Lead author, Alice T. Shaw, MD, PhD, from the Massachusetts General Hospital, reviews the first published results from a randomized phase III trial investigating crizotinib in patients with ALK-positive non-small cell lung cancer.
Lead author, Alice T. Shaw, MD, PhD, an attending physician in the Center for Thoracic Cancers at Massachusetts General Hospital, reviews the first published results from a randomized phase III trial investigating crizotinib in patients with ALK-positive non-small cell lung cancer (NSCLC).
In August 2011 the FDA approved crizotinib to treat patients with advanced ALK-positive NSCLC. This accelerated approval was based on 2 single-arm trials that demonstrated high objective response rates, Shaw notes. In June 2013, results from the first randomized phase III trial comparing crizotinib to chemotherapy were published in The New England Journal of Medicine.
In this trial, 347 patients with locally advanced or metastatic ALK-positive NSCLC who had received one prior platinum-based regimen were randomized to receive crizotinib or chemotherapy. The primary endpoint of the trial was progression-free survival (PFS) with several secondary endpoints, including response rates.
The median PFS was 7.7 months in the crizotinib group compared to 3.0 months for those receiving chemotherapy (HR = 0.49; 95% CI, 0.37 - 0.64; P < 0.001). Moreover, Shaw adds, response rates nearly tripled from 20% with chemotherapy to 65% for crizotinib treated patients. These findings confirm that patients with advanced ALK-positive NSCLC receive greater benefit from crizotinib than standard chemotherapy, Shaw summarizes.