TOKYO and RAHWAY, NJ, Sept. 17, 2024 – Eisai (Headquarters: Tokyo, CEO: Haruo Naito) and Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada) today announced results from the first interim analysis of the Phase 3 LEAP-012 trial evaluating LENVIMA® (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, plus KEYTRUDA® (pembrolizumab), the anti-PD-1 therapy from Merck & Co., Inc., Rahway, NJ, USA, in combination with transarterial chemoembolization (TACE) compared to TACE alone for the treatment of patients with unresectable, non-metastatic hepatocellular carcinoma (HCC).

东京和新泽西州拉赫韦，2024年9月17日–卫材（总部：东京，首席执行官：Haruo Naito）和美国新泽西州拉赫韦的默克公司（在美国和加拿大以外称为MSD）今天宣布了对3期LEAP-012试验的第一次中期分析结果，该试验评估了卫材发现的口服多受体酪氨酸激酶抑制剂LENVIMA®（lenvatinib），以及美国新泽西州拉赫韦的默克公司的抗PD-1疗法KEYTRUDA®（pembrolizumab），以及经动脉化疗栓塞（TACE）（与单独使用TACE治疗不可切除的非转移性肝细胞癌（HCC）患者相比）。

These late-breaking data were presented for the first time on September 14 (Central European Summer Time) during a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2024 (Presentation #LBA3).   After a median follow-up of 25.6 months (range, 12.6-43.5), LENVIMA plus KEYTRUDA in combination with TACE demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 34% (HR=0.66 [95% CI, 0.51-0.84]; p=0.0002) compared to TACE alone.

这些最新数据首次于9月14日（中欧夏季时间）在2024年欧洲肿瘤内科学会（ESMO）大会（演讲#LBA3）的总统研讨会上发布。中位随访25.6个月（范围12.6-43.5）后，LENVIMA加KEYTRUDA联合TACE显示无进展生存期（PFS）有统计学意义和临床意义的改善，与单独TACE相比，疾病进展或死亡风险降低了34%（HR=0.66[95%CI，0.51-0.84]；p=0.0002）。

Median PFS was 14.6 months (95% CI, 12.6-16.7) for the LENVIMA plus KEYTRUDA-based regimen versus 10.0 months (95% CI, 8.1-12.2) for TACE alone. At this analysis, a trend toward improvement in overall survival (OS), the trial’s other primary endpoint, was observed for the LENVIMA plus KEYTRUDA-based regimen versus TACE alone (HR=0.80 [95% CI, 0.57-1.11]; p=0.0867); the OS data are not mature and did not reach statistical significance at the time of this interim analysis.

LENVIMA加KEYTRUDA方案的中位PFS为14.6个月（95%CI，12.6-16.7），而单独TACE为10.0个月（95%CI，8.1-12.2）。在这项分析中，观察到LENVIMA加KEYTRUDA方案与单纯TACE相比，总生存期（OS）有改善的趋势，这是试验的另一个主要终点（HR=0.80[95%CI，0.57-1.11]；p=0.0867）；OS数据尚不成熟，在进行中期分析时未达到统计学意义。

The trial is continuing, and follow-up of OS is ongoing. The safety profile of the LENVIM.

试验正在继续，操作系统的后续工作正在进行中。LENVIM的安全配置文件。

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