Roche Pharmaceutical Development and Sales Overview
Venclexta (venetoclax, RG7601)
Novel small molecule Bcl-2 selective inhibitor - chronic lymphocytic leukemia
Indication
Phase/study
# of patients
Untreated chronic lymphocytic leukemia
(CLL) patients with
coexisting medical conditions
Phase III
CLL14
N=445
"
ARM A: Venclexta plus Gazyva
Relapsed or refractory chronic lymphocytic
leukemia (CLL)
Phase III
MURANO
Roche
Untreated fit chronic lymphocytic leukemia
(CLL) patients
Design
Primary endpoint
"
Status
CT Identifier
ARM B: Chlorambucil plus Gazyva
Progression-free survival
Study met primary endpoint at pre-specified
interim analysis Q4 2018
BTD granted by FDA Q1 2019
US filing completed under RTOR Q1 2019
Filed in EU Q2 2019
Data presented at ASCO 2019, ASH 2019,
ASH 2020 and EHA 2021 and EHA 2022
Data published in NEJM 2019; 380:2225-2236
Approved US Q2 2019 and EU Q1 2020
NCT02242942
"
◉
■
N=389
ARM A: Venclexta plus Rituxan
ARM B: Rituxan plus bendamustine
Progression-free survival
Study met primary endpoint at interim analysis
Data presented at ASH 2017
Filed in US Q4 2017 and EU Q1 2018
Data published in NEJM 2018; 378:1107-20
Updated data presented at ASCO 2018, ASH 2019
and ASH 2020
Approved in US Q2 2018 (priority review)
EU approval Q4 2018
NCT02005471
"
☐
Phase III
CristaLLo
N=165
ARM A: Venclexta plus Gazyva
ARM B: Fludarabine plus cyclophosphamide
plus Rituxan or bendamustine plus Rituxan
MRD negativity rate in peripheral blood at
15 months
FPI Q2 2020
NCT04285567
Joint project with AbbVie, in collaboration with The Walter and Eliza Hall Institute
Bcl-2-B-cell lymphoma 2; BTD=Breakthrough therapy designation; CLL=chronic lymphocytic leukemia; MRD-Minimal Residual Disease; ASH-American Society of Hematology; ASCO-American Society of Clinical Oncology;
EHA-European Hematology Association; RTOR=Real time oncology review; NEJM-New England Journal of Medicine
75
OncologyView entire presentation