Eisai's Lenvima moves toward Nexavar showdown with phase 3 liver cancer win

Eisai's Lenvima hit its primary endpoint in a phase 3 liver cancer study.

Right now, Bayer has the only FDA-approved first-line treatment for hepatocellular carcinoma (HCC), by far the most common type of liver cancer. But thanks to some new trial results for Eisai, it may not be alone for long.

On Wednesday, the Japanese pharma announced that its Lenvima had hit the primary endpoint in a phase 3 study, establishing noninferiority against Bayer’s Nexavar on the overall survival front. The med also charted statistically significant improvements in progression-free survival, among other secondary endpoints.

The move brings Eisai one step closer to challenging Bayer in a hefty market: An estimated 27,000-plus U.S. patients died of liver cancer in 2016, Eisai said, and an estimated 39,000 new cases will be diagnosed stateside this year.

Bayer, though, has a plan to keep its rival at bay. It’s developing Stivarga, currently used to treat colorectal cancer and gastrointestinal stromal tumors, as a second-line HCC therapy. And once it has that approval in hand—which may be soon, considering Stivarga picked up the FDA’s “priority” tag earlier this month—the German company thinks it can build a bridge between the two to keep patients in the family.

“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.

Eisai, though, will be grateful for whatever liver cancer sales Lenvima can draw up. The company has said Lenvima could one day reach blockbuster heights if all goes according to plan. But so far, England’s cost watchdogs have stymied growth of the med as a thyroid cancer treatment, prompting Eisai to consider legal action last year. Fellow cancer fighter Halaven has run into issues with Europe’s cost-effectiveness gatekeepers, too, with Germany’s IQWiG turning that drug away last year.

The company will need those meds to kick it up a notch if it hopes to recover from generic competition to Alzheimer’s hit Aricept. Its foray into the obesity space certainly isn’t getting the job done; Belviq, the Arena med it’s been hawking since 2013, has seriously struggled, but Eisai decided this year to take full control of the product nonetheless.