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Monday, April 16, 2018

=Celldex Therapeutics (CLDX) : failed phase 2b trial of treatment of triple-negative breast cancer



Celldex Therapeutics reports that the randomized Phase 2b METRIC Study of glembatumumab vedotin compared to Xeloda in patients with metastatic triple-negative breast cancers that overexpress gpNMB failed to meet its primary endpoint
The randomized, Phase 2b METRIC Study of glembatumumab vedotin compared to Xeloda (capecitabine) in patients with metastatic triple-negative breast cancers that overexpress gpNMB failed to meet its primary endpoint, progression-free survival (PFS) as assessed by an independent, central reading of patient scans (Hazard ratio = 0.95; median PFS: glembatumumab vedotin 2.9 months vs. Xeloda 2.8 months; p=0.76).
  • There was no significant advantage for glembatumumab vedotin in key secondary endpoints, including overall response rate, duration of response and overall survival. The glembatumumab vedotin safety profile was consistent with prior experience.
Celldex believes its pipeline prioritization and organizational restructuring efforts will extend financial resources beyond the guidance issued in the Company's year-end 2017 earnings press release and associated filings. The Company plans to provide revised guidance in its first quarter 2018 financial results in early May.

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