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
根据最大规模的mCSPC实际应用对比研究显示，与恩扎鲁胺相比，ERLEADA在24个月内减少死亡风险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/美通社/ - 强生（纽交所:JNJ）今天宣布一项具有里程碑意义的实际应用、头对头研究结果，显示ERLEADA（阿帕鲁胺）在转移性去势敏感型前列腺癌（mCSPC）患者中提供了与恩扎鲁胺相比的统计学显著的总生存益处，于24个月时。此项研究在里斯本举办的第六届欧洲药房肿瘤学大会（ECOP）上宣布（摘要号:P31），这项研究涵盖近4,000名患者，代表这两种雄激素受体通路抑制剂（ARPIs）在mCSPC中的最大规模的实际应用、头对头分析。
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.
该研究采用了美国食品药品监督管理局（FDA）的实际应用证据指南，并采用了严格的方法学、数据来源和大规模多样化队列，以确保研究结果的有效性。这项回顾性研究确定了在2018年12月16日至2023年12月31日期间启动ERLEADA或恩扎鲁胺的mCSPC患者，根据电子数据库中的患者数据。符合研究标准的有1,800名ERLEADA启动者和1,909名恩扎鲁胺启动者。
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，在24个月内启动ERLEADA作为他们的第一个ARPI的mCSPC患者，与首次启动恩扎鲁胺的患者相比，其死亡风险显著减少了23%（风险比[HR]为0.77；95%置信区间[CI]为0.62-0.96；P
