Fruquintinib in Pretreated Advanced NSCLC
In a Chinese phase II trial reported in the Journal of Clinical Oncology, Lu et al found that the VEGFR-1,-2, and-3 kinase inhibitor fruquintinib was active in patients with advanced nonsquamous non-small cell lung cancer (NSCLC) who progressed after two prior chemotherapy regimens.
Study Details
In the double-blind trial, 91 patients from 12 sites with progression after two chemotherapy regimens including a platinum-based doublet were randomized 2:1 between June 2014 and May 2015 to receive oral fruquintinib 5 mg once daily in 4-week cycles of 3 weeks on treatment and 1 week off (n = 61) or placebo (n = 30), both with best supportive care. Randomization was stratified by EGFR status.
The primary endpoint was progression-free survival on blinded image central review committee assessment. Approximately half of patients in both groups had EGFR-mutant disease.
Progression-Free Survival
Median follow-up for survival was 28.0 months in the fruquintinib group and 24.5 months in the placebo group. Median progression-free survival was 3.8 months in the fruquintinib group vs 1.1 months in the placebo groups (hazard ratio [HR] = 0.34, P < .001). Median overall survival was 7.7 vs 9.7 months (HR = 0.70, P = .152), with 3-month rates of 90.2% vs 73.3% and 6-month rates of 67.2% vs 58.8%. Median overall survival was 8.4 vs 5.5 months in patients with EGFR-mutant disease (HR = 0.58, P = .11). Objective response rates were 13.1% vs 0% and disease control rates were 60.7% vs 13.3%.
Adverse Events
Grade ≥ 3 adverse events occurred in 52% of the fruquintinib group vs 34% of the placebo group, with the most common in the fruquintinib group being hypertension (8.2%), hand-foot syndrome (4.9%), and proteinuria (4.9%). Serious adverse events occurred in 13.1% vs 13.3% of patients.
The investigators concluded: “Third- and fourth-line fruquintinib for advanced NSCLC was superior to placebo and had an acceptable safety profile.”
The study was supported by Hutchison MediPharma (Shanghai).
Shun Lu, MD, of Shanghai Lung Cancer Center, Jiao Tong University, is the corresponding author for the Journal of Clinical Oncology article.
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