Bristol-Myers Stops Skin Cancer Study on Positive Data

Bristol-Myers Squibb Co. (BMY) said it stopped a late-stage study of a top experimental drug after skin cancer patients showed “superior overall survival” with the medicine compared with a group on chemotherapy alone.

Patients in the chemotherapy group were “unblinded” and allowed to take the experimental drug, called nivolumab, after an analysis by the trial’s independent data monitoring committee, Bristol-Myers said today in a statement.

The company said it’s testing nivolumab in more than 35 studies against multiple tumor types. The drug is one of the first in a class that seek to help the body’s immune system attack cancer by protecting a key protein that regulates immune response, called PD-1, from manipulation by a malignancy.

The study of patients whose skin cancer had spread “represents the first well-controlled, randomized Phase 3 trial of an investigational PD-1 checkpoint inhibitor to demonstrate an overall survival benefit,” Michael Giordano, head of the New York-based company’s oncology development, said in the statement.

Bristol-Myers didn’t say how much longer patients on nivolumab survived compared with those on a common chemotherapy called dacarbazine or DTIC.

Research in immune therapies for cancer accelerated two years ago after an earlier Bristol-Myers study on nivolumab found that it shrank tumors in 28 percent of melanoma patients, 27 percent of those with kidney cancer and in 18 percent of people with advanced lung cancer. There were more than 70 presentations on immune therapies at the annual American Society of Clinical Oncology meeting earlier this month in Chicago.

The Bristol-Myers study included 418 advanced melanoma patients who couldn’t undergo surgery and hadn’t been treated for the disease. Historically, about 75 percent of patients with advanced melanoma have died within a year, “making it one of the most aggressive forms of cancer,” Bristol-Myers said.

An estimated 76,100 new melanoma cases are diagnosed annually in the U.S. with 9,710 deaths attributed to the disease, according to the National Cancer Institute.

To contact the reporter on this story: Alex Wayne in Washington at awayne3@bloomberg.net

To contact the editors responsible for this story: Reg Gale at rgale5@bloomberg.net Andrew Pollack, Ben Livesey

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