NorthWest Biotherapeutics Inc (NWBO)

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AbbVie: DMC says stop Ph3 enrollment in nGBM:

Provides Update on Depatuxizumab Mafodotin (Depatux-M), an Investigational Medicine for Newly Diagnosed Glioblastoma, an Aggressive Form of Brain Cancer

-Phase 3 INTELLANCE-1 study, conducted in collaboration with the RTOG Foundation, did not meet primary endpoint of overall survival at the interim analysis and demonstrated no survival benefit for patients receiving Depatux-M
-Independent Data Monitoring Committee responsible for interim analysis data review recommended stopping the study due to lack of survival benefit
-Enrollment in all ongoing Depatux-M studies has been halted

NORTH CHICAGO, Ill., May 17, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today 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, demonstrated no survival benefit for patients receiving Depatux-M 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. 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. 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, M.D., vice chairman and president, AbbVie.

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," said 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.

https://news.abbvie.com/news/press-releases/abbvie-provides-update-on-depatuxizumab-mafodotin-depatux-m-an-investigational-medicine-for-newly-diagnosed-glioblastoma-an-aggressive-form-brain-cancer.htm

https://clinicaltrials.gov/ct2/show/NCT02573324?titles=intellance-1&lead=abbvie&phase=2&rank=1

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