Preliminary Phase II data revealed that dacetuzumab would not have improved complete response.
Seattle Genetics has discontinued development of dacetuzumab for relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The firm believes that the mid-stage trial is not likely to meet its primary endpoint of superior complete response rate.
The Phase II MARINER study was a randomized, double-blind investigation of dacetuzumab or placebo in combination with Rituxan® (rituximab) plus ifosfamide, carboplatin, and etoposide (R-ICE) chemotherapy for patients. Initiated in December 2007, the trial was designed to accrue 224 patients, of which approximately two-third were enrolled.
After a planned interim analysis conducted on October 2, the Independent Data Monitoring Committee advised that the trial be closed. The evaluation was conducted on data from approximately half of the 224 total patients.
Dacetuzumab is a humanized mAb that targets the CD40 antigen, which is expressed on most B lineage hematologic malignancies as well as some solid tumors. Seattle Genetics is developing dacetuzumab under a worldwide collaboration agreement with Genentech.
“In collaboration with Genentech, we will conduct a detailed analysis of data from the MARINER trial,” Clay B. Siegall, Ph.D., president and CEO of Seattle Genetics. “In addition, We are continuing four ongoing Phase Ib studies of dacetuzumab for non-Hodgkin’s lymphoma and multiple myeloma.”