卫材抗癌药Halaven III期非小细胞肺癌失败（Study 302试验）

卫材（Eisai）8月8日公布了抗癌药物Halaven（eribulin mesylate）III期研究（Study 302）的积极顶线数据。

Study 302是一项全球、多中心、随机、开放标签III期研究，在540例既往接受过至少2种晚期治疗方案（包括含铂化疗方案）但病情继续恶化的晚期非小细胞肺癌（NSCLC）患者中开展，研究中将Halaven与医生选择（TPC）的单个药物（多西他赛，培美曲塞，吉西他滨或长春瑞滨）进行了疗效和安全性比较。

初步分析数据显示，该项研究未能达到改善总生存期（OS）的主要终点，2个治疗组的平均OS均为9.5个月（HR=1.16，p=0.1343）。初步的安全性分析数据表明，Halaven治疗组最常见的不良反应为食欲减退、白细胞减少、脱发、恶心和疲劳，与Halaven已知的副作用档案一致。

非小细胞肺癌（NSCLC）是一种难以治疗的肿瘤类型，对于既往已接受过2种晚期治疗方案的患者群体，目前尚无化疗药物被公认为标准治疗，该群体中仍存在着远未满足的医疗需求。

Halaven是一种合成的大田软海绵素（halichondrin B）类似物，该药是唯一的一种单药化疗药物，由卫材内部研发部门发现和开发。Halichondrin B是一种从生长在日本沿海的黑色海绵上发现的物质，能够有效治愈肿瘤。Halaven于2010年在美国上市，迄今全球共有4.9万例患者接受Halaven治疗。（生物谷Bioon.com）



英文原文：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

TOKYO, Japan I August 8, 2014 I Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today top-line results of the investigational Phase III study (Study 302) of ist 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.

"We know that NSCLC is a difficult-to-treat tumor type with no chemotherapy recognized as a standard treatment following two prior regimens. This is a disease which still has significant unmet medical needs,” said Kenichi Nomoto, PhD, President, Oncology Product Creation Unit, Eisai Product Creation Systems.“ While eribulin did not show an improvement in OS compared to TPC in this study, the trial demonstrates that eribulin has anticancer activity in advanced NSCLC patients following at least two prior regimens and further analyses of the results are ongoing. These results do not affect the current approved indications for Halaven.”

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. Eisai remains committed to the therapeutic area of oncology and to continued research with eribulin in order to help contribute to the lives of patients and their families.