12:11 PM
Apr 16, 2018
 |  BC Extra  |  Clinical News

Celldex routed after TNBC failure

Celldex Therapeutics Inc. (NASDAQ:CLDX) fell $1.39 (65%) to $0.76 on Monday after it said IV glembatumumab vedotin (CDX-011) missed the primary endpoint of improving progression-free survival (PFS) compared with Xeloda capecitabine in the Phase IIb METRIC trial to treat metastatic triple-negative breast cancer (2.9 vs. 2.8 months, HR=0.95, p=0.76).

Celldex plans to discontinue the candidate's development for all indications, including breast cancer and melanoma, and said it will review its pipeline.

Glembatumumab vedotin also missed METRIC's secondary endpoints of improving overall response rate (ORR), duration of response and overall survival (OS) vs. Xeloda. The trial enrolled 327 patients with metastatic TNBC that overexpresses glycoprotein NMB (GPNMB).

Glembatumumab vedotin is an antibody-drug conjugate (ADC) composed of a humanized IgG2 mAb against GPNMB and monomethyl auristatin E (MMAE).

Celldex's next most advanced candidates are varlilumab (CDX-1127), which is a human mAb targeting CD27, and CDX-3379, a human mAb against Erb-b2 receptor tyrosine kinase 3 (ERBB3; HER3; EGFR3).

Celldex expects to present data at several medical meetings this year from a Phase II trial of varlilumab in combination with Opdivo nivolumab for multiple cancer indications. In 3Q18, the company plans to complete enrollment of the first stage of a Phase II trial evaluating CDX-3379 in combination with Erbitux cetuximab to treat squamous cell carcinoma of the head and neck (SCCHN).

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