AbbVie Announces Initiation of Pivotal Phase III Study of Veliparib (ABT-888) in Patients with Advanced Breast Cancer

AbbVie Announces Initiation of Pivotal Phase III Study of Veliparib (ABT-888)
                   in Patients with Advanced Breast Cancer

- Trial will measure investigational compound's efficacy and safety in
patients with HER2-negative breast cancer, associated with BRCA 1, BRCA 2

- Trial designed to evaluate veliparib as first-line therapy when added to
DNA-damaging chemotherapy

- Third Phase III trial initiated by AbbVie evaluating veliparib in
difficult-to-treat tumor types

PR Newswire

NORTH CHICAGO, Ill., June 26, 2014

NORTH CHICAGO, Ill., June 26, 2014 /PRNewswire/ -- AbbVie (NYSE: ABBV) today
announced the initiation of a Phase III clinical trial evaluating the safety
and efficacy of its investigational compound, veliparib (ABT-888), when added
to carboplatin and paclitaxel, two chemotherapeutic medicines, in patients
with advanced breast cancer. Specifically, the combination of veliparib,
carboplatin and paclitaxel will be compared to treatment with carboplatin,
paclitaxel and placebo in patients with human epidermal growth factor receptor
2-(HER2) negative metastatic or locally-advanced breast cancer, containing
BRCA1 and/or BRCA2 gene mutations.

"Our Phase III program for veliparib represents an innovative approach to
developing this type of anti-cancer compound. By adding veliparib to
DNA-damaging therapies, such as carboplatin and paclitaxel, we can evaluate
its potential to provide incremental benefit to existing treatments," said
Michael Severino, M.D., executive vice president, Research and Development and
chief scientific officer, AbbVie. "This is the third Phase III trial
evaluating the efficacy and safety of veliparib, and the second evaluating the
addition of veliparib to chemotherapy for the treatment of patients with
difficult-to-treat forms of breast cancer."

The randomized, double-blind, Phase III clinical trial will recruit
approximately 270 patients. The primary efficacy outcome of the trial is
progression-free survival (PFS). The secondary pre-specified outcome measures
include overall survival (OS), clinical benefit rate (CBR), objective response
rate (ORR) and duration of response (DOR).

More information on the trial is available at

About Veliparib (ABT-888)
Veliparib is an investigational oral poly (adenosine diphosphate [ADP]–ribose)
polymerases (PARP) inhibitor being evaluated in multiple tumor types. PARP is
a naturally-occurring enzyme in the body that repairs damage to DNA, and in
certain types of cancers, repairs cancer cells. Discovered and developed by
AbbVie researchers, veliparib is being developed to help prevent DNA repair in
cancer cells and 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 III studies in non-small
cell lung cancer and breast cancer.

About HER2 Breast Cancer
Breast cancer is the second most common cancer in the world and the most
commonly diagnosed cancer in women worldwide.^1 The HER2 gene, which normally
helps cells in the breast remain healthy and function normally, can play a
role in the development of breast cancer. Specifically, in approximately 25
percent of breast cancers, the HER2 gene does not work properly, causing cells
in the breast to grow and divide in an uncontrolled way. This process, known
as HER2 gene amplification or overexpression, results in HER2-positive breast
cancer. HER2-positive breast cancers tend to grow faster, metastasize more
quickly and are more likely to recur, compared to patients diagnosed with
HER2-negative breast cancer.^2

About BRCA1 and BRCA2 Gene Mutation
It is estimated that at least five percent of breast cancer cases result from
inherited mutations or alterations in the BRCA1 and BRCA2 breast cancer
susceptibility genes.^3,4 Women with these mutations have a 40- to 85-percent
lifetime risk of developing breast cancer. Additionally, men with BRCA2
mutations carry an increased risk of breast cancer.^5

About AbbVie Oncology
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. For more information on AbbVie Oncology and
our oncology portfolio, please visit

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013
following separation from Abbott Laboratories. 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. AbbVie employs approximately 25,000 people worldwide and
markets medicines in more than 170 countries. For further information on the
company and its people, portfolio and commitments, please visit Follow @abbvie on Twitter or view careers on our Facebook or
LinkedIn page.

^1 "GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence
Worldwide in 2012." World Health Organization, International Agency for
Research on Cancer, Accessed June 11, 2014:

^2"Her2 Status.", Accessed June 11, 2014:

^3 American Cancer Society. Cancer Facts and Figures 2008. Atlanta, GA:
American Cancer Society; 2008.

^4Peto J, Collins N, Barfoot R, et al. Prevalence of BRCA1 and BRCA2 gene
mutations in patients with early-onset breast cancer. J Natl Cancer Inst.

^5National Cancer Institute (NCI). Breast cancer treatment (PDR): health
professional version. Bethesda: NCI (updated 2010 Mar 5; cited 2010 Mar 29).
Available from


Contact: Media: David Freundel, (847) 937-4522, Investors: Liz Shea, (847)
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