Seattle Genetics Inc. said its two- drug therapy, developed with Takeda Pharmaceutical Co., cut tumor size by at least half in 75 percent of patients with Hodgkin’s lymphoma, a cancer of the immune system. Seattle Genetics rose the most in three years in Nasdaq trading.
The 102 people in the company-funded trial had advanced lymphoma and hadn’t been cured by previous treatments, said Clay Siegall, president and chief executive officer of Bothell, Washington-based Seattle Genetics. The benefit of the therapy lasted at least six months for most patients, he said.
The drug, SGN-35, uses an antibody to home in on cancer cells and deliver a payload of a cancer-killing agent. Seattle Genetics plans to submit a marketing application to the U.S. Food and Drug Administration in the first half of 2011, Siegall said. Approval would make it the first of a new generation of drugs that combine antibodies and anti-cancer agents, according to Jason Kantor, an analyst with RBC Capital Markets in San Francisco.
“Results were better than expectations, and we believe FDA approval in 2011 is highly likely,” Kantor said in a note today to clients.
Seattle Genetics rose $2.14, or 18 percent, to $14.30 at 4 p.m. New York time in Nasdaq Stock Market composite trading, the greatest single-day increase since January 2007. Takeda rose 0.5 percent to 4,030 yen in Tokyo trading today.
About 8,500 people in the U.S. are diagnosed with Hodgkin’s disease every year and 1,300 die, according to the National Cancer Institute. Improved therapies have made Hodgkin’s more treatable in recent years, with about 85 percent of patients responding to the treatments, Siegall said. The 15 percent who don’t respond generally die within two to three years, he said.
The companies will seek accelerated approval for SGN-35 based on this study, the second of three rounds of testing generally required by U.S. regulators, because the medicine addresses an unmet medical need.
The trial aimed to see if the drug could cut the size of the tumor in half, called a partial response, or make it disappear, a complete response. Patients received an injection of the medicine, calibrated to their weight, every three weeks for up to 48 weeks.
Three-quarters of the patients had at least a partial response, according to a company statement. Siegall declined to be more specific and said a full report would be made at a future medical meeting.
“We believe the data are really promising for these patients who have a very poor prognosis and very few options,” Siegall said in a telephone interview yesterday. The drug “has the potential to be the first major advancement for treating people” whose cancer has returned or who didn’t respond to previous treatments, he said.
The company didn’t disclose rates of side effects. Some patients experienced fatigue; reduced white blood cell counts; diarrhea; nausea; and peripheral neuropathy, a nerve condition that causes pain and numbness in the limbs, Peggy Pinkston, a Seattle Genetics spokeswoman, said in an e-mail. The side effects in general weren’t severe, she said.
The drug, also known as brentuximab vedotin, is designed to use an antibody that recognizes and links to a receptor found on the surface of cancer cells and only minimally present or absent on healthy cells, Siegall said. Linked to the antibody is a drug that kills cells by keeping them from dividing and growing.
“It targets the cell population that we’re trying to eliminate without impacting, or only minimally impacting, normal tissue,” Siegall said.
Osaka, Japan-based Takeda is jointly developing the drug with Seattle Genetics and sharing development costs. Seattle Genetics will market the treatment in the U.S. and Canada and Takeda has rights in the rest of the world.
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