Eli Lilly's Cyramza rallies back in liver cancer with biomarker win

Eli Lilly
Eli Lilly's Cyramza is the first to post positive data in a biomarker-selected population of liver cancer patients. (Eli Lilly)

After Eli Lilly’s Cyramza flopped a phase 3 liver cancer trial in 2014, the company went back to the drawing board to design a trial for a specific subpopulation. Now, nearly four years later, it’s back with a win.

Wednesday, the Indianapolis drugmaker said Cyramza had hit a pair of survival endpoints in second-line hepatocellular carcinoma (HCC) patients with high levels of the glycoprotein alpha-fetoprotein (AFP), a biomarker the company called “a marker of poor prognosis.”

Lilly kicked off the study back in 2015 after Cyramza in a different phase 3 study demonstrated an overall survival benefit—but not a statistically significant one. This time around, Cyramza significantly topped placebo at extending both overall survival and progression-free survival, in the process becoming the first med to put up positive liver cancer results in a biomarker-selected population.

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RELATED: With Stivarga-Nexavar bridge-building complete in liver cancer, Bayer gets ready to run the table

Next up? Lilly intends to file for regulatory approvals starting in the middle of this year, it said, and if it can score some go-aheads, it’ll mean a competitive threat for liver cancer leader Bayer. Currently, the German pharma dominates the first-line liver cancer setting with blockbuster Nexavar, and it last year scored a second-line nod for Stivarga that helped it bill the two therapies as part of a single regimen.

With half of all HCC patients checking in as AFP-high, though, Cyramza could give Stivarga a run for its money in the second-line arena. And that’s not to mention existing and forthcoming competition from the immuno-oncology field; Bristol-Myers Squibb’s Opdivo scored a second-line go-ahead last September, and Merck’s Keytruda is making its way through the clinic as a treatment for the disease, too.

RELATED: Lilly's Cyramza posts modest survival win in hard-to-treat bladder cancer group

Meanwhile, Lilly is working to expand Cyramza—which also bears approvals in gastric cancer, colorectal cancer and non-small cell lung cancer—even further. Last year, the med came through with encouraging data in bladder cancer, and the company is trialing it as a treatment for EGFR-positive non-small cell lung cancer as well.

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