Celgene Corp. (CELG) stopped a trial of Revlimid, its biggest-selling drug, after more people died using the product than those who were given a competing therapy.
The study was designed to expand use of the medicine, approved for multiple myeloma, in older patients with a type of blood cancer known as B-cell chronic lymphocytic leukemia. The trial was put on hold by U.S. regulators on July 12, the company said today in a statement.
Thirty-four of 210 patients getting Revlimid died, compared with 18 of 211 patients on chlorambucil, a chemotherapy drug, leading up to the regulator’s action, according to the statement. Celgene, based in Summit, New Jersey, said it hasn’t found a reason for the imbalance and plans to continue other trials in lymphocytic leukemia.
The study halt isn’t a major blow for Celgene, said Brian Abrahams, an analyst with Wells Fargo & Co. “We view today’s news as a very minor setback and would use any weakness as a buying opportunity,” he said in a note to clients today.
Revlimid generated $3.77 billion in sales in 2012, 68 percent of Celgene’s total revenue. Celgene fell 2.6 percent to $133.05 at the close in New York. The stock has gained 98 percent in the past 12 months.
Celgene has been seeking to increase use of Revlimid by adding new indications. The halted final-stage trial was designed to support use of the drug in people age 65 and older who had other diseases or conditions that would have kept them from using regular chemotherapy. Most of the patients in the study had multiple diseases, such as diabetes, heart failure or kidney failure, Celgene said.
Revlimid is approved as a second-line treatment for multiple myeloma, a cancer in white blood cells that disproportionately affects older people. About 100,000 people in the U.S. are diagnosed each year with blood cancers, including leukemia and lymphoma, according to the U.S. Centers for Disease Control and Prevention in Atlanta.
Celgene has determined that second primary malignancies, new cancers arising after treatment, weren’t a factor in the outcome of the study, Greg Geissman, a company spokesman, said in a telephone interview today. It’s still analyzing the trial to determine whether any specific factors played a role in the imbalance, such as age, co-morbidities or regional differences in care.
“A majority of these patients that had died were much older, even 80 or older,” Geissman said. “These are patients who were not eligible for standard treatments. It’s a patient group in need, but elderly and frail, unfortunately.”
Celgene amended the trial design earlier this year to exclude patients over 80 from receiving Revlimid after observing the imbalance, and the U.S. Food and Drug Administration decided to put the study on hold, Geissman said. More recent data since Celgene’s decision showed three additional deaths in the Revlimid arm versus 10 in patients on chlorambucil, bringing the totals to 37 out of 225 patients on Revlimid and 28 out of 225 patients on chlorambucil, he said.
The clinical hold doesn’t affect Revlimid in other diseases or in other studies in CLL, Geissman said. The company also is testing the drug in patients who have received one and two lines of therapy already, without restricting the studies to older patients, he said.
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