Amgen Update: No “Significant Delays” from COVID-19 Pandemic for KRAS Inhibitor

安进(Amgen) Update : COVID-19大流行对 KRAS 抑制剂没有“重大延迟

2020-04-01 00:00:16 BioSpace


Grand Warszawski / Shutterstock Like many biopharma companies, Amgen is evaluating how the COVID-19 pandemic is affecting its operations, supply chain and clinical trial programs. Amgen stated in an SEC filing, “An increasing number of clinical sites are restricting site visits and imposing restrictions on the initiation of new trials and patient visits to protect both site staff and patients from possible COVID-19 exposure. Given the safety concerns around COVID-19 and the associated risk to maintaining normal clinical trial operations, we are making decisions study-by-study and country-by-country to minimize risk to the patients and facilities.”  At the top of the list of interest for many investors and analysts is how the pandemic will affect the company’s clinical trial of AMG 510, a KRAS inhibitor that is currently in a “potentially pivotal” Phase II trial in specific lung cancer patients. The company indicates it doesn’t expect any “significant delays,” and plans to continue its clinical trial program fairly uninterrupted, although there may be small delays depending on the course of the pandemic. The company’s Phase III trial in collaboration with AstraZeneca of tezepelumab in asthma is also fully enrolled and the company does not expect delays. And, the Phase III heart failure trial in collaboration with Cytokinetics of omecamtiv mecarbil is also fully enrolled and expected to continue uninterrupted. Amgen indicates new patients will be allowed to sign up for studies if there is potential for “significant benefit in a serious or life-threatening condition” and if the sites allow new patients to be enrolled safely. Amgen and the Amgen Foundation have committed up to $12.5 million to support COVID-19 relief efforts in the communities where its staffers live and work. They will be used for emergency response in its U.S. and international communities, patient-focused organizations and international relief efforts by Direct Relief and International Medical Corps. For its own employees, the company has committed to continuity pay and providing staff working from home in the U.S. and Puerto Rico a monthly stipend for home broadband Internet access and an allowance for necessary home office equipment. In addition, on March 28, Amgen announced positive data from the  BEIJERINCK clinical trial of Repatha (evolocumab) in patients who are HIV-positive with high low-density lipoprotein cholesterol (LDL-C) despite stable background lipid-lowering therapy. The trial showed that Repatha significantly decreased LDL-C. The company presented the results during the virtual American College of Cardiology’s 69th Annual Scientific Session. The data was also published in the Journal of the American College of Cardiology (JACC). “Certain antiretroviral treatments for HIV can increase LDL-C and change the lipid makeup of people living with HIV,” said David M. Reese, executive vice president of Research and Development at Amgen. “This study increases our overall evidence base for Repatha, but also provides us with a better understanding of cholesterol management for this under-represented patient population. These positive results show that Repatha can help these patients lower their LDL-C, one of the most important modifiable risk factors for cardiovascular disease.” The Phase IIIb BEIJERINCK trial is part of the company’s PROFICIO program, which so far consists of 35 clinical trials including more than 41,000 patients around the globe and more than 80 real-world evidence studies.
Grand Warsawski / Shutterstock 与许多生物制药公司一样,安进(Amgen)正在评估 COVID-19大流行如何影响其运营、供应链和临床试验计划。“越来越多的临床站点限制了现场访问,并对启动新的试验和患者访问施加了限制,以保护现场工作人员和患者免受可能的 COVID-19暴露。考虑到 COVID-19的安全性问题以及维持正常临床试验操作的相关风险,我们正在逐个研究和逐个国家进行决策研究,以最大限度地降低患者和设施的风险。” 许多投资者和分析师最感兴趣的是,此次大流行将如何影响公司对 AMG 510的临床试验。 AMG 510是一种 KRAS 抑制剂,目前正处于特定肺癌患者的“潜在关键” II 期试验。该公司表示,预计不会出现任何“重大延迟”,并计划继续相当不间断的临床试验计划,尽管可能会出现小的延迟,这取决于大流行的进程。 该公司与特珠单抗治疗哮喘的阿斯利康( AstraZeneca )合作进行的 III 期临床试验也已完全注册,该公司预计不会延迟。此外,第三阶段心脏衰竭试验与细胞动力学的 omecamv mecbarbil 也完全注册,并预计将继续不间断。 安进(Amgen)指出,如果“在严重或危及生命的情况下,有可能获得重大利益”,并且如果这些地点允许新患者安全登记,新患者将被允许报名参加研究。 安进和安进(Amgen)基金会已承诺提供多达1250万美元的资金,以支持 COVID-19在其工作人员居住和工作的社区的救济工作。他们将用于美国和国际社会的紧急反应,以病人为中心的组织和国际救援组织的直接救济和国际医疗队。 对于自己的员工,该公司承诺继续支付工资,并为在美国和波多黎各在家工作的员工提供家庭宽带互联网接入的每月津贴和必要的家庭办公设备补贴。 此外,3月28日,安进(Amgen)公布了 BEIJERINCKK 临床试验的阳性数据,该试验对 HIV 阳性的高低密度脂蛋白胆固醇( LDL-C )患者进行了稳定的背景降血脂治疗。试验结果表明,修复能显著降低 LDL-C 。该公司在虚拟美国心脏病学院第69届年度科学会议上展示了这一结果。这些数据也发表在美国心脏病学会杂志上。 安进(Amgen)公司研发执行副总裁戴维· M ·里斯( David M . Reese )说:“某些针对艾滋病的抗逆转录病毒疗法可以增加 LDL-C ,改变艾滋病毒感染者的脂肪组成。”“这项研究增加了我们的整体证据基础,为我们提供了更好的了解胆固醇管理的代表性不足的病人。这些积极的结果表明,修复可以帮助这些患者降低 LDL-C ,这是心血管疾病最重要的可改变的危险因素之一。” IIIb BEIJERINK 期临床试验是公司 PROFIIO 计划的一部分,目前包括35个临床试验,包括全球超过4.1万名患者和80多个真实世界的证据研究。