Merck Touts Phase 3 Success For $20B Cancer Drug Keytruda In Untreated Head And Neck Cancer Patients
Merck Touts Phase 3 Success For $20B Cancer Drug Keytruda In Untreated Head And Neck Cancer Patients
At a pre-specified first interim analysis conducted by an independent Data Monitoring Committee, there was a statistically significant and clinically meaningful improvement in EFS for patients receiving the Keytruda perioperative treatment regimen.On Tuesday, Merck & Co Inc (NYSE:MRK) announced that the Phase 3 KEYNOTE-689 trial of Keytruda (pembrolizumab), as a perioperative treatment for patients newly diagnosed with stage III or IVA, resected, locally advanced head and neck squamous cell carcinoma met its primary endpoint of event-free survival (EFS).
默沙東公司（NYSE:MRK）週二宣佈，Keytruda（pembrolizumab）作爲新診斷爲III期或IVA期局部晚期頭頸部鱗狀細胞癌患者的圍手術期治療，在第3期KEYNOTE-689試驗中實現了無事件生存率（EFS）的主要終點。
KEYNOTE-689 Phase 3 trial is evaluating Keytruda as neoadjuvant treatment then followed by Keytruda in combination with standard-of-care radiotherapy (with or without cisplatin) as adjuvant treatment and then as a maintenance therapy in treatment-naïve patients with newly diagnosed, stage III or IVA resected locally advanced, head and neck squamous cell carcinoma.
KEYNOTE-689第3期試驗正在評估Keytruda作爲新輔助治療，隨後聯合標準治療放療（伴有或不伴有順鉑）作爲輔助治療，然後作爲一線治療的維持治療，針對新診斷的III期或IVA期局部晚期切除的頭頸部鱗狀細胞癌患者。
Also Read: Summit Therapeutics' Lung Cancer Candidate Surpasses Merck's Multi-Billion Dollar Keytruda, Cuts Risk Of Disease Or Death By Half.
閱讀：Summit Therapeutics的肺癌候選藥物超越默沙東的價值數十億美元的Keytruda，將疾病或死亡風險降低一半。
At a pre-specified first interim analysis conducted by an independent Data Monitoring Committee, there was a statistically significant and clinically meaningful improvement in EFS for patients receiving the Keytruda perioperative treatment regimen.
在由獨立數據監測委員會進行的預先指定的第一次中期分析中，接受Keytruda圍手術期治療方案的患者的無事件生存率（EFS）出現了統計學上顯著且臨床意義顯著的改善。
The study also showed a statistically significant improvement in major pathological response (mPR), a key secondary endpoint, for patients in the Keytruda arm compared with adjuvant radiotherapy alone.
與僅接受輔助放射治療的患者相比，Keytruda組中患者的主要病理學反應（mPR）出現了統計上顯著的改善，這是關鍵的次要終點。
The safety profile of Keytruda was consistent with that observed in previously reported studies; no new safety signals were identified.
Keytruda的安全性概況與先前報告的研究結果一致；未發現新的安全信號。
A trend toward improvement in overall survival (OS), another key secondary endpoint.
對總生存期（OS）的改善趨勢，這是另一個關鍵的次要終點。
The OS results did not reach statistical significance in patients whose tumors were PD-L1 Combined Positive Score (CPS) ≥10 at the time of this first interim analysis.
在此次第一次中期分析時，具有PD-L1綜合陽性評分（CPS）≥10腫瘤的患者中，總生存期（OS）結果未達到統計學意義。
Due to the statistical testing hierarchy, formal testing was not performed in the CPS ≥1 and intention-to-treat (ITT) populations. OS will be evaluated at the next interim analysis.
由於統計檢驗層次，CPS大於等於1和意向治療（ITT）人群未進行正式測試。OS將在下一次中期分析中評估。
In September, Merck released topline data from the KEYFORM-007 Phase 3 study of the fixed-dose combination of favezelimab and pembrolizumab versus the standard of care for pretreated patients with microsatellite-stable metastatic colorectal cancer.
9月，默沙東發佈了來自KEYFORm-007第3期研究的頂線數據，比輔舍利單抗和帕博利珠單抗固定劑量組合療法與對於經過治療的微衛星穩定性轉移性結直腸癌患者的標準治療。
The U.S. drug giant said the study did not meet its primary endpoint of overall survival.
這家美國藥物巨頭表示，該研究未達到其總生存期主要終點。
Price Action: MRK stock is down 0.54% at $108.00 at last check Tuesday.
股票動態: 默克股票在上週二最後一次檢查時跌至108.00美元，下跌0.54%。
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Photo: Shutterstock
Photo: shutterstock
譯文內容由第三人軟體翻譯。
