Dr. Kumar on Implications of BELLINI Trial in Relapsed/Refractory Multiple Myeloma

Shaji K. Kumar, MD, professor of medicine, Mayo Clinic, discusses the takeaways from the phase III BELLINI trial which tested venetoclax (Venclexta) in combination with bortezomib (Velcade) and dexamethasone in patients with relapsed/refractory multiple myeloma.

Although the regimen showed improved progression-free survival and objective responses versus placebo plus bortezomib and dexamethasone, more deaths were reported in the venetoclax arm due to infection.

However, patients with a translocation(11;14) were shown to benefit from the addition of venetoclax without significantly increased mortality, says Kumar. Notably, similar benefit was seen with venetoclax in patients with high BCL-2 expression, but there is currently no validated assay to assess BCL-2 expression, says Kumar. Conversely, patients with low BCL-2 expression or high-risk cytogenetics do not benefit or could be harmed from the combination, says Kumar.

In the phase III CANOVA study, patients with t(11;14) will be randomized to the combination of venetoclax and dexamethasone versus pomalidomide (Pomalyst) and dexamethasone.