Merck Discontinues Certain Cancer Candidate Trials After Futility Analysis
Merck Discontinues Certain Cancer Candidate Trials After Futility Analysis
Merck is discontinuing the Phase 3 KeyVibe-003 and KeyVibe-007 trials, which are evaluating the fixed-dose combination of vibostolimab and pembrolizumab in certain patients with non-small cell lung cancer (NSCLC), based on the recommendation of an independent Data Monitoring Committee (DMC).On Monday, Merck & Co Inc (NYSE:MRK) revealed that it would discontinue the clinical development programs for vibostolimab and favezelimab.
在星期一，默沙東（紐交所：MRK）透露將終止對vibostolimab和favezelimab的臨床開發項目。
Vibostolimab is being evaluated as an investigational fixed-dose combination with Keytruda (pembrolizumab) in the KeyVibe program.
vibostolimab正在KeyVibe項目中作爲一種研究性固定劑量組合與Keytruda（pembrolizumab）進行評估。
Favezelimab is being evaluated as an investigational fixed-dose combination with pembrolizumab in the KEYFORM program.
favezelimab正在KEYFORm項目中作爲一種研究性固定劑量組合與pembrolizumab進行評估。
Merck is discontinuing the Phase 3 KeyVibe-003 and KeyVibe-007 trials, which are evaluating the fixed-dose combination of vibostolimab and pembrolizumab in certain patients with non-small cell lung cancer (NSCLC), based on the recommendation of an independent Data Monitoring Committee (DMC).
默沙東將終止3期KeyVibe-003和KeyVibe-007試驗，這些試驗評估了在某些非小細胞肺癌（NSCLC）患者中vibostolimab和pembrolizumab的固定劑量組合，基於獨立數據監測委員會（DMC）的建議。
In a pre-planned analysis, both trials met the pre-specified futility criteria for the primary endpoint of overall survival.
在一次預先計劃的分析中，這兩項試驗均達到總體生存率的預先設定失效標準。
As expected with dual checkpoint inhibitor therapy, more immune-related adverse events were observed with the fixed-dose combination than with pembrolizumab.
與雙重檢查點抑制劑治療所預期的一樣，固定劑量組合觀察到的免疫相關不良事件比pembrolizumab更多。
Considering the totality of data from the Phase 3 KeyVibe studies, including the efficacy outcomes from KeyVibe-003 and KeyVibe-007, the company has decided to discontinue the Phase 3 KeyVibe-006 trial and other vibostolimab studies.
考慮到3期KeyVibe研究的整體數據，包括KeyVibe-003和KeyVibe-007的療效結果，公司決定終止3期KeyVibe-006試驗及其他vibostolimab研究。
Separately, Merck will end the favezelimab clinical development program and stop enrollment in the Phase 3 KEYFORM-008 trial of a fixed-dose combination of favezelimab and pembrolizumab for relapsed or refractory classical Hodgkin lymphoma (cHL) whose disease has progressed following prior anti-PD-1 therapy.
此外，默沙東將結束favezelimab的臨床開發項目，並停止在3期KEYFORm-008試驗中招募患者，該試驗評估favezelimab和pembrolizumab的固定劑量組合用於經典霍奇金淋巴瘤（cHL）復發或難治性患者，且其疾病在之前的抗PD-1治療後惡化。
Patients currently in this trial may continue therapy until the study is completed.
目前參與該試驗的患者可以在研究完成之前繼續接受治療。
KEYFORM-008 is the only Phase 3 study in the KEYFORM clinical development program for which results are not available.
KEYFORm-008 是KEYFORm臨床開發項目中唯一一個結果尚未公佈的第三階段研究。
The company made this decision after a thorough evaluation of data from the favezelimab clinical program and will prioritize the development of other candidates in its comprehensive and diversified oncology pipeline.
公司在對favezelimab臨床項目的數據進行了徹底評估後作出此決定，並將優先開發其全面多樣化的腫瘤管線中的其他候選產品。
This decision is not based on any concerns about the safety of this fixed-dose combination.
這一決定並不基於對這種固定劑量組合安全性的任何擔憂。
On Tuesday, the FDA accepted Merck's Biologics License Application (BLA) for clesrovimab (MK-1654), the company's investigational prophylactic long-acting monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season.
週二，FDA接受了默沙東針對clesrovimab (Mk-1654)的生物製品許可證申請（BLA），該公司的研究性預防性長效單克隆抗體旨在保護嬰兒在其首個RSV季節免受呼吸道合胞病毒（RSV）疾病的侵害。
The FDA has set June 10, 2025, as the target action date for the Prescription Drug User Fee Act (PDUFA).
FDA已將2025年6月10日設定爲處方藥用戶收費法（PDUFA）目標行動日期。
The application is supported by results from the pivotal Phase 2b/3 CLEVER trial (MK-1654-004) of a single dose of clesrovimab administered to healthy preterm and full-term infants and interim results from the ongoing Phase 3 SMART trial (MK-1654-007) of clesrovimab versus palivizumab in infants and children at increased risk for severe RSV disease.
該申請得到了來自關鍵性2b/3期CLEVER試驗（Mk-1654-004）使用單劑量clesrovimab給予健康早產兒和足月嬰兒的結果支持，以及正在進行的3期SMARt試驗（Mk-1654-007）對比clesrovimab與palivizumab在高危嬰兒和兒童中的結果。
If approved, Merck anticipates that clesrovimab will be available for physicians and healthcare administrators to order by July 2025, with shipments arriving in time for the 2025 RSV season.
如果獲批，默沙東預計clesrovimab將在2025年7月之前向醫生和醫療管理者提供訂單，貨物將在2025年RSV季節到來前抵達。
Price Action: MRK stock is up 0.10% at $100.16 at last check Tuesday.
價格動態：默沙東股票在週二的最後檢查中上漲了0.10%，至100.16美元。
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譯文內容由第三人軟體翻譯。
