AbbVie's AML Drug Shows Positive Results In Phase 2 Study
By C. Rajan, contributing writer
AbbVie has announced the positive results of its investigational drug, Venetoclax, from a Phase 2 clinical trial in patients with acute myelogenous leukemia (AML). The company presented the study results at the American Society of Hematology's (ASH) 56th Annual Meeting in California this week.
The Phase 2 study was designed to evaluate the efficacy of Venetoclax in relapsed/refractory AML or as frontline therapy for patients who cannot undergo intensive therapy. In the 32 AML patients treated with the investigational drug, there was an overall response rate of 15.5 percent, including five patients achieving complete remission.
Furthermore, the median bone marrow blast count in patients treated with Venetoclax decreased 36 percent, with six patients showing at least a 50 percent bone marrow blast reduction, indicating a significant decrease in leukemia. The drug was also well tolerated with minimal side effects.
Based on this data, AbbVie intends to evaluate Venetoclax further in AML patients, including as part of a combination drug treatment. Venetoclax, which is developed under a collaborative agreement between AbbVie and Genentech, is currently also being evaluated in a Phase 3 clinical trial for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) and other types of cancer.
Venetoclax (ABT-199/GDC-0199) is an inhibitor of the B-cell lymphoma-2 (BCL-2) protein, which is highly expressed in cancers originating in the lymph nodes, spleen, and other immune system organs. The BCL-2 protein prevents the natural apoptosis (cell death) process in certain types of cells. By selectively inhibiting the function of BCL-2, Venetoclax causes the cancer cells to self-destruct.
"Acute myelogenous leukemia is an aggressive cancer with low survival rates, and there is a high need among patients and healthcare providers for new, effective treatment options," said Dr. Marina Konopleva, associate professor, Division of Cancer Medicine, at the University of Texas MD Anderson Cancer Center, where the drug was initially evaluated. "The results of this trial of Venetoclax are encouraging and warrant additional study in patients with AML."
Besides Venetoclax, positive clinical trial results for several other AML treatments were presented at the ASH meeting this week, including the below:
- CTI BioPharma announced the positive Phase 3 data of its investigational oral multi-kinase inhibitor, Pacritinib, in AML patients with FLT3 mutations.
- MEI Pharma reported significant clinical activity of its investigational drug, Pracinostat, in combination with azacitidine (Vidaza) in a Phase 2 study in elderly patients with newly diagnosed AML.
- Israeli biotech firm, BioLineRx, presented the positive results from an on-going Phase 2a clinical trial of its investigational drug, BL-8040, in patients with relapsed or refractory AML.