AbbVie Announces Initiation of Pivotal Phase 3 Study of Veliparib (ABT-888) for Patients with Early-Stage Triple-Negative Breast

 AbbVie Announces Initiation of Pivotal Phase 3 Study of Veliparib (ABT-888)
         for Patients with Early-Stage Triple-Negative Breast Cancer

Trial Will Compare Investigational Compound's Efficacy and Safety as an
Addition to Standard Treatment

PR Newswire

NORTH CHICAGO, Ill., Jan. 15, 2014

NORTH CHICAGO, Ill., Jan. 15, 2014 /PRNewswire/ -- AbbVie (NYSE: ABBV) today
announced the initiation of a Phase 3 clinical trial evaluating the safety and
efficacy of its investigational compound, veliparib (ABT-888) when added to
carboplatin, a chemotherapy, in women with early-stage, triple-negative breast
cancer. The three-arm trial will compare the addition of veliparib plus
carboplatin or placebo plus carboplatin to standard neoadjuvant chemotherapy.

"This new Phase 3 trial is an important step in potentially providing women
with early-stage triple-negative breast cancer with a new treatment option for
use in conjunction with surgical therapy," said Scott Brun MD, Vice President,
Pharmaceutical Development, AbbVie. "While therapies exist to treat many forms
of breast cancer, there is still a significant need for effective, targeted
therapies for women with early-stage triple-negative breast cancer, which
tends to be an aggressive, faster growing form of breast cancer."

The randomized, placebo-controlled, double-blind, Phase 3 trial will recruit
approximately 620 patients who will be randomized to one of three arms of the
trial. The primary efficacy outcome of the trial is pathological complete
response (pCR), which is achieved when there is no evidence of residual,
invasive cancer in the breast tissue and lymph node tissue, following
treatment. The secondary outcome of the trial will determine the rate of
eligibility for breast conservation after therapy. Other pre-specified outcome
measures include event-free survival (EFS), overall survival (OS), and
complete response rate (CRR). The safety of veliparib will also be evaluated
in the trial.

More information on the trial is available at www.clinicaltrials.gov
(NCT02032277). The trial will be conducted in collaboration with cooperative
groups: Alliance Oncology, German Breast Group (GBG), German Gynecological
Oncology Working Group-Breast (AGO-B), National Surgical Adjuvant Breast and
Bowel Project (NSABP), and U.S. Oncology Research.

About Veliparib (ABT-888)
Veliparib (ABT-888) is an investigational oral poly (adenosine diphosphate
[ADP]–ribose) polymerase (PARP) inhibitor being evaluated in multiple tumor
types. PARP is a naturally occurring enzyme in the body that repairs damage to
DNA, and contributes to chemotherapy resistance in cancer cells. Discovered
and developed by AbbVie researchers, veliparib is being developed to increase
the effectiveness of common DNA-damaging therapies like chemotherapy or
radiation. Veliparib is currently being studied in more than a dozen cancers
and tumor types, including Phase 2 studies in a variety of cancers, including
breast, ovarian, and non-small cell lung cancers.

About Triple-Negative Breast Cancer
Breast cancer is the most commonly diagnosed cancer in women and the second
leading cause of death among women.[i] Triple-negative breast cancer is a type
of breast cancer that grows even with the absence of three receptors –
estrogen, progesterone, or large amounts of HER2/neu protein – that often fuel
the growth of breast cancer. Triple-negative breast cancer is difficult to
treat because it does not respond to some of the most effective therapies
available to treat breast cancer. Approximately 15-20 percent of all breast
cancers in the United States and other major markets are triple-negative
breast cancer. It can occur in anyone, but research shows that it most often
occurs in younger women, African American women and women who have breast
cancer (BRCA) 1 mutations.[ii]

About AbbVie Oncology
The fight against cancer is one of the greatest battles in medicine and the
varied nature of the disease requires a diverse approach that looks at
multiple disease targets in a variety of tumor types. AbbVie's oncology
research is focused on the discovery and development of targeted therapies
that work against the processes cancers need to survive. By investing in new
technologies and approaches, we are breaking ground in some of the most
widespread and difficult-to-treat cancers, including multiple myeloma and
chronic lymphocytic leukemia. Our oncology pipeline includes multiple new
molecules in clinical trials being studied in more than 15 different cancers
and tumor types.

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013
following separation from Abbott. The company's mission is to use its
expertise, dedicated people and unique approach to innovation to develop and
market advanced therapies that address some of the world's most complex and
serious diseases. In 2013, AbbVie employed approximately 21,000 people
worldwide and marketed medicines in more than 170 countries. For further
information on the company and its people, portfolio and commitments, please
visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our
Facebookor LinkedIn page.

[i] "Breast Cancer Facts." National Breast Cancer Foundation, Accessed
December 20, 2013: http://www.nationalbreastcancer.org/breast-cancer-facts
[ii] "Facts For Life: Triple Negative Breast Cancer." Susan G. Komen, Accessed
December 20, 2013:
http://ww5.komen.org/uploadedFiles/Content_Binaries/KOMEED079100.pdf

SOURCE AbbVie

Website: http://www.abbvie.com
Contact: Media: David Freundel, (847) 937-4522; Investors: Liz Shea, (847)
935-2211
 
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