Merck Stops Lung Cancer Study For Keytruda Combo Due To Ineffective Results, Side Effects
Merck Stops Lung Cancer Study For Keytruda Combo Due To Ineffective Results, Side Effects
At a pre-planned analysis, data showed that the primary endpoint of overall survival (OS) met the pre-specified futility criteria.On Thursday, Merck & Co Inc (NYSE:MRK) announced discontinuing the Phase 3 KeyVibe-008 trial based on an independent Data Monitoring Committee (DMC) recommendation.
默沙東公司（NYSE:MRK）於星期四宣佈，基於獨立數據監察委員會（DMC）的建議，停止第三期KeyVibe-008試驗。
The trial is evaluating the investigational fixed-dose combination (coformulation) of vibostolimab and Keytruda (pembrolizumab), in combination with chemotherapy, compared to Roche Holdings AG's (OTC:RHHBY) Tecentriq (atezolizumab) in combination with chemotherapy, for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).
該試驗評估治療廣泛分期小細胞肺癌（ES-SCLC）患者一線治療的調合劑vibostolimab和Keytruda（pembrolizumab）與化療的固定劑量組合，與羅氏集團（OTC:RHHBY）的Tecentriq（atezolizumab）與化療相比。
Also Read: FDA Declines To Approve Merck-Daiichi Sankyo Partnered Lung Cancer Drug.
此外：FDA拒絕批准默沙東與大塚製藥的肺癌藥合作項目。
At a pre-planned analysis, data showed that the primary endpoint of overall survival (OS) met the pre-specified futility criteria.
在預定分析中，數據顯示主要終點-總生存期（OS）達到了預先規定的無效標準。
Additionally, when compared to patients in the control arm, patients in the vibostolimab and pembrolizumab fixed-dose combination arm experienced a higher rate of adverse events (AEs) and immune-related AEs.
此外，與對照組患者相比，使用vibostolimab和pembrolizumab固定劑量組合的患者發生不良事件（AEs）和免疫相關AEs的發生率更高。
A comprehensive analysis of this study is ongoing.
目前該研究正在進行全面分析。
Merck is notifying study investigators of the decision and that patients should stop ongoing treatment with the fixed-dose combination of vibostolimab and pembrolizumab and be offered the option to be treated with atezolizumab.
默沙東正在通知研究所涉及的調查員，要求患者停止使用vibostolimab和pembrolizumab固定劑量組合，並提供治療選擇atezolizumab。
Merck and Daiichi Sankyo recently announced that the first patient has been dosed in the IDeate-Lung02 Phase 3 trial of investigational ifinatamab deruxtecan (I-DXd) in patients with relapsed SCLC versus treatment of physician's choice of chemotherapy.
默沙東與大塚製藥最近宣佈，在SCLC復發患者中進行了探究性ifinatamab deruxtecan（I-DXd）的Ideate-Lung02第三期試驗，並進行了診斷醫師選擇的化療治療的比較。
Merck and Daiichi Sankyo also expanded their existing global co-development and co-commercialization agreement for three investigational DXd antibody-drug conjugates to include Merck's MK-6070, an investigational delta-like ligand 3 (DLL3) targeting T-cell engager that is currently being evaluated in a Phase 1/2 clinical trial.
默沙東和大塚製藥還將談判擴大他們現有的三個DXd抗體藥物的全球共同開發和商業化協議，以包括默沙東的Mk-6070，這是一種正在進行第1/2期臨床試驗的非定型連接蛋白3（DLL3）靶向T細胞抗原識別體。
The companies are planning to evaluate MK-6070 in combination with I-DXd in certain patients with SCLC, and other potential combinations. Merck obtained MK-6070 through its acquisition of Harpoon Therapeutics.
公司計劃評估Mk-6070與I-DXd在某些SCLC患者中的聯合使用和其他潛在聯合方案。默沙東通過收購Harpoon Therapeutics公司獲得了Mk-6070。
Price Action: MRK stock is up 0.82% at $113.09 at last check Thursday.
MRk股票上漲0.82%，報價113.09美元，截至星期四。
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Image created using artificial intelligence via Midjourney.
圖像由Midjourney通過人工智能創建。
