AbbVie Initiates Pivotal Phase 3 Study Of Veliparib - Quick Facts

(RTTNews) - AbbVie (ABBV) announced the initiation of a Phase 3 clinical trial evaluating the safety and efficacy of its investigational compound, veliparib (ABT-888) when added to carboplatin, a chemotherapy, in women with early-stage, triple-negative breast cancer.

The company said that three-arm trial will compare the addition of veliparib plus carboplatin or placebo plus carboplatin to standard neoadjuvant chemotherapy.

According to the company, the randomized, placebo-controlled, double-blind, Phase 3 trial will recruit approximately 620 patients who will be randomized to one of three arms of the trial. The primary efficacy outcome of the trial is pathological complete response (pCR), which is achieved when there is no evidence of residual, invasive cancer in the breast tissue and lymph node tissue, following treatment.

The secondary outcome of the trial will determine the rate of eligibility for breast conservation after therapy. Other pre-specified outcome measures include event-free survival or EFS, overall survival or OS, and complete response rate or CRR. The safety of veliparib will also be evaluated in the trial.

Veliparib (ABT-888) is an investigational oral poly (adenosine diphosphate [ADP]-ribose) polymerase or PARP inhibitor being evaluated in multiple tumor types. PARP is a naturally occurring enzyme in the body that repairs damage to DNA, and contributes to chemotherapy resistance in cancer cells. Discovered and developed by AbbVie researchers, veliparib is being developed to increase the effectiveness of common DNA-damaging therapies like chemotherapy or radiation.

The company said that Veliparib is currently being studied in more than a dozen cancers and tumor types, including Phase 2 studies in a variety of cancers, including breast, ovarian, and non-small cell lung cancers.