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 (ClinicalTrials.gov 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.
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.
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.”
- 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]