罗氏与GSK黑色素瘤复方药物在试验中疗效相似 发布日期：2014-10-08 来源：reuters
罗氏与葛兰素史克的黑色素瘤两药复方药物在各自的临床试验中有相似的良好结果，这使医生们在面对这两款皮肤癌药物时几乎不用去选择。
最新结果将对黑色素瘤的最佳治疗激起更广泛的争论，因为新一代刺激免疫系统的注射剂提供了抗击这种最致命皮肤癌的一种替代方法。 罗氏复方药物尚未上市，其复方中包含了Exelixis公司开发的一款药物，研究结果一经发布，该公司股价在上市前交易中飙升了20%。葛兰素史克的复方药物已在市场销售。然而，根据4月份的一项交易，葛兰素史克计划将其黑色素瘤药物及其它肿瘤产品卖给诺华。 这两款黑色素瘤复方药物均旨在阻断称之谓BRAF和MEK的两种蛋白质，这两种蛋白质与肿瘤生长有关，涉及了所有转移性黑色素瘤的大约一半病例，转移性黑色素瘤患者的疾病已扩散至身体的其它部位。 在罗氏发起的由495名患者参与的研究中，接受该公司威罗菲尼及试验药物Cobimetinib治疗的患者在其疾病恶化之前平均生存了9.9个月，而威罗菲尼单药治疗患者平均生存了6.2个月。 葛兰素史克由704名患者参与的试验显示，其达拉菲尼和曲美替尼组成的复方药物使患者无进展生存期增加11.4个月，而威罗菲尼治疗患者无进展生存期为7.3个月。在两款复方药物的研究中，纳入研究的患者均发生有让他们对黑色素瘤敏感的一种基因突变。 两项研究的结果在近日从马德里举行的欧洲内科肿瘤学会年会上发布。罗氏的研究结果还发表在了《新英格兰医学杂志》网络版上。苏黎世大学医院的Dummer未参与试验研究，他表示研究结果非常相似，在两家公司提供的令人信服的证据中均看到了明显的改善，这种复方治疗药物应该作为常规药物使用。“现在单药治疗几乎没有了空间，”他表示称。 副作用 鉴于几乎相同的临床结果，对两种治疗方案的选择最终可能归结为复方药物中所用到的两种BRAF抑制剂稍微不同的副作用，Dummer表示称。 葛兰素史克的达拉菲尼与较高的发烧率有关，而罗氏的威罗菲尼与光敏性有关，光敏性可引起严重的晒斑。Dummer称这一副作用可能使这款药物不太适合用于生活在阳光明媚气候的患者。罗氏计划向全球药品监管机构提交其复方药物的上市申请。 Cobimetinib是罗氏复方药物中的第二种试验药物，这款药物正由美国生物科技公司Exelixis开发。这两款复方药物是靶向癌症药物的例证，它们旨在关闭与疾病相关的非常明确的分子通路。这种方式在短期内可产生巨大的效果，但肿瘤细胞倾向于产生耐药性。 虽然将两种药物组合在一起可以延长响应，但肿瘤专家也在考虑产生更加持久效果的方法，现在注意力集中在免疫治疗药物上，这类药物可提供长期的收益。“证据表明，这些药物可在转移性黑色素瘤患者身上产生持久的肿瘤响应，即使是与使用BRAF和MEK抑制剂相比响应率较低的患者，”罗氏试验研究的研究人员在《新英格兰医学杂志》上如此写道。 规划何时使用BRAF/MEK抑制剂，何时使用免疫治疗药物，是肿瘤专家旨在解决的下一个问题，这需要借助新的临床测试手段。据世界卫生组织提供的信息，全球每年逾23万人被确诊患有黑色素瘤。如果这一疾病能早期发现，它是可能得到治愈的，但多数晚期黑色素瘤患者有较差的预后。 信源地址：http://www.reuters.com/article/2014/09/29/us-health-cancer-roche-gsk-idUSKCN0HO19320140929
Roche, GSK melanoma pill combinations look similar in showdown
(Reuters) - Rival two-pill combinations for melanoma from Roche and GlaxoSmithKline had similarly good results in separate clinical trials, leaving doctors with little to choose between the two skin cancer courses. The latest findings will fuel a wider debate about the optimal treatment of melanoma as a new generation of immune-stimulating injections offers an alternative way to fight the deadliest form of skin cancer. Roche's combination -- which includes a drug discovered by Exelixis, whose shares jumped some 20 percent in premarket trade on the study news -- is not yet available. GSK is already marketing its combined treatment. GSK, however, plans to sell its melanoma drugs and other oncology products to Novartis under a deal announced in April. [ID:nL6N0NE0Z2] Both combinations are designed to block two proteins, known as BRAF and MEK, that are associated with tumor growth and are implicated in about half of all cases of metastatic melanoma, wher the disease has spread to other parts of the body. In the 495-patient study sponsored by Roche, patients given the company's Zelboraf drug and the experimental compound cobimetinib lived a median 9.9 months before their disease worsened, against 6.2 months when they took Zelboraf alone. GSK's trial, involving 704 patients, showed its combination of the drugs Tafinlar and Mekinist increased progression-free survival by 11.4 months versus 7.3 months for patients on Zelboraf. In both cases, patients were seleced for inclusion in the studies after they had been shown to have a genetic mutation making them sensitive to such treatments. The findings from the two studies were presented on Monday at the European Society of Medical oncology annual congress in Madrid. The Roche study was also published online in the New England Journal of Medicine (NEJM). Reinhard Dummer of the University of Zurich Hospital, who was not involved in the tests, said the results were very similar and the clear improvement seen in both cases provided "convincing evidence" that such combination therapy should be used routinely. "There is hardly any space for monotherapy now," he said.
SIDE EFFECTS Given the almost identical clinical outcomes, choosing between the two regimens will likely come down to the slightly different side effect profiles of the two BRAF inhibitors used in the combinations, Dummer said. GSK's Tafinlar is linked to a higher rate of fever, while Roche's Zelboraf is linked to photosensitivity, which can cause severe sunburn. Dummer said this could make it less suitable for patients living in sunny climates. Roche plans to submit its combination to regulators around the world for approval. Cobimetinib, the second experimental pill in the Roche combination, is being developed with U.S. biotech company Exelixis. All these pills are examples of targeted cancer drugs, designed to turn off very specific molecular pathways associated with disease. This approach can have dramatic effects in the short term but tumor cells tend to go on to develop resistance. While combining two drugs extends the response, oncologists are also looking at ways to generate a much more durable effect, with attention now focusing on immunotherapy treatments that can offer longer-term benefits. "Evidence suggests that these agents can lead to durable tumor responses in patients with metastatic melanoma, albeit with lower response rates than have been observed with BRAF and MEK inhibition," researchers on the Roche study wrote in the NEJM. Working out when to use the BRAF/MEK inhibitors and when to use immunotherapy is the next question oncologists aim to tackle with a new program of clinical testing. More than 230,000 people worldwide are diagnosed with melanoma each year, according to the World Health Organization. If the disease is caught early, it can be cured -- but most people with advanced melanoma have a poor prognosis.
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