On March 21, 2019 the FDA issued an alert about the risks associated with the investigational use of Venclexta (venetoclax) for the treatment of patients with multiple myeloma. The alert is based on review of data from the Bellini clinical trial (NCT02755597, Study M14-031) evaluating the use of Venclexta combined with bortezomib, a proteasome inhibitor, and dexamethasone in patients with multiple myeloma. Cancer treatments often make use of multiple drugs, and clinical trials are often performed for newly approved drugs in multi-drug treatment combinations that oncologists believe may be productive. Venclexta is approved for treating patients with other forms of leukemia (blood cancers like chronic lymphocytic leukemia, small lymphocytic lymphoma, or acute myeloid leukemia).
The Bellini interim trial results demonstrated an approximately 2x increased risk of death for patients receiving Venclexta as compared to the control group. On March 6th, the FDA required no new patients be enrolled on the Bellini trial. Patients already experiencing clinical benefit may continue treatment after they reconsent. The FDA also suspended enrollment in other ongoing multiple myeloma clinical trials of Venclexta.
The alert presents an excellent peek into how clinical trials are evaluated for safety and efficacy on a continual basis. For the Bellini trial, an evaluation of safety and efficacy was performed using a data cutoff date of November 26, 2018. 291 randomized patients were included in the analysis, and the alert shows the statistics for overall survival of the two treatment groups in chart form. This is a commonly used format, presenting the overall survival rate plotted over time, with the cumulative incidence presented as a covariate. Additional data is also presented in the text discussion, including progression-free survival rates and information about serious adverse events.
Text Copyright © 2019 Katrina Rogers