Time to response in patients with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) receiving alectinib in the phase ii NP28673 and NP28761 studies

Shirish Gadgeel, Alice T. Shaw, Fabrice Barlesi, Lucio Crino, James C.H. Yang, Anne Marie Dingemans, Dong Wan Kim, Filippo de Marinis, Mathias Schulz, Shiyao Liu, Ravindra Gupta, Vlatka Smoljanovic, Sai Hong Ignatius Ou

Research output: Contribution to journalArticle

Abstract

Introduction: Alectinib is a highly selective and potent ALK inhibitor, approved for the treatment of patients with metastatic ALK+ NSCLC based on results from the Phase II global NP28673 (NCT01801111) and North American NP28761 (NCT01871805) studies. Methods: This exploratory analysis of two Phase II studies of alectinib (NP28673/ NP28761) investigated time to systemic response (TTR) and time to central nervous system (CNS) response (TTCR) in patients with previously treated advanced anaplastic lymphoma kinase fusion gene-positive (ALK+) non-small-cell lung cancer. Patients (n=225) received 600 mg oral alectinib twice daily and had scans every 6/8 weeks (NP28673/NP28761). Results: For NP28673 and NP28761, respectively: median follow-up was 21.3 months/17.0 months; most responders (72.6%/82.9%) responded by the first disease assessment; median TTR was 8 weeks (95% confidence interval [CI]: 8.00–8.14)/6 weeks (95% CI: 5.86–6.14); median TTCR in responders with measurable baseline CNS disease was 8 weeks (95% CI: 7.86–10.29)/6 weeks (95% CI: 5.71–not evaluable). Similar results were observed regardless of measurable/non-measurable disease. Discussion: These data suggest that alectinib achieves a rapid response in patients, both systemically and in the CNS.

Original languageEnglish
Pages (from-to)125-130
Number of pages6
JournalLung Cancer: Targets and Therapy
Volume10
DOIs
Publication statusPublished - Jan 1 2019

Keywords

  • Alectinib
  • Non-small-cell lung cancer
  • NP28673
  • NP28761
  • Time to response

ASJC Scopus subject areas

  • Oncology

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    Gadgeel, S., Shaw, A. T., Barlesi, F., Crino, L., Yang, J. C. H., Dingemans, A. M., Kim, D. W., Marinis, F. D., Schulz, M., Liu, S., Gupta, R., Smoljanovic, V., & Ou, S. H. I. (2019). Time to response in patients with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) receiving alectinib in the phase ii NP28673 and NP28761 studies. Lung Cancer: Targets and Therapy, 10, 125-130. https://doi.org/10.2147/LCTT.S209231