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Eisai plans Q1 fiscal 2017 liver cancer drug submissions to take on Bayer drug

Eisai Co. Ltd. plans to seek approvals globally in the first quarter of fiscal 2017 for its anti-cancer agent Lenvima as a first-line treatment of advanced hepatocellular carcinoma, the most common form of liver cancer.

During the Japanese company's fiscal third-quarter 2016 financial results presentation, executives said Lenvima, also known as lenvatinib, achieved the primary endpoint in a phase 3 study that pitted the drug against Bayer AG's blockbuster Nexavar, considered the standard treatment for first-line therapy.

In the head-to-head trial, 954 liver cancer patients, who had not received any prior treatment, were randomized to receive either 12 milligrams or 8 milligrams of Lenvima once daily, or 400 milligrams of Nexavar twice daily. Results from the study showed that overall survival for patients who received Lenvima was statistically as good as overall survival for those who received Nexavar.

Liver cancer is the second-leading cause of cancer-related deaths, with approximately 780,000 newly diagnosed cases and 750,000 deaths annually worldwide, the majority of which are in Asia, Eisai said.

Bayer's Nexavar, also known as sorafenib, is the only FDA-approved treatment indicated for first-line therapy in advanced liver cancer. Nexavar is also approved for advanced kidney cancer, another tumor type for which Eisai hopes to gain approval down the line with Lenvima. Approvals of Lenvima for both liver and kidney cancer may dent Nexavar sales, which according to Bayer's annual report reached €892 million in 2015.

In January, Eisai said it plans to consult various regulatory agencies regarding submissions for Lenvima in liver cancer treatment in markets such as Japan, the U.S., Europe, as well as Asia, including China. "In the fiscal year of 2017, the submission and launch preparation of Lenvima will be one of our focus areas," Terushige Iike, senior vice president and president of the oncology business group, said during the presentation.

Eisai is continuing to expand Lenvima's indication. The anti-cancer drug is already approved for thyroid cancer in 50 countries including the U.S. In January, the company initiated a phase 3 study in China, a requirement for gaining approval in the Chinese market.

The company also has ongoing clinical trials for Lenvima in six other cancer types, studying its application in combination therapy. This includes global phase 3 studies of the drug together with Merck & Co. Inc.'s Keytruda, or with Novartis AG's Afinitor, in first-line treatment of kidney cancer. The company plans to have top-line results in fiscal 2019.