BELLINI Trial of Venetoclax-Based Combination Therapy in Resistant Myeloma
Posted: Wednesday, July 1, 2020
According to the phase III BELLINI clinical trial, presented during the ASCO20 Virtual Scientific Program (Abstract 8509), adding venetoclax to bortezomib and dexamethasone improved progression-free survival, although it also increased mortality compared with placebo. Shaji Kumar, MD, of the Mayo Clinic, Rochester, Minnesota, and colleagues noted the “greatest progression-free survival improvement with venetoclax was observed in patients with t(11;14) or high BCL2-gene expression.”
The global multicenter study enrolled 291 patients with relapsed or refractory multiple myeloma. Patients were given either an 800-mg dose of venetoclax (n = 194) or placebo (n = 97) in addition to 1.3 mg/m2 of bortezomib and 20 mg of dexamethasone. All patient characteristics were balanced between the study arms, with 17% of patients having high-risk cytogenetics, 11% having t(11;14), and 34% having high BCL2-gene expression.
The research group found the most common adverse events associated with venetoclax were diarrhea, nausea, and constipation. Grade 3 and 4 adverse events for both arms included neutropenia (21% vs. 8%), thrombocytopenia (15% vs. 30%), anemia (16% vs. 15%), diarrhea (15% vs. 12%), and pneumonia (18% vs. 13%). The occurrence of serious adverse events was similar in both arms, with 54% in the venetoclax arm and 52% in the placebo arm.
The median follow-up for patients was 28.6 months, with 64 deaths (33%) in the venetoclax arm and 24 deaths (25%) in the placebo arm. The authors noted 14 treatment-emergent deaths with venetoclax compared with 1 death with placebo.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
