Lenvima不逊于Nexavar治疗不可切除的HCC

StephenW

Lenvima non-inferior to Nexavar in treating unresectable HCC
June 9, 2017

CHICAGO — Results of a phase 3 trial showed that Lenvima was non-inferior to Nexavar in median overall survival for patients with unresectable hepatocellular carcinoma, according to a presentation at the ASCO Annual Meeting.

“Results from this large phase 3 trial demonstrate the potential of [Lenvima] to improve the outcomes of liver cancer patients, and provide an overall survival benefit that is non-inferior to [Nexavar], currently the only systemic therapy approved by the European Medicines Agency for unresectable HCC,” Jeff Evans, MD, FRCP, from the University of Glasgow, said in a press release. “For a decade, there has been no advance in the first-line systemic treatment of [unresectable] HCC in Europe, so this data supports a potential new option for liver cancer patients that offers greater choice.”

The REFLECT study consisted of two treatment arms: 478 patients who received Lenvima (lenvatinib, Eisai) and 476 patients who received Nexavar (sorafenib, Onyx Pharmaceuticals). Median overall survival for patients receiving lenvatinib was 13.6 months (95% CI, 12.1-14.9) compared with 12.3 months (95% CI, 10.4-13.9) in the Nexevar group (HR = 0.92; 95% CI, 0.79-1.06).

Results of the study’s secondary endpoints showed that lenvatinib has a median progression-free survival time of 7.4 months (95% CI, 6.9-8.8) compared with 3.7 months (95% CI, 3.6-4.6) in the sorafenib group (HR = 0.66; 95% CI, 0.57-0.77) and median time to progression in the lenvatinib group was 8.9 months (95% CI, 7.4-9.2) compared with 3.7 months (95% CI, 3.6-5.4) with sorafenib (HR = 0.63; 95% CI, 0.53-0.73). Additionally, lenvatinib had an objective response rate of 24% compared with 9% in the sorafenib group (OR = 3.13; 95% CI, 2.15-4.56).

“Eisai is excited by the potential of the results seen with lenvatinib in Study 304 to provide improved outcomes for patients with unresectable HCC, who face a poor prognosis and are in need of additional treatment options,” Gary Hendler, chairman, CEO of the Europe, Middle East and Asia region and chief commercial officer of the Oncology Business Group at Eisai, said in the release. “Based on these data, Eisai plans to submit regulatory applications for lenvatinib for the first-line treatment of patients with unresectable HCC and we look forward to working closely with the European Medicines Agency and other regulatory bodies worldwide.”

Reference: Cheng A, et al. Abstract 4001. Presented at: ASCO Annual Meeting; June 2-6, 2017; Chicago.

Disclosure: Cheng reports receiving consulting or advisory fees from Bayer Schering Pharma, Bristol-Myers Squibb, Merck Serono, Novartis and ONXEO; research funding from Sanofi; and is on the speakers bureau for Novartis.

StephenW

Lenvima不逊于Nexavar治疗不可切除的HCC
2017年6月9日

芝加哥III期试验结果显示，根据ASCO年会的介绍，Lenvima在不可切除的肝细胞癌患者的中位生存期方面不逊于Nexavar。

“这项大型阶段3试验的结果表明，[Lenvima]改善肝癌患者结局的潜力，并且提供了与[Nexavar]不逊色的总体生存获益，目前是欧洲药物批准的唯一全身治疗格拉斯哥大学杰夫·埃文斯医学博士，不可切除的肝癌机构在新闻稿中说。 “十年来，欧洲不可切除的HCC的一线系统治疗一直没有进展，所以这个数据为肝癌患者提供了更多选择的潜在新选择。”

REFLECT研究包括两个治疗组：接受Lenvima（lenvatinib，Eisai）的478名患者和接受Nexavar（索拉非尼，Onyx Pharmaceuticals）的476名患者。接受莱卡替尼治疗的患者的中位生存期为13.6个月（95％CI，12.1-14.9），而Nexevar组为12.3个月（95％CI为10.4-13.9）（HR = 0.92; 95％CI为0.79-1.06）。

研究的次要终点结果显示，莱卡宾组与索拉非尼组3.7个月（95％CI，3.6-4.6）相比，中位无进展生存时间为7.4个月（95％CI，6.9-8.8）（HR = 0.66 ; 95％CI，0.57-0.77），莱卡铂组中位时间为8.9个月（95％CI为7.4-9.2），而索拉非尼为3.7个月（95％CI为3.6-5.4）（HR = 0.63; 95％CI，0.53-0.73）。另外，莱卡替尼的客观反应率为24％，索拉非尼组为9％（OR = 3.13; 95％CI，2.15〜4.56）。

欧司他公司董事长，欧洲首席执行官加里·亨德勒（Gary Hendler）表示：“Eisai对研究304中莱芬替尼研究结果的潜力感到兴奋，为”不可切除的HCC患者提供改善的结果“，他们面临预后不良，需要额外的治疗方案。” ，中东和亚洲地区以及Eisai肿瘤商业集团首席商务官在发布会上表示。 “根据这些数据，Eisai计划提交lenvatinib的监管申请，以便对不可切除的HCC患者进行一线治疗，我们期待与欧洲药品管理局和全球其他监管机构紧密合作。”

参考文献：Cheng A，et al。摘要4001.提交：ASCO年会; 2017年6月2-6日;芝加哥。

披露：Cheng报告接受拜耳先灵医药，布里斯托 - 迈尔斯·施贵宝，默克·塞洛诺，诺华和ONXEO的咨询或咨询费用;赛诺菲研究经费;并在诺华的发言局。

kite2002005

没听明白，什么是hcc治疗。。。迷糊了

StephenW

回复 kite2002005 的帖子

HCC是肝细胞癌.
不可手术切除的HCC, 目前只能使用Nexavar(sorafenib)治疗. 新的Lenvima也可以.

kite2002005

StephenW 发表于 2017-6-10 21:37
回复 kite2002005 的帖子

HCC是肝细胞癌.

发展到那样也差不多了