［메디컬투데이 김준수 기자］
릴리사의 시람자(Cyramza)라는 약물이 말기 임상시험에서 간암 환자의 수명을 늘리는 것으로 나타났다.
4일 릴리사가 밝힌 바이엘사의 표적 항암제인 넥사바(Nexavar)로 치료한 후에도 악화되었거나 이 같은 약물 치료를 받을 수 없는 가장 흔한 형의 간암을 앓는 환자에서 단일요법으로 시람자를 테스트한 말기 임상시험 결과 환자의 수명을 늘리는 것으로 나타났다.
또한 시람자는 간세포암의 진행을 늦추는 2차 목표도 달성하는 것으로 나타났다.
한편 이번 연구 참여 환자들은 진행된 간암 환자의 절반 가량이 공유하는 특징인 알파 페토프로틴(alpha fetoprotein, AFP)이라는 단백질이 높은 것으로 나타났다.
릴리사는 이 같은 임상시험 결과를 바탕으로 2018년 중반 간암 치료제로서의 FDA 승인 신청을 할 것이라고 밝혔다.
한편 시람자는 가장 최근 분기에 2억480만 달러를 릴리사에 벌어준 약물로 위암과 일종의 폐암을 포함한 여러 암 치료제로 FDA 승인을 받았다.
Eli Lilly's Cyramza rallies back in liver cancer with biomarker win
by Carly Helfand | Apr 4, 2018 12:20pm
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.
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.
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.