Two phase 3 studies evaluating veliparib (AbbVie), an investigational, oral poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor, did not meet their primary endpoints. The studies evaluated veliparib in combination with the chemotherapy regimen carboplatin and paclitaxel in patients with squamous non–small-cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC).
“Unfortunately, these data do not support the use of veliparib in combination with chemotherapy in these patients,” a company spokesman said.
The NSCLC trial was a randomized, double-blind, multicenter study designed to evaluate the efficacy and safety of veliparib combined with carboplatin and paclitaxel compared with that of placebo plus carboplatin and paclitaxel in patients with previously untreated metastatic or advanced squamous NSCLC. The patients were evaluated based on their smoking status. The intent-to-treat population of 970 patients was stratified by smoking history: those who had smoked within the past 12 months and had more than 100 smoking events in their lifetime; those who had more than 100 smoking events in their lifetime with at least 12 months since the last event; and those who had 100 or fewer smoking events in their lifetime. The primary endpoint was the improvement in overall survival in the group of patients who had smoked within the past 12 months and had more than 100 smoking events in their lifetime.
The TNBC trial was a randomized, double-blind, multicenter study designed to evaluate the efficacy and safety of the addition of veliparib to carboplatin and standard neoadjuvant chemotherapy (paclitaxel) for the treatment of 312 patients with early-stage TNBC. The patients were randomly assigned to three treatment arms: veliparib combined with carboplatin and paclitaxel; placebo combined with carboplatin and paclitaxel; or placebo combined only with paclitaxel, all followed by doxorubicin plus cyclophosphamide. The primary endpoint was the complete pathologic response.
Veliparib is an investigational oral PARP inhibitor being evaluated in multiple tumor types. PARP is a naturally-occurring enzyme in the body involved in the repair of DNA damage.
Source: AbbVie; April 19, 2017.