Abbvie announces initiation of pivotal Phase III study of veliparib (abt-888) for patients with non-small cell lung cancer

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.