Merck Pulls Plug On Two Keytruda Late-Stage Studies On Underwhelming Data
Merck Pulls Plug On Two Keytruda Late-Stage Studies On Underwhelming Data
Thursday, Merck & Co Inc (NYSE:MRK) provided updates on two Phase 3 trials, KEYNOTE-867 and KEYNOTE-630.
默沙东公司（纽交所股票代码：MRK）周四提供了两个三期试验KEYNOTE-867和KEYNOTE-630的更新。
Merck is discontinuing the Phase 3 KEYNOTE-867 trial evaluating Keytruda (pembrolizumab) in combination with stereotactic body radiotherapy (SBRT) for stage I or II non-small cell lung cancer, including those who are medically inoperable or have refused surgery.
默沙东正在停止三期KEYNOTE-867试验，评估Keytruda（注射用佩姆单抗）与立体定向放射治疗（SBRT）联合治疗Ⅰ或Ⅱ期非小细胞肺癌，包括那些无法手术或拒绝手术的患者。
The decision is based on the recommendation of an independent Data Monitoring Committee (DMC), which reviewed data from a planned interim analysis.
这一决定是基于一个独立的数据监测委员会（DMC）的建议，该委员会对计划中的中期分析的数据进行了审查。
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At the pre-specified interim analysis, Keytruda, combined with SBRT, did not demonstrate an improvement in event-free survival or overall survival, the study's primary endpoint and key secondary endpoint, respectively, compared to placebo plus SBRT.
在预定的中期分析中，Keytruda与SBRT联合治疗在事件无进展生存期或总生存期方面，未能显示出改善，这是该研究的主要终点和关键次要终点，与SBRT联合安慰剂相比。
The benefit/risk profile of the combination did not support continuing the trial.
该联合治疗的风险/效益比不支持继续进行试验。
Keytruda combined with SBRT was associated with higher rates of adverse events (AEs), including AEs leading to death, compared with SBRT and placebo.
与SBRT和安慰剂相比，Keytruda与SBRT联合治疗与更高的不良事件（AEs）发生率相关，包括导致死亡的AEs。
Merck is also discontinuing the Phase 3 KEYNOTE-630 trial of Keytruda for the adjuvant treatment of patients with high-risk locally advanced cutaneous squamous cell carcinoma (cSCC) following surgery and radiation, based on the recommendation of an independent DMC.
基于一个独立的DMC的建议，默沙东还正在停止KEYNOTE-630三期试验，该试验评估Keytruda作为高风险局部晚期皮肤鳞状细胞癌（cSCC）手术和放疗后的辅助治疗。
The DMC recommended stopping the study for futility as the risk/benefit profile did not support continuing the trial.
由于风险/效益比不支持继续试验，DMC建议停止试验。
Data from a pre-planned analysis showed that Keytruda did not cross the boundary for statistical significance in recurrence-free survival (RFS), the study's primary endpoint.
预先计划的分析数据显示，Keytruda在复发无病生存期（RFS），这项研究的主要终点，并无显著统计学差异。
The study's key secondary endpoint, OS, was not formally tested, but at the time of the analysis, the results did not favor Keytruda compared to placebo.
该研究的关键次要终点OS未经正式测试，但在分析时，结果并不支持Keytruda相对于安慰剂。
Data analyses for KEYNOTE-867 and KEYNOTE-630 are ongoing, and the results will be shared with the scientific community and regulatory agencies.
KEYNOTE-867和KEYNOTE-630的数据分析正在进行中，并将与科学界和监管机构分享结果。
Price Action: MRK stock is down 0.27% at $117.70 at the last check on Thursday.
默沙东股票的价格为117.70美元，上周四最后交易时下跌了0.27%。
- Merck Stops Lung Cancer Study For Keytruda Combo Due To Ineffective Results, Side Effects.
- 由于效果不佳和副作用，默沙东停止开展Keytruda联合用于肺癌的研究。
Photo Courtesy of Merck
图片由默沙东提供