VERONA MDS Trial: Venetoclax Plus Azacitidine Did Not Meet OS Primary End Point

An update has been issued on results from the VERONA phase 3 clinical trial, an international randomized controlled trial designed to compare oral venetoclax plus azacitidine with placebo plus azacitidine for newly diagnosed higher-risk myelodysplastic syndromes (MDS). The update was released by AbbVie.

The company reports that the VERONA trial did not meet its primary end point for overall survival outcomes, having a hazard ratio of 0.908 (stratified log-rank, P=0.3772), but no new safety signals were observed. The results from this trial will be released via presentation at a future medical congress or through publication.

Venetoclax is under development by AbbVie and Roche and is marketed as VENCLEXTA and VENCLYXTO. It is a first-in-class agent with a mechanism of action of binding and inhibiting the B-cell lymphoma-2 (BCL-2) protein to re-enable the apoptosis process in blood cancer cells.

Venetoclax currently has regulatory approvals in more than 80 countries, including the US. Its indications for use include treatment for adults who have chronic lymphocytic leukemia or small lymphocytic lymphoma. It is also used in combination with azacitidine, decitabine, or cytarabine to treat acute myeloid leukemia in adults aged 75 years and older who are unable to receive standard chemotherapy.

AbbVie mentions in its update that these newly reported data from VERONA do not affect any of the currently approved indications for venetoclax. In addition, any patients who received the venetoclax plus azacitidine combination while they were enrolled in an MDS clinical trial will be informed by their managing physician.