FDA Casts Doubt On Use Of Merck, Bristol Myers' PD-1 Cancer Drugs For Certain Type Of Gastric Cancer Patients
FDA Casts Doubt On Use Of Merck, Bristol Myers' PD-1 Cancer Drugs For Certain Type Of Gastric Cancer Patients
Cumulative data has shown that PD-L1 expression appears to be a predictive biomarker of treatment efficacy in this patient population; however, clinical trials have used different approaches to assess PD-L1 expression and different thresholds to define PD-L1 positivity.On Thursday, 26 September, the FDA's Oncologic Drugs Advisory Committee will discuss the use of immune checkpoint inhibitors in patients with unresectable or metastatic gastric and gastroesophageal junction adenocarcinoma and esophageal squamous cell carcinoma.
週四，9月26日，美國食品藥品監督管理局的腫瘤藥物顧問委員會將討論免疫檢查點抑制劑在無法手術切除或轉移性胃癌、胃食管連接腺癌和食管鱗狀細胞癌患者中的使用。
The FDA notes that the current labeling for approved checkpoint inhibitors in this indication reflects broad approvals in the intent to treat patient populations agnostic of programmed death cell ligand-1 (PD-L1) expression.
美國食品藥品監督管理局指出，在這種情況下，已批准的檢查點抑制劑當前的標籤反映出對人群的寬泛批准，而不考慮程序性死亡細胞配體-1（PD-L1）的表達。
Also Read: Cancer Medicines From Merck, Bristol Myers And BeiGene In Question, As FDA Committee To Discuss Limiting PD-1 Drugs For Stomach Cancer.
同時閱讀：默沙東、百時美斯和百濟神州的癌症藥物，因美國食品藥品監督管理局(AFDAC)委員會將討論限制胃癌PD-1藥物。
Cumulative data has shown that PD-L1 expression appears to be a predictive biomarker of treatment efficacy in this patient population; however, clinical trials have used different approaches to assess PD-L1 expression and different thresholds to define PD-L1 positivity.
累積數據顯示，PD-L1表達似乎是該患者群體中治療效果的預測生物標誌物；然而，臨床試驗採用了不同的方法來評估PD-L1表達，並採用不同的閾值來定義PD-L1陽性。
The review includes existing approvals for Bristol Myers Squibb Co's (NYSE:BMY) Opdivo (nivolumab) and Yervoy (ipilimumab), Merck & Co Inc.'s (NYSE:MRK) Keytruda (pembrolizumab), and pending applications for BeiGene Inc's (NASDAQ:BGNE) Tevimbra (tislelizumab).
這項審查包括了百時美施貴寶公司（紐交所：BMY）的歐普狄瓦（尼沙莫德）和伊沛（伊匹利莫德）的現有批准，默沙東公司（紐交所：MRK）的凱美諾（帕博利珠單抗）以及百濟神州公司（納斯達克：BGNE）的泰樂美（提雷利珠單抗）的待批申請。
In a briefing document, the FDA indicated that combining immune checkpoint inhibitors (ICIs) with standard chemotherapy does not seem to offer benefits for patients with PD-L1 expression below 1%. Patients with PD-L1 levels of 10% or higher experience the most significant benefit.
在一份簡報中，美國食品藥品監督管理局指出，將免疫檢查點抑制劑（ICIs）與標準化療聯合使用似乎並不對PD-L1表達低於1%的患者提供好處。 PD-L1水平爲10%或更高的患者經歷到最顯著的益處。
The advantages remain unclear for those with PD-L1 levels between 1% and 10%, and interpreting the data is difficult.
在PD-L1水平爲1%和10%之間的患者中，優勢尚不清楚，而且數據的解釋是困難的。
Given that patients with low or absent PD-L1 expression are unlikely to benefit, administering anti-PD-1 therapy may introduce risks, including severe immune-related adverse effects, which can further diminish the quality of life in individuals already dealing with malignancy.
鑑於PD-L1表達較低或不存在的患者不太可能受益，使用抗PD-1治療可能會帶來風險，包括嚴重的免疫相關不良反應，這可能進一步降低已經在與惡性腫瘤抗爭的人群生活質量。
"Although these results are exploratory ... strong evidence does not appear to support the use of anti-PD-L1 drugs in patients with low PD-L1 expression," the FDA said.
「儘管這些結果是探索性的...但強有力的證據似乎不支持在PD-L1表達低的患者中使用抗PD-L1藥物，」FDA表示。
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Image by PDPics from Pixabay
來自Pixabay的PDPics圖片
譯文內容由第三人軟體翻譯。