Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that the Journal
of Clinical Oncology (JCO) published results of the company’s
pivotal clinical trial of ADCETRIS™ (brentuximab vedotin) in Hodgkin
lymphoma (HL) patients with relapsed or refractory disease following an
autologous stem cell transplant (ASCT). The findings, published today
online, demonstrated that treatment with ADCETRIS as a single agent
induced durable objective responses in 75 percent of patients and was
associated with a manageable safety profile. ADCETRIS is an
antibody-drug conjugate (ADC) directed to CD30, which is expressed in HL
and anaplastic large cell lymphoma (ALCL).
Additionally, a separate pivotal clinical trial of ADCETRIS for the
treatment of relapsed or refractory systemic ALCL has been accepted for
publication and is currently in press for an upcoming issue of JCO.
“Although Hodgkin lymphoma is often viewed as a curable disease, up to
30 percent of patients relapse or are refractory following front-line
chemotherapy regimens and subsequent treatments, leaving limited
therapeutic options,” said Dr. Anas Younes, Professor of Medicine and
Director, Clinical Investigation and Translational Research Department
of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer
Center. “ADCETRIS represents a new approach that is changing the way we
treat relapsed and refractory HL patients. The complete response rate
and manageable safety profile we observed with ADCETRIS in the pivotal
trial have also generated enthusiasm among the medical community for
evaluating ADCETRIS in earlier lines of HL therapy.”
“Data from this pivotal trial served as the basis for the accelerated
approval of ADCETRIS in August 2011 for relapsed Hodgkin patients, and
is the foundation for our robust clinical development plan to broadly
evaluate ADCETRIS in earlier lines of therapy, as well as in other
CD30-positive malignancies,” said Thomas C. Reynolds, M.D., Ph.D., Chief
Medical Officer of Seattle Genetics. “We are evaluating ADCETRIS across
a broad array of CD30-positive malignancies, towards our goal of
bringing it to additional patients in need.”
The open-label, phase II study evaluated the efficacy and safety of
ADCETRIS in 102 patients with relapsed or refractory, CD30-positive HL
Highlights from the study include:
75 percent of patients achieved an objective response, the primary
endpoint of the trial, as assessed by an independent central review.
34 percent of patients achieved a complete remission.
The median duration of response was 29 weeks by independent central
review, and 47 weeks by investigator assessment. Durable complete
remissions approaching two years were observed.
Treatment with ADCETRIS was associated with manageable adverse events,
the most common being peripheral sensory neuropathy, nausea, fatigue,
neutropenia and diarrhea. The most common Grade 3 or higher adverse
events were neutropenia, peripheral sensory neuropathy,
thrombocytopenia and anemia.
ADCETRIS (brentuximab vedotin) is an ADC comprising an anti-CD30
monoclonal antibody attached by a protease-cleavable linker to a
microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing
Seattle Genetics’ proprietary technology.