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
根據最大規模的mCSPC實際應用對比研究顯示，與恩扎魯胺相比，ERLEADA在24個月內減少死亡風險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/ - 強生（紐交所:JNJ）今天宣佈一項具有里程碑意義的實際應用、頭對頭研究結果，顯示ERLEADA（阿帕魯胺）在轉移性去勢敏感型前列腺癌（mCSPC）患者中提供了與恩扎魯胺相比的統計學顯著的總生存益處，於24個月時。此項研究在里斯本舉辦的第六屆歐洲藥房腫瘤學大會（ECOP）上宣佈（摘要號:P31），這項研究涵蓋近4,000名患者，代表這兩種雄激素受體通路抑制劑（ARPIs）在mCSPC中的最大規模的實際應用、頭對頭分析。
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.
該研究採用了美國食品藥品監督管理局（FDA）的實際應用證據指南，並採用了嚴格的方法學、數據來源和大規模多樣化隊列，以確保研究結果的有效性。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或恩扎魯胺的mCSPC患者，根據電子數據庫中的患者數據。符合研究標準的有1,800名ERLEADA啓動者和1,909名恩扎魯胺啓動者。
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個月內啓動ERLEADA作爲他們的第一個ARPI的mCSPC患者，與首次啓動恩扎魯胺的患者相比，其死亡風險顯著減少了23%（風險比[HR]爲0.77；95%置信區間[CI]爲0.62-0.96；P
