Half-Year 2022 Financial and Clinical Trials Update
Roche
Venclexta
Novel small molecule Bcl-2 selective inhibitor - chronic lymphocytic leukemia
Indication
Untreated chronic lymphocytic leukemia
(CLL) patients with
coexisting medical conditions
Phase III
CLL14
Relapsed or refractory chronic lymphocytic
leukemia (CLL)
Untreated fit chronic lymphocytic leukemia
(CLL) patients
Phase/study
# of patients
N=445
ARM A: Venclexta plus Gazyva
ARM B: Chlorambucil plus Gazyva
Design
Phase III
MURANO
N=389
ARM A: Venclexta plus Rituxan
ARM B: Rituxan plus bendamustine
Phase III
CristaLLo
N=165
ARM A: Venclexta plus Gazyva
ARM B: Fludarabine plus cyclophosphamide
plus Rituxan or bendamustine plus Rituxan
Primary endpoint
Status
CT Identifier
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
☐
Progression-free survival
MRD negativity rate in peripheral blood at 15
months
Study met primary endpoint at interim analysis
☐
FPI Q2 2020
☐
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
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
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OncologyView entire presentation