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[其他] ESMO:制药巨头最新研究进展盘点

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xiaoxiao 发表于 2014-10-4 08:26:09 | 只看该作者 回帖奖励 |倒序浏览 |阅读模式

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                               ESMO:制药巨头最新研究进展盘点
                                                                                                            来源:生物谷 2014-10-03 15:19



                               
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2014年10月3日讯 /生物谷BIOON/ --2014年全球第二大肿瘤盛会-第39届欧洲临床肿瘤学会(ESMO)年会于当地时间2014年9月26日星期五下午14:30在西班牙首都马德里(Madrid)开幕,本届主题为“精准医学用于癌症治疗”。本次盛会(9月26日-30日)将有全球1.6万名代表出席,共同分享肿瘤医学中癌症研究、治疗和临床方面的最新进展。

截至目前,ESMO会议上已经公布了一些突破性的新数据。生物谷小编对数个制药巨头的最新研究进展进行了盘点:

——罗氏(Roche):HER2阳性转移性乳腺癌III期CLEOPATRA研究,Perjet在HER2+乳腺癌中取得有史以来最长的总生存期。Perjet/赫赛汀/多西他赛化疗联合治疗组总生存期(OS)达56.5个月,赫赛汀/多西他赛化疗治疗组OS数据未40.8个月。

——诺华(Novartis):肺癌药物Zykadia无进展生存期(PFS)数据破纪录。在一项I期临床研究中,在间变性淋巴瘤激酶阳性(ALK+)非小细胞肺癌(NSCLC)患者中,Zykadia用作首个ALK疗法时,平均无进展生存期(PFS)为18.4个月,这是在ALK+NSCLC群体中有史以来报道的最长的PFS数据。此外,Zykadia在脑转移患者中具有类似疗效,表明Zykadia有望治疗ALK+NSCLC脑转移群体。Zykadia是辉瑞(Pfizer)ALK抑制剂Xalkori的竞争对手。

——葛兰素史克(GSK):在一项黑色素瘤头对头研究中,GSK复方药Tafinlar/Mekinist治疗组无进展生存期(PFS)为11.4个月,罗氏Zelboraf治疗组PFS为7.3个月。在另一项研究中,罗氏Zelboraf+cobimetinib组合疗法PFS为9.9个月,Zelboraf治疗组为6.2个月。Tafinlar/Mekinist复方已获FDA批准,罗氏cobimetinib正在等待欧盟批准。

——葛兰素史克(GSK):一项III期BREAK-3研究中,Tafinlar可帮助患者存活更久。该研究在携带BRAF V600E突变的转移性黑色素瘤患者中开展,Tafinlar治疗组有45%的患者在2年后依然存活,以达卡巴嗪(DTIC)作为起始治疗药物的治疗组比例为32%。 最终的总生存期数据将于2016年获得。此前,Tafinlar基于无进展生存期(PFS)数据获批。

——百时美施贵宝(BMS):黑色素瘤III期CheckMate-037研究,在既往经Yervoy(ipilimumab)治疗的晚期黑色素瘤患者中开展,免疫疗法PD-1抑制剂Opdivo(nivolumab)治疗组客观缓解率(ORR)为32%,化疗组ORR为13%。

——默沙东(Merck & Co):晚期膀胱癌Ib期KEYNOTE-012中,新获批的免疫疗法PD-1抑制剂Keytruda(pembrolizumab)作为单药治疗时,总缓解率为24%,完全缓解率为11%。III期研究将于年底启动。今年9月FDA批准Keytruda治疗黑色素瘤,但该适应症潜力有限,前景仍依赖其他肿瘤,如非小细胞肺癌(NSCLC)。

——辉瑞(Pfizer):ALK+肺癌药物Xalkori可能新增一个药物靶标。《新英格兰医学杂志》(New England Journal of Medicine)报道的一项研究表明,Xalkori可抑制ROS-1基因重排肺癌的肿瘤生长。该研究涉及3650患者,研究中Xalkori使肿瘤体积显著缩小。这些数据证实,ROS1可能是Xalkori的一个新靶标。

——强生(JNJ):前列腺癌III期COU-AA-302研究表明,Zytiga联合泼尼松使患者生存更久。联合治疗组总生存期为34.7个月,泼尼松治疗组为30.3个月。此前,基于该项数据,强生已提交监管申请,更新Zytiga药物标签。(生物谷Bioon.com)

英文原文:ESMO: The latest skinny on drugs from Pfizer, Novartis, GSK, Merck, BMS

The European Society for Medical Oncology meeting may not be as enormous as its U.S. counterpart, but plenty of news is flowing. And some of the new data presented in Madrid over the weekend is pretty dramatic. For instance, check out the results for Perjeta, which helped patients live far longer with metastatic breast cancer. Here are some other highlights.

——Novartis ($NVS) trumpeted data on its lung cancer drug Zykadia, the ALK-inhibitor rival to Pfizer's ($PFE) Xalkori. The Novartis drug staved off cancer growth for an average of 18 months when used as a first ALK therapy, and 9 months on average in all patients, regardless of prior treatment. The drug also showed activity in the brain, suggesting that it might help treat brain metastases, the company said. Release

——GlaxoSmithKline's ($GSK) melanoma-fighting duo Tafinlar and Mekinist helped stave off cancer growth by 11.4 months, compared with 7.3 months in patients using Roche's ($RHHBY) Zelboraf, a head-to-head study found. The already approved pair may find itself competing against a Zelboraf combo, which cut the risk of cancer progression by one-half when compared with Zelboraf alone in another ESMO study. The Zelboraf partner, cobimetinib, is awaiting approval in Europe. Release | Report

——When used on its own, GSK's Tafinlar may help patients live longer, with 45% of people treated with the drug alive two years afterward, compared with 32% of patients who started out on another drug. Final overall survival numbers won't be available until 2016; the drug was approved based on the study's primary endpoint, progression-free survival. Release

——Bristol-Myers Squibb ($BMY) said 32% of melanoma patients previously treated with its targeted drug Yervoy responded to Opdivo (nivolumab), its new immunotherapy, compared with 11% in patients treated with chemo as a Yervoy follow-up. Release

——Merck ($MRK) said its newly approved immunotherapy Keytruda delivered a 24% response rate in patients with bladder cancer, when used as a standalone treatment. Ten percent of patients saw complete response, the company said. Keytruda was approved earlier this month to treat melanoma, but the hope is that it can prove effective in a variety of other cancers. Release

——Pfizer's ALK-positive lung cancer drug Xalkori may have a new target. The drug stopped growth of lung tumors driven by rearrangements in the ROS-1 gene, a New England Journal of Medicine study showed. Xalkori treatment led to "significant tumor shrinkage" in 36 of 50 study participants. Lead Author Alice Shaw of Massachusetts General said the data confirms ROS1 as a "bona fide therapeutic target" in patients with that type of tumor, an even more rare variety of lung cancer than the ALK-positive disease Xalkori is approved to treat. Release | Report

——Johnson & Johnson's ($JNJ) prostate cancer therapy Zytiga, used along with prednisone, helped patients live longer compared with prednisone plus a placebo. Both groups of patients had never been treated with chemotherapy. The Zytiga patients had a median overall survival of 34.7 months, compared with 30.3 months in the control group. The analysis was a final look at the study J&J used to win FDA approval of pre-chemo use of Zytiga.



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