Roche Pharmaceutical Development and Sales Overview
Venclexta (venetoclax, RG7601)
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
# of patients
Design
Primary endpoint
Status
CT Identifier
Phase lb
Phase lb
Phase III
VERONA
Roche
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
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
77
OncologyView entire presentation