AbbVie puts multiple myeloma investigational treatmenttrial on hold after higher proportion of deaths was observed in the venetoclaxMarch 19, 2019
AbbVie has put on hold clinical testing venetoclax (Venclexta/Venclyxto) for the investigational treatment of multiple myeloma, which being developed by AbbVie and Roche, and jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.
AbbVie said Tuesday the partial clinical hold follows a review of data from the ongoing Phase 3 BELLINI trial (M14-031), a study in relapsed/refractory multiple myeloma, in which a higher proportion of deaths was observed in the venetoclax arm compared to the control arm of the trial.
As a result of this action, no new patients should be enrolled in any studies of venetoclax for multiple myeloma until a further analysis of the data is completed. Patients who are currently enrolled in studies and receiving benefit from the therapy may continue with treatment, after consultation with their physician, the company said.
Furthermore, the company said this action does not impact any of the approved indications for venetoclax, such as chronic lymphocytic leukemia (CLL) or acute myeloid leukemia (AML), and is limited to investigational clinical trials in multiple myeloma. AbbVie remains confident in the benefit/risk profile of venetoclax in those approved indications.
“We will continue working with the FDA and worldwide regulatory agencies to determine appropriate next steps for the multiple myeloma program,” said Michael Severino, M.D., vice chairman and president, AbbVie.
Severino said the company will continue to further the research and development of venetoclax and other therapies with the potential to transform the standards of care in blood cancers.