11月25日，阿斯利康宣布
Capivasertib
（商品名：Truqap）治疗新发（
DeNovo
）转移性激素敏感性前列腺癌（mHSPC）的III期
CAPItello-281研究取得了积极结果。（AI翻译，中英对照多美，又能看原文又能看翻译）
First and only AKT inhibitor combination to demonstratebenefit in this specific subtype of prostate cancer
第一个也是唯一一个证明的 AKT 抑制剂组合 对这种特定前列腺癌亚型的益处
Positive high-level results from the CAPItello-281 Phase III trial showed that AstraZeneca’s Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of radiographic progression-free survival (rPFS) versus abiraterone and ADT with placebo in patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC).CAPItello-281 III 期试验的阳性高水平结果表明，阿斯利康的 Truqap （capivasertib） 联合阿比特龙和雄激素剥夺疗法 （ADT） 在患有 PTEN 缺陷的新发转移性激素敏感性前列腺癌 （mHSPC） 患者中，与阿比特龙和 ADT 联合安慰剂相比，在影像学无进展生存期 （rPFS） 的主要终点方面显示出具有统计学意义和临床意义的改善。
Overall survival (OS) data were immature at the time of this analysis; however, the Truqap combination showed an early trend towards an OS improvement versus abiraterone and ADT with placebo. The trial will continue as planned to further assess OS as a key secondary endpoint.在进行此分析时，总生存期 （OS） 数据尚不成熟;然而，与安慰剂相比，Truqap 联合疗法显示出 OS 改善的早期趋势。该试验将按计划继续进行，以进一步评估 OS 作为关键次要终点。
Prostate cancer is the second most prevalent cancer in men and the fifth leading cause of male cancer death globally.1 Only one third of patients with metastatic prostate cancer survive five years after diagnosis.2 Newly diagnosed mHSPC is an aggressive form of the disease associated with poor outcomes and survival.3,4 Approximately 200,000 patients are diagnosed with mHSPC each year, and one in four have PTEN-deficient tumours.5 Patients with a tumour biomarker of PTEN deficiency have a particularly poor prognosis.6前列腺癌是男性第二大常见癌症，也是全球男性癌症死亡的第五大原因。1 只有三分之一的转移性前列腺癌患者在诊断后存活 5 年。2 新诊断的 mHSPC 是一种侵袭性疾病，与不良结果和生存率相关。3,4 每年约有 200,000 名患者被诊断出患有 mHSPC，其中四分之一患有 PTEN 缺陷型肿瘤。5 具有 PTEN 缺陷肿瘤生物标志物的患者预后特别差。6
Karim Fizazi, MD, PhD, Institut Gustave Roussy, and University of Paris Saclay in Villejuif, France, and principal investigator for the trial said: “Patients with this aggressive form of prostate cancer with tumour PTEN deficiency currently face a particularly poor prognosis, and there is an urgent need for new treatments that improve upon current therapies. The results seen with capivasertib in combination with abiraterone-prednisone and androgen deprivation therapy in the CAPItello-281 trial represent a step forward for these patients.”该试验的首席研究员、古斯塔夫·鲁西研究所和法国巴黎萨克雷大学的医学博士、博士 Karim Fizazi 说：“患有这种侵袭性前列腺癌伴肿瘤 PTEN 缺陷的患者目前面临特别差的预后，迫切需要改进当前疗法的新疗法。在 CAPItello-281 试验中，capivasertib 联合阿比特龙-泼尼松和雄激素剥夺疗法的结果代表了这些患者向前迈出的一步。
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “These results show for the first time, that adding an AKT inhibitor to a standard-of-care therapy can provide benefit to patients with a biomarker of PTEN-deficient metastatic hormone-sensitive prostate cancer. By targeting a key driver of the disease, we have been able to improve upon current therapies and demonstrate the potential role of this combination in an area of critical unmet need. It will be important to see greater maturity in key secondary endpoints including overall survival.”阿斯利康肿瘤研发执行副总裁Susan Galbraith表示：“这些结果首次表明，在标准护理疗法中加入AKT抑制剂可以为具有PTEN缺陷型转移性激素敏感性前列腺癌生物标志物的患者带来益处。通过靶向疾病的关键驱动因素，我们已经能够改进当前的疗法，并展示这种组合在关键未满足需求领域的潜在作用。重要的是要看到关键次要终点（包括总生存期）的成熟度更高。
The safety profile of Truqap in combination with abiraterone and ADT in CAPItello-281 was broadly consistent with the known profile of each medicine.Truqap 联合阿比特龙和 ADT 在 CAPItello-281 中的安全性与每种药物的已知安全性基本一致。
Data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.数据将在即将举行的医学会议上展示，并与全球监管机构共享。
Prostate cancer 前列腺癌Prostate cancer is the second most prevalent cancer in men and the fifth leading cause of male cancer death globally, with an incidence of more than 1.4 million and approximately 397,000 deaths in 2022.1前列腺癌是男性第二大常见癌症，也是全球男性癌症死亡的第五大原因，2022 年的发病率超过 140 万，死亡人数约为 397,000 人。1
Metastatic prostate cancer is associated with a significant mortality rate, with only one third of patients surviving five years after diagnosis.2 Development of prostate cancer is often driven by male sex hormones called androgens, including testosterone.7转移性前列腺癌与较高的死亡率相关，只有三分之一的患者在诊断后存活 5 年。2 前列腺癌的发展通常是由称为雄激素的雄性激素驱动的，包括睾丸激素。7
Metastatic hormone-sensitive prostate cancer转移性激素敏感性前列腺癌In patients with mHSPC, also known as metastatic castration-sensitive prostate cancer (mCSPC), prostate cancer cells need high levels of androgens to drive cancer growth.4,7 Hormone therapies, such as ADT, are widely used to block the action of male sex hormones and lower the levels of androgens in the body.4,8 However, resistance to these therapies is common and there is a need to extend their use to delay disease progression and castration resistance, where the prostate cancer grows and spreads to other parts of the body despite the use of these therapies.3,4,8在 mHSPC（也称为转移性去势敏感性前列腺癌 （mCSPC））患者中，前列腺癌细胞需要高水平的雄激素来驱动癌症生长。4,7 激素疗法，如 ADT，被广泛用于阻断雄性激素的作用并降低体内雄激素的水平。4,8 然而，对这些疗法的耐药性很常见，需要扩大它们的使用范围以延缓疾病进展和去势抵抗，尽管使用了这些疗法，但前列腺癌仍会生长并扩散到身体的其他部位。3、4、8
