CHICAGO—Bayer and its stalwart Nexavar have had the first-line liver cancer field to themselves for years. But Eisai is doing its best to change that.
The Japanese company, maker of Lenvima, on Sunday announced details from a head-to-head non-inferiority study against Bayer’s Nexavar in patients with inoperable hepatocellular carcinoma. Among them: Lenvima posted a 13.6-month overall survival benefit, compared with 12.3 months for Nexavar, and it doubled median progression-free survival time with 7.4 months, compared with Nexavar’s 3.7.
And those aren’t all. Lenvima also put up significant improvements in time to progression and objective response rate, both secondary endpoints in the study, presented at the American Society of Clinical Oncology (ASCO) annual meeting.
Now, Eisai plans to submit the data to regulators—and if it can snag a green light, it’ll gain access to a wide patient pool. Hepatocellular carcinoma, the second most common cause of cancer-related death worldwide, accounts for 90% of the world’s liver cancer cases, and more than 70% of that group aren't eligible for surgery, Eisai said.
An approval win would also give Eisai the chance to give Bayer, which has long controlled the market, a run for its money.
The German drugmaker says it isn’t nervous about the competition, particularly because it just locked up an FDA approval for Stivarga as a second-line treatment. The idea is Nexavar comes first, and then Stivarga for patients who progress after that.
“We know that there are other drugs being studied in this area, but those would be one-off approvals—front line, second line—but not necessarily this continuum approach that we could actually offer physicians as they think about the totality of treatments for the patients,” company oncology head Robert LaCaze told FiercePharma at October’s European Society for Medical Oncology annual meeting.
Competition to Stivarga is on the way though, too—and it’s competition of the immuno-oncology variety. Late last month, U.S. regulators granted Bristol-Myers Squibb’s Opdivo a priority review as a treatment for HCC patients who have already been treated with Nexavar.