Seattle Genetics initiates MDS combination therapy trial

The open-label, single-arm Phase I study will assess the tolerability, pharmacokinetic profile and antitumor activity of increasing doses of SGN-33 in combination with Revlimid in up to 30 intermediate and advanced myelodysplastic syndrome (MDS) patients at multiple centers in the US. The clinical trial is being conducted in collaboration with Celgene under a clinical research agreement whereby Celgene supplies Revlimid to study participants. Under the terms of agreement, the companies will share clinical data, but Seattle Genetics retains all rights to SGN-33.

SGN-33, or lintuzumab, is a humanized monoclonal antibody that targets the CD33 antigen, which is expressed on a number of hematologic malignancies, including acute myeloid leukemia, MDS and several myeloproliferative disorders. SGN-33 has orphan drug designation from the FDA for the treatment of MDS.

Thomas Reynolds, chief medical officer of Seattle Genetics, said: “We have been impressed by Revlimid data in the treatment of MDS, as well as research demonstrating its ability to enhance the activity of monoclonal antibodies by augmenting antibody-dependent cellular cytotoxicity. Our goal is to demonstrate the potential clinical benefit of the combination for this patient population.”