Expected Results In SGN-35 Trial In Lymphoma For Seattle Genetics

Seattle Genetics has reported data from a phase-I clinical trial of SGN-35 administered to patients with Hodgkin lymphoma and other CD30-positive hematologic malignancies.

Data highlights include longer median duration of response than previously reported, and concordance between investigator-assessed and independent review of responses.

Seattle is advancing an ongoing pivotal trial of SGN-35 administered every three weeks for relapsed and refractory Hodgkin lymphoma, and a planned phase II trial for systemic anaplastic large cell lymphoma.

The pivotal trial is being conducted under a Special Protocol Assessment (SPA) with FDA. SGN-35 is an antibody-drug conjugate (ADC) comprising an anti-CD30 antibody attached by an enzyme-cleavable linker to a potent, synthetic drug payload, monomethyl auristatin E, using Seattle Genetics’ proprietary technology. The ADC is designed to be stable in the bloodstream, but to release MMAE upon internalization into CD30-expressing tumor cells, resulting in targeted cell-killing.

Thomas Reynolds, CMO of Seattle Genetics, said: “These maturing phase I data continue to reinforce our belief in the therapeutic potential of SGN-35.”

“The lengthening duration of responses and the high level of concordance between investigator-assessed and independently reviewed response data are important in bolstering our development plans, including our ongoing pivotal trial of SGN-35 in relapsed and refractory Hodgkin lymphoma,” he added.