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默克爱必妥(Erbitux)结直肠癌试验中击败罗氏安维汀(Avastin)

来源:生物谷 2013-06-02 01:21

2013年6月1日讯 /生物谷BIOON/ --默克(Merck KGaA)今天宣布,在一项结直肠癌(colorectal cancer,CRC)临床试验中,与罗氏(Roche)安维汀(Avastin)相比,该公司抗癌药爱必妥(Erbitux)已被证明能够更有效地延长患者的生命。

该试验由默克赞助,由一个独立的研究组织—德国肿瘤医学协会(AIO)开展。该项试验中所招募的患者,为肿瘤中仅含正常或野生型KRAS基因的结直肠癌患者,这类患者约占结直肠癌的60%,试验中分别将Erbitux和Avastin结合Folfiri化疗对患者进行了治疗。结果表明,Erbitux组平均存活时间比Avastin组长4个月。

根据本周末提交至美国临床肿瘤学会(ASCO)的数据,Erbitux组总生存期(overall survival,OS)平均为28.7个月,Avastin组为25个月。2组疾病无进展生存期(progression-free survival,PFS)几乎没有差别,均为约10个月。

默克拒绝就该项研究数据所带来的Erbitux额外销售潜力发表评论。

目前,Erbitux和Avastin均已获批结合化疗作为转移性KRAS野生型肠癌患者的初始治疗,但该临床试验的结果,可能会使KRAS野生型患者群体转向Erbitux治疗。

该项研究的首席研究员、德国慕尼黑大学肿瘤学Volker Heinemann教授称,该项研究表明,对于这一患者群体,应优先考虑使用Erbitux治疗。

默克拥有Erbitux在北美以外国家和地区的销售及开发权利,百时美施贵宝(BMS)则拥有Erbitux在北美的销售权。

2012年,默克所取得的Erbitux销售额为8.87亿欧元(约合11.5亿美元),百时美施贵宝Erbitux的销售额为7.02亿美元。罗氏Avastin去年的销售额为57.6亿瑞士法郎(约合60亿美元)。(生物谷bioon.com)

英文原文:Merck KGaA's Erbitux beats Avastin in bowel cancer trial

(Reuters) - Merck KGaA's cancer drug Erbitux was shown to be more effective at prolonging the lives of bowel cancer patients than Roche's Avastin, Merck said.

In a drug trial, the two drugs were each given in combination with Folfiri chemotherapy to patients whose colorectal cancer had started spreading to other organs. The results showed the Erbitux group survived on average nearly four months longer than the Avastin group.

The trial was conducted by an independent research collaborative of the German Association of Medical Oncology (AIO) and sponsored by Germany's Merck.

Only patients whose tumors contain the normal, or wild-type, version of a gene called KRAS took part in the trial. Erbitux is only approved in this patient subgroup, which accounts for about 60 percent of colorectal cancer cases.

The trial data presented at the American Society of Clinical Oncology in Chicago this weekend showed that overall survival was a median 28.7 months in the Erbitux arm and 25 months in the Avastin arm.

There was little difference, however, between the two groups in how long it took before the disease got worse, so-called progression-free survival, which was about 10 months for both.

Merck declined to comment on the additional sales potential from the results.

Both drugs are approved and are in use as initial treatments of metastatic bowel cancer in combination with chemotherapy and the findings could translate into more prescriptions of Erbitux at the expense of Avastin in the wild-type KRAS patient group.

Volker Heinemann, oncology professor at Munich University and the study's principal investigator, said the results suggest that Erbitux should be given preference over Avastin for the patient group in question while Avastin should be given to patients who could not be helped by Erbitux.

Germany's Merck has the marketing and development rights to Erbitux outside North America, while Bristol-Myers Squibb sells the product in North America with Eli Lilly receiving royalties.

Merck had 887 million euros ($1.15 billion) in Erbitux sales last year, from head and neck as well as bowel cancer, while Bristol-Myers Squibb generated $702 million in sales from the drug.

Roche posted 5.76 billion Swiss francs ($6.00 billion) in Avastin sales last year.

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