Early success for CDX 011 (Celldex) in Phase II Breast Cancer study

Preliminary results were announced from the randomized Phase IIb EMERGE study of CDX-011 (glembatumumab vedotin) antibody drug conjugate from Celldex Therapeutics, in patients with glycoprotein NMB (GPNMB) expressing, advanced, heavily pretreated Breast Cancer. Preliminary results suggest that CDX-011 induces impressive response rates compared to current, available therapies in patients with advanced, refractory breast cancers with high GPNMB expression.In this high expressing patient population, treatment with CDX-011 resulted in a 32% overall response rate (ORR; includes confirmed and unconfirmed responses), whereas treatment with Investigator's Choice (IC) single-agent chemotherapy resulted in a 13% ORR. CDX-011 also demonstrated strong response rates in patients with triple negative Breast Cancer across all levels of GPNMB expression (CDX-011 ORR of 21%; IC ORR of 0%).While data in the study are not yet mature, in patients with high GPNMB in the CDX-011 arm, a trend of improvement in progression-free survival has been observed.