* FDA submission slated for first-half 2011
* Strong trial results could boost shares to over $13 - RBC
By Deena Beasley
LOS ANGELES, Sept 27 (Reuters) - A robust 75 percent of Hodgkin lymphoma patients in a pivotal trial responded to an experimental drug being developed by Seattle Genetics (SGEN.O), according to the company.
Results of the phase-3 trial -- involving 102 patients whose disease had stopped responding to standard treatments -- clear the way for a first-half 2011 application for U.S. regulatory approval of the drug, called brentuximab vedotin.
Seattle Genetics said the trial also showed that patients who responded to brentuximab did so for a median of more than six months.
The company said further details of the trial would be presented later at a medical meeting. It said the 75 percent of responders included patients whose disease went into complete remission as well as those whose tumor burden shrank by at least 50 percent.
RBC Capital Markets, which has put brentuximab’s annual sales potential at $400 million, recently predicted that strong trial results would propel shares of Seattle Genetics to over $13. The stock closed at $12.16 on Friday.
Lymphomas are cancers of the lymphatic system. There are two major categories: Hodgkin lymphoma and non-Hodgkin lymphoma. According to the American Cancer Society, around 8,500 cases of Hodgkin lymphoma will be diagnosed in the United States this year. Globally, there are more than 30,000 cases diagnosed each year.
Most patients are cured by radiation and chemotherapy, but up to 30 percent relapse or fail to respond to front-line treatment.
“We are extremely excited with these results,” said Clay Siegall, chief executive officer of Seattle Genetics. “Brentuximab vedotin has the potential to be the first targeted therapy ever approved for Hodgkin lymphoma.”
The drug links a tumor-targeting antibody with a chemotherapy drug called monomethyl auristatin E. It targets an antigen expressed on Hodgkin lymphoma, several types of T-cell lymphoma and other hematologic malignancies.
Seattle Genetics said the safety profile of the drug during the trial was “generally consistent with prior clinical trial experience.”
The company, which is developing brentuximab with Japan’s Takeda Pharmaceutical Co Ltd (4502.T), expects to announce within the next few weeks results from another trial of patients with anaplastic large cell lymphoma.
It is also studying the drug as an initial treatment for Hodgkin lymphoma. (Editing by Muralikumar Anantharaman)