ASH 2021 | Updates from the BELLINI trial

Shaji Kumar, MD, Mayo Clinic, Rochester, MN, gives an update on the results of the BELLINI Phase III study evaluating the safety and efficacy of venetoclax plus bortezomib and dexamethasone in patients with relapsed/refractory (R/R) multiple myeloma who are proteasome inhibitor-naïve and who have received 1 to 3 prior lines of therapy (NCT02755597). After a median follow-up of four years, the progression-free survival (PFS) was 23.4 months in the venetoclax arm versus 11.4 months in the placebo arm. In addition, whilst the initial analysis of the trial showed an increase in mortality among patients treated with venetoclax, this updated analysis did not report any further increase in early deaths in the venetoclax arm. Subgroup analysis demonstrated that the addition of venetoclax provided a significant PFS benefit to patients with t(11;14) abnormality and high BCL-2 expression without any adverse impact on overall survival (OS). This interview took place at the 63rd ASH Annual Meeting and Exposition congress in Atlanta, GA.