Astellas, Pfizer’s XTANDI meets primary endpoint in phase 3 prostate cancer trial

Astellas 和辉瑞公司的 XTANDI 在3期前列腺癌试验中满足主要终点

2018-12-27 12:19:07 pharmbr

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Astellas Pharma and Pfizer reported that the phase 3 ARCHES trial evaluating XTANDI (enzalutamide) plus androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC) met its primary endpoint, improving radiographic progression-free survival (rPFS) significantly in comparison to ADT alone. The preliminary safety analysis of the ARCHES trial appears consistent with the safety profile of XTANDI in previous clinical trials in castration-resistant prostate cancer (CRPC). Detailed results will be submitted for presentation at an upcoming medical congress. Pfizer global product development oncology chief development officer Mace Rothenberg said: “While XTANDI is currently approved for both metastatic and non-metastatic CRPC, there still remains a need for more treatment options for men with metastatic hormone-sensitive prostate cancer. “With these top-line results, we believe XTANDI has the potential to help men whose disease has progressed outside the prostate gland, but still responds to treatment to lower testosterone.” Astellas senior vice president and oncology development global therapeutic area head Steven Benner said: “The results from ARCHES demonstrate a statistically significant improvement in a key marker of disease progression – radiographic progression-free survival. “Based on the top-line results of ARCHES, we look forward to discussing the data with relevant health authorities to potentially support expanding the indication for XTANDI.” XTANDI is currently approved in the U.S. and Japan for the treatment of CRPC and in the EU for the treatment of metastatic and high-risk non-metastatic CRPC. Since its initial approval in 2012, XTANDI has been prescribed to more than 330,000 men worldwide.
Astellas Pharma 和辉瑞公司报告说,评估 XTANDI (恩扎鲁胺)加雄激素剥夺治疗( ADT )的3期 ARCHES 试验符合其主要终点,与单纯 ADT 相比,改善无进展生存( rPFS )显着改善。 ARCHES 试验的初步安全性分析与 XTANDI 在以往抗阉割前列腺癌( CRPC )临床试验中的安全性概况一致。详细的结果将提交给即将召开的医学大会。 辉瑞全球产品开发肿瘤首席开发官梅斯罗滕贝格( Mace Rothenberg )表示:“尽管 XTANDI 目前已被批准用于转移性和非转移性 CRPC ,但仍有必要为转移性激素敏感前列腺癌患者提供更多治疗选择。 “有了这些顶级结果,我们相信 XTANDI 有潜力帮助那些疾病在前列腺以外发展的男性,但仍然对降低睾丸激素的治疗作出反应。” Astella 高级副总裁兼肿瘤发展全球治疗领域负责人史蒂文•班纳( Steven Benner )表示:“来自 ARCHES 的结果显示,在疾病进展的关键指标——无放射影像进展生存方面,有统计学意义的改善。 “根据 ARCHES 的一线结果,我们期待与相关卫生部门讨论数据,以可能支持扩大 XTANDI 的适应症。” XTANDI 目前在美国和日本被批准用于治疗 CRPC ,在欧盟被批准用于治疗转移性和高危非转移性 CRPC 。自2012年首次获得批准以来, XTANDI 已被全球超过33万男性使用。

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