AbbVie’s glioblastoma drug candidate fails Phase 3

NORTH CHICAGO, Ill.—AbbVie has announced today that the Phase 3 INTELLANCE-1 study of depatuxizumab mafodotin (Depatux-M, also previously known as ABT-414) in patients with newly diagnosed glioblastoma (GBM), whose tumors have EGFR (epidermal growth factor receptor) amplification, demonstrated no survival benefit for patients receiving Depatux-M according to an interim analysis.

An Independent Data Monitoring Committee responsible for interim analysis data review has recommended that 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. No new safety findings were observed. Enrollment in all ongoing Depatux-M studies has been halted.

“Glioblastoma patients and their caregivers face a devastating disease for which there are few therapeutic options,” said Michael Severino, M.D., vice chairman and president, AbbVie. “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 randomized, placebo-controlled Phase 3 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 primary endpoint was overall survival, and the interim analysis was based on data from 639 patients. The study did not meet primary endpoint of overall survival at the interim analysis, and demonstrated no survival benefit for the patients receiving Depatux-M.

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

“The highly collaborative partnership between RTOG Foundation’s scientific and physician leaders, under the leadership of Andrew Lassman, M.D., the study principal investigator, and the AbbVie team facilitated the early completion of this important international clinical trial. The RTOG Foundation’s outstanding glioblastoma experts will continue to vigorously investigate new approaches to this very challenging malignancy,” added Walter J. Curran Jr., M.D., F.A.C.R., F.A.S.C.O., RTOG Foundation board chair and executive director of the Winship Cancer Institute of Emory University.