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AbbVie ends Phase III brain tumour study due to failed primary goal

may 21, 2019 By pharmatimes

AbbVie has ended its ongoing phase III INTELLANCE-1 study of depatuxizumab mafodotin (Depatux-M, previously known as ABT-414) in some patients with newly diagnosed glioblastoma (GBM), the most aggressive cancer that begins within the brain.

An Independent Data Monitoring Committee (IDMC) recommended the study be stopped due to lack of survival benefit for patients receiving the treatment, compared to placebo when added to the standard regimen of radiation and temozolomide.

The primary endpoint was overall survival, and the interim analysis was based on data from 639 patients, meaning that Depatux-M is not approved, and its safety and efficacy have not been evaluated by regulatory authorities.

The INTELLANCE-1 trial was conducted in collaboration with the RTOG Foundation, an independent, non-profit cancer research organisation, and results will be submitted for presentation at a medical conference and for publication in a peer-reviewed journal.

"Glioblastoma patients and their caregivers face a devastating disease for which there are few therapeutic options. While we are disappointed that Depatux-M did not demonstrate a survival benefit in the INTELLANCE-1 study, we remain committed to discovering and developing therapies to address some of the most debilitating cancers," said Michael Severino, vice chairman and president, AbbVie.

Enrolment in all ongoing Depatux-M studies has been halted.

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