拜耳多吉美（Nexavar）肝癌III期未达主要终点

作者：tomato来源：生物谷2014-3-11 22:34:40

关键词： 拜耳 多吉美 Nexavar sorafenib

2014年3月11日讯/生物谷BIOON/--拜耳（Bayer）和安进（Amgen）旗下Onyx制药联合宣布，评估多吉美（Nexavar，通用名：索拉非尼，sorafenib）作为一种辅助药物，用于手术切除或局部消融后无可检测疾病的肝细胞癌（HCC）患者治疗的III期STORM试验，未能达到无复发生存的主要终点。安全性数据与Nexavar已知的属性一致。该项研究的详细数据将提交至即将召开的科学大会。

拜耳全球开发负责人Jorg Moller称，该项研究未能达到主要终点，对此我们感到失望。但我们仍将致力于探索Nexavar用于所有各阶段肝癌治疗的潜力。今天宣布的结果，并不影响Nexavar已获批的适应症。目前，Nexavar仍然是唯一一种获批用于不可切除性肝癌具有总生存期利益的系统治疗药物。

STORM是一项国际化、多中心、随机、双盲、安慰剂对照III期试验，评估了sorafenib作为一种辅助治疗药物，用于已接受潜在治愈性治疗（手术切除或局部切除）肝癌患者时相对于安慰剂的临床益处。该项研究的主要终点是无复发生存期（RFS），即肝癌无复发存活时间。次要终点包括肝癌复发时间和总生存期（OS），同时也进行了安全性和耐受性评估。研究中，超过1100例患者随机接受sorafenib（400mg，每天2次）或安慰剂治疗，治疗持续4年时间或直到肝癌复发，以先到者为准。

关于多吉美（Nexavar）：

Nexavar（sorafenib，索拉非尼）是一种口服抗癌药物，目前已获全球100多个国家批准。在欧洲，Nexavar已获批用于肝细胞癌（HCC）及既往经α干扰素或白介素2（IL-2）治疗失败或被认为不适用这类疗法的晚期肾细胞癌（RCC）的治疗。在美国，Nexavar也已获批用于局部晚期或转移性放射性碘(RAI)难治性分化型甲状腺癌（DTC）的治疗。

在临床前研究中，Nexavar已被证明能够抑制参与细胞增殖（生长）和血管生成（血液供应）过程中的多种激酶，包括Raf激酶、VEGFR-1、VEGFR-2、VEGFR-3、PDGFR-B、KIT、FLT-3和RET。

Nexavar由拜耳和安进旗下Onyx制药联合开发，拜耳拥有该药在美国以外地区的独家销售权。目前，拜耳和Onyx制药、国际研究团体、政府机构及个体研究者也在调查Nexavar在其他癌症中的疗效。（生物谷Bioon.com）

英文原文：Phase III Trial of Sorafenib as Adjuvant Therapy for Liver Cancer Did Not Meet Primary Endpoint

Berlin, March 11, 2014 – Bayer HealthCare Pharmaceuticals Inc. and Onyx Pharmaceuticals, Inc., an Amgen subsidiary, today announced that a Phase III trial evaluating sorafenib (Nexavar®) tablets as an adjuvant treatment for patients with hepatocellular carcinoma (HCC, a form of liver cancer) who had no detectable disease after surgical resection or local ablation, did not meet its primary endpoint of improving recurrence-free survival. The safety findings were consistent with the known profile of sorafenib. Data from this study will be submitted for presentation at an upcoming scientific congress.

“We are disappointed that the trial did not meet its primary endpoint. However, we remain committed to exploring the full potential of sorafenib in all stages of liver cancer,” said Dr. Jörg Möller, member of the Bayer HealthCare Executive Committee and Head of Global Development. “The outcome announced today does not affect the currently approved indications. Nexavar remains the only approved systemic treatment for unresectable HCC with a proven overall survival benefit.”

About the STORM Trial
The Phase III, randomized, double-blind, placebo-controlled STORM (Sorafenib as Adjuvant Treatment in the Prevention of Recurrence of Hepatocellular Carcinoma) trial is an international multicenter study that evaluated the clinical benefit of sorafenib versus placebo as an adjuvant treatment in patients with HCC following potential curative treatment (surgical resection or local ablation). The primary endpoint of the study was recurrence-free survival (i.e., the length of time that a patient survives without recurrence of HCC). Secondary endpoints included time to recurrence of HCC and overall survival. Safety and tolerability were also assessed. More than 1,100 patients were randomized to receive either 400 mg of sorafenib twice daily or matching placebo for four years or until disease recurrence, whichever comes first.

About Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is the most common form of liver cancer and is responsible for approximately 70-85 percent of the total liver cancer burden worldwide.(1) Liver cancer is the sixth most common cancer in the world and the second leading cause of cancer-related deaths globally. More than 780,000 cases of liver cancer are diagnosed worldwide each year (more than 395,000 in China, 52,000 in the European Union, and 30,000 in the United States) and the incidence is increasing. In 2012, approximately 746,000 people died of liver cancer including approximately 383,000 in China, 48,000 in the European Union, and 24,000 in the United States.(2)

About Nexavar® (sorafenib)
Nexavar® (sorafenib), an oral anti-cancer therapy, is currently approved in more than 100 countries worldwide. In Europe, it is approved for the treatment of hepatocellular carcinoma (HCC) and for the treatment of patients with advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy. Nexavar is also approved in the United States for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid cancer (DTC) that is refractory to radioactive iodine treatment.

In preclinical studies, Nexavar has been shown to inhibit multiple kinases thought to be involved in both cell proliferation (growth) and angiogenesis (blood supply) – two important processes that enable cancer growth. These kinases include Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.

Nexavar is also being evaluated by Bayer and Onyx, international study groups, government agencies and individual investigators in a range of other cancers.

Nexavar is co-developed by Onyx Pharmaceuticals, Inc., an Amgen subsidiary, and Bayer, except in Japan where Bayer manages all development. The companies co-promote Nexavar in the U.S. Outside of the U.S. Bayer has exclusive marketing rights, and Bayer and Onyx share profits globally, excluding Japan.

About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now includes three oncology products and several other compounds in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

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