EHA25 Virtual: BELLINI Trial Update on Venetoclax-Based Regimen in Multiple Myeloma
Posted: Tuesday, June 16, 2020
The addition of the BCL2 inhibitor venetoclax to bortezomib and dexamethasone improved progression-free survival in patients with relapsed or refractory multiple myeloma but increased mortality compared with placebo. Findings were based on updated data from the phase III BELLINI trial. In fact, the greatest improvement in progression-free survival with this regimen was seen in those with t(11;14) or high BCL2 expression, stated Shaji K. Kumar, MD, of the Mayo Clinic, Rochester, Minnesota, and colleagues during the virtual edition of the 25th European Hematology Association Annual Congress (EHA25 Virtual; Abstract EP939).
“The results set the stage for developing venetoclax alone and in combinations for treatment of multiple myeloma and raise the possibility of being the first biomarker-driven drug for myeloma, a heterogenous disease based on underlying genetic differences,” Dr. Kumar told JNCCN 360. “The positive results in the BCL2-high population are intriguing but cannot be translated to the clinic until we have a validated biomarker for determining the appropriate threshold for BCL2 expression.”
The multicenter, randomized study recruited 261 patients who had relapsed or refractory multiple myeloma. Patients were randomly assigned 2:1 to receive venetoclax or placebo in combination with bortezomib and dexamethasone. At the time of data collection in September 2019, 59 patients remained on study, including 45 in the venetoclax arm and 24 in the placebo arm.
At a median follow-up of 28.6 months, there were 64 deaths in the venetoclax arm and 24 deaths in the placebo arm. The progression-free survival rate was increased with venetoclax versus placebo, with a hazard ratio of 0.60. In addition, the overall survival was increased by 46% with venetoclax.
The most common treatment-emergent adverse events among patients in the venetoclax arm included diarrhea, nausea, and constipation. Common grade 3 or 4 adverse events in both treatment arms included neutropenia, thrombocytopenia, anemia, diarrhea, and pneumonia. Serious adverse events were reported in 54% of patients receiving venetoclax and 52% of patients receiving the placebo. Venetoclax was discontinued in 24% of patients due to adverse events.
Disclosure: The study authors reported no conflicts of interest.
