Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that it has completed enrollment of its pivotal clinical trial of brentuximab vedotin (SGN-35) for relapsed and refractory Hodgkin lymphoma. Brentuximab vedotin is an antibody-drug conjugate (ADC) targeted to CD30 utilizing the company’s proprietary ADC technology.
“Strong interest in brentuximab vedotin from investigators and patients has allowed us to rapidly complete our target enrollment of 100 patients in the pivotal trial in six months, emphasizing the substantial unmet medical need in the relapsed and refractory Hodgkin lymphoma setting,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “The pivotal trial allows for patient treatment up to approximately one year, and we expect data to be available in the second half of 2010. Our goal is to submit both a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) under the accelerated approval regulations and a Marketing Authorization Application (MAA) with the European Medicines Agency (EMEA) for conditional marketing authorization in the first half of 2011. Assuming priority review of our NDA, we would then plan to commercially launch the drug in the United States in the second half of 2011, with potential European launch to follow.”
The brentuximab vedotin pivotal trial is a single-agent, single-arm study evaluating 100 patients with relapsed or refractory Hodgkin lymphoma who previously received autologous stem cell transplant. Patients receive 1.8 milligrams per kilogram (mg/kg) of brentuximab vedotin every three weeks. The primary endpoint of the study is objective response rate assessed by independent review. Secondary endpoints include duration of response, progression-free survival, overall survival and tolerability. The pivotal trial is being conducted under a Special Protocol Assessment (SPA) from the FDA. The SPA is an agreement between the FDA and Seattle Genetics regarding the design of the pivotal trial, including size and clinical endpoints necessary to support an efficacy claim in an NDA. Brentuximab vedotin has also been granted fast track designation by the FDA for the treatment of Hodgkin lymphoma as well as orphan drug designation in the United States and Europe for both Hodgkin lymphoma and anaplastic large cell lymphoma (ALCL).
Brentuximab Vedotin Phase I Clinical Trials