Seattle Genetics, Inc. (Nasdaq: SGEN) today announced that it has
initiated a phase II clinical trial of brentuximab vedotin (SGN-35), an
antibody-drug conjugate (ADC), for the retreatment 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, M.D., Ph.D.,
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-center trial will assess safety and antitumor
response to retreatment with brentuximab vedotin. The trial is designed
to enroll 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 U.S. 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 tumor cells,
resulting in targeted cell-killing.
About Seattle Genetics
Seattle Genetics is a clinical stage biotechnology company focused on
the development and commercialization of monoclonal antibody-based
therapies for the treatment of cancer and autoimmune disease.
