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news.Seattle Genetics has initiated a Phase Ib clinical trial of SGN-40 in combination with Revlimid and dexamethasone, a steroid, for patients with relapsed or refractory multiple myeloma. As a result, the company will receive a $4 million milestone payment from its collaborator Genentech.
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The Phase Ib, open-label single-arm clinical trial is expected to enroll up to 40 relapsed or refractory multiple myeloma patients at multiple sites in the US. Patients will receive escalating doses of SGN-40 in combination with Revlimid (lenalidomide) and dexamethasone. The study will assess safety and tolerability of the combination, preliminary activity data and pharmacokinetics.
SGN-40 is a humanized monoclonal antibody that targets the CD40 antigen, which is expressed on most B lineage hematologic malignancies including non-Hodgkin’s lymphoma, multiple myeloma and chronic lymphocytic leukemia.
Under the terms of an exclusive worldwide collaboration agreement for the development and commercialization of SGN-40, Seattle Genetics and Genentech are executing on a broad development plan that includes initiating five Phase Ib-IIb clinical trials in combination with standard regimens for both multiple myeloma and non-Hodgkin’s lymphoma by early 2008, as well as advancing an ongoing Phase II single-agent clinical trial in diffuse large B-cell lymphoma.
Thomas Reynolds, chief medical officer of Seattle Genetics, said: “There is no antibody therapeutic approved for the treatment of multiple myeloma. Based on encouraging preclinical data, we are moving forward with this Phase Ib study to evaluate the safety and activity of Revlimid combined with SGN-40 in patients with multiple myeloma.”