Roche Pharmaceutical Development and Sales Overview
Alecensa (alectinib, RG7853)
New CNS-active inhibitor of anaplastic lymphoma kinase
Indication
Treatment-naïve
ALK+ advanced NSCLC
Adjuvant ALK+ NSCLC
Phase/study
# of patients
Phase III
ALEX
N=286
Design
Primary endpoint
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ARM A: Alecensa 600mg BID
ARM B: Crizotinib 250mg BID
Progression-free survival
Recruitment completed Q3 2015
Primary endpoint met Q1 2017
Data presented at ASCO 2017, 2018, ESMO 2017, 2018
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Status
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Data published in NEJM 2017; 377:829-838
CT Identifier
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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
Phase III
ALINA
N=255
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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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