AbbVie 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, IL, USA I May 17, 2019 I 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.

About the Phase 3 INTELLANCE-1 Trial and Depatuxizumab Mafodotin (Depatux-M; ABT-414)
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.1 The primary endpoint was overall survival, and the interim analysis was based on data from 639 patients. Depatux-M is not approved, and its safety and efficacy have not been evaluated by regulatory authorities.

About AbbVie in Oncology
At AbbVie, we strive to discover and develop medicines that deliver transformational improvements in cancer treatment by uniquely combining our deep knowledge in core areas of biology with cutting-edge technologies, and by working together with our partners – scientists, clinical experts, industry peers, advocates, and patients. We remain focused on delivering these transformative advances in treatment across some of the most debilitating and widespread cancers. We are also committed to exploring solutions to help patients obtain access to our cancer medicines. With the acquisitions of Pharmacyclics in 2015 and Stemcentrx in 2016, our research and development efforts, and through collaborations, AbbVie's oncology portfolio now consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in more than 300 clinical trials and more than 20 different tumor types. For more information, please visit http://www.abbvie.com/oncology.

About AbbVie
AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, FacebookLinkedIn or Instagram.

Clinicaltrials.gov (2019). NCT02573324: A Study of ABT-414 in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance1). Accessed May 2019.

SOURCE: AbbVie

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