Seattle Genetics reports SGN-40 produces responses in non-Hodgkin's lymphoma, well tolerated

New York, June 5 - Seattle Genetics, Inc. said data from its phase 1 clinical trial of SGN-40 in non-Hodgkin's lymphoma showed the drug produced objective responses in five patients and was well tolerated at doses up to 8 milligrams per kilogram.

The company is completing treatment of the final cohort of patients and plans to advance SGN-40 into phase 2 clinical trials during the second half of this year.

"The objective response data from this phase 1 study, notably in patients with aggressive types of non-Hodgkin's lymphoma, are encouraging and support our rapid advancement of SGN-40 in this setting," said Clay B. Siegall, president and chief executive officer of Seattle Genetics, in a news release.

SGN-40 is a humanized monoclonal antibody that targets the CD40 antigen, which is expressed on most B-cell lineage hematologic malignancies.

Seattle Genetics reported data from its open-label, multi-dose, single-arm phase 1 clinical trial of SGN-40 in patients with relapsed or refractory non-Hodgkin's lymphoma.

The study is designed to evaluate the safety, antitumor activity, pharmacokinetic profile and immunogenicity of escalating doses of SGN-40. Patients who experience a clinical benefit are eligible for a second cycle of therapy.

Data were reported on 29 non-Hodgkin's lymphoma patients with a median age of 59 years and a median of 3.5 prior therapies. One group of patients received weekly doses of SGN-40 over four weeks and subsequent groups received SGN-40 using an intra-patient dose-loading schedule over five weeks.

SGN-40 was well tolerated up to 8 mg/kg/week with adverse events generally occurring during the dose-loading segment of therapy rather than at the maximum dose evaluated. No immune responses to SGN-40 have been detected among the 16 patients evaluated thus far.

Five patients achieved an objective antitumor response. Four patients had partial responses, including two at 3 mg/kg, one at 6 mg/kg and one at 8 mg/kg. One patient at 4 mg/kg cohort had a complete response following one cycle of SGN-40 treatment that is ongoing after 20 weeks.

Four of the five objective responses were in patients with aggressive subtypes of non-Hodgkin's lymphoma, including three with diffuse large B-cell lymphoma and one with mantle cell lymphoma.

In addition, three patients had stable disease, 17 had progressive disease and four were not evaluable for clinical response, the company said.

Seattle Genetics, a Bothell, Wash., biotechnology company, reported the data at the American Society of Clinical Oncology annual meeting in Atlanta.

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