Merck Halts Skin Cancer Drug Trial On High Discontinuation Rate - A Setback in High-Risk Melanoma Treatment
Merck Halts Skin Cancer Drug Trial On High Discontinuation Rate - A Setback in High-Risk Melanoma Treatment
Monday, Merck & Co Inc (NYSE:MRK) announced the discontinuation of the vibostolimab and pembrolizumab coformulation arm of the Phase 3 KeyVibe-010 trial.
週一，默沙東公司（紐約證券交易所代碼：MRK）宣佈停用3期KeyVibe-010試驗的vibostolimab和pembrolizumab聯合配方部門。
The trial evaluates the investigational coformulation of vibostolimab and Keytruda (pembrolizumab) compared to Keytruda alone as adjuvant treatment for patients with resected high-risk melanoma (Stage IIB-IV).
該試驗評估了vibostolimab和Keytruda（pembrolizumab）與單獨使用Keytruda作爲切除的高風險黑色素瘤（IIB-IV期）患者輔助治療相比的研究性聯合配方。
Also Read: Merck Stock Gains On Its Blockbuster Cancer Drug Keytruda, Raises Annual Outlook.
另請閱讀： 默沙東因其重磅抗癌藥物Keytruda而上漲，提高了年度展望。
Data from a pre-planned analysis showed that the primary endpoint of recurrence-free survival (RFS) met the pre-specified futility criteria.
預先計劃分析的數據顯示，無復發生存（RFS）的主要終點符合預先規定的無效性標準。
A higher discontinuation rate of all adjuvant therapy by patients was observed in the coformulation arm versus the Keytruda-only arm, primarily due to immune-mediated adverse experiences. Thus, it is highly unlikely that the trial could achieve a statistically significant improvement in RFS.
與僅使用Keytruda組相比，觀察到協同配方組患者所有輔助治療的停藥率更高，這主要是由於免疫介導的不良經歷。因此，該試驗極不可能在RFS上實現統計學上的顯著改善。
Based on the recommendation of an independent Data Monitoring Committee (DMC), Merck is unblinding the study and recommends that patients receiving the vibostolimab and pembrolizumab coformulation be offered the option to be treated with Keytruda monotherapy.
根據獨立數據監測委員會（DMC）的建議，默沙東正在解除該研究的盲目狀態，並建議爲接受維博斯托利單抗和pembrolizumab聯合配方的患者提供接受Keytruda單一療法治療的選擇。
Data analysis from this study is ongoing.
這項研究的數據分析正在進行中。
Ongoing Phase 3 studies evaluating the vibostolimab and pembrolizumab coformulation in lung cancer include KeyVibe-003, KeyVibe-006, KeyVibe-007, and KeyVibe-008.
正在進行的評估vibostolimab和pembrolizumab在肺癌中的共同配方的3期研究包括KeyVibe-003、KeyVibe-006、KeyVibe-007和KeyVibe-007 和KeyVibe-008。
Interim external data monitoring committee safety reviews have not resulted in safety-related study modifications.
臨時外部數據監測委員會的安全審查並未導致與安全相關的研究修改。
Last week, Merck's Phase 3 KEYNOTE-B21 trial of Keytruda in combination with chemotherapy as adjuvant treatment, with or without radiotherapy, did not meet its primary endpoint of disease-free survival (DFS) for newly diagnosed, high-risk endometrial cancer patients after surgery with curative intent.
上週，默克對Keytruda聯合化療作爲輔助治療的3期 KEYNOTE-B21 試驗，無論是否進行放療，均未達到其主要終點，即新診斷的高風險子宮內膜癌患者在手術後具有治療意圖的無病生存（DFS）。
The study's other primary endpoint of overall survival (OS) was not formally tested since DFS did not reach superiority.
由於DFS沒有達到優越性，該研究的另一個主要終點即總存活率（OS）沒有經過正式測試。
Price Action: MRK shares are down 1.35% at $128.31 at last check Monday.
價格走勢：週一最後一次檢查時，MRK股價下跌1.35％，至128.31美元。
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