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全面分析临床免疫肿瘤学领域。

Comprehensive analysis of the clinical immuno-oncology landscape.

机构信息

The Anna-Maria Kellen Clinical Accelerator, Cancer Research Institute, New York, USA.

出版信息

Ann Oncol. 2018 Jan 1;29(1):84-91. doi: 10.1093/annonc/mdx755.

Abstract

Advances from immuno-oncology (IO) are changing the standard of care of many types of cancer, and the paradigm of cancer treatments and drug development is being rewritten on a regular basis. Moreover, an unprecedented number of new investigational agents and companies are entering the field of IO. As such, it has become challenging for oncology physicians conducting clinical trials, industry veterans developing IO drugs, and even regulators reviewing novel IO agents to keep track of the rapidly evolving landscape. To help the key stake holders in the field understand the latest IO landscape, we sought to present an unbiased, neutral, scientifically curated, and timely updated analysis of all the current IO agents in clinical development and the clinical trials testing these agents. We based our analyses on information collected from numerous trusted and publicly available sources. We have developed two databases. One database tracks 2004 IO agents (940 in clinical stage and 1064 in preclinical stage) against 303 targets, from 864 companies; the other tracks 3042 active clinical trials of these agents with a target enrollment of 577 076 patients. This report provides key analyses of these data. Furthermore, we will discuss a number of important and actionable trends in the current IO landscape: a large number of companies developing agents against the same IO targets; a rapid increase in the number of anti-PD-1/L1 combination studies, many of which are testing the same combinations and following inefficient patterns; and a significant increase in the number of small, investigator-initiated studies. For each of the findings, we speculate the causes and discuss a few initiatives that aim to address some of these challenges. Finally, by making these landscape analyses available, we aspire to inform the cancer community as they seek to strive for efficiencies and innovation while avoiding duplication.

摘要

免疫肿瘤学(IO)的进展正在改变许多类型癌症的治疗标准,癌症治疗和药物开发的范式也在不断被改写。此外,大量新的研究药物和公司正在进入 IO 领域。因此,对于正在进行临床试验的肿瘤医师、开发 IO 药物的行业老手,甚至是审查新型 IO 药物的监管机构来说,要跟上这一快速发展的领域已经变得极具挑战性。为了帮助该领域的主要利益相关者了解最新的 IO 格局,我们旨在对所有正在临床开发的当前 IO 药物以及正在测试这些药物的临床试验进行公正、中立、科学编纂且及时更新的分析。我们的分析基于从众多可靠和公开来源收集的信息。我们开发了两个数据库。一个数据库跟踪了 2004 种 IO 药物(940 种处于临床阶段,1064 种处于临床前阶段)针对 303 个靶点,来自 864 家公司;另一个数据库跟踪了这些药物的 3042 项活跃临床试验,预计入组患者人数为 577076 人。本报告提供了对这些数据的关键分析。此外,我们将讨论当前 IO 格局中的一些重要和可行的趋势:大量公司针对相同的 IO 靶点开发药物;抗 PD-1/L1 联合研究的数量迅速增加,其中许多研究测试的是相同的组合,遵循低效的模式;以及数量众多的小型、由研究者发起的研究显著增加。对于每一个发现,我们都推测了其原因,并讨论了一些旨在解决其中一些挑战的举措。最后,通过提供这些景观分析,我们希望在癌症社区寻求提高效率和创新的同时避免重复的情况下,为他们提供信息。

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