Despite promising progression-free survival (PFS) and response data with venetoclax in combination with bortezomib and dexamethasone, roughly twice the number of deaths due to infection in the experimental arm cast fears over the overall survival findings in patients with relapsed/refractory multiple myeloma, according to results of the double-blind, multicentre, randomised, phase 3 BELLINI trial .
In BELLINI, patients were treated with bortezomib/dexamethasone with venetoclax or placebo; the FDA has now called for a halt in enrolment because of increased risk of death (not applicable for approved indications of venetoclax).
In the late-breaking abstracts session, the trial data showed a median follow-up of 18.7 months; the median PFS was ...
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