Roche Pharmaceutical Development and Sales Overview
Venclexta (venetoclax, RG7601)
Novel small molecule Bcl-2 selective inhibitor - multiple myeloma
Indication
Phase/study
# of patients
Design
Dose escalation cohort:
Venclexta dose escalation
Safety expansion cohort (t11;14):
Venclexta expansion
Combination:
Venclexta plus dexamethasone
Phase I
N=117
Safety and maximum tolerated dose
Primary endpoint
FPI Q4 2012
Data presented at ASCO 2015
Status
CT Identifier
Relapsed or refractory multiple myeloma (MM)
Updated data presented at ASCO 2016 and ASH 2016
Data published in Blood 2017; 130(22):2401-2409 and Am J Hematol 2021 Apr
1;96(4):418-427
NCT01794520
Joint project with AbbVie, in collaboration with The Walter and Eliza Hall Institute;
Phase III
CANOVA
N=244
Venclexta plus dexamethazone vs pomalidomide plus
dexamethasone in t(11;14) positive r/r MM
Progression-free survival
FPI Q4 2018
Bcl-2-B-cell lymphoma 2; MM-multiple myeloma; r/r-Relapsed or refractory; ASCO-American Society of Clinical Oncology; ASH-American Society of Hematology
NCT03539744
Roche
76
OncologyView entire presentation