Breast Cancer Drug Eribulin (Halaven) Fails Lung Cancer Trial
No survival improvement in phase III study
Disappointing results have been reported from a phase III study of the anticancer agent eribulin mesylate (Halaven, Eisai Co., Ltd.) in patients with advanced non–small-cell lung cancer (NSCLC) that had progressed after two or more prior treatment regimens.
The global, randomized, open-label trial compared the efficacy and safety of eribulin with that of a single treatment of the physician’s choice — consisting of docetaxel, pemetrexed, gemcitabine, or vinorelbine — in 540 patients with advanced NSCLC and disease progression after at least two prior regimens for advanced disease, which included a platinum-based regimen.
A preliminary analysis showed that the study did not meet its primary endpoint of improving overall survival (OS); the median OS in both treatment arms was 9.5 months (hazard ratio, 1.16; P = 0.1343).
The most common adverse events in the eribulin arm included decreased appetite, neutropenia, alopecia, nausea, and fatigue.
Eribulin is the first agent in the halichondrin class of microtubule dynamics inhibitors. It was approved by the FDA as a treatment for metastatic breast cancer in November 2010.
Source: Eisai Co., Ltd.; August 8, 2014.