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
On Thursday, Merck & Co Inc (NYSE:MRK) announced discontinuing the Phase 3 KeyVibe-008 trial based on an independent Data Monitoring Committee (DMC) recommendation.
默沙东公司（NYSE:MRK）于星期四宣布，基于独立数据监察委员会（DMC）的建议，停止第三期KeyVibe-008试验。
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).
该试验评估治疗广泛分期小细胞肺癌（ES-SCLC）患者一线治疗的调合剂vibostolimab和Keytruda（pembrolizumab）与化疗的固定剂量组合，与罗氏集团（OTC:RHHBY）的Tecentriq（atezolizumab）与化疗相比。
Also Read: FDA Declines To Approve Merck-Daiichi Sankyo Partnered Lung Cancer Drug.
此外：FDA拒绝批准默沙东与大塚制药的肺癌药合作项目。
At a pre-planned analysis, data showed that the primary endpoint of overall survival (OS) met the pre-specified futility criteria.
在预定分析中，数据显示主要终点-总生存期（OS）达到了预先规定的无效标准。
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，与对照组患者相比，使用vibostolimab和pembrolizumab固定剂量组合的患者发生不良事件（AEs）和免疫相关AEs的发生率更高。
A comprehensive analysis of this study is ongoing.
目前该研究正在进行全面分析。
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.
默沙东正在通知研究所涉及的调查员，要求患者停止使用vibostolimab和pembrolizumab固定剂量组合，并提供治疗选择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.
默沙东与大塚制药最近宣布，在SCLC复发患者中进行了探究性ifinatamab deruxtecan（I-DXd）的Ideate-Lung02第三期试验，并进行了诊断医师选择的化疗治疗的比较。
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.
默沙东和大塚制药还将谈判扩大他们现有的三个DXd抗体药物的全球共同开发和商业化协议，以包括默沙东的Mk-6070，这是一种正在进行第1/2期临床试验的非定型连接蛋白3（DLL3）靶向T细胞抗原识别体。
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.
公司计划评估Mk-6070与I-DXd在某些SCLC患者中的联合使用和其他潜在联合方案。默沙东通过收购Harpoon Therapeutics公司获得了Mk-6070。
Price Action: MRK stock is up 0.82% at $113.09 at last check Thursday.
MRk股票上涨0.82%，报价113.09美元，截至星期四。
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Image created using artificial intelligence via Midjourney.
图像由Midjourney通过人工智能创建。