fiercepharmaNovember 15, 2018
Tag: Merck , FDA , esophageal cancer , Keytruda
Merck’s Keytruda is looking to beat its immuno-oncology rivals into yet another market, and it just posted the data that could get the job done.
On Wednesday, the New Jersey drugmaker said that in a phase 3 study pitting its star against chemo, Keytruda had lengthened the lives of previously treated esophageal or esophagogastric junction carcinoma patients whose tumors expressed certain levels of biomarker PD-L1. And it’s the first product in its ultracompetitive class of PD-1/PD-L1 cancer fighters to do so.
Merck will wait until an upcoming medical meeting to disclose detailed results of the trial, but in the meantime, it’ll be submitting them to regulatory authorities around the world, it said.
Esophageal cancer, a tough-to-treat disease, is the seventh most commonly diagnosed cancer, according to the drugmaker, which noted that an estimated 17,290 adults in the U.S. would be diagnosed this year. Worldwide, the company expects to see 572,000 new cases this year, resulting in 508,000 deaths.
And Merck is hoping to be the first I-O drugmaker to get a shot at treating the patient pool. It already holds that distinction in previously untreated lung cancer, the most lucrative market for the therapies. But Keytruda also bears approvals that its rivals can’t boast in a number of smaller markets, including primary mediastinal large B-cell lymphoma and cervical cancer.
Of course, even if Merck can win an FDA approval based on these latest data, patients won’t be eligible for Keytruda until they have already failed on another treatment. But Merck is working to change that with another ongoing phase 3 trial, which is studying the blockbuster in tandem with chemo in the front-line setting.
"We are encouraged by these results of Keytruda as monotherapy in previously treated patients and look forward to continuing our research efforts in this significant area of unmet need," Roy Baynes, M.D., Ph.D., Merck SVP and head of global clinical development, said in a statement.
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