Roche's New Immunotherapy Fails To Show Benefit Over Merck's Blockbuster Keytruda In Lung Cancer Patients
Roche's New Immunotherapy Fails To Show Benefit Over Merck's Blockbuster Keytruda In Lung Cancer Patients
On Thursday, Roche Holdings AG (OTC:RHHBY) said that the Phase 2/3 SKYSCRAPER-06 study of tiragolumab plus Tecentriq (atezolizumab) and chemotherapy versus pembrolizumab and chemotherapy as first-line treatment for locally advanced unresectable or metastatic non-squamous non-small cell lung cancer, did not meet its primary endpoints of progression-free survival (PFS) at its primary analysis.
默沙東控股公司（OTC：RHHBY）在週四表示，小基站-5g和化療聯合Tecentriq（atezolizumab）與Pembrolizumab和化療相比作爲本地晚期不可切除或轉移的非鱗狀細胞非小細胞肺癌的一線治療的第2/3期SKYSCRAPER-06研究，在首次分析中未達到其無進展生存期（PFS）的主要終點。
The hazard ratio (HR) was 1.27, and overall survival (OS) at its first interim analysis, with an HR of 1.33, was immature.
危險比（HR）爲1.27，且在第一次中期分析中，總生存期（OS）的HR爲1.33，尚未成熟。
Merck & Co Inc (NYSE:MRK) markets pembrolizumab as Keytruda.
默沙東（Merck & Co Inc）將彭布羅單抗（Pembrolizumab）市場化爲Keytruda。
Also Read: Roche To Ride Booming Obesity Treatment Market With Newly-Acquired Drug Candidate.
此外閱讀：羅氏新獲得的藥物候選品將在不斷擴大的肥胖治療市場上取得成功。
The combination of tiragolumab plus Tecentriq and chemotherapy showed reduced efficacy in both PFS and OS compared to the comparator arm in the intent-to-treat population, which includes the phase 2 and phase 3 cohorts.
Tiragolumab和Tecentriq以及化療聯合治療在意向治療總體人群中顯示出與對照組相比PFS和OS的療效降低，其中包括第二期和第三期隊列。
The overall safety profile remains consistent with those previously observed for the combination of tiragolumab plus Tecentriq and chemotherapy, and no new or unexpected findings were identified.
總體安全性與先前觀察到的Tiragolumab和Tecentriq以及化療聯合治療的安全性一致，並未發現新的或意外的發現。
Based on these results, patients and investigators will be unblinded and Roche intends to halt the study.
基於這些結果，患者和研究人員將解除盲法，默沙東打算停止該研究。
"These results are disappointing as it was our hope that this combination might yield improved outcomes for people living with metastatic non-squamous lung cancer," said Levi Garraway, Chief Medical Officer and Head of Global Product Development.
“這些結果令人失望，因爲我們希望這種組合可能會爲患有轉移性非鱗狀細胞肺癌的人們產生改善的結果，”Levi Garraway博士說，他是首席醫學官兼全球產品開發負責人。
Ongoing phase 3 studies are investigating treatment settings and indications distinct from SKYSCRAPER-06. Based on the results, Roche said it would evaluate any relevant changes needed to the ongoing tiragolumab program.
正在進行的第3期研究在SKYSCRAPER-06之外的治療設置和指標方面進行了調查。根據結果，默沙東表示將評估任何有關Tiragolumab計劃的必要變更。
On Friday, the FDA approved Roche's Vabysmo (faricimab) 6.0 mg single-dose prefilled syringe for neovascular or 'wet' age-related macular degeneration, diabetic macular edema, and macular edema following retinal vein occlusion.
週五，美國FDA批准了羅氏的Vabysmo（法瑞西單抗）6.0毫克單劑量預裝注射器，用於新生血管性或“溼性”年齡相關性黃斑變性，糖尿病性黃斑水腫和視網膜靜脈阻塞後的黃斑水腫。
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譯文內容由第三人軟體翻譯。