Merck Halts Skin Cancer Drug Trial On High Discontinuation Rate - A Setback in High-Risk Melanoma Treatment
Merck Halts Skin Cancer Drug Trial On High Discontinuation Rate - A Setback in High-Risk Melanoma Treatment
Monday, Merck & Co Inc (NYSE:MRK) announced the discontinuation of the vibostolimab and pembrolizumab coformulation arm of the Phase 3 KeyVibe-010 trial.
周一，默沙东公司（纽约证券交易所代码：MRK）宣布停用3期KeyVibe-010试验的vibostolimab和pembrolizumab联合配方部门。
The trial evaluates the investigational coformulation of vibostolimab and Keytruda (pembrolizumab) compared to Keytruda alone as adjuvant treatment for patients with resected high-risk melanoma (Stage IIB-IV).
该试验评估了vibostolimab和Keytruda（pembrolizumab）与单独使用Keytruda作为切除的高风险黑色素瘤（IIB-IV期）患者辅助治疗相比的研究性联合配方。
Also Read: Merck Stock Gains On Its Blockbuster Cancer Drug Keytruda, Raises Annual Outlook.
另请阅读： 默沙东因其重磅抗癌药物Keytruda而上涨，提高了年度展望。
Data from a pre-planned analysis showed that the primary endpoint of recurrence-free survival (RFS) met the pre-specified futility criteria.
预先计划分析的数据显示，无复发生存（RFS）的主要终点符合预先规定的无效性标准。
A higher discontinuation rate of all adjuvant therapy by patients was observed in the coformulation arm versus the Keytruda-only arm, primarily due to immune-mediated adverse experiences. Thus, it is highly unlikely that the trial could achieve a statistically significant improvement in RFS.
与仅使用Keytruda组相比，观察到协同配方组患者所有辅助治疗的停药率更高，这主要是由于免疫介导的不良经历。因此，该试验极不可能在RFS上实现统计学上的显著改善。
Based on the recommendation of an independent Data Monitoring Committee (DMC), Merck is unblinding the study and recommends that patients receiving the vibostolimab and pembrolizumab coformulation be offered the option to be treated with Keytruda monotherapy.
根据独立数据监测委员会（DMC）的建议，默沙东正在解除该研究的盲目状态，并建议为接受维博斯托利单抗和pembrolizumab联合配方的患者提供接受Keytruda单一疗法治疗的选择。
Data analysis from this study is ongoing.
这项研究的数据分析正在进行中。
Ongoing Phase 3 studies evaluating the vibostolimab and pembrolizumab coformulation in lung cancer include KeyVibe-003, KeyVibe-006, KeyVibe-007, and KeyVibe-008.
正在进行的评估vibostolimab和pembrolizumab在肺癌中的共同配方的3期研究包括KeyVibe-003、KeyVibe-006、KeyVibe-007和KeyVibe-007 和KeyVibe-008。
Interim external data monitoring committee safety reviews have not resulted in safety-related study modifications.
临时外部数据监测委员会的安全审查并未导致与安全相关的研究修改。
Last week, Merck's Phase 3 KEYNOTE-B21 trial of Keytruda in combination with chemotherapy as adjuvant treatment, with or without radiotherapy, did not meet its primary endpoint of disease-free survival (DFS) for newly diagnosed, high-risk endometrial cancer patients after surgery with curative intent.
上周，默克对Keytruda联合化疗作为辅助治疗的3期 KEYNOTE-B21 试验，无论是否进行放疗，均未达到其主要终点，即新诊断的高风险子宫内膜癌患者在手术后具有治疗意图的无病生存（DFS）。
The study's other primary endpoint of overall survival (OS) was not formally tested since DFS did not reach superiority.
由于DFS没有达到优越性，该研究的另一个主要终点即总存活率（OS）没有经过正式测试。
Price Action: MRK shares are down 1.35% at $128.31 at last check Monday.
价格走势：周一最后一次检查时，MRK股价下跌1.35％，至128.31美元。
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