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.


Keywords: alectinib, non-small-cell lung cancer, NP28673, NP28761, time to response


INTRODUCTION


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Anaplastic lymphoma kinase fusion gene-positive (ALK+) non-small-cell lung cancer (NSCLC) is a distinct subgroup of lung cancer, occurring in approximately 5% of patients with advanced NSCLC.1 The majority of patients treated with crizotinib relapse within the first year, due to either poor penetration to the central nervous system (CNS)2 or development of secondary ALK resistance mutations.1

Alectinib is a highly selective and potent ALK inhibitor, approved by the US Food and Drug Administration for the treatment of patients with metastatic ALK+ NSCLC. The approval of alectinib in patients with metastatic ALK+ NSCLC whose disease had progressed on, or who were intolerant to, crizotinib was based on data from the global NP28673 (NCT01801111) and North American NP28761 (NCT01871805) studies. A pooled analysis of data from these studies showed that alectinib achieved high overall response rates (51.3%, 95% confidence interval [CI] 44.0–58.6; data cutoff February 1, 2016 [NP28673] and January 22, 2016 [NP28761]), and that responses were durable (median 14.9 months).3

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Alectinib has also demonstrated consistent CNS efficacy. In a pooled analysis from NP28673 and NP28761, the CNS response rate was 64.0% (95% CI: 49.2–77.1) in patients with measurable CNS disease at baseline. The median duration of response in the CNS was 10.8 months.4 The CNS disease control rate was 90.0% (95% CI: 78.2–96.7) in patients with measurable CNS disease at baseline and 86% (95% CI: 79.1–91.4) in patients with measurable and non-measurable CNS disease at baseline.5

This exploratory analysis investigated how rapidly patients achieve benefit from alectinib, in terms of time to systemic response (TTR) and time to CNS response (TTCR).

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