whether the cause of death is cancer or not is not taken into consideration for this variable.
\n*2<\/sup>\u00a0Progression Free Survival (PFS): PFS is the objectively confirmed time from the commencement of cancer treatment to the date of disease progression, or date of death from any cause, whichever occurs first.
\n*3<\/sup>\u00a0Time To Progression: TTP is the objectively confirmed time from the commencement of cancer treatment to the date of disease progression. Unlike PFS, TTP does not consider death from any cause.
\n*4<\/sup>\u00a0Objective Response Rate (ORR): ORR is the combined proportion of patients whose tumor was eliminated (complete response) and whose tumor was reduced by over 30% in size (partial response) as verified by imaging assessment.<\/span><\/p>\n

 <\/p>\n

 <\/p>\n\n\n\n\n
Contacts<\/td>\n<\/tr>\n
\u00a0<\/strong><\/p>\n

 <\/p>\n

Eisai Public Relations<\/strong>
\n+81-(0)3-3817-5120<\/p>\n

Eisai Investor Relations<\/strong>
\n+81-(0)3-3817-3016<\/p>\n

 <\/td>\n

 <\/p>\n

Merck Media Relations
\n<\/strong>Pamela Eisele:\u00a0(267) 305-3558
\nAnn Bush: (908) 740-6677<\/p>\n

Merck Investor Relations<\/strong>
\nTeri Loxam: (908) 740-1986
\nMichael DeCarbo: (908) 740-1807<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n

\u2013 Notes for Editors \u2013<\/strong><\/p>\n

About the REFLECT Trial (Study 304)<\/strong>\u00a02<\/sup><\/strong><\/b><\/p>\n

REFLECT was a large (n=954) Phase 3, randomized, multicenter, open-label trial conducted by Eisai to compare the efficacy and safety of LENVIMA versus sorafenib as a first-line systemic treatment in patients with unresectable HCC. Patients at 154 trial sites in 20 countries were randomized to receive LENVIMA \u00a012 mg or 8 mg once a day depending on body weight (\u226560 kg or <60 kg, respectively) (n=478) or sorafenib 400 mg twice a day (n=476). Treatment was continued until disease progression or unacceptable toxicity. The primary endpoint of this study was OS, tested first for non-inferiority to sorafenib, then for superiority.\u00a0The key secondary efficacy endpoints of this study included PFS, TTP and ORR, tested for superiority to sorafenib.<\/p>\n

In the China package insert, REFLECT showed that LENVIMA achieved the primary endpoint, demonstrating a treatment effect on OS by statistical confirmation of non-inferiority to sorafenib. Patients treated with LENVIMA experienced a median OS of 13.6 months compared to 12.3 months with sorafenib (Hazard Ratio [HR]: 0.92; 95% Confidence Interval [CI]: 0.79-1.06). Patients randomized to the LENVIMA arm did not have a statistically significant improvement in OS compared to those in the sorafenib arm. In addition, LENVIMA showed statistically significant superiority and clinically meaningful improvements in the secondary efficacy endpoints of PFS, TTP and ORR, as confirmed by a blinded independent imaging review:<\/p>\n