And from Bloomberg:
bloomberg.com
News doesn't get much better than this.
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Seattle Genetics Inc. and Takeda Pharmaceutical Co.’s experimental drug wiped out tumors in one- third of patients with hard-to-treat Hodgkin’s lymphoma and reduced the cancer by half in another 40 percent, a study found.
Overall, 94 percent of 102 patients had their tumors shrink by at least a quarter, an “unheard-of” level of improvement in people who had failed other treatments, said study leader Robert Chen, an assistant professor at City of Hope, a nonprofit cancer center in Duarte, California. He presented the results today at the American Society of Hematology meeting in Orlando, Florida.
The drug, SGN-35, may be approved by U.S. regulators late next year and generate $420 million in annual revenue by 2015, said Jason Kantor, an analyst with RBC Capital Markets in San Francisco. The treatment uses an antibody to target and bind with a protein on the surface of lymphoma cells, then blasts them with a cancer-killing chemical. This keeps the drug out of the bloodstream and away from healthy tissue, avoiding the side effects of standard chemotherapy, Chen said.
“We had a hint this was going to be an effective agent from an earlier trial but we had no idea it was going to be this good,” said Chen, who also works as a consultant for Seattle Genetics. “Patients tolerated this drug very well.”
Initial results, released by the Bothell, Washington-based company Sept. 27, pushed shares up 18 percent, the most in three years. Bret Holley, an analyst for Oppenheimer & Co. in New York, called those results “compelling” and predicted the drug will be cleared by U.S. regulators by the end of 2011. Since then, the company’s shares increased 12 percent through Dec. 3.
Final Data
If the final data presented at the hematology meeting showed that 30 percent to 40 percent of patients had complete remissions, it would be “paradigm-shifting,” Holley said in a Dec. 1 note to investors.
The rate of complete remissions in the study was 34 percent, Chen reported.
Still, SGN-35’s commercial potential may be limited because of “the small market opportunity,” Canaccord Genuity analyst George Farmer said in a Dec. 2 note to investors.
About 8,500 people in the U.S. are diagnosed every year with Hodgkin’s lymphoma and 1,300 of them die, according to the National Cancer Institute. The disease attacks the lymphatic system, part of the body’s disease-fighting mechanism, and can lead to enlargement of the spleen, the lymph nodes and other tissues. It also causes night sweats, fever, weight loss and fatigue in about 40 percent of patients, Chen said.
People Who Relapsed
Patients tend to develop lymphoma either as young adults in their 20s or 30s or when they’re in their 60s. While the disease can be cured in about 70 percent of patients, Chen said, his study tested the drug in people who relapsed or didn’t respond to treatment.
The patients were mostly young, with a median age of 31, and had advanced cases of the disease, Chen said. All had been treated with chemotherapy and stem cell transplants drawn from their own blood.
“When patients have failed multiple lines of treatment, as these patients had, it’s usually a very difficult discussion,” Chen said. “It’s tough for the patients and for us because there’s no standard therapy. The only options are palliative care or clinical trials.”
Seattle Genetics plans to apply to the Food and Drug Administration for approval of the medicine in the first half of 2011, said chief executive officer Clay Siegall. SGN-35 would be the company’s first marketed product.
Targeting Cancer
The combination drug works like a guided missile, using an antibody to spot a protein called CD-30 found only on the surface of lymphoma cells. When it finds them, it delivers the anticancer agent, which disrupts cell division to destroy the cancer.
In the study, patients were given SGN-35 by infusion every three weeks for up to 16 cycles. Each infusion takes about a half an hour and can be administered by a nurse, Chen said.
Some patients responded almost immediately, he said. Several “had really enlarged lymph nodes and you could see them shrink in a week,” he said.
Patients maintained the reduction of their tumors for a median of 29 weeks, according to independent reviewers, Chen said. The most common serious side effects were a lowering of white blood cells in 20 percent of patients, low blood platelet counts and nerve pain in 8 percent and anemia in 6 percent, Seattle Genetics said in a statement.
Seattle Genetics has exclusive North American marketing rights and Osaka, Japan-based Takeda can sell the drug everywhere else, the companies said in December 2009 when they announced the partnership. The companies share development costs equally, except in Japan, where Takeda is solely responsible. |
