INDIANAPOLIS, Aug. 10, 2016 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) today announced that following a pre-planned
interim analysis for MONARCH 2, an independent Data Monitoring
Committee (DMC) provided the recommendation to continue the study
without modification as the interim efficacy criteria were not met.
The MONARCH 2, Phase 3 trial compares abemaciclib plus
fulvestrant* versus placebo with fulvestrant in women
with hormone-receptor-positive (HR+), human epidermal growth factor
receptor 2-negative (HER2-) locally advanced or metastatic breast
cancer.
"We had stringent criteria set for this interim analysis and we
look forward to receiving the final MONARCH 2 results in the first
half of 2017," said Richard Gaynor,
M.D., senior vice president, product development and medical
affairs for Lilly Oncology. "We remain optimistic that treatment
with abemaciclib, in combination with fulvestrant could offer
improved outcomes for patients."
The Phase 3, double-blind study, designed to evaluate the safety
and efficacy of abemaciclib in combination with fulvestrant, was
conducted across 142 sites worldwide. The intent-to-treat
population of 669 patients was randomized to receive abemaciclib or
placebo orally every 12 hours on a continuous dosing schedule,
given in combination with fulvestrant at the 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 primary
endpoint for MONARCH 2 is progression-free survival (PFS).
The trial will continue into the first half of 2017 and will
include a final analysis of PFS, overall survival and safety
data.
Lilly will await further data and continue to work with the FDA
to inform its submission plan for single-agent abemaciclib, based
on the MONARCH 1 study. This Phase 2 study evaluated the
single-agent activity and safety of abemaciclib in patients with
refractory metastatic breast cancer, whose disease had progressed
following multiple prior treatments, including chemotherapy.
Along with MONARCH 1 and MONARCH 2, Lilly currently has three
additional MONARCH 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-
locoregionally recurrent or metastatic breast cancer. Additionally,
there are two Phase 2 MONARCH trials: neoMONARCH, which is
evaluating abemaciclib in combination with a nonsteroidal aromatase
inhibitor in the neoadjuvant setting, and monarcHER, which is
evaluating abemaciclib plus trastuzumab (with or without
fulvestrant) in women with HR+, HER2+ locally advanced or
metastatic breast cancer.
For more information on additional abemaciclib trials, a
complete listing can be found on ClinicalTrials.gov.
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 246,660 new cases of invasive
breast cancer will be diagnosed and about 40,450 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
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.
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 inhibits both CDK 4 and CDK 6, and was shown in
cell-free enzymatic assays to be most active against Cyclin D 1 and
CDK 4.
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.
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 newsroom.lilly.com/social-channels.
P-LLY
© Lilly USA, LLC 2016. ALL
RIGHTS RESERVED.
*Fulvestrant (Faslodex®), MedImmune
Limited/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 locally advanced or metastatic breast cancer
and non-small cell lung 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 achieve its primary study
endpoints or receive regulatory approvals. 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: June 2, 2016.
2 American Cancer Society. What are the key
statistics about breast cancer?
http://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-key-statistics.
Accessed: June 2, 2016.
3 Metastatic Breast Cancer Network. 13 Facts about
Metastatic Breast Cancer.
http://mbcn.org/developing-awareness/category/13-things-everyone-should-know-about-metastatic-breast-cancer.
Accessed: June 2, 2016.
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