Preliminary results of the Phase IIb study EMERGE study of the drug CDX-011 were announced yesterday by Celldex Therapeutics, the study’s sponsor. The results show that CDX-011 demonstrated superior response rates in patients with metastatic breast cancer compared to treatment with single-agent chemotherapy.
Dr. Linda Vahdat, director of the Breast Center Research Program and Chief of the Solid Tumor Service at Weill Cornell Medical College, is the lead investigator in the study.
CDX-011 is a monoclonal antibody targeting cancer cells that express the GPNMB protein, which has been shown to correlate with poorer outcomes in breast cancer patients. CDX-011 partially shrank tumors in 19% of all patients enrolled in the study, compared to 14% of patients treated with the investigator’s choice of chemotherapy. Among patients whose breast cancer tumors contained high levels of the GPNMB protein, 32% of patients responded to treatment with CDX-011 compared to 13% of patients treated with single-agent chemotherapy. In addition, the study results show a strong response to CDX-011 in a subgroup of patients with triple-negative breast cancer, regardless of GPNMB levels. 21% of patients with triple-negative breast cancer responded to CDX-011 compared to none of the patients treated with chemotherapy.
“The correlation with GPNMB expression rates and clinical responses in this study confirms the role of GPNMB as a potentially new and important cancer target,” said Dr. Vahdat. “These results are promising in this heavily pretreated patient population for which there are few treatment options left. With continued positive results, CDX-011 has the potential to offer a possible new and important targeted therapy.”
Based on these preliminary results, Celldex said it plans to meet with FDA representatives to design registration studies aimed at getting CDX-011 approved as a treatment for advanced breast cancer patients with GPNMB over-expression and those with triple-negative disease.
Click here to read a press article about the study results.