Takeda终止在日本、美国和欧洲开发前列腺癌药物orteronel

来源：生物谷 2014-06-20
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2014年6月20日讯 /生物谷BIOON/ --武田（Takeda）6月19日宣布，已自愿决定终止orteronel（TAK-700）用于前列腺癌治疗的临床开发项目。该决定基于在转移性去势抵抗前列腺癌（mCRPC）患者中开展的2个III期临床研究的结果。研究发现，尽管orteronel+泼尼松（prednisone）能够延长患者的无进展生存期（PFS），但并不能延长患者的总生存期（OS）。经过对实验数据的慎重考虑，同时考虑到现有其他疗法的可用性，武田已确定该药未表现出充分的临床属性，来支持该药在mCRPC群体中的进一步推进。
2014年5月14日，武田公布了ELM-PC4研究的数据，该研究是一项关键性、国际化、双盲、随机III期研究，在未接受化疗的mCRPC男性患者中开展，数据表明，与泼尼松相比，orteronel+泼尼松疗法延长了患者的影像学无进展生存期（rPFS），达到了研究的首个主要终点，但在研究的第二个主要终点总生存期（OS）未能表现出统计学意义的显著改善。
2013年7月26日，武田公布了ELM-PC5研究的既定中期分析数据。该研究在化疗期间或化疗后病情恶化的mCRPC男性患者中开展，将orteronel+泼尼松与安慰剂+泼尼松进行了对比。既定的中期分析表明，与对照相比，orteronel+泼尼松很可能无法达到改善总生存期（OS）的主要终点(HR 0.894, p=0.226)，但在次要终点影像学无进展生存期（rPFS）方面显示出了优势(HR 0.755, p=0.00029)，该项研究随后被揭盲。
2项研究中，均未发生显著的安全性问题。武田正与试验的研究者和监管部门沟通，提供相关更新信息。同时，武田正与研究者和监管部门合作，确保参与orteronel（TAK-700）临床试验的患者转移到适当的疗法，让患者得到恰当的照顾。
Orteronel是一种实验性口服、非甾体类、选择性、17,20-裂解酶抑制剂，该酶是甾体类激素（包括雄激素）生产过程中的一个关键酶。雄激素主要是由睾丸合成和分泌，肾上腺和卵巢也能分泌少量。睾丸之外的雄激素合成对阉割性前列腺癌（CRPC）的病情恶化起到了推动作用。（生物谷Bioon.com）
英文原文：Takeda Announces Termination of Orteronel (TAK-700) Development for Prostate Cancer in Japan, U.S.A. and Europe
OSAKA, Japan--(BUSINESS WIRE)--
Takeda Pharmaceutical Company Limited (TSE:4502) announced today that it has voluntarily decided to end the development program for orteronel (TAK-700) for prostate cancer. The decision follows the results of two Phase 3 clinical trials in metastatic, castration resistant prostate cancer (mCRPC). The studies found while orteronel plus prednisone could extend the time patients lived before their cancer progressed, it did not extend overall survival in these patients. After careful consideration of the data from these trials, the company has determined that the drug has not demonstrated a clinical profile sufficient to move forward in mCRPC, given the availability of other therapies.
On May 14, 2014, Takeda announced results from ELM-PC4, a pivotal, international, double blind, randomized Phase 3 trial in men with mCRPC who had not received chemotherapy, which showed that orteronel plus prednisone improved radiographic progression free survival (rPFS) compared to prednisone alone, one of the study’s two primary endpoints, but did not show a statistically significant improvement in the study’s second primary endpoint of overall survival (OS). A previously reported Phase 3 trial, ELM-PC5, in men with mCRPC that had progressed during or following chemotherapy, was unblinded in 2013 after a pre-specified interim analysis indicated that orteronel plus prednisone would likely not meet the primary endpoint of improved overall survival when compared to the control arm. The interim analysis did show an advantage for orteronel plus prednisone for the secondary endpoint, radiographic progression-free survival over the control arm. There were no significant safety concerns in either study.
Takeda is in communication with trial investigators and the relevant regulatory authorities, to provide them with updated and current information in compliance with local regulations. Takeda is working with trial investigators and local regulatory authorities to ensure that patients who participated in the orteronel (TAK-700) trials are transitioned to appropriate therapies so that trial participants receive appropriate care. Patients enrolled in the orteronel (TAK-700) clinical trials are urged to consult their study investigators to address any questions, and before making any changes to their medication.

呵呵，

dieerfeiya 发表于 2014-6-20 03:31 PM
呵呵，

丁香园上已经有链接了，我重新补充下

不好意思，上午发帖的时候没找到有链接出处的，现在补充完善好了。

嗯 好好学习