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，默沙東公司（紐交所：MRK）公佈了關鍵的第三階段Mk-3475A-D77試驗的初步結果，該試驗評估了聯合化療的皮下給藥的pembrolizumab與靜脈注射（IV）Keytruda在治療轉移性非小細胞肺癌（NSCLC）成人患者的一線治療中的非劣性。
Pembrolizumab is available for intravenous use as Keytruda,
pembrolizumab作爲Keytruda可用於靜脈注射。
Berahyaluronidase alfa is a hyaluronidase variant developed and manufactured by Alteogen Inc.
Berahyaluronidase alfa是由Alteogen公司開發和生產的一種透明質酸酶變體。
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另請閱讀：歐洲和美國的生物-疫苗股票承壓——原因在這裏。
The Phase 3 trial met its dual primary pharmacokinetic (PK) endpoints.
第三階段試驗達成了其雙主要藥代動力學（PK）終點。
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.
具體來說，結合化療的皮下給藥pembrolizumab每六週一次在首次給藥週期中顯示出pembrolizumab的曲線下面積（AUC）暴露非劣性，以及在穩態下測量的pembrolizumab的谷濃度（Ctrough），與每六週一次結合化療的靜脈注射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，皮下給藥pembrolizumab結合化療與靜脈注射Keytruda結合化療的二級療效和安全性終點通常一致。
These results and those from ongoing analyses will be presented at an upcoming medical meeting and shared with regulatory authorities worldwide.
這些結果和正在進行的分析結果將在即將舉行的醫療會議上公佈，並與全球監管機構分享。
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.
除了階段3 Mk-3475A-D77試驗外，默沙東的皮下Pembrolizumab臨床開發計劃還包括階段3 Mk-3475A-F84試驗，該試驗評估單獨使用皮下Pembrolizumab與IV Keytruda相比，在腫瘤高PD-L1表達的轉移性非小細胞肺癌患者中進行一線治療，以及階段2 Mk-3475A-F65試驗，評估在復發或難治性經典霍奇金淋巴瘤和原發性縱隔大B細胞淋巴瘤中單獨使用皮下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.
默沙東還在進行階段2的患者偏好研究Mk-3475A-F11，評估參與者報告的對比皮下Pembrolizumab與IV Keytruda的偏好。
Price Action: MRK stock is down 0.56% at $96.03 at the last check on Tuesday.
價格動態：默沙東股票在上週二最後檢查時下跌0.56%，報96.03美元。
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Photo Courtesy of Merck
圖片由默沙東提供
譯文內容由第三人軟體翻譯。
