April 15, 2014

AbbVie Announces Initiation of Pivotal Phase III Study of Veliparib (ABT-888) for Patients with Non-Small Cell Lung Cancer

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Trial Will Evaluate Investigational Compound's Efficacy and Safety as an Addition to Standard Chemotherapy in Previously-Untreated Patients

NORTH CHICAGO, Ill., April 15, 2014 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced the initiation of a global Phase III clinical trial evaluating the safety and efficacy of its investigational compound, veliparib (ABT-888), in patients with previously untreated locally advanced or metastatic squamous non-small cell lung cancer (NSCLC). The trial will compare patients randomized to receive either the standard chemotherapies of carboplatin and paclitaxel with the addition of veliparib, versus patients receiving carboplatin and paclitaxel with the addition of placebo.  

"Lung cancer is one of most common cancers worldwide and can be difficult to treat, particularly when it is diagnosed in the more advanced stages of the disease," said Scott Brun M.D., vice president, Pharmaceutical Development, AbbVie. "This Phase III trial is an important step in the development of veliparib and in potentially providing patients with squamous non-small cell lung cancer with a new treatment option."

This randomized, placebo-controlled, double-blind, multicenter, Phase III trial will recruit approximately 900 patients. The primary efficacy outcome of the trial is overall survival (OS). Other pre-specified outcome measures include progression-free survival (PFS), and objective response rate (ORR). The safety of veliparib will also be evaluated in the trial.

More information on the trial is available at www.clinicaltrials.gov (NCT02106546).

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 breast, ovarian, and non-small cell lung cancers.

About Non-Small Cell Lung Cancer (NSCLC)
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for approximately 85-to-90 percent of diagnosed cases.i There are three common subtypes of NSCLC: adenocarcinoma, squamous cell (epidermoid) carcinoma, and large cell (undifferentiated) carcinoma. Adenocarcinoma accounts for approximately 40 percent of lung cancers and is the most common form of NSCLC in patients who smoke, have smoked or have never smoked. Adenocarcinoma typically originates in the outer parts of the lung. Squamous cell carcinoma accounts for about 25-to-30 percent of NSCLC cases, and is usually found in the middle airways of the lungs. Squamous cell is often linked to patients with a history of smoking. About 10-to-15 percent of NSCLC cases are considered large cell carcinomas, which tend to grow and spread quickly, making it a more difficult-to-treat form of NSCLC. Other subtypes exist, but are less common.ii

Lung cancer (both small cell and non-small cell) is the second most common cancer in both men and women. It accounts for about 13 percent of all new cancers in the U.S. and is the leading cause of cancer-related death among both men and women, causing more deaths than colon, breast, and prostate cancers combined.iii Worldwide, it is the most common form of cancer.iv Once NSCLC is diagnosed, treatment options can include surgery, radiation therapy, chemotherapy or targeted therapies, depending on the stage of the disease.v

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 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.

i "Non-Small Cell Lung Cancer." The American Cancer Society, Accessed March 12, 2014: http://www.cancer.org/cancer/lungcancer-non-smallcell/index?sitearea

ii "Non-Small Cell Lung Cancer: Detailed Guide." The American Cancer Society, Accessed March 12, 2014: http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/index

iii "What Are the Key Statistics About Lung Cancer?" The American Cancer Society, Accessed March 12, 2014: http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-key-statistics

iv "Lung Cancer Incidence Statistics." Cancer Research U.K., Accessed March 12, 2014: http://www.cancerresearchuk.org/cancer-info/cancerstats/types/lung/incidence/uk-lung-cancer-incidence-statistics#geog

v "What Are the Key Statistics About Lung Cancer?" The American Cancer Society, Accessed March 12, 2014: http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-treating-general-info



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