A New ALK Inhibitor for Crizotinib-Refractory Non–Small-Cell Lung Cancer

Patients with ALK-rearranged non–small-cell lung cancer (NSCLC) benefit from anaplastic lymphoma kinase (ALK) inhibitors such as crizotinib and ceritinib, although almost all experience progression, and many develop central nervous system (CNS) metastases as the first site of progression.

Now, investigators have conducted an industry-supported, global, single-arm, phase II study to assess the efficacy and safety of the newly approved, oral tyrosine kinase ALK inhibitor alectinib (600 mg twice daily) in 138 patients with crizotinib-refractory ALK-positive disease. Of these, 61% had CNS metastases at baseline.

Results were as follows:

• In 122 evaluable patients, the objective response rate (ORR; the primary endpoint) was 50%, the disease control …