来源：肿瘤资讯
BMS于2016年11月10日宣布该公司免疫治疗药物Nivolumab在一项随机双盲的三期临床研究（ONO-4538-12）达到其主要研究终点：OS。
该研究旨在探索Nivolumab在复发／不能耐受标准治疗的不可手术切除的晚期／复发胃癌（包括食管胃交界处）患者中的有效性和安全性。日本小野制药（ Ono Pharmaceutical Co. Ltd. ）是BMS 联合开发者，具体实施ONO-4538-12研究。不久两家公司将与研究者一起公布研究结果。
BMS肿瘤研发中心领导Fouad Namouni博士指出：“晚期或复发胃癌患者总体预后不佳，患者在标准化疗失败或者不能耐受化疗后，缺乏有效治疗手段。根据ONO-4538-12研究结果，Opdivo是第一个在晚期胃癌患者中体现OS获益的肿瘤免疫药物”。
ONO-4538 研究是一项随机双盲多中心对照安慰剂的III期研究，该研究样本量480例，随机分为2组，2014年10月开始启动，主要中心在日本、韩国和中国台湾。该研究的主要入组标准为：大于20岁的男性或女性；不能手术切除的晚期或复发的胃癌（包括食管胃交界处）腺癌；复发或不能耐受标准治疗；ECOG评分0-1。预计研究结果在2017年ASCO GI会议上报道。
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原文：
Opdivo (nivolumab) Demonstrates Overall Survival Benefit in Patients With Unresectable Advanced or Recurrent Gastric Cancer in Phase 3 Study
Opdivo is the first and only Immuno-Oncology agent to demonstrate overall survival advantage in patients with unresectable advanced or recurrent gastric cancer refractory to, or intolerant of, standard therapy
Thursday, November 10, 2016 6:55 am EST
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that ONO-4538-12, a Phase 3, randomized, double-blind clinical trial evaluating the efficacy and safety of Opdivo (nivolumab) in patients with unresectable advanced or recurrent gastric cancer refractory to, or intolerant of, standard therapy, met its primary endpoint of overall survival (OS). Ono Pharmaceutical Co. Ltd. of Japan, Bristol-Myers Squibb’s development partner for Opdivo, conducted the ONO-4538-12 trial. The companies will work with investigators on the future presentation of the study results.
Fouad Namouni, M.D., head of development, Oncology, Bristol-Myers Squibb, commented, “Patients with advanced or recurrent gastric cancer generally have a poor prognosis, and there are currently no standard-of-care treatment options for patients who fail to respond to or who are intolerant of standard chemotherapy. With the results from the ONO-4538-12 study, Opdivo is now the first Immuno-Oncology agent to demonstrate a survival benefit for this patient population.”
About ONO-4538-12
ONO-4538-12 is a multicenter, double-blind, randomized, placebo-controlled, Phase 3 clinical trial conducted in Japan, Korea and Taiwan, aiming to evaluate the efficacy and safety of Opdivo in patients with unresectable advanced or recurrent gastric cancer, including gastroesophageal junction cancer, refractory to, or intolerant of, standard therapy. In this study, Opdivo 3 mg/kg or placebo was administered every two weeks until disease progression or discontinuation due to unacceptable toxicity. The primary endpoint, overall survival, was assessed for the superiority of Opdivo versus placebo.
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