Half-Year 2022 Financial and Clinical Trials Update
Venclexta
Novel small molecule Bcl-2 selective inhibitor - myelodysplastic syndromes
Indication
Relapsed or refractory myelodysplastic
syndromes (MDS)
Treatment-naive myelodysplastic syndromes
(MDS)
Newly diagnosed higher-risk
myelodysplatic syndrome (MDS)
Phase/study
Phase lb
Phase lb
Phase III
VERONA
# of patients
Design
Primary endpoint
Status
CT Identifier
Cohort 1:
N=70
ARM A: Venclexta 400 mg
ARM B: Venclexta 800 mg
Cohort 2:
ARM A: Venclexta plus azacitidine
Study expansion:
Venclexta or Venclexta plus azacitidine
Safety, efficacy, Pharmacokinetics and
Pharmacodynamics
FPI Q1 2017
Recruitment completed Q1 2022
NCT02966782
N=129
Dose escalation cohort:
Venclexta plus azacitidine dose escalation
Safety expansion cohort
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Safety, Pharmacokinetics, RPTD
FPI Q1 2017
Data presented at ASH 2019, ASH 2020 and
ASCO 201
BTD granted by FDA July 2021
Recruitment completed Q1 2022
NCT02942290
"
"
N=500
ARM A: Venclexta plus azacitidine
ARM B: Placebo plus azacitidine
Complete remission rate and overall survival
■ FPI Q4 2020
NCT04401748
Joint project with AbbVie, in collaboration with The Walter and Eliza Hall Institute
Bcl-2-B-cell lymphoma 2; BTD=Breakthrough therapy designation; RPTD=Recommended phase II dose; ASH-American Society of Hematology
98
Roche
OncologyView entire presentation