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Venetoclax Plus Bortezomib and Dexamethasone in Resistant Myeloma: Final Results From BELLINI Trial

By: Joseph Fanelli
Posted: Friday, March 11, 2022

According to findings presented at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 84), using venetoclax in combination with bortezomib and dexamethasone significantly improved progression-free survival but also resulted in increased mortality when compared with a placebo in patients with relapsed or refractory multiple myeloma. Philippe Moreau, MD, PhD, of the University Hospital Hôtel-Dieu, Nantes, France, and colleagues concluded that findings from this phase III BELLINI study were consistent with a previous analysis and the oral BCL2 inhibitor venetoclax demonstrated the greatest improvement in patients with high BCL2 expression.

In this randomized, double-blind, multicenter study, the authors enrolled 291 patients with relapsed or refractory multiple myeloma. The patients received bortezomib and dexamethasone with either venetoclax (194 patients) or a placebo (97 patients). At the final overall survival analysis, 33 patients were still receiving treatment (28 with venetoclax and 5 with a placebo).

After a median follow-up of 45.6 months, 78 patients treated with venetoclax died (40%), compared with 36 in the placebo cohort (37%). The median progression-free survival was 23.4 months for those treated with venetoclax and 11.4 months for those who received a placebo. For patients with t(11;14) translocation, the median progression-free survival was 36.8 months in the venetoclax cohort and 9.3 months in the placebo group. Patients with high BCL2 expression had a median progression-free survival of 30.1 months when treated with venetoclax and 9.9 months when treated with a placebo. The median overall survival was not reached in either group of patients.

Serious adverse events occurred in 57% of patients treated with venetoclax and 55% of placebo-treated patients, with serious infections and infestations occurring in 35% and 29% of patients, respectively. In total, 26% of patients who received venetoclax experienced adverse events that led to discontinuation of treatment, compared with 11% of patients who received a placebo. Adverse events resulted in 12 deaths among those treated with venetoclax and 1 death in the placebo group.

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