INDIANAPOLIS, March 20, 2017 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) today announced that its MONARCH 2 trial of
abemaciclib met the primary endpoint of progression-free survival
(PFS). The Phase 3 study evaluated abemaciclib, a cyclin-dependent
kinase (CDK) 4 and CDK 6 inhibitor, in combination with fulvestrant
in women with hormone-receptor-positive (HR+), human epidermal
growth factor receptor 2-negative (HER2-), advanced breast cancer
who have relapsed or progressed after endocrine therapy. The
results demonstrated the addition of abemaciclib to fulvestrant
resulted in a statistically significant improvement in PFS, when
compared to the control arm of placebo plus fulvestrant. Detailed
efficacy and safety results will be presented at an upcoming
medical meeting.
"We are excited about the
outcome of our first Phase 3 study for abemaciclib. These data are
an important milestone in our goal of bringing abemaciclib to
patients with advanced breast cancer, and we look forward to our
upcoming conversations with regulators," said Levi Garraway, M.D., Ph.D., senior vice
president, global development and medical affairs, Lilly Oncology.
"This is another example of Lilly's commitment to delivering
breakthrough treatments and improving outcomes for patients with
cancer."
The global Phase 3, double-blind study was designed to evaluate
the efficacy and safety of abemaciclib, in combination with
fulvestrant, in patients with advanced (locoregionally recurrent or
metastatic) breast cancer. The intent-to-treat population of 669
patients was randomized to receive abemaciclib or placebo orally
twice a day on a continuous dosing schedule, given in combination
with fulvestrant at its approved dose and schedule, until disease
progression. Patients enrolled in the study had experienced disease
progression on or within 12 months of receiving endocrine treatment
in the neoadjuvant or adjuvant setting or while receiving
first-line endocrine therapy for metastatic disease. Patients who
had received chemotherapy in the metastatic setting were not
eligible for the study.
The most common adverse events observed were diarrhea,
neutropenia, nausea and fatigue, and were consistent with the
previous studies of abemaciclib.
Lilly intends to submit a new drug application (NDA) for
single-agent abemaciclib in the second quarter of 2017, based on
the MONARCH 1 study, for the treatment of refractory metastatic
breast cancer patients whose disease had progressed following
multiple prior treatments, including endocrine therapy and one to
two chemotherapy regimens in the metastatic setting. Lilly plans to
submit an additional application for MONARCH 2 in the third quarter
of this year.
Along with MONARCH 1 and MONARCH 2, Lilly currently has
additional trials evaluating abemaciclib in breast cancer. MONARCH
3 is a Phase 3 trial of abemaciclib in combination with a
nonsteroidal aromatase inhibitor in patients with HR+, HER2-
advanced breast cancer. Additionally, there is a Phase 2 MONARCH
trial under way: monarcHER, which is evaluating abemaciclib plus
trastuzumab (with or without fulvestrant) in women with HR+, HER2+
locally advanced or metastatic breast cancer. In each of
these studies, abemaciclib is administered on a continuous dosing
schedule.
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 CDK 4 and CDK
6. Abemaciclib (LY2835219) is an investigational, oral cell cycle
inhibitor, designed to block the growth of cancer cells by
specifically inhibiting cyclin-dependent kinases, CDK 4 and CDK 6
and was most active against Cyclin D1 and CDK 4 in cell-free
enzymatic assays. In breast cancer, Cyclin D1/CDK 4 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 under
way.
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.
Fulvestrant (Faslodex®), MedImmune/AstraZeneca.
MedImmune Limited/AstraZeneca provided fulvestrant for this
trial.
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.
[1] World Cancer Research Fund International. Breast
Cancer.
http://www.wcrf.org/cancer_statistics/data_specific_cancers/breast_cancer_statistics.php.
Accessed: March 18, 2017.
[2] American Cancer Society. What are the key
statistics about breast cancer?
http://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-key-statistics.
Accessed: March 18, 2017.
[3] Metastatic Breast Cancer Network. 13 Facts about
Metastatic Breast Cancer.
http://www.mbcn.org/13-facts-about-metastatic-breast-cancer/.
Accessed: March 18, 2017.
Refer
to:
|
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