Third- and fourth-line fruquintinib may improve progression-free survival (PFS) compared with placebo among patients with advanced non–small cell lung cancer (NSCLC), according to a study published in the Journal of Clinical Oncology.1

Previous studies demonstrated that fruquintinib — a high selective vascular endothelial growth factor receptor (VEGFR)-1, -2, and -3 kinase inhibitor — may have clinical value for patients who fail at least 2 prior lines of therapy.

For this double-blind phase 2 study ( Identifier: NCT02590965) conducted in China, researchers randomly assigned 91 patients who had failed 2 previous lines of chemotherapy — of which the first had to be a platinum-based doublet — to oral fruquintinib 5 mg daily or placebo. The median follow-up for survival was 28 months in the fruquintinib arm and 24.5 months in the placebo arm.

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The median PFS among patients who received fruquintinib was 3.8 months vs 1.1 months for placebo (hazard ratio [HR], 0.34; 95% CI, 0.20-0.57; P < .001). The 3- and 6-month survival rates were 90.2% and 67.2%, respectively, among patients treated with fruquintinib compared with 73.3% and 58.8% among patients treated with placebo.

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The objective response rate was 13.1% in the fruquintinib arm vs 0% for placebo (P = .041), and the disease control rate was 60.7% vs 13.3%, respectively (P < .001). 

Frequently reported treatment-emergent adverse events in the fruquintinib arm included hypertension, hand-foot syndrome, and proteinuria.

The authors concluded that “in patients with NSCLC who experienced treatment failure with two standard chemotherapies, fruquintinib may provide a clinically meaningful benefit.”


  1. Lu S, Chang J, Liu X, et al. Randomized, double-blind, placebo-controlled, multicenter phase II study of fruquintinib after two prior chemotherapy regimens in Chinese patients with advanced nonsquamous non-small-cell lung cancer. J Clin Oncol. 2018 Mar 12. doi: 10.1200/JCO.2017.76.7145 [Epub ahead of print]