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首页 » 癌症研究 » 好消息!安斯泰来前列腺癌新药Xtandi疗效显著优于比卡鲁胺

好消息!安斯泰来前列腺癌新药Xtandi疗效显著优于比卡鲁胺

来源:生物谷 2015-04-04 15:14

2015年4月4日讯 /生物谷BIOON/ --安斯泰来(Astellas)与合作伙伴Medivation近日公布新一代前列腺癌口服药物Xtandi(enzalutamide)第2个头对头II期研究STRIVE的顶线数据。该研究在去势抵抗性前列腺癌患者中开展,数据显示,与比卡鲁胺(bicalutamide)相比,Xtandi使疾病无进展生存期(PFS:19.4个月 vs 5.7个月)取得统计学意义的显著改善,达到了研究的主要终点。该结果与之前公布的首个头对头II期研究TERRAIN一致,详细数据将在即将召开的科学会议公布。

在美国,前列腺癌是导致男性死亡的第二大主要病因,有七分之一的男性在其一生中会确诊前列腺癌。该病通常发生在老年人群中,前列腺癌常由男性激素(包括睾酮,即雄激素)过量引发。因此,该病的常规治疗是降低患者体内的雄激素水平,临床上可通过外科手术去势和/或雄激素剥夺疗法(ADT)达到这一目的。

比卡鲁胺(bicalutamide,商品名:Casodex,康士得)是一种口服非甾体抗雄激素类药物,目前由阿斯利康(AZN)及其他仿制药公司销售。该药于1995年获批上市,联合外科手术去势用于晚期前列腺癌的治疗,后来被批准作为一种单药疗法用于早期前列腺癌的治疗,对于不愿意接受手术去势治疗的患者而言是一个福音,该药在早期前列腺癌的临床治疗中被广泛应用。

然而,即便经过雄激素剥夺疗法(ADT)治疗后,几乎所有的前列癌患者病情都会继续恶化,导致去势抵抗性前列腺癌,而癌细胞也可能扩散至身体其他部位。Xtandi则专为这类患者提供治疗选择。

Xtandi是一种雄激素受体抑制剂,于2012年获FDA批准,用于手术治疗后病情恶化的晚期转移性去势抵抗性前列腺癌(CRPC)的治疗。2014年9月和12月,FDA和欧盟进一步批准Xtandi用于雄激素剥夺疗法(ADT)治疗失败但尚未接受化疗(即化疗初治)的无症状或轻微症状的转移性去势抵抗性前列腺癌(mCRPC)的治疗。

另一方面,强生(JNJ)在2011年4月上市了新一代前列腺癌药物Zytiga,之后便一直统治市场。然而,业界认为,武田Xtandi具有单独用药的独特优势,在美欧2大市场,Xtandi将挑战Zytiga的霸主地位。(相关阅读:重磅!强生Zytiga霸主地位不保,安斯泰来前列腺癌药物Xtandi拿下欧美2大市场

关于Xtandi:

Xtandi(enzalutamide)是一种新颖的、每日一次的口服雄激素受体信号传导抑制剂,该药能够抑制雄激素受体信号传导通路中的多个步骤,旨在干扰睾酮结合前列腺癌细胞的能力,已被证明能够降低癌细胞的生长,并能诱导肿瘤细胞死亡。睾酮是一种男性激素,能够激化前列腺癌细胞的生长。

Xtandi由Medivation和安斯泰来联合开发及销售。在美国,FDA于2012年批准Xtandi上市,用于手术治疗后病情恶化的晚期转移性去势抵抗性前列腺癌(CRPC)患者的治疗。

关于STRIVE研究:

STRIVE是一项头对头II期研究,在396例去势抵抗前列腺癌患者中开展,其中257例患有转移性前列腺癌,139例为非转移性前列腺癌。这些患者此前已接受一种促黄体激素释放激素(LHRH)类似物疗法或手术去势但病情恶化。研究中,将Xtandi(enzalutamide)和比卡鲁胺(bicalutamide)用于患者的治疗,并将2者的疗效和安全性进行了对比。数据显示,与每日一次50mg剂量比卡鲁胺治疗组相比,每日一次160mg剂量Xtandi治疗组无进展生存期(PFS:19.4个月 vs 5.7个月)和中位治疗时间(14.7个月 vs 8.4个月)均具有统计学意义的显著改善,达到了研究的主要终点。

TERRAIN是该II期项目的首个头对头II期研究,在375例去势抵抗性前列腺癌患者中开始,也是将Xtandi与比卡鲁胺进行了疗效和安全性对比。该研究数据同样证实,与比卡鲁胺相比,Xtandi可显著改善无进展生存期(PFS)。(生物谷Bioon.com)

英文原文:Medivation (MDVN), Astellas Pharma (ALPMY), Post Positive Mid-Stage Trial Results For Extended Use Of Xtandi

Medivation and Astellas Pharma announced impressive Phase 2 study results for the extended use of their prostate cancer drug, Xtandi

Medivation Inc (NASDAQ:MDVN) and AstellasPharma Inc (OCTMKTS:ALPMY) today released statistically significant results from a mid-stage clinical trial which compared the safety and efficacy of their drug Xtandi (enzalutamide) against bicalutamide, for the treatment of metastatic or non-metastatic castration-resistant prostate cancer in men.

The study, called STRIVE, was conducted on 396 castration-resistant prostate cancer patients in the US, 257 of whom suffered from metastatic prostate cancer while 139 were non-metastatic prostate cancer patients. Their disease advanced despite being treated with a luteinizing hormone-releasing hormone (LHRH) analogue therapy or surgical castration. The primary endpoint of the trial was met with a statistically significant improvement in progression-free survival (PFS) seen in once-daily 160 mg Xtandi-treated patients compared to once-daily 50 mg bicalutamide-treated patients. The Xtandi-treated group demonstrated a median PFS of 19.4 months and median treatment time of 14.7 months compared to 5.7 months and 8.4 months respectively for the bicalutamide-treated group.

29.4% of the Xtandi group and 28.3% of the bicalutamide group reported serious adverse effects from the respective drugs. Grade 3 or higher cardiovascular events were exhibited by 5.1% of Xtandi-treated patients and 4% of bicalutamide-treated patients, with one seizure reported in the Xtandi group. More common adverse effects were demonstrated due to Xtandi compared to bicalutamide, with effects including fatigue, hot flush, hypertension, back pain, fall, decreased appetite and dizziness.

Detailed data from the STRIVE study, along with the secondary endpoint results and safety profiles of the respective drugs, will be presented at soon-to-be-held medical conferences.

Prostate cancer is the second most prominent cause of death in men in the US, with one out of seven men diagnosed with the disease during their lifetime. The disease usually occurs in older men, with almost 2.9 million patients alive in the US currently as per the non-profit American Cancer Society. Prostate cancer is often caused by an excess of male sex hormones including testosterone, called androgens. Hence, the conventional treatment for the disease is to reduce the level of androgens in the patient's body. This can be done either through surgical castration and/or with androgen deprivation therapy (ADT).

Bicalutamide is an oral anti-androgen without steroids which is currently being sold by AstraZenecaplc (ADR) (NYSE:AZN) and other generic-selling companies. The drug was cleared for sales back in 1995 as a combination therapy with surgical castration for the treatment of advance prostate cancer and was later marketed as mono-therapy for early-stage prostate cancer.

However, nearly all men experience progression in the disease even after ADT, resulting in castration-resistant prostate cancer. The cancer may metastasize in other parts of the body as well. Xtandi is designed as a treatment option for such patients.

Xtandi is an androgen receptor inhibitor, developed and marketed by Medivation and Tokyo-based Astellas Pharma jointly, as part of a partnership deal entered into back in 2009. The drug was approved for sale in US by the Food and Drug Administration (FDA) in 2012, for the treatment of late-stage metastatic castration-resistant prostate cancer in men, that has progressed despite surgery.

The STRIVE study comes a few months after a similar mid-stage trail called TERRAIN, which also compared the efficacy of Xtandi with bicalutamide in 396 castration-resistant prostate cancer patients.TERRAIN also established the significance of Xtandi over bicalutamide by demonstrating increased PFS among the treated trial subjects.

Maxim Group analysts raised their price target for Medivation last week from $126 to $163 apiece and reaffirmed a Buy rating, in expectation of increased Xtandi sales for the company as well as indications for its use beyond prostate cancer.

Medivation shares were up by nearly 1.7%, reaching $127.55 per share at 11.09 AM EDT in today's trading session.

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