Gilead's Trodelvy Fails To Hit Primary Goal In Late-Stage Study With Most Common Type Of Bladder Cancer
Gilead's Trodelvy Fails To Hit Primary Goal In Late-Stage Study With Most Common Type Of Bladder Cancer
On Thursday, Gilead Sciences Inc (NASDAQ:GILD) announced topline results from the confirmatory Phase 3 TROPiCS-04 study in locally advanced or metastatic urothelial cancer (mUC).
週四，吉利德科學公司（納斯達克股票代碼：GILD）公佈了針對局部晚期或轉移性尿路上皮癌（mUC）的3期Tropics-04確認性研究的主要結果。
The TROPiCS-04 study evaluated Trodelvy (sacituzumab govitecan-hziy; SG) vs. single-agent chemotherapy (treatment of physicians' choice, TPC) in patients with mUC who have previously received platinum-containing chemotherapy and anti-PD-(L)1 therapy.
Tropics-04研究評估了Trodelvy（sacituzumab govitecan-hziy；SG）對之前接受過含鉑化療和抗PD-（L）1療法的mUC患者的單藥化療（醫生選擇的治療，TPC）的對比。
Also Read: Gilead's Aggressive Push Beyond HIV Treatments – Plans To Increase Cancer-Focused CAR-T Treatment Production.
另請閱讀： 吉利德積極推動HIV治療以外的努力——計劃增加以癌症爲重點的CAR-T治療產量。
The study did not meet the primary endpoint of overall survival (OS) in the intention-to-treat (ITT) population.
該研究未達到意向治療（ITT）人群總存活率（OS）的主要終點。
A numerical improvement in OS favoring Trodelvy was observed, and trends in improvement for select pre-specified subgroups and secondary endpoints of progression-free survival and overall response rate were also shown.
觀察到操作系統在數值上有所改善，有利於Trodelvy，還顯示了某些預先指定的亞組和次要終點的無進展存活率和總體緩解率的改善趨勢。
In the overall study population, there was a higher number of deaths due to adverse events with Trodelvy compared to TPC, which were primarily observed early in treatment and related to neutropenic complications, including infection.
在整個研究人群中，與TPC相比，Trodelvy不良事件導致的死亡人數更多，後者主要是在治療早期觀察到的，與包括感染在內的中性粒細胞減少併發症有關。
Gilead will further investigate these data and is working to reiterate to treating physicians the importance of granulocyte-colony stimulating factor (G-CSF) use to prevent neutropenic complications.
吉利德將進一步調查這些數據，並正在努力向治療醫生重申使用粒細胞集落刺激因子（G-CSF）預防中性粒細胞減少併發症的重要性。
Trodelvy has a Boxed Warning for severe or life-threatening neutropenia.
Trodelvy 針對嚴重或危及生命的中性粒細胞減少症發出了盒裝警告。
"There are no changes to the known safety profile of Trodelvy for the approved breast cancer indications or other investigational uses," the company said.
該公司表示：“Trodelvy在批准的乳腺癌適應症或其他研究用途方面的已知安全性沒有任何變化。”
Gilead continues to analyze the data and will discuss the results and next steps with the FDA.
吉利德繼續分析數據，並將與美國食品藥品管理局討論結果和下一步行動。
In the U.S., Trodelvy has an accelerated approval indication for patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received platinum-containing chemotherapy and anti-PD-(L)1 therapy.
在美國，Trodelvy加快了對先前接受過含鉑化療和抗PD-（L）1療法的局部晚期或轉移性尿路上皮癌（mUC）患者的批准指示。
This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials, including the TROPiCS-04 study.
根據腫瘤反應率和反應持續時間，該適應症在加速批准下獲得批准。該適應症的持續批准可能取決於確認性試驗（包括Tropics-04研究）中對臨床益處的驗證和描述。
Price Action: GILD shares were trading lower by 2.23% at $62.65 premarket at the last check on Friday.
價格走勢：在週五的最後一次盤前支票中，GILD股價下跌2.23％，至62.65美元。
Photo via Wikimedia Commons
照片來自維基共享資源s
譯文內容由第三人軟體翻譯。