百时美施贵宝Yervoy III期前列腺癌Study 043研究失败

关键词:百时美施贵宝,Yervoy,ipilimumab,前列腺癌

2013年9月13日讯 /生物谷BIOON/ --百时美施贵宝(BMS)9月12日公布了有关抗癌药Yervoy(ipilimumab,易普利姆玛)的一项III期临床研究(Study 043)的数据。该项研究在既往经多西紫杉醇(docetaxel)治疗的晚期转移性去势抵抗性前列腺癌(mCRPC)患者中开展,将Yervoy 10mg/kg与安慰剂进行了疗效对比。结果表明,总生存期(OS)数据未取得统计学意义(11.2个月 vs 10.0个月,HR=0.85,95%CI=0.72-1.00,P=0.053),未能达到研究的主要终点。但在一些疗效终点上观察到了抗肿瘤活性,包括无进展生存期(PFS)。既定亚组分析数据预示,该药在那些不是那么晚期的mCRPC中具有最佳反应,包括癌症未扩散至肺脏和肝脏的患者。该项研究的数据,将提交至2013年9月28日举行的欧洲癌症大会(2013 European Cancer Congress)。

目前,Yervoy 3mg/kg单药疗法已获全球40多个国家批准,用于不可切除性或转移性黑色素瘤(melanoma)患者的治疗。

既定亚组分析数据,有利于Yervoy III期项目中另一项正在开展的III期随机双盲研究(Study 095),该研究在既往未经细胞毒药物治疗的无症状或有轻微症状的mCRPC患者(癌细胞尚未扩散至肺脏和肝脏)中开展,将Yervoy 10mg/kg与安慰剂进行了疗效比较,该项研究预计将于2015年完成。

此外,百时美施贵宝也在评价输液给药Yervoy在各种癌症中的疗效,包括肺癌、胃癌、卵巢癌。

关于Yervoy:

Yervoy是一种重组人单克隆抗体,阻断细胞毒性T淋巴细胞相关抗原4(CTLA-4)。CTLA-4是一种T细胞活化的负调控因子,Yervoy与CTLA-4结合后,能阻断CTLA-4与其配体CD80/CD86的相互作用。阻断CTLA-4已被证明能够增强T细胞的活化和增殖。Yervoy在黑色素瘤患者中的疗效作用机制,是间接通过T细胞介导的抗肿瘤免疫反应。FDA于2011年3月批准Yervoy 3mg/kg单药疗法用于不能手术切除或转移性黑色素瘤患者的治疗,目前该药已获全球40多个国家批准。(生物谷Bioon.com)

英文原文:Bristol's Yervoy falls short in prostate cancer study

(Reuters) - Bristol-Myers Squibb Co's immunotherapy drug Yervoy failed to significantly prolong survival among patients with advanced prostate cancer who had previously received chemotherapy, according to limited data from the first late-stage study of the drug for the condition.

Yervoy (ipilimumab) frees the immune system to attack and kill cancer cells by blocking the action of a protein called CTLA-4. The closely followed drug was approved in 2011 to treat melanoma, the most deadly form of skin cancer, and is well on its way to achieving annual blockbuster sales of $1 billion.

An abstract, or limited summary, of findings from the prostate cancer study was released on Thursday. The trial involved almost 800 patients that had failed to benefit from drugs that lower the amount of testosterone - the male hormone that fuels prostate cancer - and from treatment with a standard chemotherapy called docetaxel.

Half the patients in the trial received Yervoy after treatment with a dose of radiation, while others received a placebo after radiation.

Patients taking Yervoy lived, on average, 11.2 months, compared with 10 months for those in the placebo group, a difference that was deemed slightly below statistical significance.

Drug-related side effects, including gastrointestinal problems, were similar to those seen with Yervoy in melanoma trials.

Researchers are slated to present full results of the trial, nicknamed the "043" study, late this month at a medical meeting in Amsterdam.

The best responses to Yervoy in the prostate cancer study were in patients with less-advanced disease, including those whose cancer had not spread to the lung and liver, according to the abstract.

That could bode well for a second Phase III trial of Yervoy, expected to be completed by 2015, which has enrolled patients who are asymptomatic or have only mild symptoms of prostate cancer, and whose cancer has not spread to the lungs or liver. Although previously treated with anti-testosterone drugs, they have not taken chemotherapy.

One of the leading approved treatments for prostate cancer is Johnson & Johnson's Zytiga. In trials of patients that had not previously been treated with chemotherapy, those taking Zytiga, on average, lived five months longer than those who received a placebo.

The American Cancer Society last year estimated that more than 28,000 U.S. men would die from prostate cancer in 2012, making it the second leading cause of cancer death behind lung cancer.

Bristol-Myers is also testing Yervoy, which is given by infusion, in a variety of other cancers, including those of the lung, stomach and ovaries.

(责任编辑:lilizhao)

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