US-based biopharmaceutical firm AbbVie has started a global Phase III clinical trial of an investigational oral poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor ‘veliparib (ABT-888)’ in patients with previously untreated locally advanced or metastatic squamous non-small cell lung cancer (NSCLC).
The company said that PARP is a naturally occurring enzyme in the body that repairs damage to DNA, as well as contributes to chemotherapy resistance in cancer cells.
The trial will assess the efficacy and safety of veliparib as an addition to standard chemotherapy in previously-untreated patients.
Around 900 people will be enrolled in the trial, which will compare patients randomised 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.
AbbVie vice-president of pharmaceutical development Scott Brun 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,” Brun said.
The trial’s primary efficacy outcome is overall survival (OS), while 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 randomised, placebo-controlled, double-blind, multicentre, Phase III trial.
Veliparib is discovered and developed by AbbVie researchers to increase the effectiveness of common DNA-damaging therapies like chemotherapy or radiation.
The drug is currently being studied in over 12 cancers and tumour types, including breast, ovarian, and non-small cell lung cancers.
NSCLC is the most common type of lung cancer, accounting for about 85%-90% of diagnosed cases, and its three common subtypes include adenocarcinoma, squamous cell (epidermoid) carcinoma, and large cell (undifferentiated) carcinoma.