Home Challenging Pharma AbbVie’s Depatux-M Fails to Meet Endpoint in Phase 3 Trial; Enrollment in...

AbbVie’s Depatux-M Fails to Meet Endpoint in Phase 3 Trial; Enrollment in all Studies of Depatux-M Halted

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AbbVie’s Depatux-M Fails

AbbVie announced the phase 3 INTELLANCE-1 study of depatuxizumab mafodotin (Depatux-M, previously known as ABT-414) in patients with newly diagnosed glioblastoma (GBM), whose tumors have EGFR (epidermal growth factor receptor) amplification, failed to show benefit at an interim analysis. An Independent Data Monitoring Committee (IDMC) 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.

INTELLANCE-1 was a randomized, placebo-controlled study designed to evaluate the efficacy and safety of Depatux-M 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. No new safety findings were observed. Enrollment in all ongoing Depatux-M studies has been halted. The study was conducted in collaboration with the Radiation Therapy Oncology Group (RTOG) Foundation.

About Glioblastoma Multiforme (GBM)

GBM is the most common and most aggressive malignant primary brain tumor. Glioblastoma forms from cells called astrocytes that support nerve cells. Approximately 50% of GBM harbor EGFR amplification. Glioblastoma can be very difficult to treat and a cure is often not possible. Treatments may slow progression of the cancer and reduce signs and symptoms.

About Depatuxizumab mafodotin (Depatux-M; ABT-414)

Depatux-M is an antibody-drug conjugate (ADC) that selectively targets tumor cells with EGFR amplification or activated EGFR. Depatux-M combines the cytotoxin monomethyl auristatin F (MMAF) with a monoclonal antibody that selectively targets cells with EGFR amplification. Depatux-M is designed to remain stable in the bloodstream via a noncleavable linker and thus potentially releases the potent cytotoxin only inside targeted cancer cells.

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