|Eisai CEO Haruo Naito|
Japan's Eisai has notched up solid Phase II results for oncology treatment Lenvima plus everolimus, the company said, citing an article on the trial results published in Lancet Oncology, putting it closer to capitalizing on a breakthrough therapy designation from the U.S. FDA for the drug to treat advanced metastatic renal cell carcinoma.
The publication also builds on a presentation in Vienna last month for Lenvima (lenvatinib) and Halaven (eribulin), among other papers, at the European Cancer Congress.
In the Lancet Oncology article, Eisai summarized the key findings for the Phase II and suggested that clinical work will now advance further.
"From the results of the study, the combination of lenvatinib plus everolimus group demonstrated a significant extension in progression free survival (PFS), the study's primary endpoint, compared to the everolimus alone group," according to a press release.
"Additionally, the lenvatinib alone group demonstrated an extension in PFS compared to the everolimus alone group. Both the lenvatinib plus everolimus group and the lenvatinib alone group showed an improvement in objective response rate compared to the everolimus alone group."
In July, Eisai said it hoped for a solid launch for Lenvima, with Ivan Cheung, deputy president of the company's global oncology business, telling Bloomberg that the plan is to roll out the thyroid cancer treatment in more than 20 countries by next March, treating 2,500 patients around the world if all goes well.
Lenvima was approved by the FDA in February and by Japanese regulators in April, marking a bright spot for the company which has struggled since falling off the patent cliff in 2010, when its blockbuster Alzheimer's med Aricept lost patent protection.
But the oncology efforts are forecast by Eisai at $1 billion by 2020 and put it on a collision course with Bayer's Nexavar, seen at $1.16 billion the same year. The sales target for Eisai also depends on whether new indications in lung, kidney and liver cancer help.