AbbVie Advances Lung Cancer Drug To Phase III Trial

AbbVie announced that it is advancing its investigational lung cancer drug veliparib (ABT-888) to a global, Phase III clinical trial.

The trial will evaluate the safety and efficacy of the investigational compound in patients with previously untreated locally advanced or metastatic squamous non-small cell lung cancer (NSCLC). The Phase III trial will compare data from patients randomized to receive either the standard chemotherapies of carboplatin and paclitaxel with the addition of veliparib, against patients receiving carboplatin and paclitaxel with the addition of placebo.

The double-blind, placebo-controlled, multi-center Phase III trial will enroll an estimated 900 patients. Primary efficacy outcome is overall survival while other pre-specified outcome measures will include progression-free survival (PFS) and objective response rate (ORR).

Scott Brun, VP of Pharmaceutical Development at AbbVie, said, “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. 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.”

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer and is responsible for around 85-to-90 percent of diagnosed cases. Both small cell and non-small cell lung cancer accounts for about 13 percent of all new cancers in the U.S. Lung cancer is the second most common cancer in both men and women. The disease is the leading cause of cancer-related death in both men and women.

Veliparib (ABT-888) is an investigational oral poly (adenosine diphosphate [ADP]–ribose) polymerase (PARP) inhibitor discovered by AbbVie and is being evaluated in multiple tumor types. PARP is a naturally occurring enzyme in the body that repairs DNA damage and contributes to chemotherapy resistance in cancer cells. The drug is currently being evaluated in over a dozen cancer and tumor types, including breast and ovarian cancer aside from non-small cell lung cancer.