INDIANAPOLIS, April 24, 2017 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) today announced that following a pre-planned
interim analysis for MONARCH 3, the trial met its primary endpoint
of demonstrating statistically significant improvement in
progression-free survival (PFS). In addition, improvement was shown
in a key secondary endpoint of objective response rate (ORR). The
Phase 3 study evaluated abemaciclib, a cyclin-dependent kinase
(CDK)4 and CDK6 inhibitor, in combination with an aromatase
inhibitor (letrozole or anastrozole) compared to treatment with an
aromatase inhibitor alone in women with hormone-receptor-positive
(HR+), human epidermal growth factor receptor 2-negative (HER2-)
advanced breast cancer. Detailed efficacy and safety results will
be presented at a medical meeting in the second half of the
year.
"Today marks another important milestone in our clinical
development program for abemaciclib, a drug we believe has the
potential to be best in class," said Levi
Garraway, M.D., Ph.D., senior vice president, global
development and medical affairs, Lilly Oncology. "We are very
excited about the results seen in patients with breast cancer, from
single-agent activity to clinically meaningful benefit when used in
combination with fulvestrant or aromatase inhibitors. Along with
additional abemaciclib clinical trials in other tumor types, these
data underscore Lilly's commitment to delivering life-changing
medicines to treat and cure people living with cancer around the
world."
The global Phase 3, double-blind, placebo-controlled study was
designed to evaluate the efficacy and safety of abemaciclib in
combination with an aromatase inhibitor as initial endocrine-based
therapy for postmenopausal women with advanced (locoregionally
recurrent or metastatic) breast cancer who have had no prior
systemic treatment for advanced disease. A total of 493 patients
were randomized to receive 150 mg of abemaciclib or placebo orally
twice a day without interruption, given in combination with either
1 mg of anastrozole or 2.5 mg of letrozole once daily until disease
progression or unacceptable toxicity. The primary endpoint of the
study was PFS, with key secondary endpoints of ORR, overall
survival and safety. The adverse events were generally consistent
with previous studies of abemaciclib, with the most common adverse
events being diarrhea, neutropenia, fatigue, and nausea.
Following this MONARCH 3 interim analysis, Lilly intends to
begin global submissions of these results in the third quarter of
2017. In addition, Lilly intends to initiate MONARCH 1 and MONARCH
2 submissions beginning in the second quarter of 2017.
Other MONARCH trials currently underway include: monarcHER,
which is evaluating abemaciclib plus trastuzumab (with or without
fulvestrant) in women with HR+, HER2+ locally advanced or
metastatic breast cancer, and MONARCH plus, a Phase 3 study of
abemaciclib in combination with endocrine therapies to support
registration in China. In
addition, Lilly has an ongoing Phase 3 trial evaluating abemaciclib
in lung cancer. Lilly is also evaluating abemaciclib in patients
with brain metastases, as well as in patients with pancreatic
cancer.
Notes to Editor
About Metastatic Breast Cancer
Breast cancer is the
most common cancer in women worldwide with nearly 1.7 million new
cases diagnosed in 2012.1 In the U.S. this year,
approximately 252,710 new cases of invasive breast cancer will be
diagnosed and about 40,610 people will die from breast
cancer.2 Of all early stage breast cancer cases
diagnosed in the U.S., approximately 30 percent will become
metastatic, spreading to other parts of the body. In addition, an
estimated six to 10 percent of all new breast cancer cases are
initially diagnosed as being stage IV, or metastatic.3
Metastatic breast cancer is considered incurable, but is generally
treatable.
About Abemaciclib
In many cancers, uncontrolled cell
growth arises from a loss of cell cycle regulation due to increased
signaling from CDK4 and CDK6. Abemaciclib (LY2835219) is an
investigational, oral cell cycle inhibitor, designed to block the
growth of cancer cells by specifically inhibiting cyclin-dependent
kinases, CDK4 and CDK6 and was most active against Cyclin D1 and
CDK4 in cell-free enzymatic assays. In breast cancer, Cyclin
D1/CDK4 has been shown to promote phosphorylation of the
retinoblastoma protein (Rb), cell proliferation and tumor growth.
In hormone receptor-positive breast cancer cell lines, sustained
target inhibition by abemaciclib reduced phosphorylation of Rb,
inducing cell cycle arrest.
In 2015, the U.S. Food and Drug Administration granted
abemaciclib Breakthrough Therapy Designation based on data from the
breast cancer cohort expansion of the company's Phase 1 trial,
JPBA, which studied the efficacy and safety of abemaciclib in women
with advanced or metastatic breast cancer. In addition to its
current MONARCH clinical trials evaluating abemaciclib in breast
cancer, a Phase 3 trial of abemaciclib in lung cancer is also
underway.
For more information on additional abemaciclib trials, a
complete listing can be found on ClinicalTrials.gov (in the search
box on the home page, type in "abemaciclib").
About Lilly Oncology
For more than 50 years, Lilly has
been dedicated to delivering life-changing medicines and support to
people living with cancer and those who care for them. Lilly is
determined to build on this heritage and continue making life
better for all those affected by cancer around the world. To learn
more about Lilly's commitment to people with cancer, please visit
www.LillyOncology.com.
About Eli Lilly and Company
Lilly is a global
healthcare leader that unites caring with discovery to make life
better for people around the world. We were founded more than a
century ago by a man committed to creating high-quality medicines
that meet real needs, and today we remain true to that mission in
all our work. Across the globe, Lilly employees work to discover
and bring life-changing medicines to those who need them, improve
the understanding and management of disease, and give back to
communities through philanthropy and volunteerism. To learn more
about Lilly, please visit us at www.lilly.com and
www.lilly.com/newsroom/social-channels. P-LLY
© Lilly USA, LLC 2017. ALL
RIGHTS RESERVED.
Lilly Forward-Looking Statement
This press release contains forward-looking statements (as
that term is defined in the Private Securities Litigation Reform
Act of 1995) about abemaciclib as a potential treatment for
patients with breast cancer and reflects Lilly's current beliefs.
However, as with any pharmaceutical product, there are substantial
risks and uncertainties in the process of development and
commercialization. Among other things, there can be no guarantee
that abemaciclib will receive regulatory approvals or be
commercially successful. For further discussion of these and other
risks and uncertainties, see Lilly's most recent Form 10-K and Form
10-Q filings with the United States Securities and Exchange
Commission. Except as required by law, Lilly undertakes no duty to
update forward-looking statements to reflect events after the date
of this release.
_______________________
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1 World
Cancer Research Fund International. Breast Cancer.
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http://www.wcrf.org/cancer_statistics/data_specific_cancers/breast_cancer_statistics.php.
Accessed: April 23, 2017.
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2 American
Cancer Society. What are the key statistics about breast
cancer?
|
http://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-key-statistics.
Accessed: April 23, 2017.
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3
Metastatic Breast Cancer Network. 13 Facts about Metastatic Breast
Cancer.
http://www.mbcn.org/13-facts-about-metastatic-breast-cancer/.
Accessed: April 23, 2017.
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Refer
to:
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Erin Graves;
graves_erin_elissa@lilly.com; 908-202-6354 (media)
|
|
Phil Johnson;
johnson_philip_l@lilly.com; 317-655-6874 (investors)
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SOURCE Eli Lilly and Company