Seattle Genetics, Inc., a clinical stage biotech company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer and autoimmune disease, has initiated a phase II clinical trial of brentuximab vedotin (SGN-35), an antibody-drug conjugate (ADC), for the re-treatment of patients with Hodgkin lymphoma and systemic anaplastic large cell lymphoma (ALCL). This trial is designed to evaluate tolerability and activity when retreating patients who relapse after previously achieving an objective response to brentuximab vedotin.
"Data from our phase I clinical trials suggest that patients who responded to brentuximab vedotin, but who relapse after discontinuing their original treatment regimen, may benefit from receiving additional brentuximab vedotin therapy," said Thomas C. Reynolds, chief medical officer of Seattle Genetics. "By evaluating brentuximab vedotin in this setting, there is potential to provide further patient benefit and offer an additional therapeutic option for managing relapsed Hodgkin lymphoma and systemic ALCL."
The phase II multi-centre trial will assess safety and anti-tumour response to re-treatment with brentuximab vedotin. The trial is designed to enrol up to 50 patients with relapsed or refractory Hodgkin lymphoma or systemic ALCL who have previously achieved a complete or partial response to therapy with brentuximab vedotin. Patients will receive 1.8 milligrams per kilogram of brentuximab vedotin every three weeks.
Brentuximab vedotin is in an ongoing pivotal trial under a Special Protocol Assessment (SPA) from the US Food and Drug Administration (FDA) for relapsed or refractory Hodgkin lymphoma and a phase II trial for systemic ALCL. The company also is conducting a phase I clinical trial assessing weekly dosing of brentuximab vedotin. Brentuximab vedotin has received fast track designation from the FDA for Hodgkin lymphoma as well as orphan drug designation in the United States and Europe for both Hodgkin lymphoma and ALCL.
Brentuximab vedotin is an ADC comprising an anti-CD30 antibody attached by an enzyme cleavable linker to a potent, synthetic drug payload, monomethyl auristatin E (MMAE), using Seattle Genetics' proprietary technology. The ADC is designed to be stable in the bloodstream, but to release MMAE upon internalization into CD30-expressing tumour cells, resulting in targeted cell-killing.