Venclexta falls short in myelodysplastic syndrome

AbbVie and Roche’s Venclexta, alongside azacitidine, is a mainstay in acute myeloid leukaemia, but the partners’ hopes of going earlier have been dashed. The combo, versus azacitidine alone, has flunked in the precursor condition high-risk myelodysplastic syndrome (MDS), in the much-delayed Verona trial. The companies only said that the study didn’t meet its primary endpoint, overall survivall, with a hazard ratio of 0.908 and a p value of 0.3772. The trial had once been expected to read out in 2023. Chemo drugs like azacitidine are commonly used in MDS; more recent approvals include Bristol Myers Squibb’s Reblozyl and Geron’s Rytelo, although these are indicated for low to intermediate-risk disease. Another Venclexta trial will read out soon, Viale-T, in post-transplant AML. However, this has also been delayed, and the primary endpoint changed, from relapse-free survival to overall survival. Venclexta’s current AML approval is in combo with azacitidine in first-line patients unfit for intensive induction chemo. The partners had better news from the Cristallo study last year, testing Venclexta plus Gazyva in fit first-line CLL patients; this could broaden use from the current CLL approval, based on the CLL14 trial in unfit patients.

Recent and upcoming Venclexta readouts

Notes: *fit defined as cumulative illness rating scale ≤6 and normal creatinine clearance (current 1st-line CLL approval based on CLL14 trial in pts with comorbidities). AML=acute myeloid leukaemia; CLL=chronic lymphocytic leukaemia; MDS=myelodysplastic syndrome; MRD=minimal residual disease; RFS=relapse-free survival. Source: OncologyPipeline.