Merck's Multi-Billion Dollar Drug Keytruda's Investigational Under The Skin Injection At Par With Intravenous Formulation In Untreated Lung Cancer Patients
Merck's Multi-Billion Dollar Drug Keytruda's Investigational Under The Skin Injection At Par With Intravenous Formulation In Untreated Lung Cancer Patients
On Tuesday, Merck & Co Inc (NYSE:MRK) revealed topline results from the pivotal Phase 3 MK-3475A-D77 trial evaluating the noninferiority of subcutaneous administration of pembrolizumab together with berahyaluronidase alfa, administered with chemotherapy versus intravenous (IV) Keytruda administered with chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC).
星期二，默沙东公司（纽交所：MRK）公布了关键的第三阶段Mk-3475A-D77试验的初步结果，该试验评估了联合化疗的皮下给药的pembrolizumab与静脉注射（IV）Keytruda在治疗转移性非小细胞肺癌（NSCLC）成人患者的一线治疗中的非劣性。
Pembrolizumab is available for intravenous use as Keytruda,
pembrolizumab作为Keytruda可用于静脉注射。
Berahyaluronidase alfa is a hyaluronidase variant developed and manufactured by Alteogen Inc.
Berahyaluronidase alfa是由Alteogen公司开发和生产的一种透明质酸酶变体。
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The Phase 3 trial met its dual primary pharmacokinetic (PK) endpoints.
第三阶段试验达成了其双主要药代动力学（PK）终点。
Specifically, subcutaneous pembrolizumab administered every six weeks with chemotherapy demonstrated noninferiority of Area Under the Curve (AUC) exposure of pembrolizumab during the first dosing cycle, and trough concentration (Ctrough) of pembrolizumab measured at steady state, compared to IV Keytruda administered every six weeks in combination with chemotherapy.
具体来说，结合化疗的皮下给药pembrolizumab每六周一次在首次给药周期中显示出pembrolizumab的曲线下面积（AUC）暴露非劣性，以及在稳态下测量的pembrolizumab的谷浓度（Ctrough），与每六周一次结合化疗的静脉注射Keytruda相比。
Additionally, secondary efficacy and safety endpoints were generally consistent for subcutaneous pembrolizumab administered with chemotherapy compared with IV Keytruda administered with chemotherapy.
此外，皮下给药pembrolizumab结合化疗与静脉注射Keytruda结合化疗的二级疗效和安全性终点通常一致。
These results and those from ongoing analyses will be presented at an upcoming medical meeting and shared with regulatory authorities worldwide.
这些结果和正在进行的分析结果将在即将举行的医疗会议上公布，并与全球监管机构分享。
In addition to the Phase 3 MK-3475A-D77 trial, Merck's subcutaneous pembrolizumab clinical development program includes the Phase 3 MK-3475A-F84 trial evaluating subcutaneous pembrolizumab administered alone compared to IV Keytruda for the first-line treatment of patients with metastatic NSCLC whose tumors have high PD-L1 expression, as well as the Phase 2 MK-3475A-F65 trial evaluating subcutaneous pembrolizumab administered alone in relapsed or refractory classical Hodgkin lymphoma and primary mediastinal large B-cell lymphoma.
除了阶段3 Mk-3475A-D77试验外，默沙东的皮下Pembrolizumab临床开发计划还包括阶段3 Mk-3475A-F84试验，该试验评估单独使用皮下Pembrolizumab与IV Keytruda相比，在肿瘤高PD-L1表达的转移性非小细胞肺癌患者中进行一线治疗，以及阶段2 Mk-3475A-F65试验，评估在复发或难治性经典霍奇金淋巴瘤和原发性纵隔大B细胞淋巴瘤中单独使用皮下Pembrolizumab。
Merck is also conducting a Phase 2 patient preference study, MK-3475A-F11, evaluating participant-reported preference for subcutaneous pembrolizumab compared to IV Keytruda.
默沙东还在进行阶段2的患者偏好研究Mk-3475A-F11，评估参与者报告的对比皮下Pembrolizumab与IV Keytruda的偏好。
Price Action: MRK stock is down 0.56% at $96.03 at the last check on Tuesday.
价格动态：默沙东股票在上周二最后检查时下跌0.56%，报96.03美元。
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Photo Courtesy of Merck
图片由默沙东提供
