肝癌患者福音！拜耳向全球监管机构提交靶向抗癌药Stivarga上市申请，二线治疗晚期肝细胞癌

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Time of issue:2016-11-14 14:35
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(Summary description)德国制药巨头拜耳(Bayer)近日宣布已向全球三大主要医药市场(美国、日本、欧盟)提交了靶向抗癌药Stivarga(regorafenib，瑞戈非尼)新的监管申请文件，寻求批准Stivarga用于不可切除性肝细胞癌(HCC)患者的二线治疗。Stivarga是一种口服多激酶抑制剂，目前已在全球90多个国家获得批准治疗转移性结直肠癌(mCRC)，并获全球80多个国家批准治疗转移性胃肠道间质瘤(mGIS

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肝癌患者福音！拜耳向全球监管机构提交靶向抗癌药Stivarga上市申请，二线治疗晚期肝细胞癌

Categories:最新消息
Author:
Origin:
Time of issue:2016-11-14 14:35
Views:

Information

　　德国制药巨头拜耳(Bayer)近日宣布已向全球三大主要医药市场(美国、日本、欧盟)提交了靶向抗癌药Stivarga(regorafenib，瑞戈非尼)新的监管申请文件，寻求批准Stivarga用于不可切除性肝细胞癌(HCC)患者的二线治疗。Stivarga是一种口服多激酶抑制剂，目前已在全球90多个国家获得批准治疗转移性结直肠癌(mCRC)，并获全球80多个国家批准治疗转移性胃肠道间质瘤(mGIST)。Stivarga由拜耳开发，由拜耳和Onyx(目前已成为Amgen旗下公司)联合推广。

　　Stivarga二线治疗不可切除性肝细胞癌(HCC)监管文件的提交，是基于III期临床研究RESORCE的对比数据。该研究在接受拜耳抗癌药多吉美(Nexavar，通用名：sorafenib，索拉非尼)治疗期间病情进展的573名不可切除性肝细胞癌(HCC)患者中开展，调查了Stivarga联合最佳支持治疗(BSC)的疗效和安全性，并与安慰剂+BSC进行了对比。数据显示，与安慰剂+BSC治疗组相比，Stivarga+BSC治疗组总生存期(OS)显著延长(中位OS：10.6个月 vs 7.8个月;HR 0.63; 95% CI:0.50-0.79; p<0.001)，死亡率显著降低37%，达到了研究的主要目标。该研究中，Stivarga的安全性和耐受性与该药已知的临床属性一致。相关数据已于今年6月在西班牙巴塞罗那举行的欧洲肿瘤内科学会(ESMO)第18届世界胃肠癌大会(WCGC)上公布。

　　近年来，肝癌的发病率在全球范围内持续升高，目前仅有一种获批治疗肝癌的系统疗法(即拜耳的多吉美Nexavar)，还没有被临床证明或获批治疗晚期肝细胞癌(HCC)的二线治疗方案。Stivarga在III期临床研究RESORCE中治疗肝细胞癌所表现出的强大疗效，将为医生、医疗保健提供者及患者提供第二个被临床证明的治疗方案。

　　除了主要终点之外，该研究也达到了全部次要终点(采用mRECIST[改良的实体肿瘤反应评价标准]和RECIST 1.1标准评估)。与安慰剂+BSC治疗组相比，Stivarga+BSC治疗组无进展生存期显著延长(中位PFS：3.1个月 vs 1.5个月，HR=0.46[95% CI:0.37-0.56]，p<0.001)、疾病进展时间显著延长(中位TTP：3.2个月 vs 1.5个月，HR=0.44[95% CI:0.36-0.55]，p<0.001)、疾病控制率(DCR，包括完全缓解、部分缓解、病情稳定)显著提高(65.2% vs 36.1%，p<0.001)、总缓解率(完全缓解+部分缓解)显著提高(10.6% vs 4.1%，p=0.005)。次要终点的所有数值均基于mRECIST标准评估。

　　该研究中，Stivarga的安全性和耐受性与该药已知的临床属性一致。Stivarga治疗组最常见的不良事件(3级或更高)包括高血压(Stivarga组15.2% vs 安慰剂组4.7%)、手足皮肤反应(12.6% vs 0.5%)、疲劳(9.1% vs 4.7% )、腹泻(3.2% vs 0%)。

　　对于中国这样的肝癌大国来说，它的出现为广大肝癌患者带来了福音。但考虑到2004年Stivarga在美国申请专利，直达2012年才上市，而直到现在中国内地还没有上市的状况，恐怕我们还得耐心等待。

　　肝癌：癌症相关死亡第二大主要病因，中国是肝癌大国

　　肝细胞癌(HCC)是最常见的肝脏癌症类型，约占所有肝癌病例的70-85%。肝癌是全球第六大癌症，也是癌症相关死亡的第二大主要病因。据估计，在全球范围内，每年确诊肝癌病例超过78万例(中国超过39.5万例，欧盟5.2万例，美国3万例)，确诊率还在持续上升。在2012年，全球大约74.6万人死于肝癌，其中中国死亡病例38.3万例，欧盟4.8万例，美国2.4万例。

　　Stivarga是一种口服多激酶抑制剂，能够阻断数个促血管生成VEGF受体酪氨酸激酶，这些激酶在肿瘤的血管生成中发挥着重要作用。除了VEGFR 1-3之外，该药还可以抑制各种癌和肿瘤微环境中的多种激酶，包括TIE-2，RAF-1，BRAF V600，KIT, RET, PDGFR及FGFR，每种激酶单独和联合调控肿瘤的生长、基质微环境的形成及疾病的进展。

　　Sorafenib是一种口服抗癌疗法，已在多项临床试验中被证明有抑制多种促进细胞增殖和血管生成激酶的作用，从而达到抑制肿瘤生长的效果。主要用于治疗肝细胞癌、肾细胞癌和分化型甲状腺癌。

　　新闻来源： http://news.bioon.com/article/6692267.html

　　本新闻经华讯团队重新编辑整理并添加分析意见。

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Electronic Arts pledges free use for five accessibility patents

Electronic Arts pledges free use for five accessibility patents Recently, Electronic Arts (EA) announced a patent pledge that gives other companies and developers free access to five of its current accessibility-related patents and technology. The company promised not to enforce against any party for infringing any of the listed patents. Instead, EA hopes to encourage “innovation” and build new features that make video games more inclusive on a much larger scale by opening up the patents. Electronic Arts (EA) is an American video game company founded in 1982. The company owns many popular and famous games, such as The Sims, SimCity, Apex Legends, Madden NFL and FIFA. Each of the games has more than 30 or 50 million sales volume. Significantly, esports involves FIFA and Apex Legends into the event list. Apex Legends has up to 1 billion players, and it is so popular that it has a Switch version. Within the freely available patents, one of which grabs everyone’s attention -- Apex Legends’ ping system (patent No. US 11097189). The ping system in Apex Legends, which excellently allows players to make communication and teamwork quick and easy without hearing or speaking, has been praised both as an impressive alternative to voice chat and as a great accessibility feature for players with a variety of disabilities. The other patents include the technology widely used in the FIFA and Madden NFL. The innovations can automatically detect and modify colors (patent No. US 10118097 and CN 107694092) and contrast ratios (patent No. US 10878540) to improve gamers’ visibility with colorblindness and low vision. Furthermore, one of the patents relates to personalized sound technology, helping players with hearing issues by modifying or creating music based on their preferences (patent No. US 10790919). The code of the mentioned technology is published on EA’s GitHub, and it is open to all developers. Thus, the developers can use it or adapt it for their games without spending the costs to research. It is good that EA shares the patents for free use and aims to create an accessibility-increased gaming environment for players. However, it is not “unconditional” to use the listed patents. In the pledge, EA mentioned that it may terminate the promise for a specific party which files a patent infringement lawsuit or other patent proceedings against EA. We can see parts of EV’s ambition behind the announcement—to build a large game developer league and a community of shared interests. Reference: https://www.ea.com/commitments/positive-play/accessibility-patent-pledge https://iknow.stpi.narl.org.tw/Post/Read.aspx?PostID=14562 https://www.polygon.com/22639469/apex-legends-electronic-arts-patent-pledge-accessibility-developers https://www.theverge.com/2021/8/24/22638535/ea-accessibility-patent-pledge-apex-legends-ping-system https://www.gamesradar.com/ea-secures-a-patent-for-the-apex-legends-ping-system-and-its-giving-it-away-for-free/ https://dotesports.com/apex-legends/news/apex-legends-ping-system-is-now-patent-free-for-accessibility https://www.nintendolife.com/news/2021/08/apex_legends_ping_system_now_patent-free_as_ea_announces_accessibility_pledge Recently, Electronic Arts (EA) announced a patent pledge that gives other companies and developers free access to five of its current accessibility-related patents and technology. The company promised not to enforce against any party for infringing any of the listed patents. Instead, EA hopes to encourage “innovation” and build new features that make video games more inclusive on a much larger scale by opening up the patents. Electronic Arts (EA) is an American video game company founded in 1982. The company owns many popular and famous games, such as The Sims, SimCity, Apex Legends, Madden NFL and FIFA. Each of the games has more than 30 or 50 million sales volume. Significantly, esports involves FIFA and Apex Legends into the event list. Apex Legends has up to 1 billion players, and it is so popular that it has a Switch version. Within the freely available patents, one of which grabs everyone’s attention -- Apex Legends’ ping system (patent No. US 11097189). The ping system in Apex Legends, which excellently allows players to make communication and teamwork quick and easy without hearing or speaking, has been praised both as an impressive alternative to voice chat and as a great accessibility feature for players with a variety of disabilities. The other patents include the technology widely used in the FIFA and Madden NFL. The innovations can automatically detect and modify colors (patent No. US 10118097 and CN 107694092) and contrast ratios (patent No. US 10878540) to improve gamers’ visibility with colorblindness and low vision. Furthermore, one of the patents relates to personalized sound technology, helping players with hearing issues by modifying or creating music based on their preferences (patent No. US 10790919). The

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