AbbVie Inc. (ABBV) announced new results from an open-label, multi-center phase II study evaluating the preliminary efficacy of venetoclax (ABT-199) for the treatment of relapsed or refractory acute myelogenous leukemia (AML) or as frontline therapy for patients unfit for intensive therapy. The results were presented at the annual meeting of the American Society of Hematology (ASH).
In this study, the venetoclax group showed an overall response rate of 15.5%. Out of 32 patients, one achieved complete response, while four showed complete response with incomplete blood count recovery.
Based on the data, AbbVie stated its intention to conduct additional studies for evaluating venetoclax in combination with other drugs for the treatment of AML.
We note that the company is already evaluating venetoclax in a phase III study for the treatment of relapsed or refractory chronic lymphocytic leukemia and other types of cancer. AbbVie has an agreement with Genentech (a subsidiary of Roche (RHHBY)) for the development of venetoclax.
Meanwhile, AbbVie has an important regulatory event coming up with the FDA expected to respond on its marketing application for its hepatitis C virus (HCV) combination for the treatment of genotype 1 (GT1) HCV patients. A response from the agency is expected by year-end.
Chances of gaining EU approval seem high with the European Medicines Agency’s European Committee for Medicinal Products for Human Use issuing positive opinions for the all-oral, interferon-free combination of Viekirax (ombitasvir/paritaprevir/ritonavir) plus Exviera (dasabuvir) for use with or without ribavirin in patients with GT1 and genotype 4 (GT4) chronic HCV infection. A final decision in the EU should be out in the first quarter of 2015.
We expect investor focus to remain on updates on the regulatory status of the HCV combination.
AbbVie holds a Zacks Rank #2 (Buy). Some better-ranked stocks in the biotech sector are Biogen Idec Inc. (BIIB) and Amgen Inc. (AMGN). Both carry a Zacks Rank #1 (Strong Buy).
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