AbbVie (IL, USA) has announced that it halted enrolment in all studies of depatuxizumab mafodotin (Depatux-M, previously known as ABT-414) after an interim analysis of a Phase III trial (INTELLANCE-1) demonstrated that the drug failed to prolong overall survival compared to placebo in individuals with newly diagnosed glioblastoma whose tumors have EGFR amplification.
An Independent Data Monitoring committee recommended the study be stopped due to lack of survival benefit for patients receiving Depatux-M compared with placebo when added to the standard regimen of radiation and temozolomide.
The randomized, placebo-controlled Phase III study was designed to evaluate the efficacy and safety of Depatux-M versus placebo when administered with concurrent radiation and temozolomide and with adjuvant temozolomide in participants with newly diagnosed EGFR-amplified glioblastoma. The primary endpoint was overall survival, and the interim analysis was based on data from 639 patients.
“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,” commented Michael Severino (President of AbbVie).
The trial was being conducted in collaboration with the RTOG Foundation and the full results from the trial will be submitted for presentation at a medical conference and for publication in a peer-reviewed journal.
Previously, Depatux-M was granted Orphan Drug Designation by US and European regulators for the treatment of glioblastoma multiforme, in addition to rare pediatric disease designation by the US FDA for use in children with EGFR-amplified diffuse intrinsic pontine glioma.
At present, Depatux-M is not approved, and its safety and efficacy have not yet been evaluated by regulatory authorities.
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