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.
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.
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.