Seattle Genetics, Inc. (Nasdaq:SGEN) today reported data from two phase
Ib clinical trials of dacetuzumab, one in combination with Rituxan®
(rituximab) and Gemzar® (gemcitabine) for diffuse large B-cell lymphoma
(DLBCL), and the other in combination with Revlimid® (lenalidomide) for
multiple myeloma. In addition, data were reported describing a
diagnostic gene signature that may identify lymphoma patients who are
more likely to respond to dacetuzumab therapy. Dacetuzumab is a
humanized antibody targeting CD40 that the company is developing under a
worldwide collaboration agreement with Genentech, a wholly owned member
of the Roche Group. The data were presented during the American Society
of Hematology (ASH) 51st Annual Meeting being held in New
Orleans, Louisiana.
“Data from these two phase Ib trials demonstrate that dacetuzumab is
well tolerated in combination with other therapies commonly used in the
treatment of DLBCL and multiple myeloma,” said Thomas C. Reynolds, M.D.,
Ph.D., Chief Medical Officer of Seattle Genetics. “The objective
responses observed in these heavily pre-treated patients provide
rationale to further assess the contribution of dacetuzumab to these
combination therapies. With Genentech, we are continuing to evaluate
next steps in these settings, and are also enrolling patients to two
additional combination phase Ib trials for follicular lymphoma and
multiple myeloma from which data are planned in 2010.”
DLBCL Phase Ib Trial
This single-arm trial enrolled 33 patients with relapsed or refractory
DLBCL who received escalating doses of dacetuzumab ranging from 4
milligrams per kilogram (mg/kg) to 12 mg/kg in combination with Rituxan
and Gemzar. Patients were heavily pre-treated, with a median of three
prior systemic therapies, and the median age was 67 years. Ninety-seven
percent had previously received a Rituxan-containing regimen.
The combination was generally well-tolerated and no maximum tolerated
dose was determined. The majority of adverse events were Grade 1 or 2 in
severity. The most common adverse events were nausea, fatigue and
thrombocytopenia. Objective responses were achieved in 50 percent of
patients (15 out of 30 patients with response assessments), including
eight with complete responses and seven with partial responses. The
median duration of response was 5.1 months. (Abstract # 586)
Multiple Myeloma Phase Ib Trial