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.
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
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Forward-Looking Statements
Some statements in this
news release are, or may be considered, forward-looking statements
for purposes of the Private Securities Litigation Reform Act of
1995. The words "believe," "expect," "anticipate," "project" and
similar expressions, among others, generally identify
forward-looking statements. AbbVie cautions that these
forward-looking statements are subject to risks and uncertainties
that may cause actual results to differ materially from those
indicated in the forward-looking statements. Such risks and
uncertainties include, but are not limited to, competition from
other products, challenges to intellectual property, difficulties
inherent in the research and development process, adverse
litigation or government action, and changes to laws and
regulations applicable to our industry. Additional information
about the economic, competitive, governmental, technological and
other factors that may affect AbbVie's operations is set forth in
Item 1A, "Risk Factors," of AbbVie's 2018 Annual Report on Form
10-K, which has been filed with the Securities and Exchange
Commission. AbbVie undertakes no obligation to release publicly any
revisions to forward-looking statements as a result of subsequent
events or developments, except as required by law.
1 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.
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SOURCE AbbVie