A BREAKTHROUGH ADVANCE FOR THE TREATMENT OF REFRACTORY HODGKIN LYMPHOMA

LOS ANGELES (Reuters) Sep 27 - A robust 75% of Hodgkin's lymphoma patients in a pivotal trial responded to an experimental drug being developed by Seattle Genetics, the company said on Monday.

Results of the phase III trial -- involving 102 patients with relapsed or refractory disease -- 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 additional details of the trial would be presented within the next few weeks. It said the 75% figure included complete and partial responders (whose tumor burden shrank at least 50%).

"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 an anti-CD30 monoclonal antibody with a chemotherapy drug called monomethyl auristatin E. It targets CD30-expressing tumor cells in patients with Hodgkin's lymphoma, several types of T-cell lymphomas and other hematologic malignancies.

Brentuximab vedotin has been granted orphan drug designation by the U.S. Food and Drug Administration and the European Medicines Agency for the treatment of Hodgkin's lymphoma and anaplastic large cell lymphoma and has been granted fast track designation by the FDA for Hodgkin's lymphoma.

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, expects to announce within the next few weeks results from another trial of patients with anaplastic large-cell lymphoma.

In the current trial, all patients had already undergone autologous stem cell transplant. Seattle Genetics is also studying the drug as an initial treatment for Hodgkin's lymphoma.