AbbVie Initiates Veliparib Phase III Study In Breast Cancer
AbbVie announced that it has started the Phase III clinical trial investigating the safety and efficacy of its investigational compound veliparib (ABT-888) added to two chemotherapeutic medicines carboplatin and paclitaxel in patients with advanced breast cancer.
Veliparib is an oral poly (adenosine diphosphate [ADP]–ribose) polymerases (PARP) inhibitor under development as potential treatment in multiple tumor types, including Phase III studies in non-small cell lung (NSCLC) cancer and breast cancer. PARP naturally occurs in the body as an enzyme that repairs DNA damage and cancer cells in some types of cancers. Veliparib is currently being developed to help prevent repair of damaged DNA in cancer cells and to boost the effectiveness of common DNA-damaging therapies, such as chemotherapy or radiation.
The double blind, randomized Phase III trial will enroll around 270 patients. Specifically, the investigational combo treatment of veliparib, carboplatin, and paclitaxel will be assessed against carboplatin, paclitaxel, and placebo in patients with human epidermal growth factor receptor 2-(HER2) negative metastatic or locally-advanced breast cancer, carrying BRCA1 and/or BRCA2 gene mutations. The primary efficacy endpoint of the trial is progression-free survival (PFS) while secondary pre-specified outcome measures will include clinical benefit rate (CBR), objective response rate (ORR), overall survival (OS), and duration of response (DOR).
Michael Severino, EVP of Research and Development and CSO at AbbVie, said, “Our Phase III program for veliparib represents an innovative approach to developing this type of anti-cancer compound. By adding veliparib to DNA-damaging therapies, such as carboplatin and paclitaxel, we can evaluate its potential to provide incremental benefit to existing treatments. This is the third Phase III trial evaluating the efficacy and safety of veliparib, and the second evaluating the addition of veliparib to chemotherapy for the treatment of patients with difficult-to-treat forms of breast cancer.”
Breast cancer is the second most common cancer around the world. At least five percent of breast cancer cases are estimated to result from inherited mutations or alterations in the BRCA1 and BRCA2 breast cancer susceptibility genes. Women with the BRCA1 and BRCA2 mutations have a 40 to 85 percent lifetime risk of developing breast cancer.