AbbVie has halted enrollment in all ongoing studies of depatuxizumab mafodotin (Depatux-M), after an Independent Data Monitoring Committee (IDMC) recommended a phase 3 study of the treatment be stopped due to a lack of survival benefit.
The phase 3, ‘INTELLANCE-1’ study, was examining depatuxizumab mafodotin as a potential treatment for patients with newly diagnosed glioblastoma (GBM) with epidermal growth factor receptor (EGFR) amplification.
A total of 640 newly diagnosed GBM patients with EGFR amplification were enrolled in the study and randomized to receive either placebo or depatuxizumab mafodotin with concurrent radiation and temozolomide, and with adjuvant temozolomide in subjects with newly diagnosed EGFR-amplified GBM.
The interim analysis found no survival benefit vs placebo, leading the Company to make the decision to halt enrollment in all ongoing studies of depatuxizumab mafodotin.
“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, MD, vice chairman and president of AbbVie.
For more information visit AbbVie.com.