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

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 www.clinicaltrials.gov (NCT02163694).

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 http://oncology.abbvie.com.

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 www.abbvie.com. 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: http://www.nationalbreastcancer.org/breast-cancer-facts

2 "Her2 Status." BreastCancer.org, Accessed June 11, 2014: http://www.breastcancer.org/symptoms/diagnosis/her2

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

4 Peto 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. 1999;91(11):943-9.

5 National Cancer Institute (NCI). Breast cancer treatment (PDR): health professional version. Bethesda: NCI (updated 2010 Mar 5; cited 2010 Mar 29). Available from http://www.cancer.gov/cancertopics/pdq/treatment/breast/healthprofessional/all pages.

SOURCE AbbVie

Posted: June 2014

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