Drug Therapy Shrinks Hodgkin's Lymphoma Tumors in Clinical Trial
An experimental drug called SGN-35 has been successful in shrinking tumor by at least half in 75% of patients with Hodgkin’s lymphoma in a clinical trial by Seattle Genetics Inc. and Takeda Pharmaceutical Co. The companies plan to submit a marketing application to the US Food and Drug Administration in the first half of 2011.
Hodgkin's Lymphoma Treatment Provides Partial Response for at Least Six Months
SGN-35, also known as brentuximab vedotin, is an injected medication that uses an antibody to recognize and link to a receptor on cancer cells and deliver a cancer-killing agent called monomethyl auristatin E (MMAE). Benefits of the therapy lasted for at least six months in most patients. Patients receive the drug every three weeks for up to 48 weeks.
The clinical trial, which included 102 people with advanced lymphoma that had not been cured by other treatments, was the first to combine antibodies and anti-cancer agents and results were better than expectations, according to Jason Kantor, an San Francisco analyst with RBC Capital Markets.
Side effects, in general, were not severe according to a Seattle Genetics spokeswoman, and included fatigue, reduced white blood cell counts, diarrhea, nausea, and peripheral neuropathy (pain and numbness in the limbs).
Because the medicine addresses an unmet medical need, the companies hope to become approved through the FDA’s accelerated approval process, which expedites the review of experimental treatments for serious diseases such as cancer. If approved, Seattle Genetics will market the treatment in the US and Canada and Japan-based Takeda will market to the rest of the world.
According to the National Cancer Institute, about 8,500 people in the United States are diagnosed with Hodgkin’s disease every year. Hodgkin’s lymphoma is a type of cancer originating from the white blood cells, or lymphocytes and attacks the body’s immune system and its ability to fight infection.
Survival rate for the disease is very good in most patients, but about 15% do not respond to standard therapies. These patients generally die within two to three years of diagnosis.
“We believe the data are really promising for these patients who have a very poor prognosis and very few options,” said Seattle Genetics CEO Clay B. Siegall. 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.