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Pivotal Phase III Study Evaluates Veliparib (ABT-888) in Lung Cancer Patients

Treatment added to standard chemotherapy with carboplatin and paclitaxel

AbbVie has 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 study will compare patients randomly assigned to receive either standard chemotherapy with carboplatin and paclitaxel (on day 1 of a 21-day cycle) with the addition of veliparib (on days –2 to 5 [7 days]), or carboplatin and paclitaxel (on day 1 of a 21-day cycle) with the addition of placebo (on days –2 to 5 [7 days]).

This randomized, placebo-controlled, double-blind, phase III trial will recruit approximately 900 adult patients (18 years of age or older) with a life expectancy of more than 12 weeks. The study’s primary efficacy outcome is overall survival (up to 3 years after the first dose of study drug). Other pre-specified outcome measures include progression-free survival, the objective response rate, and the duration of response. The safety of veliparib will also be evaluated.

The estimated study completion date is March 2016.

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 that contributes to chemotherapy resistance in cancer cells. Veliparib is being developed to increase the effectiveness of common DNA-damaging therapies, such as chemotherapy and radiation. The compound is being studied in more than a dozen cancers and tumor types, including breast cancer, ovarian cancer, and NSCLC.

NSCLC is the most common type of lung cancer, accounting for approximately 85% to 90% of diagnosed cases. There are three common subtypes of NSCLC: adenocarcinoma, squamous-cell (epidermoid) carcinoma, and large-cell (undifferentiated) carcinoma. Adenocarcinoma accounts for approximately 40% 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% of NSCLC cases and is usually found in the middle airways of the lungs. Squamous-cell disease is often linked to patients with a history of smoking. About 10% to 15% of NSCLC cases are considered large-cell carcinomas, which tend to grow and spread rapidly, making them a more difficult-to-treat form of NSCLC.

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% of all new cancers in the U.S. and is the leading cause of cancer-related death among men and women, causing more deaths than colon, breast, and prostate cancers combined. Worldwide, it is the most common form of cancer. Once NSCLC is diagnosed, treatment options include surgery, radiation therapy, chemotherapy, or targeted therapies, depending on the stage of the disease.

Sources: AbbVie; April 15, 2014; and ClinicalTrials.gov; April 14, 2014.

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