The trial is being conducted under a special protocol assessment, which is an agreement between the FDA and Seattle Genetics regarding the trial design necessary to support an efficacy claim in a new drug application. SGN-35 is an antibody-drug conjugate (ADC) that utilizes Seattle Genetics’s technology to empower antibodies by linking them to potent cell-killing drugs.
The single-arm pivotal trial will assess efficacy and safety of single-agent SGN-35 in 100 patients with relapsed or refractory Hodgkin lymphoma who previously received autologous stem cell transplant. Patients will receive 1.8mg/kg of SGN-35 every three weeks.
The primary endpoint of the trial 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 US, Canada and Europe.
Seattle Genetics also plans to initiate a Phase II study of single-agent SGN-35 in approximately 55 patients with relapsed or refractory systemic ALCL in the first quarter of 2009. In addition, the company is continuing dose escalation in an ongoing Phase I clinical trial of SGN-35 administered on a weekly basis, and expects to report data from this trial during 2009.
Clay Siegall, president and CEO of Seattle Genetics, said: 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.