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BELLINI trial survival analysis: Venetoclax vs placebo in RRMM
Results from a survival analysis of the phase III BELLINI trial (NCT02755597) evaluating the efficacy and safety of venetoclax vs placebo in combination with bortezomib and dexamethasone in 291 patients with relapsed/refractory multiple myeloma (RRMM) were published by Kumar et al. in Lancet Haematology. The primary endpoint was progression-free survival (PFS).
Key data: The median PFS was 23.4 months vs 11.4 months (hazard ratio [HR], 0.58; 95% confidence interval [CI], 0.43–0.78; p = 0.00026) in the venetoclax vs placebo group. The median PFS was longer with venetoclax for translocation (11;14)-positive status (36.8 months vs 9.3 months; p = 0.00041) and BCL2high (30.1 months vs 9.9 months; p < 0.0001) vs placebo.
Key learning: Patients with RRMM treated with venetoclax vs placebo plus bortezomib and dexamethasone had improved survival outcomes, especially those with t(11;14) and BCL2high. The findings support a biomarker-driven approach using venetoclax in the management of RRMM.
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