Adding the investigational oral poly-ADP-ribose polymerase (PARP) inhibitor veliparib to carboplatin and paclitaxel chemotherapy regimens failed to prolong overall survival for patients with metastatic squamous non–small-cell lung cancer (NSCLC) and early-stage triple-negative breast cancer (TNBC), according to findings from two multicenter randomized, double-blind, placebo-controlled phase III clinical trials announced by AbbVie.
“Unfortunately, these data do not support the use of veliparib in combination with chemotherapy in these patients,” said Gary Gordon, MD, PhD, AbbVie’s vice president of oncology clinical development, in a press release.1
Phase III clinical trials of veliparib plus chemotherapy are ongoing for non-squamous NSCLC, BRCA1/2 mutation-positive breast cancer and ovarian cancer, the company noted.
Veliparib inhibits the DNA-repair enzyme PARP.
The squamous NSCLC study had enrolled 970 patients and the TNBC study enrolled 312 patients. The NSCLC study stratified participants by tobacco-smoking history and the primary study endpoint was overall survival among patients who had smoked in the past year and had more than 100 smoking events in their lifetime, but the researchers also analyzed outcomes for the entire intent-to-treat study population.
For TNBC patients, they were randomized to one of three 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 studies’ detailed results will be presented at research meetings and published in a peer-reviewed journal, the company announced.
AbbVie Pressroom. AbbVie Announces Topline Results from Two Phase 3 Studies Investigating Veliparib in Combination with Chemotherapy for the Treatment of Patients with Advanced or Metastatic Squamous Non-Small Cell Lung Cancer and Early-Stage Triple-Negative Breast Cancer. 2017 Apr 19.