Background:Relugolix is an oral GnRH receptor antagonist approved for men with advanced prostate cancer. Relugolix treatment has demonstrated an ability to lower testosterone to sustained castration levels in the phase 4 HERO study. Herein, we describe the results of a secondary endpoint of castration resistance-free survival (CRFS) during 48 weeks of treatment and profile patients with castration-resistant prostate cancer (CRPC).Methods:Subjects were 2:1 randomized to either relugolix 120 mg orally once daily (after a single 360 mg loading dose) or 3-monthly injections of leuprolide for 48 weeks. CRFS, defined as the time from the date of first dose to the date of confirmed prostate-specific antigen progression while castrated or death due to any reason was conducted in the metastatic disease population and the overall modified intention-to-treat (mITT) populations.Results:The CRFS analysis (mITT population) included 1074 men (relugolix: n = 717; leuprolide: n = 357) with advanced prostate cancer as well as 434 men (relugolix: n = 290; leuprolide: n = 144) with metastatic prostate cancer. In the metastatic disease populations, CRFS rates were 74.3% (95% CI: 68.6%, 79.2%) and 75.3% (95% CI: 66.7%, 81.9%) in the relugolix and leuprolide groups, respectively (hazard ratio: 1.03 [0.68, 1.57];p= 0.84) at week 48. Results in the overall mITT population were similar to the metastatic population. No new safety findings were identified.Conclusions:In men with metastatic disease or in the overall population of the HERO study, CRFS assessed during the 48-week treatment with relugolix was not significantly different than standard-of-care leuprolide. Relugolix had similar efficacy for men with/without CRFS progression events.
背景：Relugolix是一种口服GnRH受体拮抗剂，已获批用于晚期前列腺癌男性患者。在第四期HERO研究中，Relugolix治疗已证明能将睾酮降至持续去势水平。本文描述了48周治疗期间去势抵抗无进展生存期（CRFS）这一次要终点的结果，并对去势抵抗性前列腺癌（CRPC）患者进行了特征分析。 方法：受试者按2:1比例随机分配至Relugolix组（每日一次口服120 mg，首次负荷剂量360 mg）或亮丙瑞林组（每3个月注射一次），治疗持续48周。CRFS定义为从首次给药日期至确认出现去势状态下前列腺特异性抗原进展或任何原因导致死亡的日期。该分析在转移性疾病人群和总体改良意向治疗（mITT）人群中进行。 结果：CRFS分析（mITT人群）包括1074名晚期前列腺癌男性（Relugolix组：n = 717；亮丙瑞林组：n = 357），其中434名（Relugolix组：n = 290；亮丙瑞林组：n = 144）为转移性前列腺癌患者。在转移性疾病人群中，第48周时Relugolix组和亮丙瑞林组的CRFS率分别为74.3%（95% CI：68.6%，79.2%）和75.3%（95% CI：66.7%，81.9%）（风险比：1.03 [0.68，1.57]；p = 0.84）。总体mITT人群的结果与转移性人群相似。未发现新的安全性问题。 结论：在HERO研究的转移性疾病患者或总体人群中，Relugolix治疗48周期间的CRFS与标准治疗药物亮丙瑞林相比无显著差异。无论是否发生CRFS进展事件，Relugolix对男性患者的疗效均相似。
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