Seattle Genetic initiates pivotal SGN-35 trial

US biotechnology firm Seattle Genetics has initiated a pivotal trial of SGN-35 for patients with relapsed or refractory Hodgkin's lymphoma. The  study is being conducted under a Special Protocol Assessment, which is  an agreement between the Food and Drug Administration and the company  regarding the design necessary to support an efficacy claim in a New  Drug Application. SGN-35 is an antibody-drug conjugate that utilizes  Seattle Genetics' proprietary technology to empower antibodies by  linking them to potent cell-killing drugs.

"Through a combination of focused effort by our team and strong interest  from investigators, we were able to treat our first patient in this  pivotal trial within five weeks of receiving the SPA," said Clay  Siegall, chief executive of the firm. "We believe SGN-35 has a  potentially rapid path to regulatory approval, and this pivotal trial is  a significant step toward bringing this promising ADC to Hodgkin  lymphoma patients in need of new and better treatments. Our goal is to  submit the NDA in 2011 under the accelerated approval regulations,"  he  added.

The single-arm pivotal trial will assess the efficacy and safety of  single-agent SGN-35 in 100 patients with relapsed or refractory  Hodgkin's lymphoma who previously received autologous stem cell  transplant. Subjects will receive 1.8mg/kg of the drug every three  weeks. The primary endpoint will be objective response rate assessed by  an independent radiographic facility. Secondary endpoints include  duration of response, progression-free survival, overall survival and  tolerability. The company plans to enroll patients at more than 30 sites  in the USA, Canada and Europe.