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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.

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.
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Yang JC, Ou SI, De Petris L, Gadgeel S, Gandhi L, Kim DW, Barlesi F, Govindan R, Dingemans AC, Crino L, Lena H, Popat S, Ahn JS, Dansin E, Golding S, Bordogna W, Balas B, Morcos PN, Zeaiter A, Shaw AT,


Yang JC, Ou SI, De Petris L, Gadgeel S, Gandhi L, Kim DW, Barlesi F, Govindan R, Dingemans AC, Crino L, Lena H, Popat S, Ahn JS, Dansin E, Golding S, Bordogna W, Balas B, Morcos PN, Zeaiter A, Shaw AT, (click to view)

Yang JC, Ou SI, De Petris L, Gadgeel S, Gandhi L, Kim DW, Barlesi F, Govindan R, Dingemans AC, Crino L, Lena H, Popat S, Ahn JS, Dansin E, Golding S, Bordogna W, Balas B, Morcos PN, Zeaiter A, Shaw AT,

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Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer 2017 07 05() pii S1556-0864(17)30570-1
Abstract
INTRODUCTION
Alectinib demonstrated clinical efficacy and an acceptable safety profile in two phase II studies (NP28761 and NP28673). Here we report pooled efficacy and safety data after 15 and 18 months’ longer follow-up than the respective primary analyses.

MATERIALS AND METHODS
Enrolled patients had ALK-positive NSCLC and had progressed on, or were intolerant to, crizotinib. Patients received oral alectinib 600 mg twice daily. The primary endpoint in both studies was objective response rate (ORR) assessed by an independent review committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Secondary endpoints included disease control rate (DCR); duration of response (DOR); progression-free survival (PFS); overall survival (OS); and safety.

RESULTS
The pooled dataset included 225 patients (n=138 NP28673; n=87 NP28761). The response-evaluable (RE) population included 189 patients (84%; n=122 NP28673; n=67 NP28761). In the RE population, ORR by IRC was 51.3% (95% confidence interval [CI], 44.0-58.6; all partial responses), DCR was 78.8% (95% CI, 72.3-84.4), and median DOR was 14.9 months (95% CI, 11.1-20.4) after 58% of events. Median PFS by IRC was 8.3 months (95% CI, 7.0-11.3) and median OS was 26.0 months (95% CI, 21.4-not estimable). Grade ≥3 adverse events (AEs) occurred in 40% of patients, 6% withdrew treatment due to AEs and 33% had AEs leading to dose interruptions/modification.

CONCLUSION
This pooled data analysis confirmed the robust systemic efficacy of alectinib in ALK-positive NSCLC with a durable response rate. Alectinib also had an acceptable safety profile with a longer duration of follow-up.

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