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

AbbVie

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