A phase III trial failed to demonstrate superiority of eribulin over treatment of physician’s choice in patients with heavily pretreated non–small-cell lung cancer.
A phase III trial failed to demonstrate superiority of eribulin over treatment of physician’s choice (TPC) in patients with heavily pretreated non–small-cell lung cancer (NSCLC). The agent did have activity in this setting, but did not improve outcomes over other options.
“Despite the availability of second-line therapies, including pemetrexed, erlotinib, and docetaxel, clinical evidence of third-line or later treatment options still remains limited,” wrote study authors led by Nobuyuki Katakami, MD, PhD, of the Institute of Biomedical Research and Innovation Hospital in Kobe, Japan.
Eribulin is a microtubule dynamics inhibitor, and earlier research had suggested it may be effective in NSCLC. The new trial was a randomized, open-label, phase III study including 540 patients who had received at least two prior therapies, including a platinum-based doublet and an EGFR tyrosine kinase inhibitor. They were randomized to receive either eribulin (270 patients) or TPC (270 patients). Results of the study were published in Annals of Oncology.
In the TPC cohort, 27% received vinorelbine, 32% received gemcitabine, 24% received docetaxel, and 17% received pemetrexed. Most patients had received at least three prior treatment regimens; patient characteristics were well balanced between the groups.
The median overall survival was 9.5 months for both the eribulin and the TPC groups, for a hazard ratio (HR) of 1.16 (95% CI, 0.95–1.41; P = .13). The median progression-free survival was also similar, at 3.0 months with eribulin and 2.8 months with TPC, for an HR of 1.09 (95% CI, 0.90–1.32; P = .39).
The objective response rate was 12% with eribulin, and 15% with TPC; 51% of eribulin patients had stable disease, compared with 43% of those in the TPC group. The clinical benefit rate and disease control rate were also no different between the study arms, and quality-of-life measures were also similar.
Serious adverse events were seen in 36% of eribulin patients and in 32% of TPC patients. Grade 3 or higher asthenia occurred more frequently in the eribulin group (8.2% vs 2.6%). One treatment-related death occurred with eribulin (cardiac failure).
“Our results are in contrast to those of previous phase III trials with eribulin in patients with metastatic breast cancer or advanced liposarcoma or leiomyosarcoma, in which a significant improvement in overall survival with eribulin vs comparator was observed,” the authors wrote. Still, the agent has shown activity in the third-line setting, with a manageable safety profile, they concluded.