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Celldex’s Phase II Breast Cancer Study Fails, Shares Plunge


Celldex Therapeutics, Inc. CLDX announced the failure of its lead pipeline candidate, glembatumumab vedotin, in a phase IIb breast cancer study – METRIC. The candidate failed to meet the primary endpoint of progression-free survival (“PFS”) benefit over Roche’s RHHBY chemotherapy, Xeloda, in the treatment of metastatic triple-negative breast cancers that overexpress gpNMB.

An assessment of the data from the mid-stage study showed that glembatumumab vedotin achieved a PFS of 2.9 months versus 2.8 months for Xeloda. The candidate was also not able to demonstrate significant advantage in key secondary endpoints, including overall response rate, duration of response and overall survival.

Following the failure, Celldex has decided to discontinue studies evaluating glembatumumab vedotin across all indications. The company is currently restructuring its pipeline to focus on five candidates in ongoing clinical studies, which includes varlilumab. It may also reduce its workforce.

With no approved products in Celldex’s portfolio, the discontinuation of clinical studies following the failure of its lead candidate came as a major setback, pulling the stock down by more than 60% on Apr 16. The stock has declined 73.2% so far this year, compared with the industry’s decline of 8.2%.

Celldex is evaluating varlilumab, a CD27 agonist, in combination with Bristol-Myers’ BMY Opdivo in a mid-stage study in several indications. Another phase II study is currently enrolling patients to evaluate CDX-3379 in combination with Eli Lilly’s LLY Erbitux for the treatment of head and neck cancer.

The company will provide revised estimates in its first-quarter earnings release to include the impact of its restructuring initiatives.

Celldex carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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