Data Show Longer Duration of Responses and Concordance between
Investigator-Assessed and Independent Review of Responses
Seattle Genetics, Inc. (Nasdaq: SGEN) today reported data from a phase I
clinical trial of SGN-35 administered every three weeks 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. The data were presented at the 14th
Congress of the European Hematology Association (EHA) being held in
Berlin, Germany.
“These maturing phase I data continue to reinforce our belief in the
therapeutic potential of SGN-35,” said Thomas C. Reynolds, M.D., Ph.D.,
Chief Medical Officer of Seattle Genetics. “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.”
SGN-35 Phase I Trial
In the phase I dose-escalation study, cohorts of patients received doses
of SGN-35 every three weeks, ranging from 0.1 milligrams per kilogram
(mg/kg) to 3.6 mg/kg. The median age of patients was 36 years. Enrolled
patients had received a median of three prior chemotherapy regimens and
73 percent had received a prior autologous stem cell transplant.
Forty-four patients were evaluable for response, including 41 with
Hodgkin lymphoma, two with systemic anaplastic large cell lymphoma
(ALCL) and one with angioimmunoblastic T-cell lymphoma.
The objective response rate across all dose levels based on investigator
assessment was 39 percent, compared to 41 percent based on independent
review. For patients treated at doses of 1.2 mg/kg and higher, the
overall response rate was 54 percent based on investigator assessment,
compared to 57 percent based on independent review. Currently, the
median duration of response is at least 7.3 months with eight patients
remaining in ongoing response. SGN-35 was generally well tolerated. The
majority of adverse events were Grade 1 and 2, with the most common
being fatigue, fever, peripheral neuropathy, diarrhea and nausea.
Seattle Genetics 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.
