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Final Data from Celldex Therapeutics Inc's CDX-011 Phase 2 Study in Metastatic Breast Cancer Supports Overall Survival Benefit in Patients with High GPNMB Expression

Saturday, 8 Dec 2012 08:03am EST 

Celldex Therapeutics Inc announced final results from its randomized Phase 2b EMERGE study of CDX-011 in patients with glycoprotein NMB (GPNMB)-expressing, advanced, heavily pretreated breast cancer. CDX-011 is an antibody-drug conjugate that targets and binds to GPNMB, a specific protein that is expressed in breast cancer which promotes the migration, invasion and metastasis of the disease. It is also highly expressed in triple negative breast cancers where it is associated with increased risk of recurrence. The results presented at the 2012 CTRC-AACR San Antonio Breast Cancer Symposium confirm preliminary findings reported in May and establish proof of principle with evidence of higher activity in patient subgroups with high GPNMB expression (expression in ≥25% of tumor cells), including those with triple negative disease. Progression free and overall survival benefits were demonstrated in the subgroup of patients with triple negative disease that also highly expressed GPNMB, and strong trends towards benefits were seen in all patients with high GPNMB expression. This benefit in overall survival is seen despite the fact that more than a third of control patients received CDX-011 as a cross over at the time of disease progression. While the study was not powered to demonstrate statistical significance between the arms, beneficial activity in targeted patient populations that highly expressed GPNMB was consistently observed and, in some cases, was statistically significant. 

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