Johnson & Johnson Presents Results From Study Showing That ERLEADA Demonstrates Statistically Significant And Clinically Meaningful Improvement In Overall Survival Compared To Enzalutamide In Patients With Metastatic Castration-sensitive Prostate Cancer
Johnson & Johnson Presents Results From Study Showing That ERLEADA Demonstrates Statistically Significant And Clinically Meaningful Improvement In Overall Survival Compared To Enzalutamide In Patients With Metastatic Castration-sensitive Prostate Cancer
The analysis demonstrated patients with mCSPC who initiated ERLEADA as their first ARPI had a statistically significant 23 percent reduction in their risk of death at 24 months compared to patients who initiated on enzalutamide (hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.62-0.96;Largest head-to-head real-world study in mCSPC demonstrated that ERLEADA reduced risk of death by 23 percent at 24 months compared to enzalutamide
最大規模的mCSPC現實世界對照研究表明，ERLEADA相比恩扎盧胺，在24個月時死亡風險降低了23％
LISBON, Portugal, Oct. 2, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced the results of a landmark real-world, head-to-head study showing that ERLEADA (apalutamide) provided a statistically significant overall survival benefit at 24 months compared to enzalutamide in patients with metastatic castration-sensitive prostate cancer (mCSPC). Presented at the 6th European Congress of Oncology Pharmacy (ECOP) in Lisbon, Portugal, on October 2 (Abstract #P31), this study of nearly 4,000 patients represents the largest real-world, head-to-head analysis of these two androgen receptor pathway inhibitors (ARPIs) in mCSPC.
葡萄牙里斯本，2024年10月2日/ PRNewswire/ - 強生公司（紐交所: JNJ）今天宣佈了一項里程碑的真實世界對照研究結果，顯示ERLEADA（阿帕魯胺）在患有轉移性去勢敏感型前列腺癌（mCSPC）患者中，相較於恩扎盧胺，在24個月時提供了統計學上顯著的整體生存益處。這項研究在葡萄牙里斯本的第6屆歐洲藥房學大會（ECOP）上報告（摘要#P31），涵蓋了近4000名患者，是迄今爲止對這兩種雄激素受體通路抑制劑（ARPI）在mCSPC中進行的最大規模真實世界對照分析。
The study applied U.S. Food and Drug Administration (FDA) real-world evidence guidance and employed robust methodology, data sources and a large, diverse cohort to ensure validity of its findings. The retrospective study identified mCSPC patients who initiated ERLEADA or enzalutamide between December 16, 2018 – December 31, 2023, based on patient data in electronic databases. There were 1,800 ERLEADA and 1,909 enzalutamide initiators who met study criteria.
該研究遵循美國食品藥品監督管理局（FDA）的真實世界證據指南，採用了嚴謹的方法論、數據來源和大規模多樣化隊列，以確保結果的有效性。這項回顧性研究確定了在2018年12月16日至2023年12月31日期間啓動ERLEADA或恩扎盧胺的mCSPC患者，這是基於電子數據庫中的患者數據。符合研究標準的有1800名ERLEADA和1909名啓動恩扎盧胺的患者。
The analysis demonstrated patients with mCSPC who initiated ERLEADA as their first ARPI had a statistically significant 23 percent reduction in their risk of death at 24 months compared to patients who initiated on enzalutamide (hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.62-0.96; P<0.019). The proportion of patients alive at 24 months (87.6 percent) observed in the ERLEADA cohort in this real-world analysis is consistent with that in the Phase 3 TITAN trial (82.4 percent).1 TITAN demonstrated a statistically significant superior overall survival benefit of ERLEADA plus androgen deprivation therapy (ADT) compared to ADT alone at the primary analysis after a median 22.7 months of follow-up (HR 0.67; 95% CI, 0.51-0.89; P=0.005) and at the final analysis after a median 44 months of follow-up (HR 0.65; 95% CI, 0.53-0.79; P<0.0001).1,2
分析表明，作爲第一個ARPI啓動ERLEADA的mCSPC患者在24個月時死亡風險顯著降低了23％，相對於首次在恩扎盧胺上啓動的患者（風險比[HR]，0.77; 95％置信區間[CI]，0.62-0.96; P
譯文內容由第三人軟體翻譯。
