Eisai Announces Top-Line Phase III Trial Results of Eribulin in Patients with Advanced Non-Small Cell Lung Cancer Following at Least Two Prior Regimens

Editor’s note: Researchers conducted a clinical trial with volunteer patients to test whether anticancer drug eribulen (brand name Halaven) might help treat people with advanced non-small cell lung cancer that has worsened despite two or more treatment attempts. Some of the patients enrolled in the trial were treated with eribulen and, for comparison, the rest received standard treatments. Unfortunately, the patients who were treated with eribulen did not survive significantly longer than the patients who received standard treatments, so at this time, it does not appear to be a good alternative for these types of patients.

“Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, ‘Eisai’) announced today top-line results of the investigational Phase III study (Study 302) of its in-house developed anticancer agent eribulin mesylate (‘eribulin,’ Brand name: Halaven®) in patients with advanced non-small cell lung cancer (NSCLC) that has progressed following two or more prior treatment regimens.

“Study 302 was a global, multicenter, randomized, open-label Phase III trial comparing the efficacy and safety of eribulin with a single treatment of physician’s choice (TPC) consisting of either docetaxel, pemetrexed, gemcitabine or vinorelbine in 540 patients with advanced NSCLC and disease progression following at least two prior regimens for advanced disease, which included a platinum-based regimen.

“The preliminary analysis of the study showed that Study 302 did not meet its primary endpoint of improving overall survival (OS); the median OS in both arms was 9.5 months (Hazard Ratio 1.16; p=0.1343). The preliminary safety analysis showed that the most common adverse reactions in the eribulin arm were decreased appetite, neutropenia, alopecia, nausea and fatigue, which were consistent with the known side-effect profile of eribulin.”