Half-Year 2022 Financial and Clinical Trials Update
Alecensa
New CNS-active inhibitor of anaplastic lymphoma kinase
Indication
Treatment-naïve
ALK+ advanced NSCLC
Phase/study
# of patients
ARM A: Alecensa 600mg BID
Design
ARM B: Crizotinib 250mg BID
Primary endpoint
Progression-free survival
Phase III
ALEX
N=286
Status
CT Identifier
▪ Recruitment completed Q3 2015
Primary endpoint met Q1 2017
■ Data presented at ASCO 2017, 2018, ESMO 2017, 2018
Data published in NEJM 2017;377:829-838
"
CNS data presented at ESMO 2017
■
Final PFS and updated OS presented at ESMO 2019
▪ Approved in US Q4 2017 (priority review) and in EU Q4 2017
NCT02075840
Adjuvant ALK+ NSCLC
Phase III
ALINA
N=255
ARM A: Alecensa 600mg BID
☐
ARM B: Platinum-based chemotherapy
Disease-free survival
FPI Q3 2018
Recruitment completed Q4 2021
NCT03456076
In collaboration with Chugai
ALK-anaplastic lymphoma kinase; CNS= Central nervous system; NSCLC=non-small cell lung cancer; OS-Overall survival, PFS=Progression-free survival; ASCO-American Society of Clinical Oncology; NEJM-New England
Journal of Medicine; ESMO-European Society for Medical Oncology
Roche
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OncologyView entire presentation