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

Sai Hong Ignatius Ou, Shirish M. Gadgeel, Fabrice Barlesi, James Chih Hsin Yang, Luigi De Petris, Dong Wan Kim, Ramaswamy Govindan, Anne Marie Dingemans, Lucio Crino, Hervé Léna, Sanjay Popat, Jin Seok Ahn, Eric Dansin, Emmanuel Mitry, Barbara Müller, Walter Bordogna, Bogdana Balas, Peter N. Morcos, Alice T. Shaw

Research output: Contribution to journalArticlepeer-review

8 Scopus citations

Abstract

Objectives: A pooled analysis of two open-label phase II studies of alectinib (NP28673 [NCT01801111] and NP28761 [NCT01871805]) demonstrated clinical activity in patients with advanced, anaplastic lymphoma kinase-positive (ALK+) non-small-cell lung cancer (NSCLC) previously treated with crizotinib. Longer-term and final pooled analyses of overall survival (OS) and safety data from the two studies are presented here. Patients and methods: The pooled population totaled 225 patients (NP28673: n = 138, NP28761: n = 87) who received 600 mg oral alectinib twice daily until disease progression, death, or withdrawal. OS was defined as the time from date of first treatment to date of death, regardless of cause. OS was estimated using Kaplan–Meier methodology, with 95% confidence intervals (CIs) determined using the Brookmeyer–Crowley method. Safety was assessed through adverse event (AE) reporting. Results: Baseline characteristics were generally comparable between the studies. At final data cutoff (October 27, 2017 [NP28673], October 12, 2017 [NP28761]; median pooled follow-up time, ∼21 months), 53.3% of patients had died, 39.1% were alive and in follow-up, and 7.6% had withdrawn consent or were lost to follow-up. Alectinib demonstrated a median OS of 29.1 months (95% CI 21.3–39.0). No new or unexpected safety findings were observed. The most common all-grade AEs included constipation (39.1%), fatigue (35.1%), peripheral edema (28.4%), myalgia (26.2%), and nausea (24.0%). Conclusion: Updated results from this pooled analysis further demonstrate that alectinib has robust clinical activity and a manageable safety profile in patients with advanced, ALK+ NSCLC pretreated with crizotinib.

Original languageEnglish
Pages (from-to)22-27
Number of pages6
JournalLung Cancer
Volume139
DOIs
StatePublished - Jan 2020

Keywords

  • ALK+
  • Alectinib
  • NSCLC
  • Overall survival
  • Pooled analysis
  • Safety

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