Celldex Therapeutics will present the interim results of a phase IIb study testing the efficacy of a new monoclonal antibody in patients with advanced breast cancer, in a live webcast on Wednesday.
The study is centered on glembatumumab vedotin, or CDX-011, an antibody drug conjugate that consists of fully-human monoclonal antibody, CR011, which is linked to a drug called monomethyl-auristatin E (MMAE). The drug is administered intravenously and binds to glycoprotein NMB (GPNMB), a protein expressed in breast cancer and other tumors that is associated with tumor migration, invasion, and metastases. The drug is released into the cells where it interferes with cell growth and may lead to cell death in the tumor.
The EMERGE study was a randomized, multicenter, controlled phase IIB study that completed enrollment in December 2011. As part of the study, 124 patients with advanced breast cancer were randomized in a 2:1 ratio to receive either CDX-011 or an “investigator’s choice” single agent chemotherapy. The primary endpoint of the study is overall response rate.
In May 2012, CDX-011 was granted fast track designation for the study from the FDA for the treatment of advanced, refractory, or resistant breast cancer patients who expressed GPNMB. Fast track designation is granted when the FDA decides to expedite the review process of a particular drug that can treat serious diseases or fill an unmet medical need.
The company had planned to present the results at the American Society of Clinical Oncology (ASCO) meeting in June. However, a clerical error in which the study was submitted to the incorrect category resulted in ASCO not considering the study for acceptance.
OncLive.com will be tweeting live updates from the webcast on Wednesday, May 23, beginning at 4:30 PM EST.