INDIANAPOLIS, July 13, 2016 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) and Boehringer Ingelheim today announced a new
collaboration on a Phase 1b study that will evaluate the safety and
tolerability of abemaciclib (LY2835219), Lilly's cyclin-dependent
kinase (CDK) 4 and CDK 6 inhibitor, in combination with BI 836845,
Boehringer Ingelheim's insulin-like growth factor (IGF)-1/IGF-2
ligand neutralizing antibody, in patients diagnosed with HR+, HER2-
mBC. Based on the Phase 1b trial results, the collaboration has the
potential to expand to Phase 2 trials in patients with HR+, HER2-
mBC and other solid tumors. Enrollment is scheduled to begin in
late 2016, and Boehringer Ingelheim will be the sponsor of the
study program.
"We are pleased to join with Boehringer Ingelheim to study
the potential of their molecule in combination with Lilly's
abemaciclib, for which we have an active Phase 3 development
program underway," said Richard
Gaynor, M.D., senior vice president, product development and
medical affairs for Lilly Oncology. "For patients living with
metastatic breast cancer, the limited treatment options available
make this an important area of focus for our efforts to advance the
most innovative treatments."
Dr. Mehdi Shahidi, medical head,
solid tumor oncology, Boehringer Ingelheim commented, "Boehringer
Ingelheim is excited about initiating this collaboration with Lilly
to investigate a novel combination of two compounds that have
individually shown promising results in metastatic breast cancer
and have a complementary mode of action. We hope that this study
will lay foundations for making much needed new therapies available
to patients with metastatic breast cancer."
Lilly's abemaciclib is designed to block the growth of cancer
cells by specifically inhibiting CDK 4 and CDK 6. In many cancers,
uncontrolled cell growth arises from a loss of control in
regulating the cell cycle due to increased signaling from CDK 4 and
CDK 6. Boehringer Ingelheim's BI 836845 is an IGF
ligand-neutralizing antibody that binds to both IGF-1 and IGF-2
preventing activation of the respective receptor resulting in
decreased growth-promoting signaling, which may decrease tumor
growth. In a Phase 1b/2 trial BI 836845 has shown promising
preliminary efficacy and good clinical safety in combination with
everolimus and exemestane in patients with HR+ mBC.1
The rationale for the collaboration is based upon the hypothesis
that these two agents, in combination, could offer a more complete
pathway interference and could potentially prolong cell cycle
arrest. For HR+, HER2- mBC patients, this could translate to a
reversal of resistance to hormone therapy.
About Metastatic Breast Cancer
Breast cancer is
the most common cancer in women worldwide with nearly 1.7 million
new cases diagnosed in 2012.2 In the U.S. this
year, approximately 246,600 new cases of invasive breast cancer
will be diagnosed and about 40,450 women will die from breast
cancer.3 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, with an estimated
six to 10 percent of all new breast cancer cases initially being
stage IV, or metastatic.4 Approximately 75 percent
of breast cancers are hormone receptor-positive and are typically
managed with endocrine therapies, including aromatase inhibitors
and selective estrogen receptor modulators.5 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 FDA 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.
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 metastatic breast cancer
and reflects Lilly's current belief. 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 future study
results will be consistent with the results to date or 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 Cortes J
et al. Phase 1b/2 trial of BI 836845, an insulin-like growth factor
(IGF) ligand-neutralizing antibody, combined with exemestane (Ex)
and everolimus (Ev) in hormone receptor-positive (HR+) locally
advanced or metastatic breast cancer (BC): primary phase 1b
results. J Clin Oncol 34, 2016 (suppl; abstr 530).
|
2 World
Cancer Research Fund International. Breast Cancer.
http://www.wcrf.org/cancer_statistics/data_specific_cancers/breast_cancer_statistics.php.
Accessed: May 3, 2016.
|
3 American
Cancer Society. What are the key statistics about breast cancer?
http://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-key-statistics.
Accessed: May 3, 2016.
|
4
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: May 3, 2016.
|
5
Hortobagyi GN. Everolimus plus exemestane for the treatment of
advanced breast cancer: a review of subanalyses from BOLERO-2.
Neoplasia. 2015; 17:279-8.
|
|
|
Refer
to:
|
Erin Graves;
graves_erin_elissa@lilly.com ; 908-202-6354 (media)
|
|
Phil Johnson;
johnson_philip_l@lilly.com ; 317-655-6874 (investors)
|
Logo - http://photos.prnewswire.com/prnh/20031219/LLYLOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/lilly-and-boehringer-ingelheim-announce-clinical-trial-collaboration-in-metastatic-breast-cancer-300297800.html
SOURCE Eli Lilly and Company