Erbitux, a cancer treatment made by Indianapolis-based Eli Lilly and Co.'s Imclone unit, failed to help patients with advanced stomach tumors in a late-stage clinical trial.
The trial results are a setback for German drug company Merck KGaA, which markets the treatment outside of North America. Erbitux is Merck's second-biggest-selling medicine and it was hoping an approval would expand sales.
The drug, combined with two other medicines, didn’t extend the length of time that patients lived without their disease getting worse, said Darmstadt-based Merck said in a prepared statement Thursday..
Patients in the trial, dubbed Expand, had inoperable cancer of the stomach or gastro-esophageal junction and hadn’t received prior chemotherapy or radiation, Merck said. They got Erbitux along with cisplatin, a standard chemotherapy, and the capecitabine cancer drug. Typically, they would receive only palliative chemotherapy, according to Merck.
“We are disappointed that the Expand trial did not show a benefit for patients,” the lead investigator in the study, Florian Lordick of Hannover Medical School in Germany, said in the statement. “Patients with advanced gastric cancer currently have few treatment choices and a poor prognosis, and we will continue to investigate other treatment options for these patients in the hope of being able to offer improved outcomes.”
Merck rang up $1.1 billion in Erbitux sales last year, making it the company’s second-biggest-selling product after Rebif for multiple sclerosis. It’s approved for colorectal cancer as well as tumors of the head and neck.
Lilly and Bristol-Myers Squibb Co. market the drug in the United States and Canada, while Merck promotes it and sells it elsewhere. Lilly said it realized total revenue of $409 million from Erbitux in 2011.
Merck has applied for approval to sell the drug for lung cancer in the European Union. The company said May 9 that Erbitux failed to show a benefit for stage-three colon cancer patients when given with chemotherapy as a way to prevent the cancer’s return following tumor removal, compared with chemotherapy alone.
The study included 904 patients in 25 countries, Merck said. Gastric cancer is the second leading cause of cancer- related death worldwide, leading to more than 700,000 deaths a year, Merck said.
Lilly shares were down 25 cents Thursday morning, to $42.91 each.