It’s been a long road for Eli Lilly’s Cyramza in liver cancer after it belly-flopped a phase 3 trial five years ago. On the back of a successful second attempt, the drugmaker has finally accomplished what once seemed out of reach—but these days, there's a lot more competition in the field than there used to be.
Monday, the FDA approved Cyramza for the treatment of liver cancer patients who have failed on Bayer's Nexavar, and in that field, it'll go up against a range of big-name rivals. But unlike those rivals, Cyramza has a targeted green light, clearing it specifically to treat patients with high levels of the glycoprotein alpha-fetoprotein (AFP), a biomarker that can lead to worse outcomes. It affects about 40% of patients with hepatocellular carcinoma, the most common form of liver cancer, Lilly said.
"While there have been some recent advances, there are still limited treatment options for people with this type of cancer and—until now—there was no treatment option specifically indicated for patients with increased alpha-fetoprotein concentrations,” Andrew Zhu, the lead investigator in Cyramza's phase 3 HCC trial, said in a statement. “These patients can have more aggressive disease and a poorer prognosis with increased angiogenesis."
Cyramza’s approval, its fifth for advanced or metastatic cancer, will give Lilly a shot at competing with Bayer’s recent second-line launch, Stivarga, which the German drugmaker has positioned as part of a Nexavar care continuum. Alongside Stivarga, immuno-oncology blockbusters Keytruda from Merck and Opdivo from Bristol-Myers Squibb also have second-line approval for liver cancer, and Exelixis' Cabometyx received its own approval in January.
Luckily for Lilly, also on Monday, the FDA pulled warnings on Cyramza’s label for hemorrhage, gastrointestinal perforation and impaired wound healing, the company said, which will help its ability to compete.
Monday’s regulatory win followed a period of soul searching for Lilly after Cyramza missed its primary endpoint in a phase 3 trial in 2014.
After it failed to significantly top placebo at extending patient lives in its first go-round, Cyramza showed in April 2018 that it could both extend lives and stave off cancer progression in the biomarker population.
The drug still has a long way to go to give Bayer a run for its money, though. Bayer raked in a combined €284 million ($319.7 million) from Nexavar and Stivarga in the first quarter, with the drugs posting 13.6% and 38.6% annual sales growth, respectively. By contrast, Cyramza cleared $183.6 million in global sales in the first quarter with a more modest 8% expansion.
With another indication to tout, Lilly isn’t resting on its laurels with Cyramza, for which it's pursuing an additional indication in non-small cell lung cancer.
In March, the company released clinical data showing a combination of Cyramza and Roche’s Tarceva bested a tandem of Tarceva and placebo in treating first-line patients with EGFR-mutated lung cancer. If the drug wins approval in that indication, it will square off with heavyweights in the field, not the least of which is AstraZeneca’s Tagrisso and its $1.86 billion in global sales in 2018.