[HTML][HTML] Pooled systemic efficacy and safety data from the pivotal phase II studies (NP28673 and NP28761) of alectinib in ALK-positive non-small cell lung cancer

JCH Yang, SHI Ou, L De Petris, S Gadgeel… - Journal of Thoracic …, 2017 - Elsevier
Introduction Alectinib demonstrated clinical efficacy and an acceptable safety profile in two
phase II studies (NP28761 and NP28673). Here we report the pooled efficacy and safety …

Pooled overall survival and safety data from the pivotal phase II studies (NP28673 and NP28761) of alectinib in ALK-positive non-small-cell lung cancer

SHI Ou, SM Gadgeel, F Barlesi, JCH Yang, L De Petris… - Lung Cancer, 2020 - Elsevier
Objectives A pooled analysis of two open-label phase II studies of alectinib (NP28673
[NCT01801111] and NP28761 [NCT01871805]) demonstrated clinical activity in patients …

Alectinib versus crizotinib in treatment-naive advanced ALK-positive non-small cell lung cancer (NSCLC): Primary results of the global phase III ALEX study.

AT Shaw, S Peters, T Mok, SM Gadgeel, JS Ahn… - 2017 - ascopubs.org
LBA9008 Background: Alectinib, a TKI targeting ALK, has shown robust efficacy in crizotinib-
naïve/resistant ALK+ NSCLC. J-ALEX showed superiority of alectinib 300mg BID vs …

Final progression-free survival results from the J-ALEX study of alectinib versus crizotinib in ALK-positive non-small-cell lung cancer

K Nakagawa, T Hida, H Nokihara, M Morise, K Azuma… - Lung Cancer, 2020 - Elsevier
Abstract Objectives The J-ALEX study compared the efficacy and safety of alectinib with
crizotinib in Japanese patients with advanced ALK-positive non-small-cell lung cancer …

Three-Year Follow-Up of an Alectinib Phase I/II Study in ALK-Positive Non–Small-Cell Lung Cancer: AF-001JP

T Tamura, K Kiura, T Seto, K Nakagawa… - Journal of Clinical …, 2017 - ascopubs.org
Purpose Alectinib is an anaplastic lymphoma kinase (ALK)–specific kinase inhibitor that
seems to be effective against non–small-cell lung cancer (NSCLC) with a variety of ALK …

Alectinib versus Crizotinib in Untreated ALK-Positive Non–Small-Cell Lung Cancer

S Peters, DR Camidge, AT Shaw… - … England Journal of …, 2017 - Mass Medical Soc
Background Alectinib, a highly selective inhibitor of anaplastic lymphoma kinase (ALK), has
shown systemic and central nervous system (CNS) efficacy in the treatment of ALK-positive …

A phase II, open-label, multicenter study of the ALK inhibitor alectinib in an ALK+ non-small-cell lung cancer (NSCLC) US/Canadian population who had progressed …

L Gandhi, A Shaw, SM Gadgeel, G Riely, J Cetnar… - 2015 - ascopubs.org
8019 Background: Crizotinib is an approved treatment for patients (pts) with ALK-rearranged
(ALK+) NSCLC. However, progression on crizotinib, particularly in the CNS, frequently …

[HTML][HTML] Updated overall survival and final progression-free survival data for patients with treatment-naive advanced ALK-positive non-small-cell lung cancer in the …

T Mok, DR Camidge, SM Gadgeel, R Rosell… - Annals of oncology, 2020 - Elsevier
Background The ALEX study demonstrated significantly improved progression-free survival
(PFS) with alectinib versus crizotinib in treatment-naive ALK-positive non-small-cell lung …

Alectinib versus crizotinib in patients with ALK-positive non-small-cell lung cancer (J-ALEX): an open-label, randomised phase 3 trial

T Hida, H Nokihara, M Kondo, YH Kim, K Azuma… - The Lancet, 2017 - thelancet.com
Background Alectinib, a potent, highly selective, CNS-active inhibitor of anaplastic
lymphoma kinase (ALK), showed promising efficacy and tolerability in the single-arm phase …

Pooled Analysis of CNS Response to Alectinib in Two Studies of Pretreated Patients With ALK-Positive Non–Small-Cell Lung Cancer

SM Gadgeel, AT Shaw, R Govindan… - Journal of Clinical …, 2016 - ascopubs.org
Purpose Alectinib has shown activity in the CNS in phase I and II studies. To further evaluate
this activity, we pooled efficacy and safety data from two single-arm phase II studies …