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.
默沙东控股公司（OTC：RHHBY）在周四表示，小基站-5g和化疗联合Tecentriq（atezolizumab）与Pembrolizumab和化疗相比作为本地晚期不可切除或转移的非鳞状细胞非小细胞肺癌的一线治疗的第2/3期SKYSCRAPER-06研究，在首次分析中未达到其无进展生存期（PFS）的主要终点。
The hazard ratio (HR) was 1.27, and overall survival (OS) at its first interim analysis, with an HR of 1.33, was immature.
危险比（HR）为1.27，且在第一次中期分析中，总生存期（OS）的HR为1.33，尚未成熟。
Merck & Co Inc (NYSE:MRK) markets pembrolizumab as Keytruda.
默沙东（Merck & Co Inc）将彭布罗单抗（Pembrolizumab）市场化为Keytruda。
Also Read: Roche To Ride Booming Obesity Treatment Market With Newly-Acquired Drug Candidate.
此外阅读：罗氏新获得的药物候选品将在不断扩大的肥胖治疗市场上取得成功。
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以及化疗联合治疗在意向治疗总体人群中显示出与对照组相比PFS和OS的疗效降低，其中包括第二期和第三期队列。
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.
总体安全性与先前观察到的Tiragolumab和Tecentriq以及化疗联合治疗的安全性一致，并未发现新的或意外的发现。
Based on these results, patients and investigators will be unblinded and Roche intends to halt the study.
基于这些结果，患者和研究人员将解除盲法，默沙东打算停止该研究。
"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.
“这些结果令人失望，因为我们希望这种组合可能会为患有转移性非鳞状细胞肺癌的人们产生改善的结果，”Levi Garraway博士说，他是首席医学官兼全球产品开发负责人。
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.
正在进行的第3期研究在SKYSCRAPER-06之外的治疗设置和指标方面进行了调查。根据结果，默沙东表示将评估任何有关Tiragolumab计划的必要变更。
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.
周五，美国FDA批准了罗氏的Vabysmo（法瑞西单抗）6.0毫克单剂量预装注射器，用于新生血管性或“湿性”年龄相关性黄斑变性，糖尿病性黄斑水肿和视网膜静脉阻塞后的黄斑水肿。
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