检查点抑制剂已改变了肿瘤学局势，为全球癌症患者带来了新的希望。允许免疫系统攻击癌症的检查点抑制剂已成为许多近期临床进展和免疫肿瘤（IO）疗法的总体发展的催化剂。
But their extraordinary impact has also crowded the research environment with more trials than there may be patients to serve. As the PD-1/PD-L1 treatment modality continues to play a major role in IO, it is drawing a flood of new competitors into the research landscape.
十年后
The US Food and Drug Administration (FDA) approved the first checkpoint inhibitor anti-CTLA4 to treat melanoma in 2012. Since then, they have become the backbone of the oncology treatment space, displacing chemotherapy for many indications.
尽管人群之间的反应率有所不同，但对于那些对这些治疗做出反应的患者，与化学疗法相比，反应持续持久，无进展生存期和整体生存。这些发现已在转移性环境中从挽救疗法到前线疗法以及许多肿瘤类型的新辅助和佐剂环境中的挽救疗法的检查点抑制剂。
The progress has been amazing, especially given the short amount of time these treatments have been in the marketpace.
In the decade since the first approval, FDA has approved seven more PD-1/PD-L1 inhibitors; four anti-PD1s; and three anti-PD-L1 monolobal antibodies (mAbs), including the recent加速抗PD1 MAB Dostarlimab的批准, in April 2021.
这些疗法对患者的生活产生了深远的影响，并为开发人员带来了大量的收入来源。平均治疗费用可以超过$ 150,000，而组合疗法可以超过$300,000for some treatment options.
在首次批准后的五年内，检查站抑制剂市场的年收入超过了105.6亿美元。到2025年，预计将到达300亿美元, with a CAGR of more than 20% per year. Much of this growth will come from emerging markets, where demand for innovative cancer treatments is growing.
目前，许多兴奋是关于联合疗法和新配方的。大约83％的抗PD1/L1活性研究是测试组合方案，包括IO疗法，靶向疗法，化学疗法和放射性疗法。现在正在开发多个PD-1/PD-L1抑制剂来进行口服递送。对于患者而言，这可能是一个重要的gamechanger，他们可以在家中接受这些治疗，而不是在诊所坐着几个小时接受IV输注。
太多好事了吗？
All of this success is creating a frenzy in the research space, as developers race to bring the next best checkpoint inhibitor, or combination therapy to market. As of December 2021, IQVIA data shows that there are more than 4,897 clinical trials testing anti-PD1/L1 mAbs, 4,062 of which are currently active. This represents a 267% increase in the total number of clinical trials since 2017.
虽然创新对于改善抗PD-1/PD-L1疗法至关重要，但临床试验的数量，新型组合或“ me-too” PD-1/pd-l1s，在这个领域引入了挑战，以寻找患者以前尚未暴露于检查点抑制剂。许多试验正在测试免疫疗法，这些免疫疗法仅对市场上的市场提供标称的改进，因此在临床医生或患者的热情中面临挑战。
The FDA’s top oncologists, Rick Pazdur and Julia Beaver have commented recently on the development landscape with these therapies. “Efforts to corral this enthusiasm should focus on increased international partnerships between sponsors of approved checkpoint inhibitors and those developing novel agents to be used with anti–PD-1 and anti–PD-L1 antibodies rather than developing ‘me too’ drugs,” Beaver and Pazdur wrote in the New England Journal of Medicine in2021年12月。
他们感叹当前的景观包括许多希望采取一条熟悉的公司，尽管较短的途径加速了批准（这类PDL1中有45％的适应症已经采用了加速路线），通常是通过单臂试验进行的，并且是作为确认的。随机临床试验“旨在验证其收益的旨在显示出不一致的结果”。
FDA“现在警告赞助商开发检查点抑制剂，以免为了获得药物批准而进行难治性疾病的患者进行单臂试验，” Pazdur和Beaver写道。
寻求声称自己正在开发“更好”检查点抑制剂的赞助商应该将其代理人与已经批准的代理进行比较；不幸的是，没有证据表明正在进行这种随机试验。”他们补充说。
For further discussion of trends in the PD-1/PD-L1 inhibitor space, please see recent publications by IQVIA experts, including this February 2022 article onChallenges and opportunities in the PD1/PDL1 inhibitor clinical trial landscape;这是2020年的作品the rise in combination therapies for PD1/PDL1 inhibitor trials。
有关IQVIA肿瘤学临床研究服务的更多信息，
please visit//m.kurtisdurfey.com/solutions/therapeutics/oncology.