AbbVie stops enrollment as Depatux-M study fails to meet primary goal

20th May 2019 (Last Updated May 20th, 2019 00:00)

AbbVie has stopped enrollment for its Phase III INTELLANCE-1 study of depatuxizumab mafodotin (Depatux-M) to treat patients with newly diagnosed glioblastoma (GBM) after the drug could not meet the primary goal.

AbbVie stops enrollment as Depatux-M study fails to meet primary goal
Histopathological image of cerebral glioblastoma. Credit: KGH.

AbbVie has stopped enrollment for its Phase III INTELLANCE-1 study of depatuxizumab mafodotin (Depatux-M) to treat patients with newly diagnosed glioblastoma (GBM) after the drug could not meet the primary goal.

An Independent Data Monitoring Committee (IDMC) recommended the study be stopped due to the lack of survival benefit for patients receiving Depatux-M compared with placebo.

When added to the standard regimen of radiation and temozolomide, Depatux-M failed to meet the primary goal of achieving overall survival (OS) in newly diagnosed patients when compared to patients given a placebo along with radiation and temozolomide.

The randomised, placebo-controlled INTELLANCE-1 trial, conducted in collaboration with non-profit cancer research organisation RTOG Foundation, tested the drug to treat the aggressive form of brain cancer known as GBM.

AbbVie vice-chairman and president Michael Severino said: "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.”

The 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 subjects with newly diagnosed EGFR-amplified GBM.

The interim analysis was based on data collected from 639 patients.

"We remain committed to discovering and developing therapies."

Regulatory authorities have not evaluated the safety and efficacy of Depatux-M.

In January this year, AbbVie’s ibrutinib (imbruvica) failed to meet the primary goal of improving progression-free survival (PFS) or OS in the Resolve trial (PCYC-1137) designed to treat patients with metastatic pancreatic adenocarcinoma.