Date: 2014-08-08
Type of information: Results
phase: 3
Announcement: results
Company: Eisai (Japan)
Product: Halaven® (eribulin mesylate)
Action
mechanism: Eribulin is a non-taxane, microtubule dynamics inhibitor indicated for the treatment of patients with breast cancer who have previously received at least two chemotherapeutic regimens for metastatic disease and whose prior therapy should have included an anthracycline and a taxane. Eribulin belongs to a class of antineoplastic agents, the halichondrins, which are natural products, isolated from the marine sponge Halichondria okadai. It is believed to work by inhibiting the growth phase of microtubule dynamics without affecting the shortening phase and sequesters tubulin into non-productive aggregates.
Disease: advanced non-small cell lung cancer (NSCLC) that has progressed following two or more prior treatment regimens
Therapeutic area: Cancer - Oncology
Country:
Trial
details: 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.
Latest
news: * On August 8, 2014, Eisai announced top-line results of the investigational Phase III study (Study 302) of its in-house developed anticancer agent eribulin mesylate (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. Detailed results of the study will be presented at a future academic conference. Eribulin, first in the halichondrin class of microtubule dynamics inhibitors with a novel mechanism of action, was first approved as a treatment for metastatic breast cancer in the United States in November 2010, and is approved in more than 50 countries worldwide, including countries in Europe and Asia, as well as Japan.
