Alectinib is highly active and well tolerated in patients with advanced, crizotinib-refractory anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), including those with central nervous system (CNS) metastases, a new study published online ahead of print in the Journal of Clinical Oncology has shown.1
Crizotinib, a tyrosine kinase inhibitor (TKI), improves progression-free survival compared with chemotherapy in ALK-rearranged NSCLC, but disease progression typically occurs. Therefore, researchers sought to evaluate the safety and efficacy of alectinib, a potent and selective ALK TKI that possesses excellent CNS penetration, in patients with crizotinib-refractory ALK-positive NSCLC.
For the phase 2 study, researchers enrolled 138 patients, of which 84 had CNS metastases and 96 had received prior chemotherapy. All participants received alectinib 600 mg orally twice daily.
Results showed that among the 122 evaluable patients, the overall response rate was 50% (95% CI, 41 – 59) with a median duration of response of 11.2 months (95% CI, 9.6 – not reached). Of those who had prior chemotherapy, the overall response rate was 45% (95% CI, 35 – 55).
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Researchers found that median progression-free survival for all 138 patients was 8.9 months (95% CI, 5.6 – 11.3), and the CNS disease control rate was 83% (95% CI, 74 – 91) with a median CNS duration of response of 10.3 (95% CI, 7.6 – 11.2).
In regard to safety, the most common adverse events associated with alectinib treatment were constipation, fatigue, and peripheral edema. Adverse events were most grade 1 or 2.
- Ou SI, Ahn JS, De Petris L, et al. Alectinib in crizotinib-refractory ALK-rearranged non-small-cell lung cancer: a phase II global study [published online ahead of print November 23, 2015]. J Clin Oncol. doi: 10.1200/JCO.2015.63.9443.