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AbbVie Halts Disappointing Brain Cancer Study
05/17/2019
 

AbbVie has stopped a Phase 3 study called INTELLANCE-1 that was evaluating  depatuxizumab mafodotin in patients with newly diagnosed glioblastoma (GBM), whose tumors have EGFR (epidermal growth factor receptor) amplification, based on data that demonstrated no survival benefit for treated patients. An interim analysis by the company’s independent data monitoring committee recommended the study be stopped, and enrollment in all ongoing depatuxizumab mafodotin studies has been halted, AbbVie says.

 

The randomized, placebo-controlled Phase 3 study was designed to evaluate depatuxizumab mafodotin versus placebo when administered with concurrent radiation and temozolomide and with adjuvant temozolomide in subjects with newly diagnosed EGFR-amplified GBM. The primary endpoint was overall survival, and the interim analysis was based on data from 639 patients.


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