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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

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 Facebook or 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


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